BioWorld's Biotechnology State of the Industry Report 2011

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The BioWorld® BioTechnology STaTe of The induSTry reporT 2011

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tAble of Contents

Analysis 11Biotech ‘Just Deals With It’ in 2010 13Biotech’s IPO Rally Counters Tough Markets, R&D Setbacks 18Uncertainty Clouds Health Care Reform, FDA Approval Process 20Investments Rebounded, But European Biotechs Still Underfunded 23The Light Bulb Burns Bright in the Discovery Phase 26

FinancialData 29

CorporateDeals 1152010 Biotech M&As and Collaborations: ‘No Big Deal’ 117

BiotechProductDevelopment 241

ReportCardForWallStreet 299

StockPerformance 311

Restructurings 317

Lawsuits 325

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list of tAbles

Analysis 11Revenue of the Market-Leading Biotech Drugs in 2010 14Revenue of the Top Biotech Drugs, 2003-2010 17

FinancialData 29Biotech Money Raised By Month In 2010: Jan. - Dec. 31Initial Public Offerings Of Biotechnology In 2010 32Biotechnology Follow-On Offerings In 2010 352010 Initial Public Offerings 442010 Follow-on Offerings 44Gross Proceeds of Biotech Public Stock Offerings 45Biotech Money Raised: 1997-2010 46Nasdaq Stock Index 47BioWorld Stock Index 2010 47Other Financings Of Public Biotech Companies In 2010 49 Venture Capital And Other Investments In Private 76Biotechnology Companies In 2010 76Milestone Payments From Corporate Partners in 2010 94Grants and Awards Given to Biotech Companies in 2010 101

CorporateDeals 1152010-2009 M&As 1172009-2010 Biotech-Pharma Collaborations 1172009-2010 Biotech-Biotech Collaborations 1172010 Top 10 M&As 1182010 Top 10 Biotech-Pharma Collaborations 1192010 Top 10 Biotech-Biotech Collaborations 121Biotech Mergers And Acquisitions In 2010 123Biotechnology Company Deals With Pharmaceutical Companies In 2010 131Modified Deals Between Biotechs and Pharmas in 2010 159Terminated Deals Between Biotechs and Pharmas in 2010 167Manufacturing/Supply/Distribution Deals Between Biotechs and Pharmas in 2010 170Biotechnology Company Deals With Other Biotechnology Companies In 2010 179Biotech–Biotech Collaborations: Modified Agreements for 2010 205Biotech–Biotech Collaborations: Terminated Agreements in 2010 209Manufacturing, Marketing And Distribution Agreements Between Biotech Companies 211 in 2010 Collaborations Between Biotechnology Companies And Government/Nonprofit 216 Institutions In 2010

BiotechProductDevelopment 241Biotechnology Products Approved by the FDA in 2010 243Biotech Products: 1982-2010, A-Z 249FDA Actions on Pending Applications in 2010 273Licensing Applications Filed and Pending at FDA in 2010 277Recommendations by FDA Advisory Panels in 2010 282Overseas Approvals and Other Regulatory Actions in 2010 285Orphan Designations Granted in 2010 292

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ReportCardForWallStreet 299U.S. Public Offering Performance By Underwriter: Jan. 1 - Dec. 31, 2010 301U.S. Public Offering Performance By Underwriter: Jan. 1 - Dec. 31, 2010 303Lead Underwriter Performance on All U.S. Offerings: Jan. 1 - Dec. 31, 2010 305Lead Underwriter Performance on All U.S. Offerings: Jan. 1 - Dec. 31, 2010 306Underwriters’ Performance on IPOs: Jan. 1 - Dec. 31, 2010 307Underwriters’ Performance on IPOs: Jan. 1 - Dec. 31, 2010 308Underwriters’ Performance on IPOs: Jan. 1 - Dec. 31, 2010 309

StockPerformance 3112010 U.S. Biotechnology Stock Report 3132010 British Biotechnology Stock Report 3152010 Canadian Biotechnology Stock Report 316

Restructurings 317Biotech Restructurings, Scale-Backs, Bankruptcies 319

Lawsuits 325Biotech Lawsuits: Jan. 1 - Dec. 31, 2010 327

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A N A LY S I S


stAte of the industry: AnAlysis

Biotech ‘Just Deals With It’ in 2010By Michael J. HarrisExecutive Editor, Market Reports

Recession begets lost revenue, begets exit-less strategy, begets displeased investors, begets downsizing, begets more bad news down the line, until . . . catastrophe! Well, at least in the automobile, housing and financial industries.

Some primary metrics in the biotechnology industry, particularly number of deals and financing investments, were officially down – but far from taking the market out of balance or significance.

Biotechnology, with significant participation from big pharma, embarked upon a unique biopartnering strategy long ago that has endured through everything from biotech’s industry startup through the 21st century recession. And even though it may be undergoing a slight retooling in 2011 , as pharma vows to rely less on M&A as a coping strategy, that business relationship dynamic is still the keystone of both markets’ stability in the present economic environment.

Biopartnering is less an “I don’t need anyone else” strategy that is broadly employed in most other major markets, and more of a “let’s exploit the sum of our parts” tactic. Deal-making in biotech remains almost exclusively uncopied in other markets, based not on competition of triumph over rivals, but on an undertaking to use the core strengths of all involved.

Have you ever heard of Ford Motor Co. and General Motors Co. putting their too-big-to-fail heads together and producing a product to wring market share in a competitive environment? Unlikely, as almost every market outside of drug development is a go-it-alone universe, rather than the elementary sum-of-our-parts model employed by biotech and pharma.

Wal-Mart and Target collaborating to market a better anything? Only in biotech!

That’s how hundreds of the top-selling drugs were brought to market, to millions of patients and by the billions to investors. It is difficult to find a drug that has no deal in its history. Looking at the BioWorld Top 25 Biotechnology Drugs list for 2010, those 25 drugs split $84.292 billion in profit among partners, up from 2009 total of $76. 168 billion, a 10.7 percent increase. And it is practical to consider that none of these therapeutics would be approved without the intervention of that business expedient.

As M&A is Out; Partnering Is in . . . Even MoreThe new attitude of pharma that is guiding the senior

market to stop trying to be biotech and, instead, just try to be like biotech, is news that will reverberate throughout 2011 and influence industry behavior, activity and performance.

Just as breaking up with a friend is almost painless compared to the consequences of ending a marriage; it’s a lot easier to get out of a bad partnership than it is to negate the adverse cost of an incompatible acquisition.

This pharma trend-in-the-making will undoubtedly take some steam out of the biotech exit strategy model, but would not appear to have enough sway to critically dampen down the prospects for biotechnology market growth, nor will it likely diminish biotech’s capacity to attract pharma suitors to contribute money and resources for its innovation engine. The less-is-better attitude regarding M&A deals will change the way things are done in the biopharma transaction milieu, but ultimately, the most practicable scenario that unfolds will that the M&A reticence will kindle and ignite a swell of activity in the less risky alternative of engaging in biopartnering transactions.

An ongoing trend is observably unfolding in the market, as we have seen the acquisition, on average, of one large cap biotech per year over the past few years and that theme has legs, based on general industry buzz and projections that infer the futures of just about every biotech frontrunner to be under big pharma M&A consideration. Market-leading biotechs such as Biogen Idec Inc., Human Genome Sciences Inc., Amgen Inc. and Gilead Sciences Inc. seem to be on someone’s list of most likely candidates to be acquired in the current market environment. Those companies that are undergoing restructuring measures to identify and cut back money-leaking aspects of their operations are particularly attractive to the big pharmas that are still in the biotechnology shopping mall.

Biotechnology still has that sheen of innovation that pharma is, at least, years away from mirroring. Although biopartnering is down, as shown by the data in the Deals chapter, in 2010 and market growth is not breaking records thus far in 2011 , the observable panic verifiably resides in pharma, not biotech. If biotech feels the need to worry about something, its speculative apprehension should focus on the potential of pharma to overreach in its endeavor to correct its M&A appetite. In an effort to recover from its overindulgence in biotech prix fixes, big pharma could refuse to pull the trigger on sound deals that might be advantageous, but would be considered “too soon” after the fallout from its M&A binge.

Even that scenario, which absolutely will not marginalize the stride of biopartnering, is also not likely to enduringly capsize the biopharma M&A model. That outlook is attributable to the broad industry professional


Rank Drug name (maker) Indication 2010 Revenue1 Avastin (Roche) Colorectal cancer, non-small-cell lung cancer $7,212M2 Rituxan (Roche) Non-Hodgkin’s lymphoma, rheumatoid arthritis $7,077M3 Humira (Abbott) Rheumatoid arthritis, psoriatic arthritis $6,548M4 Herceptin (Roche) Breast cancer $6,045M5 Lantus (Sanofi-Aventis) Types I and II diabetes $4,883M6 Remicade (J&J) Crohn’s disease, ankylosing spondylitis, arthritis, ulcerative $4,610M colitis, rheumatoid arthritis, plaque psoriasis7 Gleevec (Novartis) Chronic myelogenous leukemia, gastrointestinal stromal tumors $4,265M8 Neulasta (Amgen) Infection associated with chemotherapy-induced neutropenia $3,558M9 Enbrel (Amgen) Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, $3,534M plaque psoriasis10 Copaxone (Teva) Multiple sclerosis $3,316M11 Taxotere (Sanofi-Aventis) Breast cancer, non-small-cell lung cancer, prostate cancer, gastric $2,953M cancer, squamous cell carcinoma of the head and neck12 Atripla (Gilead Sci) HIV $2,927M13 Truvada (Gilead Sci) HIV $2,650M14 Epogen (Amgen) Anemia $2,524M15 Avonex (Biogen Idec) Multiple sclerosis $2,518M16 Aranesp (Amgen) Anemia $2,486M17 Rebif (Merck Serono) Multiple sclerosis $2,323M18 Alimta (Lilly) Lung cancer $2,209M19 Erbitux (Lilly) Colorectal cancer, head and neck cancer $2,192M20 Humalog (Lilly) Diabetes $2,054M21 Procrit/Eprex (J&J) Anemia $1,934M22 Cialis (Lilly) Erectile dysfunction $1,699M23 Betaseron (Bayer Sch) Multiple sclerosis $1,681M24 Lucentis (Roche) Wet age-related macular degeneration, macular edema $1,621M following retinal vein occlusion 25 Tarceva (Roche) Pancreatic cancer, non-small-cell lung cancer $1,473MSource: BioWorld research.

Revenue of the Market-Leading Biotech Drugs in 2010

acknowledgement and projections citing biotechnology as the drug market of the immediate future.

In gradual-to-overdrive progress since the turn of the century, biotech’s rise is slowly wresting revenue market share from pharma’s 100-year grip in the drug development market, but is taking over the pace of drug development at a breakneck pace. BioWorld data reveal that biopartnering deals are averaging more than one deal per day over most of this 11-year-old century and that by mid-decade, more than half of the top 100 revenue-generating drugs will be biotech products. That news implicates pharma’s current interest, reliance and participation in the biotechnology market, as well as implying the practicality and probability of its biopartnering involvement going forward.

Deals may be down, M&As may be in for a respite and VC financing may be idling at a yellow-light intersection; however, biotechnology drug revenue is on a decade-long streak of increasing value, the valve on its innovation spigot is stripped open, and no matter how dire the financing

prognostications are, VCs still prefer biotech above all other markets on a par with the all-the-rage high technology market. Biotech’s cup may not be running over and it’s not exactly a glass-half-full/half-empty parable, so let’s just agree to acknowledge that biotechnology seems to have weathered the economic storm and is navigating its aftermath competently.

Usually, market leaders of the pack receive acknowledgment, but biotech was founded to go against the grain of convention and has since been a risky market. But if you think about it, there has been nothing in its history to date – decisions, circumstances, misfortune, competition, etc. – that has appreciably affected the progress of biotech’s maturation and value. Since 2010 was a flat-to-moderate growth market year in many essential biotech metrics and was far from being the worst year, despite some cause-for-concern issues that linger into 2011 , it’s practical to presume measured success in 2011 and assume market growth dominance beyond that, on schedule.


Biopartnering’s Impact and Value is Evident in Drug Revenues

Innovation may be where the drug development cycle begins, but commercialization is where it pays off. No matter how you look at it, big pharma’s imprint is all over the final round of the process, with 18 of the top 25 drugs bearing the names of pharma companies as the drug developer.

The drug is still the prize in biotech and the top-selling list of drugs in 2010 features 23 of the top revenue-generating drugs from the 2009 list, with only Roche’s Tamiflu and Amgen’s Neupogen dropping off and being replaced by two other Roche products: Lucentis and Tarceva.

Each of the top four drugs, (Avastin, Rituxan, Humira and Herceptin) increased its revenue by more than $1 billion over 2009 totals. All but three drugs (Enbrel, Aranesp and Procrit/Eprex) showed revenue increases compared to their 2009 totals.

Considering its status as a pharmaceutical company, it may seem strange that Roche is poised to rule the biotech drug list for the most of the present decade. The owner of Genentech Inc. has five drugs on the top 25 list, including the top two, and three of the top four spots, and its Avastin is projected to lead the pack through mid-decade on the way to becoming biotech’s first-ever $10 billion drug.

Washington: Incredibly Busy, but no Finishing Touch

Some long-standing, critical things finally got done, but did not get finalized. Do patent reform, biosimilars and health care reform ring a bell? If not, there’ll be time in 2011(and perhaps beyond) to catch up on the relative, and enduring, goings-on in those imperative market-bearing issues.

Government flexed its muscle, flashed its badge and pounded its gavel on some of the industry’s most powerful companies on many occasions throughout the past year, doling out verdicts, rejections, warnings and penalties for a host of proceedings, applications, shortcomings and deceptions in matters involving manufacturing plant violations, denial of obesity drug approval applications, unscrupulous marketing practices, patent infringement and more.

It was better to be a brand maker than a biogenerics drugmaker, as 2010 proved to afford another year of market exclusivity, due to the omission of a successful conversion of biosimilars law into regulatory implementation. The law was passed, but the formula for biosimilar determination remains muddled by matters of bureaucracy and uncertainty, while patent-holding drug companies indefinitely reap market-share-as-usual profits, even beyond patent expirations in some cases.

The FDA has finally been given the authority to regulate biosimilar versions of biotech brand drugs, but cannot perform its legislated duties until the agency acquires the know-how to confidently determine just what constitutes a biosimilar. The agency has the green light, but cannot find the pathway. In drug development, it seems to be increasingly possible that it could take as long to enact relative legislation as it takes to develop a drug to market stage. Is it practical to think that the approval process for each biosimilar submission will be addressed differently . . . sort of a personalized medicine approach to drug approval? But this may be rightfully so since biosimilars are slightly modified versions of the drugs they aim to copy, unlike generics, which are exact duplicates. This difference will likely be played out in patent wars as well as regulatory paths yet to be defined.

From the Bench: The ‘I’ Word Seeks to Offset the ‘P’ Word

An examination of the bench stage of R&D indicates that the science of discovery is as vigorous as usual. Likewise, as usual, is that the bench is miles and years away from the market.

The bench phase in the drug development cycle is fueled by ideas, proof-of-concept and the dreaded designation of “potential.” In other words, it is as far from the market as an investor or R&D program can be . . . and typically, much too far from commercialization to even think about proffering the slightest guarantee of success. No one is going to be persuaded into buying into a scientific paper with the hope of overnight riches.

The potential of genomics research provided “first-time-ever” news of disease marker identification gene function in vital indication markets such as cancer on a consistent basis, and even had revolutionary synthetic genomics success in kick-starting the cellular cytoplasm process form man-made genomes.

The stage of biotechnology science discovery is much more than concepts, but it is, even more than that, also a lot less than a product. Although it may represent the hardest sell in the drug development world, innovation at the concept stage is, nonetheless, a powerful drug itself to agencies, nonprofits and financiers with a vested interest in particular disease indications and it even have occasional appeal to patient investors with more altruistic or long-range pecuniary motives. The discovery phase continued in 2010 to churn out bright ideas, present ground-breaking papers and display positive clinical results, not the least of which was the big news in CAPRISA 004 that produced the historic evidence of a microbicide that showed efficacy in helping to prevent sexual disease transmission. And not just any sexual disease, rather HIV, a disease that has largely defied clinical therapeutic containment endeavors.


Innovation has never been one of biotech’s character flaws. Its Achilles’ heel is strictly on the clout-cash-and-resources back end of the drug development process. But as long as biotech continues to produce a glut of innovation, as it did in 2010, something will stick to the wall and attract the partner with the corresponding interest, the philanthropist with the apposite passion, the investor with the considered instinct – and if all else fails – the government agency charged with funding the most gifted undeveloped research and the most talented researchers with nascent programs.

And a couple of the year’s most prominent story lines – one involving unreliable data from longevity predictor gene studies and the other culminating with the implosion of a well-known autism study – reminded that biotechnology research is also in the invalidation business, in which it identifies and challenges dubious theories and refutable science, ideally before extensive time and resources are committed to problematic research agendas.

Budget Cuts for Science’s Key Funding Agencies Could’ve Been Worse

The science R&D/funding arm of the U.S. government did not completely escape the budget-cutting swath of federal legislation, walking away with some funding intact.

The past-the-11th-hour budget deal agreement reached in April 2011 on Capitol Hill to keep the government from shutting down included millions of dollars in funding cuts for several major science-funding agencies. However, that chagrin is mitigated by the fact that the cuts affecting health science R&D were not as deep as initially proposed.

The National Institutes of Health now faces a reduction of $260 million, but that is markedly less than the $1 .6 billion figure that was earmarked for slashing in an earlier bill that was passed by the House of Representatives. The Department of Energy’s Office of Science will undergo a $20 million budget cut under the latest bill, compared to an $866 million reduction in the earlier House version (H.R. 1), while the Centers for Disease Control and Prevention, now faces a $730 million cut in funding, instead of the H.R. 1 amount of $1 .4 billion. None of the key agencies received their traditional budget increases, but the cuts to their budgets that endow research grants and advance innovation started out as a threat of much more austerity.

Is the Sky Still Falling in Europe?Queue the soundbite: “This could be the year that

Europe turns the corner, depending on a few factors such as . . .”

For quite a few years, variations on that outlook have been the most optimistic viewpoint to which most industry analysts have been guardedly willing to commit. But wait! In 2010, there were actually indications, as there were in

many of the previous years, that the biotech market might be apt to regain some of its vim. At the least, there were enough indicators to show that the market definitely had not lost its will to the protracted slump that has suffocated many of its constituent companies, damaged its funding capacities and deflated a substantial amount of the European biotechnology market’s R&D energy.

As more evidence that deals have emerged to be the distinguishing dynamic that anchors the global market and may be even be an intervening factor in the re-emergence of the European market, the pharma industry is candidly acknowledging the value of biopartnering and adopting the new model of less upfront “signing bonus” risk, with more deference to the milestone, or back-end-laden, pay-for-results deal model. This is a model that would make the European market less of a risk to edgy pharmas that have become very judicious in that market. An anticipation of more brisk collaboration activity comes with the optimism that more clinical successes will be the payoff.

Europe has been under-productive in the clinic and underfunded in the market for so long that risk has become the four-letter word no one is willing to chance. As the funding opportunities retract, it stands to reason that in-house talent will be downsized and the ability to compete for the best available external talent will severely compromised. That is one principal consequence working against that market now and looms to be a corollary effect whenever that market would eventually begin to make a profoundly perceptible comeback move.

However, the public acknowledgement of a commitment by pharma to risk-averse biopartnering as the latest go-to dynamic that will be pursued to turn things around on the continent, is at least a tactic that has a chance to provide an upside in a stalled market.

Perhaps the biggest bad news from Europe was the spate of devastating late-stage clinical failures and new drug application rejections that hit that market. If that trend continues in 2011 in this already-precarious market, it would be a crippling blow to any chance for a timely market-wide recovery in Europe.

Baby steps are usually the first phase in any recovery, so positive indicators such as Europe’s head start on the U.S. market in stem cell technology, clinical trial potential shown in under-addressed disease indications and a focus on orphan drug R&D opportunities, might not be primed to deliver the blockbuster success that the European biotechnology market most needs, but they may be sufficient to attract enough funding, pharma deals and clinical trial advances to persuade the chorus of Chicken Little analysts and expert observers to once again don the rose-colored glasses.

If You Innovate, They Will ComeAs far the whole market is evaluated, the menacing


force of recession and its lingering repercussions and looming ramifications may have sank a number of companies and careers and been a substantial part of biotech’s story; however growth, profitability, innovation, new product successes and investor partiality buoyed quite a few more companies through the year than were lost to the roughness of the pitching market.

Despite some declining market indicators in 2010 that by and large reflect the economic environment, rather than the biotech industry itself, the global biotechnology

market can still lay claim to: having a prolific science engine that delivers more innovation than the investment or R&D markets can manage; being one of the top two or three most attractive destinations for venture capital investment throughout this century; riding a long-term market growth rate that surpassed pharma’s average growth and achieved overall profitability in 2010; and is poised to incrementally dominate the top-selling drug list on its way to becoming the predominant face of drug development in the 21st century.

Rank Drug name (maker) 2010 2009 2008 2007 2006 2005 2004 20031 Avastin (Roche) $7,212M $5,832M $4,479M $4,070M $2,380M $1,133M $545M (US)2 Rituxan (Roche) $7,077M $5,705M $5,082M $5,467M $3,881M $1,831M $1,574M $1,489M3 Humira (Abbott) $6,548M $5,488M $4,521M $3,064M $2,044M $1,400M $852M $246M4 Herceptin (Roche) $6,045M $4,936M $4,394M $4,809M $3,150M $2,416M $1,591M $2,064M5 Lantus (Sanofi-Aventis) $4,883M $3,080M $3,159M $3,160M $2,172M $1,476M $1,025M $400M (US)6 Remicade (J&J) $4,610M $4,304M $3,748M $3,327M $3,014M $2,535M $2,145M $1,729M 7 Gleevec (Novartis) $4,265M $3,900M $3,700M $3,050M $2,554M $2,170M $1,634M $1,128M8 Neulasta (Amgen) $3,558M $3,318M $3,000M $2,710M $2,288M $1,700M $1,300M9 Enbrel (Amgen) $3,534M $3,871M $5,982M $5,275M $4,379M $3,673M $1,900M $1,300M 10 Copaxone (Teva) $3,316M $2,800M $2,262M $1,713M $1,414M $1,176M $936M $720M11 Taxotere (Sanofi-Aventis) $2,953M $2,177M $2,622M $2,941M $2,284M $1,956M $1,747M $1,577M12 Atripla (Gilead Sci) $2,927M $2,382M $1,570M $903M $206M13 Truvada (Gilead Sci) $2,650M $2,490M $2,110M $1,589M $1,190M $568M $68M14 Epogen (Amgen) $2,524M $2,569M $2,456M $2,489M $2,511M $2,455M $2,600M $2,400M15 Avonex (Biogen Idec) $2,518M $2,323M $2,203M $1,870M $1,710M $1,540M $1,417M $1,168M16 Aranesp (Amgen) $2,486M $2,652M $3,137M $3,614M $4,121M $3,273M $2,500M $1,600M17 Rebif (Merck Serono) $2,323M $2,062M $1,668M $1,912M $1,452M $1,270M $1,091M $819M18 Alimta (Lilly) $2,209M $1,706M $1,155M $854M $612M $463M19 Erbitux (Lilly) $2,192M $1,594M $1,457M $1,430M $1,100M $413M $261M20 Humalog (Lilly) $2,054M $1,959M $1,736M $1,475M $1,300M $1,198M $1,102M $1,021M21 Procrit/Eprex (J&J) $1,934M $2,245M $2,460M $2,885M $3,180M $3,324M $3,589M $3,984M22 Cialis (Lilly) $1,699M $1,559M $1,445M $1,144M $971M $747M $552M $203M23 Betaseron (Bayer Sch) $1,681M $1,647M $1,439M $1,586M $1,311M $1,046M $941M $926M24 Lucentis (Roche) $1,621M $1,342M $1,076M $1,110M $535M 25 Tarceva (Roche) $1,473M $1,461M $1,361M $1,189M $911M $434MNOTE: Some figures not originally reported in U.S. dollars. Exchange rates used for conversion were for that year.

SOURCE: BioWorld research from company press releases and SEC filings. Companies and/or drugs not reporting drug sales in SEC documentsmay be excluded.

Revenue of the Top Biotech Drugs, 2003-2010


Financings: A ‘Year in Transition’

Biotech’s IPO Rally Counters Tough Markets, R&D SetbacksBy Jennifer BoggsAssistant Managing Editor

With the realization that a rapid and painless economic recovery was a mere pipe dream, 2010 brought biotech a mixed bag. While fundraising was up from 2009 – and the industry celebrated the creaking open of the initial public offering (IPO) window – the year also was defined by a number of surprising regulatory setbacks.

But first, the good news.Overall, the industry managed to raise a healthy chunk

of capital. BioWorld Insight reported public and private financings totaling $19.3 billion for the year, up from the $17.6 billion in 2009, though that figure is still a far cry from the $24.8 billion raised back in the pre-economic-meltdown year of 2007.

“2010 wasn’t a horrible year, in terms of aggregate dollars,” said Glen Giovannetti, global biotechnology leader and Ernst & Young LLP. “But the trend continues of investors being very selective.”

Private company financings were up slightly in 2010 – $4.5 billion vs. $4.3 billion in 2009. The largest venture rounds in 2010 included Reata Pharmaceuticals Inc., which added $78 million in a Series G round aimed at giving the Irving, Texas-based company enough runway to get its chronic kidney disease drug bardoxolone to the FDA. Redwood City, Calif.-based Pearl Therapeutics Inc. also had success reaching out to new investor Vatera Healthcare Partners, which led a $69 million Series C round in October.

Breaking it down by round showed that 55 firms closed designated Series A financings in 2010. Total Series A funding reached $774.7 million for the year. (Two companies did not disclose amounts.) BioWorld Snapshots showed that 52 firms raised a total of $1 . 1 billion in Series B rounds, while 30 companies pulled in about $727.9 million in Series C funding for the year. Eighteen firms closed Series D or later-stage rounds, raising a total of $447. 1 million.

Yet, going forward, industry experts continue to expect venture capital to contract, especially as many funds start to reach – even exceed – their decade marks.

Stan Fleming, managing member at Forward Ventures, said he thinks the venture community is in for a tough 2011 . “The overall macroenvironment is showing signs of improvement, but biotech is still locked in the depths of the great recession. And, for the bio venture community, it’s more like the great depression,” he said.

There’s less new money in the private market these days, leaving many syndicates to rely on inside rounds. And most of the venture money remains in the hands of a few. “It’s a pretty inefficient market in the first place,” Fleming added. “But with

so few buyers, it’s not really a market at all; it’s more of a club.”In the year ahead, it will come down to whether the

venture community can gain access to new money. Fleming isn’t optimistic, but a few funds did manage to scrape together some new cash last year. In fact, 2010 ended with reports that new firm Longwood Founders Management LLC managed to raise $85 million in an inaugural fund, with the aim of backing early stage innovation.

A Small [IPO] Window of OpportunityProbably the best news of 2010 was the opening of the IPO

window, following nearly two years of no IPO exits for biotech. BioWorld Insight reported that 19 biotechs priced on global markets last year and, altogether, those offerings brought in about $1 .2 billion and averaged about $64 million per offering.

The downside was that nearly every company priced below its anticipated range and most traded down after hitting the market. A handful also ended up having to return to public or private investors later in the year for additional capital, such as AVEO Pharmaceuticals Inc., of Cambridge, Mass., which raised a $61 million PIPE less than seven months after pricing an IPO at about a 35 percent discount to its target price.

And the IPO market became more uncertain as the year wore on. Fourth quarter IPOs seemed particularly harsh. Palo Alto, Calif.-based Anacor Pharmaceuticals Inc. slashed its offering price to $5 (from the hoped-for $16 to $18 range) and raised the number of shares from 4.7 million to 12 million. And San Diego-based specialty pharma firm Zogenix Inc. had hoped to sell 6 million shares priced between $12 and $14 each, but had to settle for pricing 14 million shares at a mere $4 each.

But the rash of steeply discounted IPOs that ended 2010 left Forward Venture’s Fleming to believe that the window is closing. “And as the window closes, strong companies step back. They can afford to wait,” he said. “It’s the weaker companies that have no choice and end up being very vulnerable to the monopolistic pricing.”

So far in 2011 , similar stories are playing out. Four biotechs went public on Nasdaq in the first quarter – AcelRx Pharmaceuticals Inc., Pacira Pharmaceuticals Inc., Endocyte Inc. and BG Medicine Inc. – and all slashed their offering prices by considerable margins. And Clarus Therapeutics Inc. opted to postpone its IPO in February, citing unfavorable market conditions.

As of March 31 , 13 firms have pending IPOs, and some remain optimistic that the window will remain, though perhaps not widely, open for additional firms to squeak through.


“I think we’ll see a similar number of companies [price IPOs in 2011], but stronger companies,” said Jack Florio, an investment banker at Brinson Patrick Securities.

E&Y’s Giovannetti agreed. “It’s not going to be a bull rush,” he noted, but for companies in Phase II- or Phase III-stage development, with validating partnerships and a solid R&D plan, the IPO will remain a possible exit.

For companies already established on the public markets, most were able to go to investors when they needed in 2010, with 72 follow-on offerings last year vs. 54 offerings in 2009. But the amounts were more conservative. In 2010, follow-ons raised $5.6 billion and averaged $78. 1 million each, while fewer offering in 2009 brought in $6.5 billion and averaged $120.5 million each.

But in 2010, biotech also began embracing some of the financing vehicles that have been used for years in other industries, Florio said. Brinson Patrick recorded 25 at-the-market financings in 2010 compared to only nine the year before. And equity credit lines continued to be a popular flexible financing tool, with about a dozen of those in 2010.

Biotech and Wall Street in 2010Stock activity in the always-volatile biotech industry had

its ups and downs in 2010. As a whole, the industry held its own. The AMEX Biotech Index jumped 37.7 percent over 2009, while the Nasdaq Biotech Index gained 15 percent. Biotech heavyweights Celgene Corp. and Amgen Inc. remained fairly steady, up 6 percent and down 3 percent, respectively.

Gilead Sciences Inc. dropped 16 percent in 2010, while Biogen Idec Inc.’s stock gained 25 percent over 2009. Genzyme Corp., coming off a disastrous 2009 on manufacturing troubles related to its leading enzyme replacement therapies, rebounded in 2010, jumping 45 percent for the year due to Sanofi-Aventis SA’s buyout bid. Cambridge, Mass.-based Genzyme and Paris-based Sanofi finally reached a $20. 1 billion deal, plus contingent value rights largely connected to the success of multiple sclerosis candidate alemtuzumab, in February.

Unlike 2009, the big stock winners of 2010 weren’t easy to spot. In 2009, the industry had Human Genome Sciences Inc., which saw its stock surge more than 1 ,000 percent on positive late-stage data for now-approved lupus drug Benlysta (belimumab), and Dendreon Corp., which soared following approval of the first cancer vaccine Provenge (sipuleucel-T).

Regulatory triumphs were harder to come by in 2010. In fact, drug approvals were down – 21 biologics license application and new molecular entity approvals last year vs. 26 in 2009 – though part of that was due to fewer companies filing for approval in 2010.

But the FDA stunned Wall Street in May by rejecting InterMune Inc.’s idiopathic pulmonary fibrosis drug pirfenidone, though the Brisbane, Calif.-based firm ended up as one of the sector’s biggest gainers for the year, thanks to

a positive recommendation by the European Committee for Medicinal Products for Human Use. InterMune’s stock price increased 179 percent over 2009.

Others weren’t so lucky. Another FDA surprise, the rejection of once-weekly GLP-1 drug Bydureon (exenatide), sent shares of partners Amylin Pharmaceuticals Inc. and Alkermes Inc. falling. And the long-awaited obesity drugs failed to get past the agency. Arena Pharmaceuticals Inc., which boasted only an early stage pipeline beyond obesity candidate lorcaserin, was one of the biggest decliners of the year, sinking about 52 percent.

Other decliners included Affymax Inc., which fell 73 percent for the year, primarily due to disappointing safety data in its top-line results for anemia candidate Hematide, the drug it was hoping to position against Thousand Oaks, Calif.-based Amgen’s Aranesp (darbepoetin alfa). RNAi firm Alnylam Pharmaceuticals Inc. also declined last year – by 44 percent – after Novartis AG declined a $100 million option to all of Alnylam’s targets under the firms’ collaboration, and partner Roche AG announced in November that it planned to discontinue efforts in RNAi. Cambridge, Mass.-based Alnylam also cut its staff by 25 percent in September.

Industry Remains in Cost-Cutting ModeAs in 2009, last year saw more than its share of dramatic

restructurings, and those cuts left firms leaner and forced many to cut programs that either weren’t producing or were too long term.

Basel, Switzerland-based Roche’s RNAi exit, which resulted in a 6 percent workforce reduction – about 4,800 employees – represented more than half of the roughly 7,600 jobs lost in 2010, according to BioWorld Snapshots. That figure compares to about 5, 100 jobs cut in 2009. While fewer companies reported cutbacks in 2010 – 33 vs. 85 – biotech executives still faced realizations that they would need to concentrate resources on only the most advanced promising candidates.

South San Francisco-based Exelixis Inc., for instance, dropped work on all of its internal programs except for XL184, a dual MET/VEGFR inhibitor that yielded stellar Phase II data. And Biogen Idec Inc., of Cambridge, Mass. said in November that it was moving out of the cardiovascular and oncology arenas to focus more efforts on its more lucrative franchises, including multiple sclerosis.

Companies could continue to make cutbacks in 2011 , but it’s unlikely the wave of restructurings that plagued the industry over the past two years will continue. If 2010 taught the sector anything, it’s that capital efficiency should be a long-term strategy rather than a short-term solution.

“It was a year in transition,” said Brinson Patrick’s Florio. “In 2009, folks were scrambling to survive and just waiting for everything to get back to normal, but this is the new normal.”


The View from Washington

Uncertainty Clouds Health Care Reform, FDA Approval ProcessBy Mari SerebrovWashington Editor

From beginning to end, 2010 was riddled with uncertainty, especially in Washington, D.C.

Take the Affordable Care Act (ACA), the health care reform legislation passed last spring amid much fanfare among the Democrats in the 111th Congress. The law promised biotechs a biosimilar pathway with 12 years of exclusivity, a share of $1 billion in R&D tax credits and grants, and a bigger market due to expanded health insurance coverage.

In exchange, biotechs would have to be more upfront about conflicts of interest and cough up some of the $90 billion in taxes that would be levied against pharmaceutical companies over a 10-year period.

From the outset, the voluminous law was punctuated with question marks. Namely, could it survive a court battle? Today, several states are challenging the constitutionality of mandating health care coverage, the linchpin of the act, all the way to the Supreme Court. If that part falls, the entire law could be rendered void because Congress didn’t include a severability clause. (Such a clause permits a part of a law, if deemed unconstitutional, to be removed while keeping all other provisions intact.)

Regardless of what happens in the courts, the 112th Congress, which has more of a Republican complexion, is trying to undo various parts of the bill. Even President Barack Obama has some changes he wants to make. In his 2012 budget request in February, the president called for cutting the exclusivity period for biosimilars to seven years and prohibiting “evergreening,” a process that would allow brandmakers to tweak their products and receive an additional 12 years of exclusivity. Rep. Henry Waxman (D-Calif.) also has renewed his fight for shorter exclusivity.

Biosimilars put into law, but not into practiceWhile the future of the 12-year exclusivity may be

in doubt, the entire approval pathway for biosimilars is shrouded in uncertainty as industry waits to see how the FDA will implement it. The problem is that the ACA doesn’t clearly map out a pathway; rather, it gives the FDA a destination and says, “Go find it.”

Thus, the agency is theoretically left with the discretion to approve a biosimilar without any sort of clinical testing outside of basic pharmacokinetic/pharmacodynamic studies and declare it interchangeable with the reference drug – even if it has undefined “minor differences” from the original.

However, it also could require strenuous clinical trials

and restrict substitution, which would set up a system encouraging multiple competing brand biologics with no competition from biogenerics.

Because of the iffyness of this regulatory latitude, some companies have continued following the old route, pursuing biologic license applications (BLAs) for their biosimilars, rather than chasing down the new 351(k) pathway. Teva Pharmaceuticals, for instance, filed traditional BLAs for two biosimilars, its granulocyte-colony stimulating factor product and its Neupoval version of Amgen Inc.’s Neupogen.

Merck scrapped plans for MK-2578, a biosimilar to Amgen’s Aranesp, after the FDA said it would require trials evaluating the cardiovascular effects of the drug. But Merck, hoping the agency would be less rigorous in what it requires from other biosimilar candidates, said it expected the new abbreviated pathway to help it get its remaining portfolio of biosimilars to market.

The fact that Sandoz had to sue to get the agency to act on its biosimilar growth hormone Omnitrope and considering that the Office of Generic Drugs sat on abbreviated new drug applications (NDAs) for three generic versions of Sanofi-Aventis SA’s blood thinner Lovenox (enoxaparin) for more than five years, had industry experts predicting it would be a long time before the FDA establishes a reliable, predictable 351(k) pathway that applicants can use with some confidence.

Last year, the FDA finally approved Momenta Pharmaceuticals Inc.’s generic Lovenox, which it developed in partnership with Sandoz, the generic unit of Novartis AG. The agency said the approval process took so long because it had to determine whether it had the authority to review a complex generic drug like Lovenox. It also had to develop criteria to demonstrate the generic’s “sameness” to the brand product, and it had to address potential heparin contamination issues, after tainted products from China caused several deaths.

ACA Raised More Issues than it Resolved in 2010Meanwhile, other provisions of the ACA, should it survive

the court challenges, could remain up in the air because of pressure to curb spiraling federal deficits. In the midterm elections in November, Republicans swept the House and gained seats in the Senate on a pledge to cut government spending.

That pledge clouds the chances for getting programs such as the Cures Acceleration Network (CAN) funded. The ACA included $500 million in funding for the network,


designed to speed development of therapies that might not otherwise be funded by the marketplace. The big question now is whether the network will be funded by the government.

Unable to pass a budget for fiscal 2011 , which started last October, Congress has kept the government afloat for more than half a year on continuing resolutions (CRs) tied to 2010 spending levels. The CRs don’t include funding for new programs such as CAN. If the network eventually gets budgeted this year, the National Institutes of Health plans to roll it into its National Center for Advancing Translational Sciences that’s set to open Oct. 1 .

Another ACA provision that could be undermined because of funding is the Patient-Centered Outcomes Research Institute, a nonprofit corporation tasked with identifying priorities for comparative-effectiveness research (CER).The health care act mandated that $10 million be set aside in fiscal 2010 to fund the institute, $50 million in fiscal 2011 and $150 million next year.

The institute became a reality in September when 19 board members were named to serve staggered terms. But continued funding remains an issue for the corporation charged with carrying out CER – one of the most contentious measures for industry in the health care reform law.

Fearing that “comparative effectiveness” would translate to “cost effectiveness,” the Biotechnology Industry Organization fought hard to ensure the act specifically prohibited the government from denying coverage solely on the basis of CER data. However, the trade group remained concerned about how CER would be implemented over time.

Some experts worried that CER would create a barrier that makes existing products in the marketplace far more competitive while holding newer, more innovative products to tougher approval standards.

FDA’s Half-Empty/Half-Full PerformanceEven without CER fully in force, the FDA’s approval

process was unpredictable in 2010. Citing a drop in the number of applications, the agency approved 21 new molecular entities last year, down from 25 in 2009 and 24 in 2008. Although the agency hit or surpassed its 90 percent PDUFA goal for timely reviews of standard NDAs/BLAs last year, only 78 percent of priority NDAs/BLAs with 2010 PDUFA dates were reviewed within six months.

That’s worrisome for the pharmaceutical industry, which started negotiating the reauthorization of PDUFA with the FDA last year. Before the negotiations began on new user fees and performance requirements for the FDA, the Pharmaceutical Research and Manufacturers of America (PhRMA) identified timely review of new applications as a critical issue.

“It is essential that new drug reviews be accomplished

in a way that is efficient, predictable and well-coordinated within FDA,” PhRMA said.

Regulatory uncertainty also was reflected in the drug candidates the FDA rejected. Three widely anticipated new weight loss therapies – Vivus Inc.’s Qnexa, Arena Pharmaceuticals Inc.’s Lorcaserin and Orexigen Therapeutics Inc.’s Contrave – were not approved. Instead, the agency issued complete response letters for Qnexa and Lorcaserin, neither of which got the support of the Endocrinologic and Metabolic Drugs Advisory Committee.

More questions were raised when some notable drugs were pulled from the market or had their availability severely restricted: the weight loss drug Meridia, the diabetes drug Avandia and the painkillers Darvon and Darvocet.

The future of accelerated approvals also became dubious as the FDA hardened its stance on the approvals in an effort to avoid potential future problems. The agency revisited several past accelerated approvals– Roche AG’s Avastin for breast cancer, Pfizer Inc.’s Mylotarg for acute myeloid leukemia and Shire plc’s ProAmatine for orthostatic hypotension.

In addition, it refused to consider Roche and Immunogen Inc.’s trastuzumab-DM1 for accelerated approval, despite the fact that it has shown activity in HER-2 positive breast cancer patients who have failed multiple courses of prior therapy.

One of the issues the FDA cited with accelerated approvals was getting companies to come up with the follow-up data to support the approval in a timely manner. For instance, Mylotarg was approved in 2000, but Pfizer (then Wyeth) didn’t start the confirmatory studies until 2004.

In the case of Avastin, the FDA yanked the HER2-negative metastatic breast cancer indication because four follow-up studies failed to demonstrate that the drug prolonged overall survival in breast cancer. They also didn’t confirm the magnitude of benefit originally observed in the randomized, multicenter, open-labeled E2100trial, which showed a 52 percent increase in progression-free survival in patients treated with Avastin.

The FDA’s Risk Evaluation and Mitigation Strategy (REMS) authority is one way the agency could force companies to go to market with plans already in hand for following up on accelerated approvals. But with no final REMS guidance from the FDA, and what appear to be inconsistencies between the 2009 draft guidance and the law establishing REMS, drugmakers have been left without much clarity.

The ambiguities increased as the FDA moved toward requiring REMS for classes of drugs last year. In addition to the growing number of REMS, numerous public comments on the draft guidance raised concerns about the costs and time-consuming burdens for drugmakers, prescribers and pharmacies involved in implementing the programs.


Law & Order: Washington - Government Gets Tough on Drugs

REMS implementation also raised another question: How would monetary fines be imposed for noncompliance?For instance, if a pharmacy or prescriber failed to give a patient the required medication guide, could the drugmaker be fined $250,000 for “every single” medication dispensed without the guide?

Aside from possible REMS penalties, biopharmaceuticals faced a growing danger of criminal prosecution in 2010 as the Department of Justice (DOJ) stepped up investigations into off-label violations and fraud allegations. Drugmakers, including Allergan Inc., Novartis AG and AstraZeneca plc, were involved in eight of 10 of DOJ’s fraud-related settlements last year.

In addition, the government collected about $3. 1 billion under the False Claims Act in fiscal 2010, with about 80 percent of that coming from health care companies. Many of the cases resulted from whistle-blower suits.

To curb off-label promotion and kickbacks, government officials proposed using a statute that permits prosecutors to charge executives with a misdemeanor offense of not acting as a responsible corporate officer if a company fails to comply with misbranding rules.

To strengthen that club, the Department of Health and Human Services’ Office of Inspector General proposed excluding culpable individuals from future participation in Medicare and Medicaid if their company violates off-label promotion rules. Such exclusion could effectively ban company officials or staff from the health care industry.

Assigning responsibilities to corporate board members in corporate integrity agreements could be another remedy.

Along with the stepped-up investigations, a rash of drug safety issues and manufacturing problems, which led to major recalls, especially at Johnson & Johnson subsidiary McNeil Consumer Healthcare, had some members of Congress calling for increased authority for the FDA.

As chairman of the House Oversight and Government Reform Committee last year, Rep. Edolphus Towns (D-N.Y.) insisted the FDA should have the authority to automatically recall suspect products, rather than having to persuade a drugmaker to do a recall.

An Impending Court Ruling and a Looming Pat-ent Reform Bill Have Blockbuster Implications

As if fears of criminal prosecutions, hefty fines and debarment from federal programs and increased FDA authority weren’t enough to worry about, industry also saw the underlying foundation for several key biotech patents seriously threatened in 2010.

In a sweeping summary judgment against Myriad Genetics Inc., Judge Robert Sweet of the U.S. District Court for the Southern District of New York in Manhattan ruled that the U.S. Patent and Trademark Office (PTO) had improperly granted seven BRCA gene patents to Myriad because they involved a law of nature. If allowed to stand, the decision could eliminate the validity of all gene patents.

Myriad appealed the case, brought in May 2009 by the American Civil Liberties Union and a coalition of patients, pathologists, genetic researchers and other scientists that argued gene patents stifle research and competition and limit options for medical care.

The U.S. Court of Appeals for the Federal Circuit is expected to rule on the appeal by early fall. But ultimately, the issue appears to be destined for the U.S. Supreme Court.

The ruling came as industry faced a steep patent cliff as patents on several blockbuster drugs began to expire. Amid pipeline worries, drugmakers had to continue to contend with a long wait to get new patents through the PTO, which struggled with a historic logjam created, in part, by Congress raiding patent fees for other purposes.

As it had in the past, Congress failed to deliver on its promise of patent reform. However, 2011 could be the year the job gets done. The Senate overwhelmingly passed a bill that would provide the first substantial reform to the patent system in 60 years. Not only does it safeguard the PTO’s funding, it also would switch the U.S. to a first-to-file system, putting it in step with the rest of the world.

A similar bill, with a few key differences, was introduced in the House, but it remains to be seen whether the two chambers will work out their differences. In other words, the uncertainty continues.


The View from Europe

Investments Rebounded, But European Biotechs Still UnderfundedBy Nuala MoranBioWorld International Correspondent

After the capital-starved privations of the financial crisis, the only way was up for the European biotechnology sector in 2010. Investment did rebound – venture capital investment in France rose by 56 percent to �148 million (US$208.5 million), for example, and there were seven initial public offerings (IPO), compared to a mere one in 2009.

But venture capital funding remains lower than before the credit crunch, and with the exception of Zealand Pharma A/S, which raised $67.9 million, IPOs were for small amounts and did not represent exits for the investors. In other words, the numbers flatter to deceive, with the sector as a whole remaining dramatically underfunded.

Yet rising public investment in R&D – in many cases as part of government economic stimulus packages – means Europe’s science base is as strong and superior as ever.

The most significant advance in 2010 was that the pharma industry openly acknowledged that flexible, nimble and innovative biotech companies provide it with the best route to tapping this resource. The result was yet another redrawing of biotech business models, to structure companies for long-term collaborations with pharma, with the aim of an eventual trade sale.

Trial Failures Rock the SectorOverhanging this shift is the sector’s endless tango with

risk. The CEO of Zealand Pharma, David Solomon, admitted the IPO in November 2010 was “tricky” even though the company was presenting a relatively low-risk portfolio, with lixisenatide, its GLP-1 agonist, having reported success in three Phase III trials in Type II diabetes and partnered with Sanofi-Aventis Group.

The toll that risk takes was underlined by a number of late-stage failures. In the UK these eviscerated the sector, with three of the best-funded public companies putting up for sale signs as a result.

The gene therapy specialist Ark Therapeutics plc has regrouped and downsized following the European Medicines Agency’s rejection of its glioma treatment Cerepro. But when Antisoma plc’s lead product AS1413 for treating acute myeloid leukemia and Renovo plc’s anti-scarring treatment Juvista, failed in Phase III, both companies decided to call it a day in March 2011 .

Another high-profile Phase III failure, of the insomnia treatment almorexant, has drawn Actelion, Europe’s largest

biotech (and the only one in the global top 10) into a distracting and very public conflict with the activist investor Elliott Advisors. The bad news on almorexant followed the failure four months earlier of clazosentan in a Phase III pivotal trial in stroke, and the missing of the primary endpoint in a trial designed to widen the label of Tracleer (bosentan) beyond pulmonary arterial hypertension to idiopathic pulmonary fibrosis in March 2010.

It’s clear at this point that the company will be likely restructure and rethink its portfolio.

Similarly, in Denmark the Phase III failure of zalutumumab forced the resignation of one of Europe’s most high profile biotech CEOs, Lisa Drakeman, with the inevitable corporate remodeling following in her wake. Santhera AS too, was hit with a 43 percent fall in its share price when idebenone flopped in a Phase III study in Friedrich’s ataxia. And there was a first set back for the Austrian vaccines company Intercell AG, when its Traveler’s diarrhea vaccine failed to show significant effect in Phase III. That led to a reduction in headcount and a 40 percent cut in R&D funding at the Vienna-based company.

These examples highlight the all-or-nothing, binary nature of the whole biotech enterprise and underline that to date few European biotechs have built broad enough pipelines, or have deep enough pockets, to withstand a product flop.

Success in the Clinic Builds ValueWith very few marketed products, success in the clinic

is by far the most important source of value, as evidenced by Zealand’s Pharma’s success in going public on the back of positive results in the lixisenatide Phase III studies. Thrombogenics NV too, was boosted by two successful Phase III trials of microplasmin in treating vitreomacular adhesion, allowing it to raise �56 million in a placing to fund the US and European launch of the product.

There were also earlier-stage advances in the clinic for companies that are staking ground in new types of therapy, such as stem cells. So, for example, after managing to stay afloat over five long years of negotiations with regulators on both sides of the Atlantic and dealing with repeated requests for more preclinical data, ReNeuron plc finally got approval for the first regulated trial of a fetal stem cell product. ReN001 , a neuronal cell line, is currently being tested in a Phase I/II


trial in stroke at Glasgow University Hospital in the UK.Another example of European biotechs applying

advances in molecular biology to get a handle on previously untreatable diseases include Prosensa Therapeutics BV, which advanced its exon skipping treatment for Duchenne’s muscular dystrophy (DMD) into Phase III. Also, Trophos SA moved a novel construct it has christened a ‘mitochondrial pore modulator’ into a pivotal trial in spinal muscular atrophy.

Orphan Drugs Increase in Strategic ImportanceEuropean biotechs are increasingly looking to orphan

drugs as a lower-risk route through development. The significance of this was underlined in a review of the state of play 10 years after the enactment of the European Union’s orphan drugs legislation, which showed R&D relating to rare diseases increasing as a proportion of total research funding. Orphan drugs also are proving an important route for biotechs to tap into a new, non-dilutive source of funding from medical charities that exist to promote research into the diseases they represent.

But more potently, the move into rare diseases has put European biotechs in a prime position to benefit from pharma’s newly kindled interest in the field, which has seen companies including Pfizer Inc., Novartis AG and GlaxoSmithKline plc form dedicated rare diseases units. As a result, orphan drugs have formed the basis of more out-licensing and collaboration deals, with Prosensa NV’s $678 million agreement with GlaxoSmithKline for its exon-skipping DMD treatment being a prime example.

A New Partnering ModelWhile pharma has long recognized the contribution

biotech can make to its pipelines, in 2010 pharmaceutical executives finally came up with a partnering model with which they are comfortable. These new model deals typically come with small up-front payments or an equity investment, R&D funding for the biotech to carry on doing the work, milestones, and an option for the pharma partner to in-license products at a later date.

Underlying these deals is the fact that pharma is finally confronting and dealing with the diseconomies of scale in its research and development. It no longer wants to go out and buy another company or product and bring it in house.

This led to high value deals – Galapagos NV’s $374 million osteoarthritis pact with Servier, or its chronic obstructive pulmonary disease deal with Roche at $400 million; Orexo AB and Johnson & Johnson’s $585 million collaboration on preclinical modulators; the Cellzome/GSK $655 million agreement in inflammatory diseases; or NicOx SA and Bausch and Lomb’s $179.5 million deal in glaucoma.

But despite the numbers, such deals can still leave biotech partners hanging on for the next milestone payment

– reminiscent perhaps of waiting for VCs to hand out the next tranche of cash in the old days.

In the absence of other funding sources, European biotechs have no alternative but to go along with this. As a result, they remain exposed to those convulsions of partnering – the big pharma pipeline review, or one pharma company being taken over by another – that are impossible to plan for, and which make it more difficult for biotechs to become self sustaining.

So for example, when Roche gave back rights to the cervical cancer vaccine TG4001 to Transgene in February 2011 , its share price fell from �15 to �12 – even though the Strasbourg-based company was getting the product back with full rights and a Phase IIb trial, paid for by Roche, fully recruited and yet to report.

There was greater calamity in store for Italian biotech Philogen SpA in March 2011 , when a sudden change of heart by Bayer Schering Pharma over two antibody programs, forced the Milan-based biotech to pull a proposed IPO.

Some Inspiration and Cheer for InvestorsWhatever the vagaries of pharma partners and the

reverses of clinical development, a number of companies raised follow-on funding, either as a result of validation of a technology elsewhere, or on the back of their own progress. The most notable example of reflected glory was Transgene’s $181 million June 2010 fundraising, which was inspired by the FDA’s approval of Dendreon Corp’s Provenge prostate cancer vaccine.

On the back of strong Phase IIb data Karo Bio AB was able to raise $80 million for the Phase III development of eprotirome in familial hypercholesterolemia, while Ablynx NV raised $68.3 million as it advanced its nanobody antibody constructs further into the clinic. And Agennix AG took in $105 million for an all-or-nothing bet on its immune modulator talactoferrin, a recombinant version of lactoferrin, in treating non-small cell lung cancer.

There were two remarkable financing rounds for private biotechs, with Symphogen AS raising $131 million in January 2011 , while in March 2010 Archimedes Pharma Ltd. raised $96.9 million to pay for the commercialization of PecFent, a nasally-administered version of fentanyl for treating cancer breakthrough pain.

The biggest source of inspiration for investors was Johnson & Johnson’s $2.4 billion purchase of Dutch vaccines company Crucell NV. Another big ticket acquisition was Shire’s purchase of gastrointestinal diseases specialist Movetis NV for $565 million.

There was little hard cash changing hands for biotech/biotech M&A. BTG plc acquired Biocompatibles plc in an all-share deal valued at $284.5 million. Biotie Therapies Corp.’s all-share merger with Synosia Therapeutics Holding AG was tagged at $120 million and Wilex AG picked up Heidelberg


Pharma AG for $27 million in stock.There was a rare – old fashioned cash exit for VC

investors in RespiVert Ltd., which was acquired by Centocor Ortho Biotech Inc. The terms were not disclosed, but Imperial Innovations plc, the technology transfer arm of Imperial College London realized $13.8 million from the sale of its 13.4 percent stake in the company, for an investment of $3.2 million. The other venture capital investors to cash in were SV Life Sciences, Fidelity Biosciences and the largest shareholder, Advent Venture.

Governments Maintain Support Europe’s governments remain keen to nurture their

biotech sectors, and while supportive policies cannot make up for a dearth of private investment for clinical development, they continue to be important in promoting the formation and development of new companies.

This is best exemplified by France, where the government sold off shares in the state owned electricity company and is investing the money in science-based start-ups. Amongst other measures, it has set up a combined grant and loan scheme that allows companies to raise significant sums against predetermined milestones. One beneficiary is NeoVacs SA, which has a $11 .2 million award for the development of an antibody for treating rheumatoid arthritis in patients who have become resistant to TNF-alpha products.

The European Commission also is very sympathetic to biotechs, offering R&D funding through its Framework Research program. However, the commission has struggled to bring about promised regulatory reforms that are important to the industry, such as improving the current costly and bureaucratic system for getting approvals for clinical trials, and creating a single European patent.

Critically though, public investment in the science base, and a desire to see this spawn companies, means that Europe continues to have good flow of start-ups. In 2010 some of these were able to put together impressive first rounds. Syntaxin Ltd, for example, raised $28.6 million, and antibody start-up Crescendo Ltd. raised $7. 1 million.

The desired end of all this activity is of course, new therapies, and 2010 saw approval for three products. These are Archimedes Pharma’s PecFent , Pharming Group NV’s Rhucin, a version of human C1 inhibitor produced in the milk of transgenic rabbits for treating hereditary angioedema and GW Pharma plc’s cannabis-based Sativex, for treating spasticity caused by multiple sclerosis.

These are all important products serving unmet medical needs. But they also serve as an important reminder that at the end of the development pipeline one thing will give European biotech solidity and assurance, and that is having marketed products.


The View from the Bench

The Light Bulb Burns Bright in the Discovery Phase By Anette BreindlScience Editor

With the number of scientific papers continuing to rise at dizzying rates, a stab at a comprehensive update of the year’s most important biomedical discoveries would fill its own annual report. Selecting from the bounty, we have included some of the most important advances.

The most notable of these is the successful CAPRISA trial of a microbicide that can, finally, protect against HIV infection.

Most of our highlights, however, are in areas where progress was made on a broad front. The simultaneous progress of large-scale genome-wide association studies (GWAS) and personalized genomics, and the many resistance tricks of cancer cells that researchers are bringing to light, are examples of such fields that had general momentum in 2010.

Genome ResearchGenomics continues to forge ahead, with researchers

identifying ever-new disease risk factors. The exact number of human genomes that has been sequenced is difficult to pin down at any given time. But in October 2010, Nature estimated that 180 complete genomes had been sequenced – and that that number would rise tenfold by the end of 2011 . Larger-scale genome projects, such as the Thousand Genomes Project (which, in a fabulous example of inflation, is sequencing the genomes of about 2,500 individuals) and The Cancer Genome Project both reported advances in 2010. The larger the number of genomes, the better the chances of finding rare variants; in a October, 2010 update on the 1000 Genomes Project, scientists reported they had seen about 15 million SNPs, 1 million short insertion/deletion changes and more than 20,000 structural variations in their pilot data, and that fully half of those variations were new.

At the other end of the scale, scientists are also plugging away at the Personal Genome Project, which combines genetic and environmental information about (anonymous) individuals to learn how genetics and environmental factors interact to produce traits.

And in May, researchers reported long sought-after success in yet another aspect of genomics: they succeeded in “booting up” one cell’s cytoplasm with the artificially reconstructed genome of another cell. The work marked the culmination of 15 years of effort by genomics pioneer J. Craig Venter and his team.

In another attempt at artificial life, a separate team reported in January 2011 that it had managed to create amino acid sequences from scratch that folded into functional

proteins, and that those proteins could substitute for naturally occurring ones and carry out metabolic functions in bacteria. The work received less press attention than the synthetic genome. But in its attempt to create proteins not found in nature may ultimately have farther-reaching implications.

Stem Cells: Everybody’s DifferentStem cell research continued to enable insight into more

diseases than we can list. But among the most important research of the year were several studies about stem cells themselves, and how different types of stem cells differ from each other.

The iPS cells of different species can differ in important ways: scientists discovered that female human iPS cells do not reactivate their silenced X chromosome during reprogramming, while mouse iPS cells do. The authors were sanguine about their discovery, noting that it enables the generation of cells that are genetically identical except for the inactivated X chromosome – an ability that could be a boon for studying X-linked diseases.

Less encouraging was a report last February that iPS cells are prone to premature aging, and were far less able then embryonic stem cells to go through repeated cell division cycles while keeping their stem-like properties.

A report last May showed that iPS cells and embryonic stem cells differed in their expression of FMR protein, which is the critical protein in Fragile X syndrome. By March of 2011 , a trifecta of studies had shown that induced pluripotent cells differ from embryonic stem cells, and from the skin cells that are used to make them, in three predictable ways. Induced pluripotent stem cells had a mutation rate ten times higher than that of their parent cells. They also have differences in copy number variations, and epigenetic abnormalities, that set them apart.

Another study also showed that embryonic cells and iPS cells differ in their metabolic pathways, which may reflect their different environments; in fact, many of the observed differences may be due to the conditions under which cells are cultured.

Cancer Resistance Like stem cell research, the field of cancer research is

too broad to list every advance that is worthy of attention over the course of a year. What stood out over the past year, however, was the critical mass of papers that reported on mechanisms of tumor resistance to a wide variety of drugs


ranging from off-patent stalwarts to new, still-in-clinical-trial stars. In an example of the former, two studies described that resistance to microtubule-targeting agents such as taxol (first approved in 1992) arises through mutations in a tumor suppressor. Studies also described resistance mechanisms for newer targeted drugs such as erlotinib, and even for those still in clinical trials: in November, two studies reported independent resistance mechanisms for the experimental melanoma drug PLX4032. More than half of all patients develop resistance to PLX4032 within a year, apparently via a multitude of mechanisms, though this did not prevent the drug from giving patients both an overall survival and a progression-free survival advantage in a phase III trial whose results were reported in January.

While mutations are certainly a tumor’s standard way around a chemotherapy roadblock, surprisingly, they are not an absolute prerequisite to developing resistance. A study published last April showed that cancer cells could acquire resistance to erlotinib (Tarceva) through epigenetic mechanisms. The resistance was reversible, and so such epigenetic alterations might be behind the clinical observation that “drug holidays” – taking a patient off of a medication for a period of time -- can sometimes restore the sensitivity to a drug after resistance has developed.

The ideal way to deal with mutation-based resistance, in the meantime, is not by taking on one mutation at a time, but by finding points where resistance pathways converge. In March, 2011 , one study identified the SRC kinase as one such point of convergence for resistance to trastuzumab (herceptin.) And the developers of PLX4032 are working on second-generation agents that “will hopefully not have this resistance issue,” company executives told BioWorld when topline results of the BRIM trial were published.

Microbicides: Successful on the 12th AttemptAnother successful trial in 2010 was, in many ways, the

polar opposite of the BRIM trial. While PLX4032 barreled through the clinical trials process at record speed, when the CAPRISA 004 trial finally reported success, it was the 12th trial to test the abilities of a vaginal microbicide to prevent HIV infection.

Because they can be controlled by women, and be used without a partner’s consent or even knowledge, microbicides have long been considered a path to protection that could withstand some of the practical realities of the lives of women who are at high risk for HICV infection. But getting a grip on those medical risks proved to be a challenge, with some earlier experimental microbicides actually increasing the risk of infection. In the CAPRISA trial, that risk was reduced by 40 percent with regular use. Those women who used it most consistently reduced their risk by more than half. The risk of contracting herpes was also reduced by about 50 percent.

Obesity Reaches a (Mountain) Plateau2010 began with a classic example of good news/

bad news on the obesity front: in January, the Centers for Disease Control and Prevention reported that the numbers for the percentage of the population that is obese had been stable for five (men) to ten (women and children) years, long enough to consider the rate stable. The bad news, of course, was the large number of large people: obesity rates for adults are at 1/3 of the population, and those of children at almost 20 percent.

The Secret to a Long LifeDisproving theories is an integral part of the scientific

process, and from that perspective, 2010 may turn out to be a fruitful year for longevity research. A July study purported to show a longevity gene signature consisting of 150 SNPs that, together, could predict with about 75 percent accuracy whether a person would live beyond the age of 90. Those longevity genes appeared to work by somehow counteracting the effects of disease genes: 100-year-old individuals with the longevity signature appeared to have many disease risk genes at the same rate as their peers.

But the longevity signature may turn out to be short-lived: in November, Science published an editorial expression of concern about the paper after it became clear that the study had produced several false positives, partly due to the use of at least one genotyping chip that produced artifacts and partly due to skipping certain quality control procedures. The authors planned to reanalyze their data, and in November, Science said that it would make a final decision after the results from the reanalysis were in. As of late March 2011 , the editorial department was still evaluating the paper.

And On and On and OnIn the meantime, a widely noted study published in

February, 2011 , showed that at least one “longevity gene” extends health, but not lifespan, in humans. When the gene in question, for insulin-like growth factor 1 or IGF-1 , is mutated, it prevents individuals from responding properly to growth hormone signaling. In affected individuals, the result is Laron syndrome or dwarfism – but also an almost complete protection against cancer and diabetes. The study showed that basic mechanisms of aging are conserved from roundworms all the way through to humans.

To the scientific community, the retraction was old news. But 2010 was the year when it officially happened: The Lancet formally retracted the 1998 paper purporting to show a link between autism and MMR vaccination. The retraction, of course, did little to convince believers in the theory, who continue to see lead author Andrew Wakefield as an anti-establishment fighter for the truth. Somewhat more surprisingly, it also did not convince those who reject the idea of a link to move on to more productive debates.


In January of 2011 , a new report detailed how Wakefield falsified the medical records of his subjects, listing several children with preexisting developmental problems as developing normally in their pre-vaccine medical records.

Somewhat paradoxically, the authors noted the ongoing damage to public health caused by Wakefield’s paper and the vaccine skepticism it has engendered, as well as the resources it has taken away from research into other possible causes of autism.

Depression: A Quicker Fix? Research into depression made strides on different

fronts, some with potential for treatments, and others in finding out what causes depression in the first place. On the treatment front, the most hopeful bit of news may be that there is nothing inevitable about the slow speed with which current antidepressants work. In August, researchers from Yale University reported how the brain changes in response to ketamine – an anesthetic that can have an antidepressant effect, within hours, in patients who are resistant to other antidepressants.

Ketamine’s rapid effects are not new, but the drug needs to be given intravenously and under direct medical supervision. The identification of the pathway ketamine acts on, however, opens up the possibility of targeting other

points in the pathway, hopefully by oral drugs with less abuse potential.

In October, a team including some of the same scientists identified one possible target: a phosphatase that regulates the same pathways as ketamine and is overexpressed in the brains of depressed patients, and of animals subjected to chronic stress.

Other studies suggested that gene therapy to parts of the midbrain, or blocking the interaction between two types of dopamine receptors rather than one receptor by itself, as is more typically the case, might be novel ways to treat severe depression.

And a large meta-analysis weighed in on the question of whether resilience, or the ability to bounce back from stressful life events, is related to the genetic variant of a serotonin transporter that a person possesses. Such an association had been reported in 2003, but not all attempts to replicate the finding had been successful.

The December study, a meta-analysis which is the largest to date, suggested there is an association for childhood maltreatment and medical stressors, but not “significant life events” – quite possibly because of the widely differing definitions of stressful life events, which, depending on the study, could range from the death of a close relative to having a father without a college education.


BioWorld®

F I N A N C I A L

D ATA

Biotech Money Raised By Month In 2010: Jan. - Dec.Type of financing

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Total ($M)

Public offerings

536.4 349.5 642.0 464. 1 620.6 81 .0 47.9 102.9 586.9 2,418.3 638.5 371 .6 6,859.7

Public/other

236.4 147.4 450.0 272.7 278.7 1 ,692.2 2,299 820.3 149.6 481 .4 820.9 326. 1 7,975. 1

Private biotechs

533.2 221 .5 342.6 497.6 299.7 557.5 628.8 221 .6 485. 1 314.0 257.0 124.4 4,483.0

Total ($M) 1 ,306 718.4 1 ,434.6 1 ,234.4 1 , 199.0 2,330.7 2,976. 1 1 , 144.8 1 ,221 .6 3,213.7 1 ,716.4 822. 1 19,317.8

Notes:

Public offerings = Initial, follow-on.

Private biotechs = Financings of private firms.

Public/other = Other financings of public companies, including loans, bridge financings, exercises of warrants, debt offerings, rights offerings, standard private placements, PIPE financings and institutional offerings of registered stock.

Money from exercised overallotment options are included in the month that the offering first priced. In all cases, numbers are rounded and may vary slightly from other charts in which exact totals are used.



Initial Public Offerings Of Biotechnology In 2010Company(Symbol)#

Date Filed

DateComm.

Shares/Units (M)

Price SharesOut (M)@

Lead, OtherUnderwriters

Gross(US$M)

Post-OfferingMarketCap (M)%

FEBRUARYCBio Ltd.(Australia;ASX:CBZ)

11/11/09 2/8/10 N/A N/A N/A N/A A$7. 1($6. 1)

N/A

IronwoodPharmaceuticalsInc. (IRWD)

11/23/09 2/3/10 19.2S $11 .25 97.4 J.P. MorganMorgan Stanley (co-lead)Credit Suisse (co-lead)BofA Merrill LynchWedbush PacGrow Life Sci.

$216 $1 ,095.8

MARCHAntheraPharmaceuticals(ANTH)

9/15/09 3/2/10 6.604S $7 22.2 Deutsche Bank Sec.Piper JaffrayCowen & Co.Merriman Curhan Ford

$46.23 $155.4

AVEOPharmaceuticalsInc. (AVEO)

12/17/09 3/12/10 9.97S $9 30.6 J.P. MorganMorgan Stanley (co-lead)Leerink SwannCanaccord Adams

$89.73 $275.4

CorMedix Inc.(AMEX:CRMD-U)

3/26/10 3/26/10 1 .925U $6.50 11 .4 Maxim Group LLC $12.5 $37. 1

APRILAB Science-Promesses SA(France; Euronext:AB)

4/27/10 4/28/10 2. 17S �12.68($16.84)

N/A N/A �27.5$36.45)

N/A

AlimeraSciences Inc.(ALIM)

10/30/09 4/22/10 6.55S $11 31 .05 Credit Suisse SecuritiesCitigroup (co-lead)Cowen & Co.Oppenheimer & Co.

$72.05 $341 .55

Codexis Inc. (CDXS)

12/28/09 4/22/10 6S $13 34 Credit SuissePiper JaffrayRBC Capital Mar.Pacific Crest Sec.

$78 $442

Tengion Inc.(TNGN)

12/24/09 4/9/10 6S $5 12.4 Piper Jaffray & Co.Leerink Swann (co-lead)

$30 $62

JUNEAposense Ltd.(Israel; TASE:APSN)

6/8/10 6/8/10 N/A N/A N/A N/A $24 $230


AUGUSTNuPathe Inc. (PATH)

5/14/10 8/6/10 5S $10 14.5 Leerink SwannLazard Capital (co-lead)Needham & Co.

$50 $145

Trius Therapeutics Inc. (TSRX)

11/6/10 8/4/10 10S $5 23.6 Citigroup Global MarketsPiper Jaffray & Co.Canaccord Genuity Inc.JMP Securities

$50 $118

OCTOBERAegerion Pharmaceuticals Inc. (AEGR)

8/10/10 10/25/10 5S $9.50 16.9 Leerink SwannLazard Capital (co-lead)Needham & Co.Canaccord GenuityCollins Stewart

$47.5 $160.55

Pacific Biosciences Inc. (PACB)

8/16/10 10/27/10 12.5S $16 50. 1 J.P. Morgan Securities Morgan Stanley (co-lead)Deutsche Bank SecuritiesPiper Jaffray & Co.

$200 $801 .6

NOVEMBERAnacor Pharmaceuticals Inc. (ANAC)

9/10/10 11/24/10 13.38S $5 27.98 Citigroup GlobalDeutsche Bank (co-lead)Cowen and Co. LLCWedbush PacGrow

$66.9 $139.9

Complete Genomics Inc. (GNOM)

7/30/10 11/12/10 6S $9 25.8 UBS Investment BankJefferies & Co. (co-lead)Robert W. Baird & Co. Inc. Cowen and Co.

$54 $232.2

Zealand Pharma A/S (Denmark; CSE:ZEAL)

11/4/10 11/24/10 4.3S DKK86 ($15.8)

N/A Danske Bank A/SJefferies International Bryan, Garnier & Co.SEB Enskilda (all co-leads)

DKK372($67.9)

N/A

Zogenix Inc. (ZGNX)

9/8/10 11/23/10 14S $4 33.6 Wells FargoLeerink SwannOppenheimer & Co. Steifel Nicolaus Weisel

$56 $134.4

InitialPublicOfferings


DECEMBERVentrus Biosciences Inc. (VTUS)

7/20/10 12/17/10 2.9S $6 6.7 Rodman & RenshawNational Securities (co-lead)

$17.4 $40.2

Total: $1,220.76MNumber of IPOs in 2010: 19Average value of IPOs in 2010: $64.25MNotes:

# Unless otherwise indicated, shares are traded on the Nasdaq exchange.

@ This column reflects the shares outstanding following the offering, when disclosed.

% Market capitalization is calculated based on the offering price.

AMEX = American Stock Exchange; ASX = Australian Stock Exchange; CSE = Copenhagen Stock Exchange; TASE = Tel Aviv Stock Exchange.

Currency conversions are based on exchange rates at the time of the deal.

InitialPublicOfferings


Biotechnology Follow-On Offerings In 2010Company(Symbol)#

Date Filed

DateComm.

Shares/Units (M)

Price SharesOut (M)@

Lead, OtherUnderwriters

Gross(US$M)

Post-OfferingMarketCap (M)%

JANUARYAastromBiosciencesInc. (ASTM)

2/19/09 1/15/10 52.07U $0.26 220. 1 Oppenheimer & Co. $13.5 $57.2

AchillionPharmaceuticalsInc. (ACHN)

10/16/09 1/22/10 11 .8S $2.08 38.5 Roth Capital Partners;Noble Financial Capital; National Securities

$24.5 $80. 1

AMAGPharmaceuticalsInc. (AMAG)

1/19/10 1/21/10 3.6S $48.25 20.99 Morgan Stanley, J.P. Morgan (co-lead), Goldman, Sachs (co-lead), Leerink SwannBaird, Canaccord Adams

$173.7 $1 ,012.8

InterMune Inc.(ITMN)

9/29/09 1/21/10 7S $14. 10 53.7 Goldman, Sachs; Canaccord Adams; JMP Securities; Leerink Swann; Oppenheimer & Co.

$98.7 $757. 17

Pharmasset Inc.(VRUS)

6/26/08 1/28/10 1 .83S $18.75 30. 13 Leerink Swann $34.31 $564.9

Sinovac BiotechLtd. (China; SVA)

11/30/09 1/28/10 11 .5S $5.75 54. 1 UBS Investment Bank; Piper Jaffray (co-lead)

$66. 13 $311 . 1

SyntaPharmaceuticalsInc. (SNTA)

8/28/08 1/8/10 6.43S $4.50 40.33 Lazard Capital Markets; RBC Capital Markets

$28.94 $181 .5

ZymoGeneticsInc. (ZGEN)

12/11/08 1/7/10 16. 1S $6 85.2 Leerink Swann; Wedbush PacGrow; William Blair & Co.; Canaccord Adams; McAdams Wright Ragen

$96.6 $511 .2

FEBRUARYBioCurex Inc.(Canada; OTC BB:BOCX)

1/20/10 2/1/10 1 .3U $5 157.9 Paulson Investment Co. $6.5 $789.5

DiscoveryLaboratoriesInc. (DSCO)

6/18/08 2/19/10 27.5S $0.60 149.2 Lazard Capital Markets $16.5 $89.52

Labopharm(Canada; DDSS)

12/14/10 2/12/10 13.5U $1 .70 70.96 Deutsche Bank Sec.Canaccord AdamsDundee Capital MarketsVersant Partners

$22.95 $120.6

NeoStem Inc.(AMEX:NBS)

2/11/10 2/11/10 5.75S $1 .35 42.95 Roth Capital Partners Maxim GroupGilford Securities

$7.8 $57.98

OptimerPharmaceuticalsInc. (OPTR)

12/24/09 2/25/10 4.88S $11 38.24 Jefferies & Co. $53.68 $420.6


Senomyx Inc.(SNMX)

9/2/08 2/16/10 7. 1S $2.80 38.3 Deutsche Bank Sec.Needham & Co.Roth Capital Partners

$20 $107.24

MARCHAblynx NV(Belgium; BR:ABLX)

3/10/10 3/16/10 6.7S |7.50 N/A KBC SecuritiesUBS Invest. (co-lead)Piper Jaffray Ltd.KBC BankKempen & Co.

|50($68.3)

N/A

Dyax Corp.(DYAX)

3/25/10 3/25/10 19.55S $3.25 97.65 Jefferies & Co. Inc.Needham & Co. LLC (co-lead)

$63.55 $317.4

LexiconPharmaceuticalsInc. (LXRX)

3/9/10 3/17/10 96.5S $1 . 15 273.9 Morgan StanleyJ.P. Morgan Sec. (co-lead)Cowen and Co. LLCThomas Weisel Partners

$111 $315

Micromet Inc.(MITI)

3/11/10 3/12/10 11 .5S $7 80.7 Goldman, Sachs & Co.Piper JaffrayRBC Capital MarketsNeedham & Co. LLCRoth Capital PartnersLadenburg, Thalmann & Co.Maxim Group LLC

$80.5 $564.9

NeurocrineBiosciences(NBIX)

12/3/07 3/5/10 10.37S $2.20 54.57 Jefferies & Co. $22.8 $120. 1

SomaxonPharmaceuticalsInc. (SOMX)

11/10/09 3/29/10 6.9S $8.25 32.8 Jefferies and Co.Oppenheimer & Co. Inc.

$56.9 $270.6

Theravance Inc.(THRX)

3/19/10 3/25/10 8.6S $11 .50 72.8 Morgan StanleyCredit SuisseLeerink Swann

$98.9 $837.2

APRILARCABiopharmaInc. (ABIO)

4/1/10 4/1/10 1 .075S $6.33 8.7 N/A $6.8 $55.07

ArdeaBiosciencesInc. (RDEA)

4/6/10 4/9/10 4S $20 22.6 Jefferies & Co. Inc.Oppenheimer & Co. (co-lead)

$80 $452

DynavaxTechnologiesCorp. (DVAX)

4/2/10 4/13/10 30.3U $1 .45 86.5 Wedbush PacGrow Life $44 $125.6

Exact SciencesCorp. (EXAS)

12/3/07 4/14/10 4.2S $4.50 40.03 Robert W. Baird & Co. $18.9 $180. 14

IdenixPharmaceuticalsInc. (IDIX)

10/17/08 4/30/10 6.46S $4.35 72.8 Thomas Weisel PartnersLeerink SwannWilliam Blair & Co.

$28. 1 $316.68

Follow-onOfferings


NileTherapeuticsInc. (NLTX)

4/8/10 4/23/10 7.475U $0.70 34.57 Maxim Group LLCLadenburg Thalmann & Co.

$5.23 $24.2

NPSPharmaceuticalsInc. (NPSP)

8/5/09 4/16/10 10.35S $5.50 58.9 Canaccord AdamsNeedham & Co. LLC

$56.9 $323.95

MAYAvanirPharmaceuticalsInc. (AVNR)

9/23/09 5/7/10 11 .5S $2.75 95. 1 Jefferies & Co.Canaccord Adams

$31 .6 $261 .5

ImmunoGenInc. (IMGN)

4/22/10 5/7/10 10.35S $8 67.8 J.P. MorganOppenheimer & Co.RBC Capital MarketsCantor Fitzgerald & Co.Morgan Joseph

$82.8 $542.4

JazzPharmaceuticalsInc. (JAZZ)

4/5/10 5/12/10 7S $8.35 38.54 Barclays Capital $58.45 $321 .8

Pharmasset Inc.(VRUS)

5/11/10 5/14/10 3.68S $29 33.98 CitibankJ.P. MorganCanaccord GenuityRobert W. Baird

$106.72 $985.42

RegeneRx Bio- pharmaceuticals Inc. (AMEX:RGN)

4/27/10 5/19/10 13. 12U $0.41 73.52 Maxim Group LLCBoenning & Scattergood

$5.38 $30. 14

SalixPharmaceuticalsLtd. (SLXP)

5/27/10 5/27/10 N/A N/A N/A BofA Merrill LynchJefferies & Co. Inc. (co-lead)

$300 N/A

ZiopharmOncology Inc.(ZIOP)

5/10/10 5/28/10 7S $5 48.8 Jefferies & Co.JMP Securities LLC

$35 $244

JUNEClinical DataInc. (CLDA)

6/28/07 6/9/10 2.24S $14.30 29.7 BMO Capital MarketsWedBush PacGrowRoth Capital

$32 $424.7

CorceptTherapeuticsInc. (CORT)

2/13/08 6/25/10 5S $3 72 Thomas Weisel Partners $15 $216


6/11/10 6/18/10 35.7U $0.28 189.7 Lazard Capital MarketsBoenning & Scattergood

$10 $53. 1

JULYBioMimetic Therapeutics Inc. (BMTI)

7/14/10 7/15/10 5.64S $8.50 27.74 J.P. Morgan SecuritiesCanaccord GenuityWedbush PacGrow

$47.94 $235.79

AUGUSTPharmagap Inc. (Canada; CDNX:GAP)

8/11/10 8/11/10 16.7U $0. 18 N/A Capital Street Group C$3 ($2.9)

N/A

Follow-onOfferings


SEPTEMBERHalozyme Therapeutics Inc. (HALO)

1/5/10 9/8/10 8.3S $7.50 100.3 Barclays Capital $62.25 $752.25

MAP Pharmaceuticals Inc. (MAPP)

4/16/10 9/30/10 3S $14.50 29.7 Lazard Capital MarketsWedbush PacGrow Life Sci.

$43.5 $430.7

NPS Pharmaceuticals Inc. (NPSP)

8/5/09 9/16/10 7.9S $6 66.9 Jefferies & Co.Canaccord Gen. (Co-lead)

$47.4 $401 .4

Vertex Pharmaceuticals Inc. (VRTX)

2/19/10 9/24/10 N/A N/A N/A Bank of America Merrill Lynch

$400 N/A

Vical Inc. (VICL) 1/29/10 9/24/10 15S $2.25 71 .2 Jefferies & Co.Stifel Nicolaus Weisel (Co-Lead)Canaccord Genuity

$33.75 $160.2

OCTOBERAnadys Pharmaceuticals Inc. (ANDS)

4/23/09 10/15/10 13.9S $1 .80 57. 1 Lazard Capital Markets $25 $102.78

Ariad Pharmaceuticals Inc. (ARIA)

1/21/10 10/25/10 16S $3.70 126.9 Jefferies & Co. Inc.Oppenheimer & Co. (co-lead)

$59.2 $469.53

Celgene Corp. (CELG)

10/4/10 10/5/10 Notes N/A N/A Citigroup Global MarketsJ.P. Morgan Sec. (Co-Lead)Morgan Stanley (Co-Lead)

$1 .25B N/A

Chelsea Therapeutics International Inc. (CHTP)

9/30/10 10/4/10 8.21S $4.90 49.07 Deutsche Bank Sec.Needham & Co. LLC

$40.23 $240.4

Cubist Pharmaceuticals Inc. (CBST)

10/19/10 10/19/10 Conver-tible notes

NA N/A Goldman Sachs & Co.Morgan Stanley (co-lead)Citigroup Global MarketsRBC Capital Markets

$450 N/A

Cytori Therapeutics Inc. (CYTX)

2/11/09 10/8/10 4.6S $4.50 50.5 Jefferies & Co. Inc. $20.7 $227.25

Dynavax Technologies Corp. (DVAX)

10/6/10 10/28/10 26.45S $1 .70 114.75 Jefferies & Co.Wedbush PacGrowCowen and Co.

$44.97 $195. 1

GTx Inc. (GTXI) 1/17/08 10/27/10 14.3S $2.80 50.7 Lazard Capital Markets $40 $141 .96

Follow-onOfferings


OncoGenex Pharmaceuticals Inc. (OGXI)

7/17/09 10/19/10 3.2U $15.75 9.7 Stifel Nicolaus WeiselNeedham & Co.Rodman & RenshawWedBush PacGrow

$50 $152.8

Regeneron Pharmaceuticals Inc. (REGN)

10/6/10 10/8/10 6.325S $27.69 86.33 Citibank Global Markets

$175. 14 $2,390.5

SunesisPharmaceuticals Inc. (SNSS)

5/20/10 10/4/10 44. 1U $0.35 265.3 Cowen and Co. LLCThinkEquity LLC

$15.5 $92.9

NOVEMBERAvanir Pharmaceuticals Inc. (AVNR)

9/23/09 11/16/10 20S $4.40 113.9 Jefferies & Co. Inc.Canaccord Genuity Inc.Wedbush PacGrow LifeSummer Street ResearchMerriman Capital

$88 $501 . 16

Cadence Phar-maceuticals Inc. (CADX)

9/17/09 11/8/10 12.5S $8 63. 1 Deutsche Bank SecuritiesLeerink Swann LLCJMP Securities Wedbush PacGrow Life SciencesCanaccord Genuity Inc.

$100 $504.8

Cerus Corp. (CERS)

12/17/08 11/10/10 7.37U $2.85 47.3 Jefferies & Co. Inc. Robert W. Baird (co-lead)

$21 $134.8

Exact Sciences Corp. (EXAS)

9/7/10 11/4/10 10S $6 50.5 Jefferies & Co. Inc.Robert W. Baird (co-lead)Lazard Capital MarketsRodman & Renshaw

$60 $303

Micromet Inc. (MITI)

11/2/09 11/12/10 9.9S $7.30 90.9 Piper Jaffray $72.27 $663.57

NeoStem Inc. (AMEX:NBS)

5/19/10 11/17/10 6.34U $1 .45 64. 1 Cowen and Co.Maxim Group LLCNational Sec. Corp.

$9.2 $92.9

PharmAthene Inc. (AMEX:PIP)

2/13/09 11/1/10 4.945S $3.50 41 .05 Roth Capital Partners $17.3 $143.7

Somaxon Pharmaceuticals Inc. (SOMX)

11/19/10 11/19/10 8.8S $2.95 44.2 Piper Jaffray & Co. $25.96 $130.39

DECEMBERAastrom Biosciences Inc. (ASTM)

12/10/10 12/10/10 10U $2.25 38.6 Stifel Nicolaus WeiselNeedham and Co. LLCRoth Capital partners

$22.5 $86.85

Geron Corp. (GERN)

7/22/09 12/7/10 20S $5 122.6 J.P. MorganLazard Capital (co-lead)Rodman & RenshawRoth Capital partnersWBB Securities

$100 $613

Follow-onOfferings


Momenta Pharmaceuticals Inc. (MNTA)

12/22/09 12/09/10 4.219S $14.35 49.62 UBS Investment BankCowen and Co.Canaccord Genuity

$60.54 $712.05

Sequenom Inc. (SQNM)

10/5/10 12/3/10 16. 1S $6 92.4 Jefferies & Co. Inc.Lazard Capital MarketsPiper Jaffray & Co.

$96.6 $554.4

XenoPort Inc. (XNPT)

7/13/10 12/9/10 4S $7. 15 34.6 Morgan StanleyRBC Capital MarketsWedbush Pacgrow Life

$28.6 $247.39

YM BioSciences Inc. (Canada; AMEX:YMI)

11/30/10 12/14/10 28.75S $1 .60 109.95 Roth Capital PartnersJMP SecuritiesRodman & Renshaw

$46 $175.92

Total: $5,639.09MNumber of follow-on offerings in 2010: 72Average value of follow-ons in 2010: $78.32M

Notes:# Unless otherwise indicated, shares are traded on the Nasdaq exchange.@ This column reflects the shares outstanding following the offering, when disclosed.% Market capitalization is calculated based on the offering price.AMEX = American Stock Exchange; BR = Brussels Stock Exchange; CDNX = Canadian Venture Stock Exchange; OTC BB = Over-the-Coun-ter Bulletin Board.Currency conversions are based on exchange rates at the time of the deal.

Follow-onOfferings


After-Market Performance: IPO Class Of 2010Company (Symbol)# Offering

DateOffering Price

12/31/10 Close Percent Change

FEBRUARYIronwood Pharmaceuticals Inc. (IRWD) 2/3 $11 .25 $10.35 -8%

MARCHAnthera Pharmaceuticals (ANTH) 3/2 $7 $4.88 -30%

AVEO Pharmaceuticals Inc. (AVEO) 3/12 $9 $14.62 +62%

CorMedix Inc. (AMEX:CRMD-U) 3/26 $6.50 $1 .82 -72%

APRILAlimera Sciences Inc. (ALIM) 4/22 $11 $10.38 -6%

Codexis Inc. (CDXS) 4/22 $13 $10.60 -18%

Tengion Inc. (TNGN) 4/9 $5 $2.54 -49%

AUGUSTNuPathe Inc. (PATH) 8/6 $10 $9.06 -9%

Trius Therapeutics Inc. (TSRX) 8/4 $5 $3.71 -26%

OCTOBERAegerion Pharmaceuticals Inc. (AEGR) 10/25 $9.50 $14. 17 +49%

Pacific Biosciences Inc. (PACB) 10/27 $16 $15.91 -1%

NOVEMBERAnacor Pharmaceuticals Inc. (ANAC) 11/24 $5 $5.37 +7%

Complete Genomics Inc. (GNOM) 11/12 $9 $7.47 -17%

Zogenix Inc. (ZGNX) 11/23 $4 $5.67 +42%

DECEMBERVentrus Biosciences Inc. (VTUS) 12/17 $6 $6.62 +10%

Notes:

This chart includes IPOs of biotechnology companies conducted on U.S. markets. None occurred in the months of January, May, June, July and September.


AMEX = American Stock Exchange


After-Market Performance: Follow-On Offerings Class Of 2010Company (Symbol)# Offering Date Offering

Price12/31/10 Close

Percent Change

JANUARYAastrom Biosciences Inc. (ASTM) 1/15 $0.26 ($2.08

adjusted)$2.56 +23%

Achillion Pharmaceuticals Inc. (ACHN) 1/22 $2.08 $4. 15 +100%

AMAG Pharmaceuticals Inc. (AMAG) 1/21 $48.25 $18. 10 -62%

InterMune Inc. (ITMN) 1/21 $14. 10 $36.40 +158%

Pharmasset Inc. (VRUS) 1/28 $18.75 $43.56 +50%

Sinovac Biotech Ltd. (China; SVA) 1/28 $5.75 $4.52 -21%

Synta Pharmaceuticals Inc. (SNTA) 1/8 $4.50 $6. 12 +36%

ZymoGenetics Inc. (ZGEN) 1/7 $6 $9.76 +63%

FEBRUARYDiscovery Laboratories Inc. (DSCO) 2/19 $0.60 ($8. 10

adjusted)$3.33 -59%

Labopharm (Canada; DDSS) 2/12 $1 .70 $0.97 -43%

NeoStem Inc. (AMEX:NBS) 2/11 $1 .35 $1 .41 +4%

Optimer Pharmaceuticals Inc. (OPTR) 2/25 $11 $11 .31 +3%

Senomyx Inc. (SNMX) 2/16 $2.80 $7. 13 +155%

MARCHDyax Corp. (DYAX) 3/25 $3.25 $2. 16 -34%

Lexicon Pharmaceuticals Inc. (LXRX) 3/17 $1 . 15 $1 .44 +25%

Micromet Inc. (MITI) 3/12 $7 $8. 12 +16%

Neurocrine Biosciences (NBIX) 3/5 $2.20 $7.64 +247%

Somaxon Pharmaceuticals Inc. (SOMX) 3/29 $8.25 $3. 15 -62%

Theravance Inc. (THRX) 3/25 $11 .50 $25.07 +118%

APRILARCA Biopharma Inc. (ABIO) 4/1 $6.33 $3. 17 -50%

Ardea Biosciences Inc. (RDEA) 4/9 $20 $26 +30%

Dynavax Technologies Corp. (DVAX) 4/13 $1 .45 $3.20 +121%

Exact Sciences Corp. (EXAS) 4/14 $4.50 $5.98 +33%

Idenix Pharmaceuticals Inc. (IDIX) 4/30 $4.35 $5.04 +16%

Nile Therapeutics Inc. (NLTX) 4/23 $0.70 $0.62 -11%

NPS Pharmaceuticals Inc. (NPSP) 4/16 $5.50 $7.90 +44%

MAYAvanir Pharmaceuticals Inc. (AVNR) 5/7 $2.75 $4.08 +48%

ImmunoGen Inc. (IMGN) 5/7 $8 $9.26 +16%

Jazz Pharmaceuticals Inc. (JAZZ) 5/12 $8.35 $19.68 +136%

Pharmasset Inc. (VRUS) 5/14 $29 $43.56 +50%

RegeneRx Bio- pharmaceuticals Inc. AMEX:RGN; now OTC BB:RGNXW)

5/19 $0.41 $0.06 -85%

Ziopharm Oncology Inc. (ZIOP) 5/28 $5 $4.66 -7%


JUNEClinical Data Inc. (CLDA) 6/9 $14.30 $15.91 +11%

Corcept Therapeutics Inc. (CORT) 6/25 $3 $3.86 +29%

Discovery Laboratories Inc. (DSCO) 6/18 $0.28 ($3.60 adjusted)

$3.33 -8%

JULYBioMimetic Therapeutics Inc. (BMTI) 7/15 $8.50 $12.70 +49%

SEPTEMBERHalozyme Therapeutics Inc. (HALO) 9/8 $7.50 $7.92 +6%

MAP Pharmaceuticals Inc. (MAPP) 9/30 $14.50 $16.74 +13%

NPS Pharmaceuticals Inc. (NPSP) 9/16 $6 $7.90 +32%

Vical Inc. (VICL) 9/24 $2.25 $2.02 -10%

OCTOBERAnadys Pharmaceuticals Inc. (ANDS) 10/15 $1 .80 $1 .42 -21%

Ariad Pharmaceuticals Inc. (ARIA) 10/25 $3.70 $5. 10 +38%

Chelsea Therapeutics International Inc. (CHTP) 10/4 $4.90 $7.50 +53%

Cytori Therapeutics Inc. (CYTX) 10/8 $4.50 $5. 19 +15%

Dynavax Technologies Corp. (DVAX) 10/28 $1 .70 $3.20 +88%

GTx Inc. (GTXI) 10/27 $2.80 $2.65 -5%

OncoGenex Pharmaceuticals Inc. (OGXI) 10/19 $15.75 $16.79 +7%

Regeneron Pharmaceuticals Inc. (REGN) 10/8 $27.69 $32.87 +19%

Sunesis Pharmaceuticals Inc. (SNSS) 10/4 $0.35 $0.52 +49%

NOVEMBERAvanir Pharmaceuticals Inc. (AVNR) 11/16 $4.40 $4.08 -7%

Cadence Phar-maceuticals Inc. (CADX) 11/8 $8 $7.55 -6%

Cerus Corp. (CERS) 11/10 $2.85 $2.46 -14%

Exact Sciences Corp. (EXAS) 11/4 $6 $5.98 -0.3%

Micromet Inc. (MITI) 11/12 $7.30 $8. 12 +16%

NeoStem Inc. (AMEX:NBS) 11/17 $1 .45 $1 .41 -3%

PharmAthene Inc. (AMEX:PIP) 11/1 $3.50 $4.23 +21%

Somaxon Pharmaceuticals Inc. (SOMX) 11/19 $2.95 $3. 15 +7%

DECEMBERAastrom Biosciences Inc. (ASTM) 12/10 $2.25 $2.56 +14%

Geron Corp. (GERN) 12/7 $5 $5. 19 +4%

Momenta Pharmaceuticals Inc. (MNTA) 12/09 $14.35 $14.97 +4%

Sequenom Inc. (SQNM) 12/3 $6 $8.03 +34%

XenoPort Inc. (XNPT) 12/9 $7. 15 $8.52 +19%

YM BioSciences Inc. (Canada; AMEX:YMI) 12/14 $1 .60 $2.33 +46%

Notes:

This chart includes U.S. follow-on offerings of biotechnology companies. None occurred in the month of August.


AMEX = American Stock Exchange; OTC BB = Over-the-Counter Bulletin Board.

After-MarketPerformance:Follow-onOfferings


536

127

494248

621

57 48 2.9

587

2171

394 354

0200400600800

1000120014001600180020002200

Jan. (8) Feb. (6) March (7) April (8) May (8) June (3) July (1) Aug. (1) Sept. (5) Oct. (11) Nov. (8) Dec. (6)

2010 Initial Public Offerings

19 IPOs; $1 ,220.76M Total Gross Proceeds

Month (Number of IPOs)

Gro

ss P

roce

eds

($M

)

536

127

494248

621

57 48 2.9

587

2171

394 354

0200400600800

1000120014001600180020002200

Jan. (8) Feb. (6) March (7) April (8) May (8) June (3) July (1) Aug. (1) Sept. (5) Oct. (11) Nov. (8) Dec. (6)

72 Follow-on Offerings; $5,639M Total Gross Proceeds

Month (Number of Offerings)

Gro

ss P

roce

eds

($M

)

2010 Follow-on Offerings


1,2641,981

498735

867186

520784

419320

19393

396340

2,3944,020

7,9922,386

3,9368,907

1,191866

2131,533

569417

199196

506274

1,3641,544

1,9371,207

981,281

1,685840

1,5871,476

1,9511,160

5003,0171,403

2,385481

8561,193

277779

0479

1,2092,685

2,9713,455

4,7685,347

5,748

0 1,000 2,000 3,000 4,000 5,000 6,000 7,000 8,000 9,000 10,000

1Q:962Q:963Q:964Q:961Q:972Q:973Q:974Q:971Q:982Q:983Q:984Q:981Q:992Q:993Q:994Q:991Q:002Q:003Q:004Q:001Q:012Q:013Q:014Q:011Q:022Q:023Q:024Q:021Q:032Q:033Q:034Q:031Q:042Q:043Q:044Q:041Q:052Q:053Q:054Q:051Q:062Q:063Q:064Q:061Q:072Q:073Q:074Q:071Q:082Q:083Q:084Q:081Q:092Q:093Q:094Q:091Q:102Q:103Q:104Q:10

Gross Proceeds ($M)

Qua

rter

:Yea

rGross Proceeds of Biotech Public Stock Offerings

First Through Fourth Quarter 1996-2010Initial and Follow-on Offerings Combined


5,3685,189

10,75537,658

14,06510,248

16,48520,814

20,11520,287

24,77411,084

17,58119,318

0 10,000 20,000 30,000 40,000 50,000

19971998199920002001200220032004200520062007200820092010

In Millions ($M)

Year

Biotech Money Raised: 1997 - 2010Biotech Money Raised: 1997-2010

BioWorld® State of the Industry Report 2011 47

790

810

830

850

870

890

910

930

950

970

990 Nasdaq Stock Index 2010

-5

0

5

10

15

20

25

30 BioWorld Stock Index 2010

Nasdaq Stock Index

BioWorld Stock Index 2010

1/1/2010

1/29/2010

2/26/2010

3/26/2010

4/23/2010

5/21/2010

10/8/2010

9/10/2010

8/13/2010

12/3/2010

6/18/2010

7/16/2010

11/5/2010

12/31/2010

3/26/2010

4/23/2010

5/21/2010

2/26/2010

1/1/2010

1/29/2010

12/31/2010

12/3/2010

11/5/2010

8/13/2010

7/16/2010

6/18/2010

9/10/2010

10/8/2010

Other Financings Of Public Biotech Companies In 2010TOTAL: $7,975. 1MCompany(Symbol)#

Type OfFinancing

Number OfShares, UnitsOr Warrants (M)

AmountRaised(M)

Investors; Placement Agents; Details(Date)@

JANUARYAccessPharmaceuticalsInc. (OTC BB:ACCP)

Registered directoffering

2. 1S $6.3 Access raised $6.3M offering 2. 1M shares at $3each; Rodman & Renshaw LLC acted as sole lead placement agent; EarlyBirdCapital Inc. acted as a subagent (1/25)

AdventrxPharmaceuticalsInc. (AMEX:ANX)

Registered direct offering of Series Econvertible pre-ferred stock

W for 12.5S $19 Investors received preferred stock convertibleinto shares of common stock at a conversionprice of $0.38115; investors also will receivewarrants to purchase an aggregate of 12.5Mshares (1/5)

BioInventInternationalAB (Sweden;SSE:BINV)

Privateplacement ofcommon stock

5.4S SEK150($21)

BioInvent raised $21M issuing 5.4M new shares subscribed by DnB NOR Asset Management and B&E Participation AB (1/15)

CellTherapeuticsInc. (CTIC)

Private placement ofstock and warrants

24.7S andW for 8.6S

$30 Cell Therapeutics raised $30M through the sale of preferred stock convertible into 24.7M shares and the sale of warrants to buy up to 8.6M shares priced at $1 . 18 apiece (1/15)

CortexPharmaceuticalsInc. (OTC BB:CORX)

Private placementof a convertible promissory note

N/A $1 .5 Cortex completed a $1 .5M private placement of a convertible promissory note with Samyang Optics Co. Ltd., of Korea (1/19)

Curis Inc.(CRIS)

Registereddirect offering

6.4U $16.25 Curis raised $16.25M offering 6.4M units at $2.52 per unit; RBC Capital Markets is acting as the sole lead placement agent, and Rodman & Renshaw LLC is co-agent (1/25)

CyclacelPharmaceuticalsInc. (CYCC)


N/A $7.2;$5.9

Cyclacel raised $7.2M and could raise another$2.3M as part of the offering with select insti-tutional investors; Roth Capital Partners LLC served as sole placement agent, while Merriman Curhan Ford & Co. served as finan-cial advisor (1/12); company planned to raise $5.9M in gross proceeds and up to another $2M in a registered direct offering to certain existing institutional investors; it involves the sale of 2.35M units at $2.50 each (1/22)

EntreMed Inc.(ENMD)


3. 1S $2.5 EntreMed raised $2.5M offering 3. 1M shares at80 cents apiece; Wharton Capital Markets LLC acted as exclusive placement agent (1/13)

GenVec Inc.(GNVC)


14U $28 GenVec raised $28M offering 14M units priced at $2 each; each unit consists of one commonshare and 0.30 five-year warrants to purchasean additional common share at an exercise price of $2.75 (1/28)

Geron Corp.(GERN)


N/A $10 Geron sold shares of stock to investors for gross proceeds of $10M (1/19)


OtherFinancingsOfPublicBiotechCompanies


Company(Symbol)#

Type OfFinancing


AmountRaised(M)


MDRNA Inc.(MRNA)


5.4S andW for 3.5S

$5.5 MDRNA raised $5.5M through the sale of 5.4Mshares priced at $1 .02125 per share; investors also will receive warrants to buy about 3.5M shares at $1 each (1/15)

Oragenics Inc.(AMEX:ONI)


10.01S $2.5 Oragenics placed 10.01M shares at 25 cents per share for $2.5M (1/6)

Osteologix Inc.(OTC BB:OLGX)

Securitiespurchaseagreement

1 .99S $1 Osteologix raised $1M by selling 1 .99M shares (1/6)

Pharming Group NV(the Netherlands;Amsterdam:PHARM)

Convertibledebtfinancing

N/A �7.5($10.8)

Pharming Group secured a convertible debt financing structured as a one-year, nonlisted convertible debt instrument that is convert-ible into Pharming shares at 72 cents (1/6)

ResverlogixCorp. (Canada;TSX:RVX)

Privateplacement

3. 19S C$8($7.5)

Completed a $7.5M second tranche of a place-ment announced in December, issuing about 3. 19M common shares at C$2.50 per unit (1/29)

RosettaGenomics Ltd.(ROSG)


2.5S andW for 1 .3S

$5. 1 Rosetta raised $5. 1M selling 2.5M shares and warrants for 1 .3M shares in units; Rodman & Renshaw LLC acted as exclusive placement agent(1/15)

SilenceTherapeuticsplc (UK; LSE:SLN)

Privateplacement

N/A £15($24)

Silence raised $24M via a subscription and placing with institutional investors and the investment vehicles of major pharmaceutical companies; this occurred following its merger with Intradigm Corp. (1/7)

Vical Inc. (VICL) Equity facility N/A – Vical secured an issuer-managed equity facili-ty under which it may sell up to $25M of com-mon stock to Azimuth Opportunity Ltd. over a 24-month period (1/12)

WEXPharmaceuticalsInc. (Canada;TSX:WXI)

Rights offering N/A C$34.51($32.36)

WEX said its rights offering is fully subscribed and the company is issuing 265.48M restrict-ed voting shares at C$0. 13 per share, for gross proceeds of C$34.51M; Pharmagesic Holdings Inc. is acquiring an additional equity stake (1/28)

FEBRUARYAccessPharmaceuticalsInc. (OTC BB:ACCP)

Privateplacement ofstock andwarrants

2. 1S and Wfor 1 .05S

$6.3 Access raised $6.3M through the placement (2/3)

AngelBiotechnologyHoldings plc(UK; LSE:ABH)

Privateplacement

N/A £1 .4($2.2)

Angel raised $2.2M in a private placement (2/10**)

BrainStormCell Thera-peutics Inc.(OTC BB:BCLI)

Investment $2S $1 .5 BrainStorm raised $1 .5M from three investors (2/18)



Company(Symbol)#

Type OfFinancing


AmountRaised(M)


CardiomePharma Corp.(Canada; CRME)

Credit facility N/A $25 Cardiome drew down $25M from a $100M credit facility provided by Merck & Co. Inc. (2/18)

EntreMed Inc.(ENMD)

Registereddirectoffering

3.8S $2.5 EntreMed raised $2.5M through the direct sale of 3.8M shares priced at 65 cents each (2/8)

GTC Biothera-peutics Inc.(GTCB)

Loan N/A $7 GTC got a $7M loan from its partner LFB Biotechnologies, with a term of 36 months and an interest rate of 4% (2/23)

ICoTherapeuticsInc. (Canada;CDNX:ICO)

Exercisedcommon sharepurchasewarrants

3.2W $0.969 ICo said about 3.2M common share purchase warrants were exercised for proceeds of $968,813 (2/11)

IntellectNeurosciencesInc. (OTC BB:ILNS)

Interimfinancing

N/A ND Several shareholders agreed to provide inter-im funding (2/11)

Neuralstem Inc.(AMEX:CUR)

Privateplacementand warrantexercise

0.647Sand W

$5.2 Neuralstem raised $1 .5M through the place-ment and $3.7M from warrant exercises (2/19)

PalatinTechnologiesInc. (AMEX:PTN)


9.6U $2.6 Palatin raised $2.6M selling 9.6M units at 27 cents each; each unit consists of one share of common stock, a Series A warrant to purchase 0.33 of one share at 30 cents per share, and a Series B warrant to purchase 0.33 of one share at 27 cents per share (2/26)

PoniardPharmaceuticalsInc. (PARD)

Committedequity facility

N/A – Poniard entered a committed equity financingfacility under which it may sell up to $20M of common stock to Commerce Court Small Cap Value Fund Ltd. over an 18-month period (2/25)

ProMetic LifeSciences Inc.(Canada; TSX:PLI)

Loan andinvestment

N/A $13 ProMetic secured a $10M loan for five years, plus received a $3M investment for 17.85M common shares of ProMetic to Abraxis BioScience (2/12)

Pro-Pharma-ceuticals Inc.(AMEX:PRW)


N/A $0.325 Pro-Pharmaceuticals closed a $325,000 tranche of a private placement through the sale of stock and warrants to 10X Fund LP (2/3)

ProtoxTherapeuticsInc. (Canada;TSX:PRX)

Privateplacementof units

N/A C$6.5($6. 18)

Protox raised $6. 18M in the private placement at C45 cents per unit (2/8; revised 3/1)

SironaBiochem Corp.(Canada; CDNX:SBM)

Privateplacement

2. 15U $0.215 Sirona raised $215,000 in the nonbrokered pri-vate placement of 2. 15M units, each compris-ing one common share and one transferrable share purchase warrant, priced at 10 cents per unit (2/2)



Company(Symbol)#

Type OfFinancing


AmountRaised(M)


SpectralDiagnosticsInc. (Canada;TSX:SDI)


N/A $4.38 Spectral raised an additional $4.38M for a total of $18.38M in the private placement; $14M of the total was accounted for in December 2009 (2/4)

Uluru Inc.(AMEX:ULU)


5S $1 Uluru raised $1M through the sale of 5M shares at 20 cents each; Rodman & Renshaw managed the offering (2/4)

Vernalis plc(UK; LSE:VER)


39.4S £30($47)

Vernalis raised $47M that it will use to buy back its royalty stream from Paul Capital Healthcare for frovatriptan (2/16)

Vyteris Inc.(OTC BB:VYTR)

Private place-ment of seniorsubordinatedconvertiblepromissorynotes

Notes andW for 5.3S

$1 .06 Vyteris raised $1 .06M through the placement(2/9)

XOMA Ltd.(XOMA)


42U $21 XOMA sold 42M units for 50 cents apiece, with each unit consisting of one common share and one five-year warrant to purchase 0.45 common shares at an exercise price of 70 cents; Lazard Capital Markets LLC served as the sole bookrunning manager for the offering (2/3)

MARCHAgennix AG(Germany; FSE:AGXA)

Privateplacement

1 .87S �9.8($13)

Agennix raised about $13M in a private place-ment (3/23)

AmicusTherapeuticsInc. (FOLD)


4.9S andW for 1 .85S

$18.5 Amicus is offering to sell 4.9M shares and warrants to buy up to about 1 .85M shares at $3.74 each (3/1)

Biomoda Inc.(OTC BB:BMOD)

Privateplacement

N/A $2 Biomoda raised $2M in stock with a syndicate of institutional investors; LifeTech Capital acted as the exclusive placement agent (3/18)

BioSantePharmaceuticalsInc. (BPAX)


10.4S andW for 5.2S

$18 BioSante raised $18M through Great Point Partners LLC and Deerfield Management Co. (3/5)

BradmerPharmaceuticalsInc. (Canada;TSX:BMR)


10.5S $1 Bradmer is raising $1M through the placement of up to 10.5M shares at 9.5 cents per share (3/5)

CardiumTherapeuticsInc. (AMEX:CXM)


2.3U $11 .3 Cardium raised $11 .3M offering 2.3M units at $5 each (3/10)

ChelseaTherapeuticsInternationalLtd. (CHTP)


6.7S andW for 2.3S

$18.2 Chelsea raised $18.2M in the offering; Leerink Swann served as lead placement agent, with Needham & Co. LLC as co-placement agent (3/9)

ClevelandBioLabs Inc.(CBLI)

Privateplacement ofcommon stockand warrants

1 .53S and W for 1 .01S

$5 Cleveland BioLabs raised $5M in the place-ment (3/1)



Company(Symbol)#

Type OfFinancing


AmountRaised(M)


CytoCore Inc.(OTC BB:CYOE)

Investment 2.7S and0.217W

$1 .35 CytoCore said NeoMed Management is taking a 6.3% investment in the company (3/12)

DARABioSciencesInc. (DARA)

Privateplacementof commonstock andwarrants

3.6S andW for 1 .8S

$1 .7 DARA raised $1 .7M through the sale of 3.6M shares of common stock and warrants to pur-chase 1 .8M shares of common stock (3/2)

Fibrocell Science Inc.(OTC BB:FCSC)


5. 1U $3.8 Fibrocell raised $3.8M placing 5. 1M units at 75cents each, with each unit consisting of one common share and one warrant to purchase an additional share at 98 cents (3/4)

Genta Inc.(OTC BB:GNTA)

Privateplacement ofconvertiblenotes

N/A $25 Genta is raising $25M in the placement (3/9)

InterleukinGenetics Inc.(AMEX:ILI)


4.37S andW for 1 .75S

$5.3 Interleukin raised $5.3M in the offering; Rodman & Renshaw acted as placement agent (3/8)

LexiconPharmaceuticalsInc. (LXRX)

Privateplacement

88.29S $101 .5 Lexicon raised $101 .5M through a private placement with Invus LP; the placement was done concurrently with a public offering and included an original 59.29M-share placement, plus an additional 29M shares purchased later (3/17)

MabCure Inc.(OTC BB:MBCI)

Privateplacement

2U $1 MabCure secured $1M through a $500,000 cash investment and the conversion of a $500,000 bridge loan (3/9)

MedgenicsInc. (IsraelLSE:MEDG)

Privateplacement

14.3S £0.73($1 . 1)

Medgenics raised $1 . 1M pricing 14.3M shares at 5 pence each and another 192,591 shares at 6.5 pence each (3/8)

Medivir AB(Sweden; SSE:MVIRB)

Rightsoffering

N/A SEK300($41 .2)

Medivir raised $41 .2M through the rights offering of class B shares to existing share-holders (3/30)

MethylGeneInc. (Canada;TSX:MYG)

Investment N/A C$8.9($8.7)

MethylGene entered an agreement to raise gross proceeds of up to $8.7M in nondilutive capital from 1819400 Ontario Inc. and 1815303 Ontario Ltd. (3/29)


Warrantexercise

1S $1 .75 NeoStem raised $1 .75M with RimAsia Capital Partners LP exercising its warrant to purchase1M shares at $1 .75 each (3/19)

NexMed Inc.(NEXM)

Refinance N/A $1 .4 NexMed raised $1 .4M from refinancing the mortgage on its manufacturing facility in New Jersey; the mortgage secures the issuance of new convertible notes due Dec. 31 , 2012, which total $4M (3/18)

NPSPharmaceuticalsInc. (NPSP)

Sale of royalty rights

N/A $38.4 NPS raised $38.4M by selling royalty rights forhyperparathyroidism drug Regpara to a fund managed by DRI Capital Inc. (3/3)

Orexo AB(Sweden;SSE:ORX)

Placement ofconvertiblebonds

N/A SEK111($15.6)

Orexo raised $15.6M by placing a convertible bond with Novo (3/16)



Company(Symbol)#

Type OfFinancing


AmountRaised(M)


OxiGene Inc.(OXGN)


6.6S $7.5 OxiGene is raising about $7.5M through the sale of about 6.6M shares of common stock and warrants to certain institutional investors; Roth Capital Partners LLC acted as the sole placement agent (3/12)

PoniardPharmaceuticalsInc. (PARD)


4.2S $6.3 Poniard raised $6.3M through the sale of about 4.2M shares of common stock priced at $1 .49 each to Commerce Court Small Cap Value Fund Ltd. under an existing committed equity financing facility (3/16)

Prolor BiotechInc. (Israel;BE:M3D)


10.3S $24.4 Prolor raised $24.4M for about 10.3M shares ofcommon stock to accredited investors at $2.35 per share (3/19)

Pro-Pharma-ceuticals Inc.(OTC BB:PRWP)

Private placement ofSeries B convertiblepreferred stock andwarrants

N/A $0.335 Pro-Pharmaceuticals closed a $335,000 tranche of a private placement of up to $6M with 10X Fund LP (3/12)

ProvectusPharmaceuticalsInc. (OTC BB:PVCT)


7. 1S andW for 3.55S

$7.5 Provectus raised $7.5M through a placement of 10M shares priced at 75 cents each plus warrants to buy another 5M shares with an exercise price of $1 (3/15)

ResponseGenetics Inc.(RGDX)


3S $4 Response Genetics raised $4M in a placement of 3M shares at $1 .31 each; investors were new and existing investors and certain funds man-aged by Lansdowne Partners LP (3/9)

RXiPharmaceuticalsCorp. (FSE:RXK)

Private placement ofcommon stock and warrants

2.7S andW for 0.54S

$16.2 RXi is raising about $16.2M through the sale ofunits priced at $6 each; Rodman & Renshaw LLC is exclusive placement agent (3/24)

SemBioSysGenetics Inc.(Canada;PK:SBIYF)

Private placement ofshares

10.2S C$1 .8($1 .74)

SemBioSys raised $1 .74M in a placement of 10.2M shares priced at C17.5 cents each (3/4)

SenescoTechnologiesInc. (AMEX:SNT)

Privateplacement ofconvertiblepreferredstock andwarrants

0.011S andW for 35.9S

$11 .497 Senesco is raising $11 .497M through the place-ment of up to 11 ,497 shares of convertible pre-ferred stock and warrants to purchase up to 35.9M shares (3/30)

SyntopixGroup plc (UK;LSE:SYN)

Privateplacement

2.99S $3.8 Syntopix raised $3.8M in a placing of 2.99M shares (3/17**)

ThromboGenicsNV (Belgium;

Exercise ofwarrants

N/A �0.6($0.798)

ThromboGenics raised $797,763 through the exercise of warrants by a number of the com-BR:THR)

UnigeneLaboratoriesInc. (OTC BB:UGNE)

Three-yearconvertiblesenior securedterm notesplacement

N/A $13.64 Unigene issued $33M in notes due 2013, in ex-change for about $19.36M of existing noncon-vertible senior secured term notes, which are due in 2011 , and the payment of $13.64M in cash; an entity managed by Victory Park Capital Advisors LLC is the sole investor in the transaction (3/18)



Company(Symbol)#

Type OfFinancing


AmountRaised(M)


Wilex AG(Germany;BE:WL6)

Standby equitydistributionagreement

N/A – Wilex can draw down up to $27. 1M through thestock deal with YA Global Master SPV Ltd. (3/24)

YM BioSciencesInc. (Canada;AMEX:YMI)


N/A $17.5 YM raised $17.5M through the placement of units at $1 .20 each; Roth Capital partners LLC served as lead placement agent (3/9)

APRILActiveBiotech AB(Sweden;SSE:ACTI)

Share offering

N/A SEK149($20.7)

Active Biotech raised $20.7M in a new share offering that was managed by Sectoral Asset Management (4/2)

AdherexTechnologiesInc. (AMEX:ADH)

Privateplacement

N/A C$7.2($7.2)

Adherex entered agreements with SouthpointCapital Advisors LP and certain other inves-tors for a $7.2M private placement (4/22)

AEternaZentaris Inc.(Canada;TSX:AEZ)


11 . 1S andW for 4.4S

$15 AEterna is selling $15M worth of securities to institutional investors (4/19)

Affitech A/S(Denmark;CSE:AFFI)

Investment N/A �20.9($28)

Affitech raised $28M through the investment from Trans Nova Investments Ltd. (4/22)

ALDAPharmaceuticalsCorp. (Canada;CDNX:APH)


3.08U $0.616 ALDA raised $616,000 by placing 3.08M units at 20 cents each; each unit consists of one common share of ALDA and one nontransfer-able share purchase warrant (4/30)

AlnylamPharmaceuticalsInc. (ALNY)

Investment 0.055S $0.993 Alnylam raised $993,462 from partner Novartis AG, which elected to exercise fully its right to purchase 55,223 shares (4/27)

AntheraPharmaceuticalsInc. (ANTH)


2.6S $17. 1 Anthera raised $17. 1M placing 2.6M shares at $6.58 each (4/8)

Benitec Ltd.(Australia;ASX:BLT)

Privateplacement oftwo-yearconvertiblenotes

N/A A$6.47($6)

Benitec raised $6M through the issuance of four two-year convertible notes (4/13)

BioAlliancePharma SA(France; Paris:BIO)

Equity stake N/A ND Therabel Group took an equity stake in BioAlliance, according to a European license agreement for Loramyc and Setofilm worth $68.9M (4/28)

BioDeliverySciencesInternationalInc. (BDSI)


2.8S andW for 1 .4S

$10 BioDelivery raised $10M selling 2.8M shares priced at $3.54 each and issued warrants for about 1 .4M additional shares (4/21)

CannasatTherapeuticsInc. (Canada;CDNX:CTH)


N/A C$2.5($2.5)

Cannasat raised $2.5M through a placement of units, each consisting of one common share and one-half of a warrant, at a price of 10 cents per unit; Wellington West Capital Inc. is acting as lead placement agent (4/8)



Company(Symbol)#

Type OfFinancing


AmountRaised(M)



Private placementof common stock and warrants

Preferredstock and Wfor 20S

$20 Cell Therapeutics raised $20M in a stock sell to three institutional investors (4/1)

Cerus Corp.(CERS)

Credit facility N/A $5 Cerus received a $5M loan through a $10M credit facility from Oxford Finance Corp. (4/7)

CorceptTherapeuticsInc. (CORT)

Warrantexercise andprivateplacement

W for 4.3S $7.6 Corcept raised $7.6M through the exercise ofwarrants ($7. 1M) and a private placement of warrants to purchase 4.3M shares ($500,000) (4/23)

CytoDyn Inc.(PK:CYDY)

Privateplacements

N/A $3 CytoDyn raised $3M through an offering of restricted common stock to a select group of investors and an offering of convertible pre-ferred shares to a broader range of investors (4/1)

Diamyd MedicalAB (Sweden;SSE:DIAMB)

Privateplacement ofnew B shares

0.292S SEK35($4.8)

Diamyd raised $4.8M in the placement of 291 ,667 new B shares (4/1)

EntreMed Inc.(ENMD)


5.8S $3 EntreMed raised $3M in an offering of 5.8M shares for 51 .8 cents apiece (4/20)

EpigenomicsAG (Germany;FSE:ECX)

Privateplacement

N/A �33. 1($44.8)

Epigenomics raised $44.8M through an investment from Abingworth LLP (4/7)

GenerexBiotechnologyCorp. (GNBT)


2S $0.945 Generex raised $945, 180 in the first tranche of an agreement with Seaside 88 LP; Seaside can purchase up to 49.5M shares of stock, and intends to purchase 2M shares every two weeks in up to 25 tranches; Midtown Partners & Co. LLC acted as placement agent (4/9)

IGILaboratoriesInc. (AMEX:IG)

Private placement ofSeries C convertiblepreferred stock

N/A $1 .55 IGI raised $1 .55M through the placement (4/1)

Incuron LLC(joint venture ofClevelandBioLabs Inc.,CBLI, andBioprocessCapital Ventures)

Investment N/A $5.7 A $5.7M investment was put into Incuron by Bioprocess, which has committed to a total $18M investment (4/27)

ManhattanPharmaceuticalsInc. (OTC BB:MHAN)


121U $3 Manhattan closed its private placement sell-ing 121 units, including the conversion of about $400,000 of existing debt into 17 units, for an aggregate of $3M of its common stock and warrants to accredited investors (4/15)


Rights offering N/A $3.4 Priced its rights offering at SEK62 per share; some of the total money raised, $44.6M, was was accounted for in March (4/28)



Company(Symbol)#

Type OfFinancing


AmountRaised(M)


NovaDelPharma Inc. (OTC BB:NVDL)


9S and Wfor 4.5S

$1 .5 NovaDel raised $1 .5M through the sale of 9M shares of common stock to institutional investors at $0. 165 per share; the investors also will receive five-year warrants to buy about 4.5M shares at $0.25 per share; Chardan Capital Markets LLC served as the placement agent (4/1)

OndineBiopharmaCorp. (Canada;TSX:OBP)


12.5U C$0.75($0.75)

Ondine raised $749,868 through the issuance of 12.5M units, each consisting of one com-mon share and one share purchase warrant (4/7)

Pacgen Bio-pharmaceuticalsCorp. (Canada;CDNX:PGA)

Privateplacement ofsubscriptionreceipts

10 receipts C$0.6($0.6)

Pacgen raised $600,740 through the place-ment of 10M subscription receipts priced at C6 cents each (4/21)

PharmAtheneInc. (AMEX:PIP)


1 .67S andW for 0.5S

$2.5 PharmAthene raised $2.5M in the placement; Roth Capital Partners served as sole place-ment agent (4/9)

PolyMedixInc. (OTC BB:PYMX)

Credit facility N/A $10 PolyMedix took an advance of $10M on a $14Mcredit facility with Hercules Technology II, LP, an affiliate of Hercules Technology Growth Capital Inc. (4/2)

RadientPharmaceuticalsCorp. (AMEX:RPC)

Convertiblepromissory note andwarrantfinancing

N/A $10.4 The second note financing was offered to 25 accredited investors with similar discount terms and lender fees to that of the first financing for net proceeds of $3.225M with warrants to purchase 6.5M shares of common stock (4/15); the company had a third closing that raised another $3.9M; all told, the compa-ny raised $10.4M (4/19)

TransdelPharmaceuticalsInc. (OTC BB:TDLP)

Private debtfinancing

N/A $1 Transdel issued a two-year senior convertiblepromissory note with an annual interest rate of 7.5% to an existing shareholder (4/9)

ValeantPharmaceuticalsInternationalInc. (NYSE:VRX)

Privateplacement ofsenior unec-ured notes

N/A $35 Valeant priced its private placement of $400Mof 7.625% senior unsecured notes due 2020, with $365M going to repurchase 3% convert-ible subordinated notes due 2010; the rest is going toward and acquisition and general cor-porate purposes (4/8)

MAYAdventrxPharmaceuticalsInc. (AMEX:ANX)


1 .8S $19.2 Adventrx raised $19.2M in the offering, with Rodman & Renshaw LLC acting as the exclu-sive placement agent (5/4)



Company(Symbol)#

Type OfFinancing


AmountRaised(M)


AlexzaPharmaceuticalsInc. (ALXA)

Loanagreement

W for 0.376S $15 Alexza secured $15M through Hercules Technology Growth Capital, issuing warrants to purchase 376,394 shares of common stock at $2.69 per share (5/6); company obtained a committed equity facility to sell up to $25M of registered common stock to Azimuth Opportunity Ltd. over a 24-month period (5/28)

AnadysPharmaceuticalsInc. (ANDS)


5.8S $12.5 Anadys raised $12.5M in the offering of 5.8M shares at $2. 15 apiece (5/27)

AspenBioPharma Inc.(APPY)

Privateplacement of units

2.4U $10 AspenBio raised $10M by placing 2.4M units, each consisting of one share of common stock and one warrant to purchase 0.285 shares of stock (5/3)

BioTime Inc.(BTIM)

Exercise ofstock purchasewarrants

N/A $8 BioTime received an additional $8M from two investors who elected to exercise early and in full, the stock purchase warrants acquired under a May 2009 agreement; investors were Broadwood Partners LP and George Karfunkel (5/12)

BSD MedicalCorp. (BSDM)


1 .64S andW for 1 .23S

$2.5 BSD sold 1 .64M shares at $1 .52 per share for gross proceeds of about $2.5M; the company also was issuing warrants to purchase 1 .23M shares to the investors (5/4)

CBio Ltd.(Australia;ASX:CB2)

Convertibleloan agreement

N/A A$12.45($10.77)

CBio secured $10.77M in funding through SpringTree Special Opportunities Fund LP (5/19)



52.5S $21 Cell Therapeutics entered a deal to sell $21M of Series 5 preferred shares convertible into 52.5M shares to three institutional investors (5/25)

ConjuChemBiotechnologiesInc. (Canada;TSX:CJB)


N/A $30 ConjuChem is recapitalizing the company with new investors subscribing about $35M of new common shares, with $5M of the pro-ceeds going toward debt (5/19)

CriticalOutcomeTechnologiesInc. (Canada;CDNX:COT)


3U $1 Critical Outcome closed the first tranche of a placement of units, selling 3M units priced at 35 cents each; each unit comprises one com-mon share and one-half a share purchase war-rant (5/3)

International Stem Cell Corp.(OTC BB:ISCO)

Private placement of nonconvertible Series F preferred stock

N/A $10 International Stem Cell received a commit-ment for Socius CG II Ltd. to purchase up to $10M in stock (5/6)

La JollaPharmaceuticalCo. (OTC BB:LJPC)

Privateplacement

29S $6 La Jolla is raising $6M through the sale of 29Mshares, plus the sale of convertible preferred stock and three-year warrants (5/26)



Company(Symbol)#

Type OfFinancing


AmountRaised(M)


MagForce Nano-technologies AG(Germany;BE:MF6)

Standby equitydistributionagreement

N/A – MagForce can sell up to $26. 1M in shares through multiple tranches with YA Global Master SPV Ltd. (5/5)

MediciNovaInc. (MNOV)

Senior securedterm loan

N/A $15 MediciNova entered a $15M loan with Oxford Finance Corp. (5/12)

NeurogesXInc. (NGSX)

Financing N/A $40 NeurogesX signed a $40M deal with Cowen Healthcare Royalty Partners, creating a debt obligation to be repaid by royalties and mile-stones gained through an overseas Qutenza deal with Astellas Pharma Inc. (5/3)

Oxygen Bio-therapeuticsInc. (OXBT)


1 .7S andW for 0.732S

$4.93 Oxygen raised $4.93M through the sale of stock and warrants (5/5)

Paion AG(Germany;BE:PA8)

Equity facilityagreement

N/A �15($18.8)

Paion entered an $18.8M equity facility agree-ment with Commerce Court Small Cap Value Fund Ltd. managed by Acqua Capital Management Inc. (5/14)

Pro-Pharma-ceuticals Inc.(OTC BB:PRWP)

Privateplacement

N/A $0.31and $0.57

Pro-Pharmaceuticals raised $310,000 in a tranche of a private placement of up to $6M with 10X Fund LP (5/5); it closed on another $570,000 to complete the placement (5/12)

Sequenom Inc.(SQNM)

Privateplacement

12.435S $51 .6 Sequenom raised $51 .6M through the place-ment of shares at the huge discount of $4. 15 each; Jefferies & Co. Inc. was sole lead place-ment agent, and Lazard Capital Markets LLC served as co-placement agent (5/13)

TapimmuneInc. (OTC BB:TPIV)

Private placement ofsenior securedconvertiblenotes

N/A $1 .53 Tapimmune raised $1 .53M through the place-ment conducted by Olympus Securities LLC (5/20)

JUNEAeternaZentaris Inc.(Canada; TSX:AEZ)


8.8S $12. 1 Aeterna raised $12. 1M through institutional investors; Rodman & Renshaw LLC acted as the exclusive placement agent (6/17)

Ambrilia Biopharma Inc. (Canada; TSX:AMB)

Nondilutivefinancing

N/A $2 Ambrilia raised $2M in a nondilutive financing (6/3)

AoxingPharmaceuticalCo. Inc.(AMEX:AXN)

Bank loanfinancing

N/A $8.05 Aoxing completed a bank loan financing with China Citic Bank and Bank of Communications of China (6/9)

Aradigm Corp.(OTC BB:ARDM)


34.7S and7.5W

$5 Aradigm raised $5M through a private place-ment of 34.7M shares for 11 .8 cents each as well as 7.5M warrants exercisable at the same price; Ladenburg Thalmann & Co. Inc. acted as the sole placement agent (6/22)

ArenaPharmaceuticalsInc. (ARNA)

Privateplacement

11S $35.5 Arena agreed to sell 11M shares to Deerfield Management for $35.5M (6/4)



Company(Symbol)#

Type OfFinancing


AmountRaised(M)




7. 1U $15 BioSante raised $15M offering 7. 1M units at $2. 1025 each, with each unit consisting of onecommon share and one five-year warrant exercisable at $2.45 to purchase half of an additional common share; Rodman & Renshaw LLC acted as the placement agent, with JMP Securities LLC, Oppenheimer & Co. Inc. and Trout Capital LLC acting as financial advisors (6/22)

CadencePharmaceuticalsInc. (CADX)

Loan facility N/A $20 Cadence secured a $30M loan facility, receiv-ing $20M now and $10M on FDA approval of Ofirmev (6/23)

Celsion Corp.(CLSN)

Committedequity finan-cing facility

N/A – Celsion may sell up to $15M of common stock to Small Cap Biotech Value Ltd. over a 24-month period; Reedland Capital Partners will act as placement agent (6/18)

ColumbiaLaboratoriesInc. (CBRX)

Subordinatedterm loan

N/A $15 Columbia signed a $15M term loan with Watson Pharmaceuticals Inc. (6/2)

CriticalOutcomeTechnologiesInc. (UK;CDNX:COT)

Privateplacement

3.2U C$1 . 1($1 .05)

Critical Outcome priced 3.2M units at C35 cents each; each unit comprises one common share and one-half of one common share pur-chase warrant (6/2)

CytoriTherapeutics(CYTX)

Loan facility N/A $50 Cytori entered a $20M secured loan facility from GE Capital, Healthcare Financial Services, Oxford Finance Corp. and Silicon Valley Bank; it also raised a total of $30M from a Seaside 88 LP financing (6/15)


Committedequity finan-cing facility

N/A – Discovery Laboratories secured a facility withKingsbridge Capital Ltd., which has commit-ted to providing up to $35M over three years through the purchase of up to about 31 .6M shares (6/15)

EpiCept Corp.(EPCT)


6. 1S $6.2 EpiCept raised $6.2M through an offering; Rodman & Renshaw LLC acted as the exclu-sive placement agent (6/29)

Exelixis Inc.(EXEL)

Financings N/A $160 Exelixis entered agreements providing for two separate financing transactions with Silicon Valley Bank and Deerfield Management (6/4)

Genzyme Corp. (GENZ)

Privateplacement ofsenior notes

N/A $1 ,000 Genzyme is offering $500M worth of 3.625% senior notes due 2015 and $500M worth of 5%senior notes due 2020 (6/16); company is using the money to repurchase its common stock (6/21)

GTC Biothera-peutics Inc.(OTC BB:GTCB)

Convertibledebt financing

N/A $7 GTC Biotherapeutics closed a new $7M financ-ing by LFB Biotechnologies SAS (6/17)



Company(Symbol)#

Type OfFinancing


AmountRaised(M)


HanaBiosciencesInc. (OTC BB:HNAB)

Privateplacementof stock

0.4S $40 Hana entered an agreement with Warburg Pincus and Deerfield Management for the sale of up to $100M in preferred stock; the sale of $40M closed June 7 (6/8)

HarborBioSciencesInc. (HRBR)

Private placementof common stock and warrants

5.9S andW for 3.5S

$2.06 Harbor raised $2.06M; Chardan Capital Markets LLC served as the placement agent (6/8)

LorusTherapeuticsInc. (Canada;TSX:LOR)


N/A $17.5 Lorus offered $17.5M in units, with each unitconsisting of one common share and one-half of a warrant to purchase common shares; Global Hunter Securities LLC has agreed to act as placement agent in the U.S. and D&D Securities Inc. is the placement agent in Canada (6/7)


Option and warrant exercises and an equity financingdrawdown; regis-tered direct offering

N/A;2.3U

$2.5;$5

NeoStem raised $2.5M, including $700,000 from the exercise of a warrant (6/9); it also raised $5M in a registered direct offering of 2.3M units for $2. 15 each (6/28)

NeuralstemInc. (AMEX:CUR)


3.57U $10 Neuralstem agreed to sell $10M of units at $2.80 apiece; each unit consists of one share of common stock and three-fourths of a com-mon stock purchase warrant; Noble Financial Capital Markets acted as the sole placement agent (6/28)



10U $2 Palatin is raising $2M in an offering of 10M units, each comprising one share of common stock and a warrant to purchase 0. 14 of one share of common stock priced at 20 cents each (6/28)

PCI BiotechHolding ASA(Norway; LSE:OTGL)

Oversubscribedrights issue

N/A NOK90($13.8)

PCI Biotech raised $13.8M through the rights issue (6/11)

PharmacyclicsInc. (PCYC)


8S $52 Pharmacyclics is offering 8M shares at $6.51 to raise $52M (6/18)

ProteomeSciences plc(UK; LSE:PRM)

Privateplacement

0.24S £4.8($6.9)

Proteome raised $6.9M through the place-ment (6/9**)

RexahnPharmaceuticalsInc. (AMEX:RNN)


6.67S andW for 2S

$10 Rexahn raised $10M through the offering; Rodman and Renshaw acted as the exclusive placement agent (6/29)

Soligenix Inc.(OTC BB:SNGX)

Common stockpurchase agree-ments

25.2S andW for 15. 1S

$5. 16 Soligenix raised $5. 16M through existing and new investors; National Securities Corp. and Griffin Securities Inc. served as co-placement agents on the financing (6/17)

Transgene SA(France; Paris::TNG)

Rights offering 7.7S �152($185.2)

Transgene raised $185.2M from a rights offer-ing (6/4)

YM BioSciences Inc. (Canada; AMEX:YMI)

Private placement ofcommon stock

2.5S $3.2 YM BioSciences raised about $3.2M through a private placement of 2.5M shares to be issued at $1 .27 each (6/4)



Company(Symbol)#

Type OfFinancing


AmountRaised(M)


JULYAdeona Pharmaceuticals Inc. (AMEX:AEN)

Equity financing 1 .2S $1 Adeona raised $1M placing 1 .2M shares with Seaside 88 LP; Enclave Capital served as placement agent (7/7)

Advanced Life Sciences Holdings Inc. (OTC BB:ADLS)

Private placement of units

0.714U $3 Advanced Life Sciences offered up to 714,286 units at $4.20 each to raise $3M; Dawson James Securities acted as the exclusive place-ment agent (7/2)

Advaxis Inc. (OTC BB:ADXS)

Private placement of Series B preferred stock

0.00075S $7.5 Advaxis raised $7.5M through the sale of 750 shares of Series B preferred stock priced at $10,000 per share; Optimus Capital Partners agreed to buy the shares over three years; Advaxis also issued an affiliate of Optimus a warrant to purchase up to 40.5M shares of common stock (7/21)

Affymax Inc. (AFFY)

Sale of auction rate securities

N/A $5 Affymax generated $10.4M through the sale of auction rate securities held by UBS AG; $5.4M of the total was used to repay a loan from UBS, so remaining proceeds were $5M (7/21)

ALDA Pharmaceuticals Corp. (Canada; CDNX:APH)


3.25U -$0.291 ALDA did not proceed on the terms disclosed April 15 for a private placement due to prevail-ing market conditions; it was expected to raise $616,000, which was accounted for in the April chart; instead, it raised $325,000; the excess amount of $291 ,000 is being removed from the total (7/29)

Bionovo Inc. (BNVI)

Private placement of common stock

N/A $15 Bionovo is receiving $15M through Aspire Capital Fund LLC, which will buy Bionovo's common stock over two years (7/8)

Cell Therapeutics Inc. (CTIC)

Private placement of preferred stock and warrants

0.004S $4.06 Cell Therapeutics entered into an agreement to sell 4,060 shares of Series 6 preferred stock and warrants to buy an aggregate of 5.8M shares of common stock to an accredit-ed investor (7/27)

Gilead Sciences Inc. (GILD)

Private placement of convertible senior notes due 2014 and 2016

N/A $2,200 Gilead priced an offering of convertible senior notes to qualified institutional buyers and expects net proceeds of $2. 166B (7/27)

International Stem Cell Corp. (OTC BB:ISCO)

Investment N/A $10 International Stem Cell secured $10M from German investment fund ARG Vermo-gensver waltung AG and independent European sources (7/23)

MediciNova Inc. (MNOV)

Sale of auction rate securities

N/A $9.5 MediciNova netted $9.5M after repaying the ARS loan from UBS AG (7/8)

Northwest Biotherapeutics Inc. (OTC BB:NWBO)

Private placement of restricted common stock

N/A $2.65 Northwest raised $2.65M from private inves-tors and SDS Capital (7/8)

Novelos Therapeutics Inc. (OTC BB:NVLT)

Private placement of common stock and warrants

21 .4S and W for 16.07S

$1 .5 Novelos entered an agreement with institu-tional investors to sell 21 .4M shares of com-mon stock and five-year warrants to purchase up to 16.07M shares at 7 cents per share (7/23)



Company(Symbol)#

Type OfFinancing


AmountRaised(M)


Omeros Corp. (OMER)

Committed equity financing facility

N/A (up to $40M)

Omeros may sell up to $40M of its shares of common stock to investor Azimuth Opportunity Ltd. over 24 months (7/30)

Oncothyreon Inc. (ONTY)


N/A (up to $20M)

Oncothyreon secured a facility to sell up to $20M of its shares to Small Cap Biotech Value Ltd. over a 24-month period (7/8)

Oragenics Inc. (AMEX:ONI)


5S $2 Oragenics raised $2M through the placement of 5M shares with the Koski Family Limited Partnership at a price of 40 cents per share (7/8)

PharmAthene Inc. (AMEX:PIP)

Registered direct offering

2.79S and 1 .32W $3.9 PharmAthene is raising $3.9M by selling 2.79M shares at $1 .40 each along with 1 .32M six-year warrants with an exercise price of $1 .63 each; Roth Capital Partners served as the sole placement agent (7/21)

StemCells Inc. (STEM)


7S $6. 1 StemCells raised $6. 1M by selling the shares to Seaside 88 LP at $0.865 per share, a 12.6% discount; Seaside has agreed to purchase an additional 5M shares 12 weeks after the initial closing (7/1)

Sunesis Pharmaceuticals Inc. (SNSS)

Private placement of stock

103.6S $28.5 Sunesis raised $28.5M pricing 103.6M shares at $0.275 cents each; investors were Bay City Capital, New Enterprise Associates, Alta Partners, Caxton Advantage Life Sciences Fund, Merlin Nexus, Nextech Venture, OpusPoint Partners, Venrock Associates and Vision Capital Advisors and members of Sunesis' management (7/2)

XOMA Ltd. (XOMA)


N/A (up to $30M)

XOMA can sell up to $30M of its registered common shares to Azimuth Opportunity Ltd. over a 12-month period (7/27)

AUGUSTAchillion Pharmaceuticals Inc. (ACHN)

Private placement of stock and warrants

19.8S $50 Achillion is raising $50M offering 19.8M shares and warrants; investors are Domain Associates , Clarus Ventures , Quaker BioVentures and Pappas Ventures (8/20)

Aeolus Pharmaceuticals Inc. (OTC BB:AOLS)

Private placement of common stock and a seven-year warrant

2.5S and W $1 Aeolus raised $1M from Xmark Opportunity Partners LLC via two of its institutional share-holders, exchanging 2.5M shares of common stock and a seven-year warrant to purchase 0.75 units of additional shares at $0.50 per share (8/16)

Alexza Pharmaceuticals Inc. (ALXA)


6.7U $18 Alexza raised $18M in an offering of 6.7M units, each consisting of one share and a war-rant to purchase half a share, priced at $2.70 (8/6)

Arena Pharmaceuticals Inc. (ARNA)

Direct public offering

8.95S $30 Arena raised $60M through the sale of 8.95M shares at $6.70 each, but $30M of the total will pay a portion of a loan; the shares were sold to entities affiliated with Deerfield Management (8/9)



Company(Symbol)#

Type OfFinancing


AmountRaised(M)


ARYx Therapeutics Inc. (ARYX)

Bridge financing N/A $4 ARYx secured bridge financing of up to $6.3M in two related loan transactions, the first pro-viding up to $4M from existing investors including entities affiliated with MPM Capital, and the second involving the amendment of an existing loan agreement with Lighthouse Capital Partners V LP to allow about $2.3M of required payments to Lighthouse to be deferred and extended as a new loan commit-ment to ARYx (8/17)

Biodel Inc. (BIOD) Private placement of common stock and warrants

2.4S and W for 2.4S

$9.4 Biodel raised about $9.4M through the sale of shares and warrants in units priced at $3.93 apiece; Wedbush PacGrow Life Sciences, Leerink Swann LLC and William Blair & Co. LLC acted as co-lead placement agents (8/30)

BioTime Inc. (AMEX:BTIM)

Exercise of warrants W for 5. 1S $9.2 BioTime completed its warrant discount offer, raising $9.2M, pricing warrants for 5. 1M shares at $1 .818 per share (8/23)

Dyadic International Inc. (PK:DYAI)

Private placement of convertible subordi-nated secured promissory notes

N/A $3 Dyadic completed a private placement of $3M in notes with two investors (8/25)

Elan Corp. plc (Ireland; NYSE:ELN)

Private placement of senior notes due 2016

N/A $200 Elan priced its offering of $200M in 8.75% senior notes by its subsidiaries, Elan Finance plc and Elan Finance Corp. (8/13)

Emisphere Technologies Inc. (OTC BB:EMIS)


3.5S and W for 2.6S

$7 Emisphere raised $3.5M through the place-ment of units sold at $1 .01 apiece; it also entered a purchase agreement with MHR Fund Management LLC to sell 3.5M shares and warrants for 2.6M shares (8/30)

Helix BioPharma Corp. (Canada; TSX:HBP)


4.53U $11 Helix closed a private placement of 4.53M units at $2.43 each; each unit consists of one common share and one common share pur-chase warrant (8/10)

Idera Pharmaceuticals Inc. (IDRA)


4U $15 Idera raised $15M in the offering of 4M units of stocks and warrants, priced at $3.71 , to cer-tain institutional investors (8/4)

IntelGenx Technologies Corp. (Canada; CDNX:IGX)


6.5U C$2.6 ($2.5)

IntelGenx raised $2.5M in a private placement offering of 6.5M units priced at C40 cents apiece; each unit consists of one common share and one common share purchase war-rant (8/30)

Lorus Therapeutics Inc. (Canada; TSX:LOR)

Shareholder rights offering and investment

N/A -$12 Due to market conditions, Lorus did not com-plete its $17.5M public equity offering report-ed in June; instead, it is doing a shareholder rights offering and is receiving a $4M invest-ment from director Herbert Abramson, plus $1 .5M in loans from Abramson; the difference is being removed from the total (8/31)



Company(Symbol)#

Type OfFinancing


AmountRaised(M)


MannKind Corp. (MNKD)


18.2S Not disclosed

MannKind entered an agreement with Seaside 88 LP for the sale of 700,000 shares of com-mon stock every two weeks over the course of a year for a total of up to 18.2M shares (8/13)


Private placement of senior convertible notes due 2015

N/A $100 MannKind is placing the notes, which will have an approximate conversion price of $6.80 per share; an additional $10M in notes could be purchased to cover overallotments (8/20)

Mondobiotech Holding AG (Switzerland; SWX:RARE)

Private placement N/A CHF 7.3M ($7M)

Mondobiotech raised $7M in its second financing transaction (8/4**)

Mylan Inc. (MYL) Private placement of senior notes

N/A $300 Mylan placed $300M in notes due 2020 with proceeds to be used to acquire Bioniche Pharma Holdings Ltd., of Galway, Ireland (8/16)

Neurokine Pharmaceuticals Inc. (Canada; OTC BB:NEUKF)

Debt conversion and private place-ment of shares and warrants

8S and W for 5S $0.04 Neurokine raised $40,000 through conver-sion of debt and the issuance of 8M shares and warrants to purchase 5M shares (8/13)

Raptor Pharmaceutical Corp. (RPTP)


4.9U $15 Raptor raised $15M under the placement of 4.9M units at $3.075 per unit (8/11)

Regenicin Inc. (OTC BB:WDSTD)

Convertible loans and a private place-ment of common stock

N/A $3.25 Regenicin raised $3.25M in the financing, with NewOak Capital Inc. and Smith Point Ltd. as co-placement agents (8/19)

Repros Therapeutics Inc. (RPRX)

Private placement N/A $6.8 Repros raised $6.8M through sales agent Thalmann & Co. Inc. (8/4)

Vivalis SA (France; Paris:VLS)

Discounted rights issue

N/A E30.3 ($40. 1)

Vivalis raised $40. 1M in a discounted rights issue directed at existing shareholders (8/4**)

SEPTEMBERAddex Pharmaceuticals Ltd. (Switzerland; SWX:ADXN)

Private placement of shares and convert-ible notes

0.59S CHF20 ($19.88)

Addex raised CHF6M ($5.98M) through the issuance of 593,567 new registered shares and CHF14M ($13.9M) through the issuance of zero coupon six-month mandatory convert-ible notes to Biotechnology Value Fund (9/16)


Exercise of unit war-rants

N/A $1 .5 Advanced Life received $1 .5M in proceeds from the exercise of warrants issued in its July offering that raised $3M; the company also entered into an agreement with YA Global Master SPV Ltd. for the sale of up to $10M of common stock over a two-year period (9/30)

Anthera Pharmaceuticals Inc. (ANTH)


10.5U $31 .5 Anthera raised $31 .5M in an offering of 10.5M units at $3 per share; each unit is one share and one warrant to purchase 0.40 shares at an exercise price of $3.30 per share (9/22)



Company(Symbol)#

Type OfFinancing


AmountRaised(M)


Apricus Biosciences Inc. (APRI)


1 .7U $9.3 Apricus entered agreements with selected investors to sell up to 1 .7M units at $5.40 each; Dawson James Scurities acted as the exclusive placement agent (9/30)

Aradigm Corp. (OTC BB:ARDM)

Exercise of warrants W for 7.5S $0.891 Aradigm received proceeds of $891 ,000 from the exercise of warrants (9/24)

Arno Therapeutics Inc. (PK:ARNI)

Private placement of securities

N/A $15 Arno raised $15M in a financing led by UTA Capital LLC and Pontifax Funds; Riverbank Capital Inc. acted as placement agent (9/14)

Dyadic International Inc. (PK:DYAI)

Private placement of convertible notes

N/A $1 Dyadic added $1M to its private placement of $3M, resulting in gross proceeds of $4M (9/8)


At-the-market stock offering

1S $2 Dynavax received $2M initially, with Aspire Capital paying $2 per share; Dynavax will receive another $28M over the next 25 months as part of the deal (9/22)

EntreMed Inc. (ENMD)

Securities purchase agreement

N/A $5. 1 EntreMed raised $5. 1M through a group of investors (9/9)

Genesis Biopharma Inc. (OTC BB:GNBP)


0.93S and W for 0.47S

$0.7 Genesis Biopharma raised $700,000 through the private offering (9/24)


Rights offering 5S $5.5 Lorus raised $5.5M by offering 5M shares (9/30)

NanoViricides Inc. (OTC BB:NNVC)

Investment of Series B convertible pre-ferred stock

0.25S $2.5 Nanoviricides raised $25M with Seaside 88 purchasing the stock for $10 per share (9/23)

Oncothyreon Inc. (ONTY)


4.24U $14.9 Oncothyreon raised $14.9M by selling 4.24M units at $3.50 each, with each unit consisting of one common share and one five-year war-rant to purchase 0.75 of an additional share with an exercise price of $4.20 (9/27)

Protox Therapeutics Inc. (Canada; TSX:PRX)

Investment N/A C$35 ($33.8)

Private equity firm Warburg Pincus has com-mitted to invest up to $33.8M in Protox, com-prised of an initial tranche of $10M, and an additional tranche of $25M (9/30)

Stellar Biotechnologies Inc. (CDNX:KLH)

Private placement of stocks and warrants

3U C$1 .05 ($1 .01)

Stellar raised $1 .01M in a private placement of 3M units priced at C35 cents per unit (9/30)

Titan Pharmaceuticals Inc. (OTC BB:TTNP)

Loan and security agreement

N/A $5 Titan entered an amended loan agreement with Oxford Finance Corp. for the $5M term loan (9/29)

OCTOBERAgennix AG (Germany; PK:GAGXF)

Combined rights offering and private placement

N/A E78.4 ($107.8)

Agennix priced the offering at E3.81 per share; Piper Jaffray Ltd. and WestLB AG acted as joint global coordinators on the transaction (10/4)

Alimera Sciences Inc. (ALIM)

Revolving line of credit and a term loan

W for 0.08S $12.5 Alimera secured a $20M credit facility provid-ed by Silicon Valley Bank, and a $12.5M term loan provided by MidCap Financial LLC and Silicon Valley Bank (10/18)



Company(Symbol)#

Type OfFinancing


AmountRaised(M)



Private placement N/A $9.3 Apricus raised $9.3M in a securities offering; Dawson James Securities acted as the exclu-sive placement agent (10/6)

Bionovo Inc. (BNVID)


2.7S and 2W $3 Bionovo raised $3M by selling about 2.7M shares priced at $1 . 10 apiece and will issue about 2M warrants; William Blair & Co. LLC is acting as exclusive placement agent (10/4)

ChemGenex Pharmaceuticals Ltd. (Australia; ASX:CXS)

Investment N/A $14.7 Cephalon Inc. provided up to $14.7M to ChemGenex for a note convertible at 49 cents per share (10/25)

Cyclacel Pharmaceuticals Inc. (CYCC)


8.3U $22. 1 Cyclacel raised $22. 1M in a sale of stock and warrants; Lazard Capital Markets LLC served as the lead placement agent, and Roth Capital Partners LLC served as the co-placement agent for the offering (10/6)

Cytomedix Inc. (AMEX:GTF)


3.7S and W for 1 .8S

$13 Cytomedix secured a $13M financing through a registered direct offering of shares and war-rants, plus $10M and $1 .5M equity purchase agreements (10/11)

DARA BioSciences Inc. (DARA)


0.613U $1 .4 DARA raised $1 .4M in an offering of 612,667 units, with each unit consisting of one share and 0.5 warrants to purchase one share, to institutional investors (10/27)

DiaGenic ASA (Norway; OSLO:DIAG)

Private placement of shares

140S NOK70 ($12)

DiaGenic raised $12M through the private placement of 140M shares priced at NOK0.50 each (10/8)

Discovery Laboratories Inc. (DSCO)



$0.5 Discovery Laboratories raised $500,000 through PharmaBio Development Inc.’s pur-chase of 2.4M shares at 21 cents per share and warrants of 1 .2M shares for 27.3 cents per share (10/14)

Galapagos NV (Belgium; BR:GLPG)

Share offering 2.4S E28.7 ($39.6)

Galapagos raised $39.6M, placing 2.4M shares with institutional and other qualified investors (10/20**)

Hybrigenics SA (France; Paris:ALHYG)

Equity line N/A E1 .43 ($1 .99)

Hybrigenics amended an agreement with YA Global Master SPV Ltd. for a total equity line of E 12M ($16.7M); it has drawn down E 1 .43M (10/12)

iBio Inc. (OTC BB:IBPM)


3S and W for 3S $6 iBio raised $6M by placing 3M shares at $2 each; each investor was issued a warrant to purchase the same number of shares at a cash exercise price of $2.20 per share for a period of five years (10/28)

IS Pharma plc (UK; LSE:ISPH)


4.6S £3.6 ($5.7)

IS Pharma raised $5.7M through the issue of about 4.6M shares at 77 pence per share with Abingworth LLP (10/7)

Karo Bio AB (Sweden; SSE:KARO)

Rights issue and equity-based credit facility

N/A SEK530 ($79.7)

Karo Bio secured SEK530M by raising SEK300M in a rights issue that is fully guaran-teed and another SEK230M in an equity-based credit facility (10/27)



Company(Symbol)#

Type OfFinancing


AmountRaised(M)


Omeros Corp. (OMER)

Financing involving future net proceeds

3W for 0. 133S each

$25 Omeros raised $25M exchanging a share of future net proceeds of its GPCR antibody ther-apeutic to Vulcan Capital and Life Sciences Discovery Fund; the deal includes warrants for Vulcan to purchase common stock at exer-cise prices of $20, $30 and $40; the three five-year warrants are good for 133,333 shares each (10/26)

Ore Pharmaceuticals Holdings Inc. (PK:ORXE)

Debt and equity investment

3. 1S and a five-year note

$5.3 Ore raised $5. 1M through the sale of $1 . 1M in shares at 35 cents each and a five-year note for $4.2M to Steel Partners Ltd. (10/26)

Oxygen Biotherapeutics Inc. (OXBT)

Placement of senior unsecured promis-sory notes

N/A $5 Oxygen entered a note purchase agreement with JP SPC 1 Vatea Segregated Portfolio to sell $5M of senior unsecured promissory notes in a series of closings between Oct. 31 and Dec. 31 (10/14)

PDL BioPharma Inc. (PDLI)

Private placement of notes

Notes $88 PDL raised $88M through the placement of 2015 notes for cash (10/28)

Pluristem Therapeutics Inc. (Israel; PSTI)


4.375S and W for 2.625S

$5.25 Pluristem raised $5.25M in the placement with selected institutional and private inves-tors; Rodman & Renshaw LLC acted as the U.S. placement agent (10/13)

QRxPharma Ltd. (Australia; ASX:QRX)

Private placement 16.47S $14 QRxPharma raised $14M by issuing shares at 85 cents each (10/4)

SciClone Pharmaceuticals Inc. (SCLN)

Debt financing facility

N/A (up to $15M)

SciClone said that Silicon Valley Bank increased the existing debt financing facility from $6M to $15M (10/6)

Sirona Biochem Corp. (Canada; CDNX:SBM)

Nonbrokered pri-vate placement of units

10.5U C$1 .05 ($1 .03)

Sirona raised $1 .03M by selling 10.5M units for C10 cents each, with each unit consisting of one share and one two-year warrant exercis-able at C20 cents (10/29)



6U $3.6 Stellar offered 6M units at 60 cents each to raise $3.6M; each unit consists of one share and one transferable share purchase warrant (10/27)

Stellar Pharmaceuticals Inc. (Canada; OTC BB:SLXCF)


1U $1 Stellar is arranging a nonbrokered private placement of up to 1M units for $1 per unit (10/6)

ThromboGenics NV (Belgium; BR:THR)

Exercise of warrants W for 0.289S E2.8 ($3.9)

ThromboGenics raised $3.9M as the result of the exercise of warrants by a number of employees (10/28)

NOVEMBERAdamis Pharmaceuticals Corp. (OTC BB:ADMP)


40S $10 Adamis signed a $10M deal with Estes Holdings Ltd., selling 40M shares at 25 cents each (11/12)



Company(Symbol)#

Type OfFinancing


AmountRaised(M)


Allon Therapeutics Inc. (Canada; TSX:NPC)

Private financing N/A $10 Allon closed a $10M financing with Isar Pharma KS (11/3)

Anacor Pharmaceuticals Inc. (ANAC)

Private placement 2S $10 Anacor raised $10M with a private placement of 2M shares at $5 a share to funds affiliated with existing investor Venrock Associates (11/29)

Anavex Life Sciences Corp. (OTC BB:AVXL)


0.397U $1 .09 Anavex raised $1 .09M through a private place-ment of 397,482 units for $2.75 each, with each unit representing one common share and one-half of an 18-month warrant with an exercise price of $4.50 (11/23)

AVEO Pharmaceuticals Inc. (AVEO)

Private investment 4.5S $61 AVEO raised $61M selling 4.5M shares at $13.50 each to a group of investors; J.P. Morgan Securities LLC and Canaccord Genuity Inc. are joint lead placement agents, and RBC Capital Markets Corp. served as co-placement agent (11/1)

BiondVax Pharmaceuticals Ltd. (Israel; TASE:BNDX)

Standby equity distribution

1 .45S $1 .25 BiondVax sold 1 .45M shares at NIS3. 105 each to YA Global Investments LP (11/11)

BioTime Inc. (AMEX:BTX)

Exercise of warrants N/A $6.97 BioTime raised a total of $24. 17M over the past 18 months from exercises of warrants; it raised $8M in May, $9.2M in August and $6.97M in November (11/5)

Clavis Pharma ASA (Norway; OSLO:CLAVIS)


4.4S $25.7 Clavis raised $25.7M in the placement of 4.4M shares at NOK35 ($5.84) per share; ABG Sundial Collier ASA and Carnegie ASA led the placement, and existing and new investors participated (11/19)


Private placement 60S NOK30 ($4.9)

DiaGenic received proceeds of $4.9M through the allocation of 60M new shares at NOK0.50 per share (11/24)

Endo Pharmaceuticals Holdings Inc. (ENDP)

Private offering of senior unsecured notes due 2020

N/A $400 Endo disclosed a private offering of $400M in notes due 2020 (11/16)

EpiCept Corp. (EPCT)



$1 .9 EpiCept raised $1 .9M in the placement; Rodman & Renshaw LLC acted as exclusive placement agent (11/9)

GeneNews Ltd. (Canada; TSX:GEN)

Private placement N/A C$2. 1 ($2.09)

GeneNews raised $2.09M through a unit offer-ing and an offering of five-year senior 15% redeemable convertible secured debentures (11/12)

iBio Inc. (OTC BB:IBPM)

Private placement N/A $1 .4 iBio completed a placement begun in October, bringing the total raised to $7.4M; Financial Capital Markets acted as placement agent (11/19)


Rights offering 4.2U C$4.6 ($4.58)

Lorus sold 4.2M units for C$1 . 1 1 apiece; each unit consists of one share and one warrant to purchase a share (11/11)



Company(Symbol)#

Type OfFinancing


AmountRaised(M)


Lpath Inc. (OTC BB:LPTN)


6.9S and W $4.9 Lpath closed a private placement of 6.9M shares of Class A stock at 70 cents per share and warrants to purchase the number of shares of Class A stock equal to 50% of the number of common shares they purchased; Griffin Securities Inc., Musket Research Associates Inc. and Andrew Garrett Inc. served as placement agents for the financing (11/18)

Marina Biotech Inc. (MRNA)

Securities purchase agreement

1 .8S $8.7 Marina sold 1 .8M shares at $1 .84 per share to raise $8.7M; LifeTech Capital acted as place-ment agent (11/8)

Neoprobe Corp. (OTC BB:NEOP)


3.2S $6 Neoprobe added about $6M in an offering of 3.2M shares priced at $1 .90 each (11/9)



10.6U $9.8 NeoStem raised $9.8M by offering 10.6M units, each containing one share of Series E, 7%, senior, preferred stock, convertible at $2.0004, to mature on May 20, 2013, and a warrant to purchase 0.25 shares of stock with an exercise price of $2.0874 and 0.0155 shares of common stock; the company raised $9.2M in a concurrent public offering, bring-ing total proceeds to $19M (11/17)

Oncolytics Biotech Inc. (Canada; ONCY)

Bought deal financing 5.4U C$25 ($24.5)

Oncolytics raised $24.5M through the sale of 5.4M units – each consisting of one common share and one-half of one common share pur-chase warrant – priced at C$4.60 apiece (11/1)

PDL BioPharma Inc. (PDLI)

Private placement of convertible senior notes

N/A $88 PDL raised $88M by placing convertible senior notes due 2015; it also exchanged $92M in notes due 2012 with $92M in notes due 2015 (11/8)

PharmaGap Inc. (Canada; CDNX:GAP)

Private placement of equity units

4. 1U $0.572 PharmaGap raised $572,000 issuing 4. 1M units, each consisting of one common share and one warrant to purchase a common share, priced at 14 cents per unit (11/22)

Regenicin Inc. (OTC BB:RGIN)

Private placement N/A $0.468 Regenicin raised $467,550 through a private placement and converted $500,000 of debt into equity (11/12)

Sernova Corp. (Canada; CDNX:SVA)


6.67U $0.999 Sernova raised $998,861 in a private place-ment (11/8)

Stem Cell Therapeutics Corp. (Canada; CDNX:SSS)

Execution of warrants

12.2W C$1 .82 ($1 .81)

Stem Cell received proceeds of $1 .81M for the execution of 12.2M warrants (11/4)

Synta Pharmaceuticals Corp. (SNTA)

Private placement 1 .4S $5 Synta raised $5M through the sale of 1 .4M shares at $3.47 each (11/12)

Theravance Inc. (THRX)

Investment 5.75S $129.3 GlaxoSmithKline plc purchased 5.75M shares of Theravance for $22.50 per share (11/30)



Company(Symbol)#

Type OfFinancing


AmountRaised(M)


DECEMBERAccess Pharmaceuticals Inc. (OTC BB:ACCP)


2.3S $6 Access raised $6M selling 2.3M shares at $2.55 each; Access also will issue 700,000 shares in the form of warrants to purchase common stock at $3.06; Hudson Securities was the placement agent (12/13)



0.03U $0. 1 Anavex raised $100,000 pricing 29,851 units at $3.35 each; each unit consists of one common share and one-half of a two-year warrant to purchase an additional share with an exercise price of $4.50 (12/3)

Bavarian Nordic A/S (Denmark; CSE:BAVA)


1 .05S DKK205 ($36.2)

Bavarin Nordic raised $36.2M in a placement of 1 .05M shares at DKK195 apiece (12/3)

BioSante Pharmaceuticals Inc. (BPAX)


10.6U $18 BioSante raised $18M through an offering of stock and warrants priced at $1 .70 each, with each unit consisting of one common share and one five-year warrant to purchase half of an additional share with an exercise price of $2; Rodman & Renshaw LLC acted as the exclusive placement agent (12/29); the com-pany also extended its $25M committed equi-ty financing facility with Kingsbridge Capital Ltd. (12/28)

Ceapro Inc. (Canada; CDNX:CZO)

Private placement 1 .6S $0. 129 Ceapro raised $129,668 by offering 1 .6M shares at 8 cents each to its directors (12/14)

Cleveland BioLabs Inc. (CBLI)

Registered direct sale

1 .4S $8.39 Cleveland BioLabs is raising $8.39M through the registered direct sale of 1 .4M shares priced at $5.99 each; HFP Capital Markets LLC and Rodman & Renshaw LLC served as co-placement agents (12/28)

Crucible International Biotechnologies Corp. (subsidiary of Microbix Biosystems Inc.; Canada; TSX:MBX)

Private placement ND ND Crucible received start-up capital in an undis-closed amount; the funding gives Crucible a post-money valuation of $14M (12/3)

Curaxis Pharmaceutical Corp. (OTC BB:CURX)

Equity purchase agreement

14.5S $10.7 Curaxis agreed to a $25M equity purchase and line of credit agreement with Southridge Partners II; the initial amount sold is 14.5M shares at 74 cents each for $10.7M in proceeds (12/9)



0.0048U $4.8 DARA raised $4.8M by offering 4,800 units priced at $1 ,000 each, with each unit consist-ing of one Series A share convertible into 400 common shares, one Class A warrant to pur-chase 200 common shares, and one Class B warrant to purchase 200 shares; Ladenburg Thalmann & Co. Inc. served as the placement agent (12/30)



Company(Symbol)#

Type OfFinancing


AmountRaised(M)


Genta Inc. (GNTA) Investment N/A $5 Genta received $5M from a control account related to its $25M private placement of con-vertible notes issued in March 2010 (12/16)

International Stem Cell Corp. (ISCO)

Investment and equity facility

0.333S $0.5 International Stem Cell raised about $500,000 by selling 333,333 shares at $1 .50 each to Aspire Capital Fund LLC, which also agreed to provide a $25M facility that can be accessed over the next three years (12/14)


Private Placement 1 .6S C$1 .7 (US$1 .69)

Lorus closed a private placemnt of 1 .6M com-mon shares priced at C$1 .05 per share for gross proceeds of about C$1 .7M. About 1 .4M shares were subscr ibed by Herbert Abramson, a director of the company, and his aggregate holding increased to about 41% of the issued and outstanding common shares (12/2)

Medivir AB (Sweden; SSE:MVIRB)

Private placement of B-series shares

2.25S $40.6 Medivir raised $40.6M in a private placement (12/6)

Molecular Insight Pharmaceuticals Inc. (MIPI)

Private placement 100S $45 Molecular Insight entered into a financing commitment from Savitr Capital, which is pay-ing 45 cents per share; the financing is tied to the company’s filing for Chapter 11 bankruptcy (12/13)

Neurologix Inc. (OTC BB:NRGX)

Investments N/A $7 Neurologix received $7M from Corriente Advisors, GE Pension Trust and Palisade Capital Management LLC (12/7)

OctoPlus NV (the Netherlands; Amsterdam:OCTO)

Private placement 3.3S E4 ($5.2) OctoPlus raised $5.2M by placing 3.3M shares with new and existing investors, including CEO-elect Jan Egberts (12/21)

Oxford BioMedica plc (UK; LSE:OXB)


400S £20 ($31 .7)

Oxford offered 400M new shares at 5 pence each to raised $31 .7M (12/14)

Pharming Group NV (the Netherlands; Euronext:PHARM)

Placement of non-convertible debt notes and equities

N/A $25.5 Pharming agreed to receive $25.5M from Socius CG II Ltd. in return for the notes and equities (12/6)

Plethora Solutions Holdings plc (UK; LSE:PLE)

Private placement 8.2S $1 . 1 Plethora raised $1 . 1M by issuing 8.2M shares (12/6)

Provectus Pharmaceuticals Inc. (OTC BB:PVCT)

Equity financing facility and invest-ment

1U $1 Provectus received a $1M investment from Lincoln Park Capital Fund LLC, which also set up a $30M committed equity financing facili-ty (12/29)

Rosetta Genomics Ltd. (Israel; ROSG)


2.5S $2.5 Rosetta raised $2.5M by selling 2.5M shares at $1 each, plus 1 .25M five-year warrants with an exercise price of $1 .30 and 625,000 war-rants with an exercise price of 1 cent; Rodman & Renshaw LLC acted as the placement agent (12/1)



Company(Symbol)#

Type OfFinancing


AmountRaised(M)


Thrombogenics Inc. (Belgium; BR:THR)


2.9S $75 Thrombogenics raised $75M through the placement of 2.9M shares at $25.42 each (12/6)

Access Pharmaceuticals Inc. (OTC BB:ACCP)


2.3S $6 Access raised $6M selling 2.3M shares at $2.55 each; Access also will issue 700,000 shares in the form of warrants to purchase common stock at $3.06; Hudson Securities was the placement agent (12/13)



0.03U $0. 1 Anavex raised $100,000 pricing 29,851 units at $3.35 each; each unit consists of one common share and one-half of a two-year warrant to purchase an additional share with an exercise price of $4.50 (12/3)

Bavarian Nordic A/S (Denmark; CSE:BAVA)


1 .05S DKK205 ($36.2)

Bavarin Nordic raised $36.2M in a placement of 1 .05M shares at DKK195 apiece (12/3)



10.6U $18 BioSante raised $18M through an offering of stock and warrants priced at $1 .70 each, with each unit consisting of one common share and one five-year warrant to purchase half of an additional share with an exercise price of $2; Rodman & Renshaw LLC acted as the exclusive placement agent (12/29); the com-pany also extended its $25M committed equi-ty financing facility with Kingsbridge Capital Ltd. (12/28)

Ceapro Inc. (Canada; CDNX:CZO)

Private placement 1 .6S $0. 129 Ceapro raised $129,668 by offering 1 .6M shares at 8 cents each to its directors (12/14)


Registered direct sale

1 .4S $8.39 Cleveland BioLabs is raising $8.39M through the registered direct sale of 1 .4M shares priced at $5.99 each; HFP Capital Markets LLC and Rodman & Renshaw LLC served as co-placement agents (12/28)

Crucible International Biotechnologies Corp. (subsidiary of Microbix Biosystems Inc.; Canada; TSX:MBX)

Private placement ND ND Crucible received start-up capital in an undis-closed amount; the funding gives Crucible a post-money valuation of $14M (12/3)

Curaxis Pharmaceutical Corp. (OTC BB:CURX)

Equity purchase agreement

14.5S $10.7 Curaxis agreed to a $25M equity purchase and line of credit agreement with Southridge Partners II; the initial amount sold is 14.5M shares at 74 cents each for $10.7M in proceeds (12/9)



Company(Symbol)#

Type OfFinancing


AmountRaised(M)




0.0048U $4.8 DARA raised $4.8M by offering 4,800 units priced at $1 ,000 each, with each unit consist-ing of one Series A share convertible into 400 common shares, one Class A warrant to pur-chase 200 common shares, and one Class B warrant to purchase 200 shares; Ladenburg Thalmann & Co. Inc. served as the placement agent (12/30)

Genta Inc. (GNTA) Investment N/A $5 Genta received $5M from a control account related to its $25M private placement of con-vertible notes issued in March 2010 (12/16)

International Stem Cell Corp. (ISCO)

Investment and equity facility

0.333S $0.5 International Stem Cell raised about $500,000 by selling 333,333 shares at $1 .50 each to Aspire Capital Fund LLC, which also agreed to provide a $25M facility that can be accessed over the next three years (12/14)


Private Placement 1 .6S C$1 .7 (US$1 .69)

Lorus closed a private placemnt of 1 .6M com-mon shares priced at C$1 .05 per share for gross proceeds of about C$1 .7M. About 1 .4M shares were subscr ibed by Herbert Abramson, a director of the company, and his aggregate holding increased to about 41% of the issued and outstanding common shares (12/2)


Private placement of B-series shares

2.25S $40.6 Medivir raised $40.6M in a private placement (12/6)

Molecular Insight Pharmaceuticals Inc. (MIPI)

Private placement 100S $45 Molecular Insight entered into a financing commitment from Savitr Capital, which is pay-ing 45 cents per share; the financing is tied to the company’s filing for Chapter 11 bankruptcy (12/13)

Neurologix Inc. (OTC BB:NRGX)

Investments N/A $7 Neurologix received $7M from Corriente Advisors, GE Pension Trust and Palisade Capital Management LLC (12/7)


Private placement 3.3S E4 ($5.2) OctoPlus raised $5.2M by placing 3.3M shares with new and existing investors, including CEO-elect Jan Egberts (12/21)



400S £20 ($31 .7)

Oxford offered 400M new shares at 5 pence each to raised $31 .7M (12/14)

Pharming Group NV (the Netherlands; Euronext:PHARM)

Placement of non-convertible debt notes and equities

N/A $25.5 Pharming agreed to receive $25.5M from Socius CG II Ltd. in return for the notes and equities (12/6)

Plethora Solutions Holdings plc (UK; LSE:PLE)

Private placement 8.2S $1 . 1 Plethora raised $1 . 1M by issuing 8.2M shares (12/6)



Company(Symbol)#

Type OfFinancing


AmountRaised(M)


Provectus Pharmaceuticals Inc. (OTC BB:PVCT)

Equity financing facility and invest-ment

1U $1 Provectus received a $1M investment from Lincoln Park Capital Fund LLC, which also set up a $30M committed equity financing facili-ty (12/29)



2.5S $2.5 Rosetta raised $2.5M by selling 2.5M shares at $1 each, plus 1 .25M five-year warrants with an exercise price of $1 .30 and 625,000 war-rants with an exercise price of 1 cent; Rodman & Renshaw LLC acted as the placement agent (12/1)

Thrombogenics Inc. (Belgium; BR:THR)


2.9S $75 Thrombogenics raised $75M through the placement of 2.9M shares at $25.42 each (12/6)

Notes:

This chart does not include real estate or manufacturing plant financings, or debt deals done to replace existing debt.

# Unless otherwise indicated, shares are traded on the Nasdaq exchange; @ Refers to the date of the press release. ** Denotes the date the item ran in BioWorld International. Currency conversions are based on exchange rates at the time of the deal.

The date indicated refers to the BioWorld Today issue in which the news item can be found.

N/A = Not applicable; ND = Not disclosed.

AMEX = American Stock Exchange; ASX = Australian Stock Exchange; BE = Berlin Stock Exchange; BR = Brussels Stock Exchange; CDNX = Canadian Venture Exchange; CSE = Copenhagen Stock Exchange; FSE = Frankfurt Stock Exchange; LSE = London Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; PK = Pink Sheets; SSE = Stockholm Stock Exchange; SWX = Swiss Stock Exchange; TASE = Tel Aviv Stock Exchange; TSX = Toronto Stock Exchange.

Venture Capital And Other Investments In Private Biotechnology Companies In 2010

TOTAL: $$4,483MCompany Location Date Amt. (M) Details

JANUARYAcetylonPharmaceuticalsInc.

Boston 1/12 $2 Acetylon received a $2M investment from a new undisclosed private investor

ActonPharmaceuticalsInc.

Marlborough, Mass.

1/7 $15 Acton completed a $15M round of financing led by Sequoia Capital

Adocia SA Lyon, France 1/13 E14($20.3)

Adocia raised $20.3M in a second funding round

AlnaraPharmaceuticalsInc.

Cambridge, Mass.

1/28 $35 Alnara raised $35M in a Series B round; investors were MPM Capital, Frazier Healthcare Ventures, Third Rock Ventures and Bessemer Venture Partners

BINDBiosciences Inc.

Cambridge, Mass.

1/14 $11 BIND raised $11M in a Series C round led by DHK Investment, with participation by all existing investors, Polaris Venture Partners, Flagship Ventures, ARCH Venture Partners and Nano-Dimension, as well as new private investors

BioLeap Inc. New Hope, Pa. 1/13 $5 BioLeap raised $5M in venture financing from Adams Capital Management and Quaker BioVentures

CantabPharmaceuticalsplc

Cambridge, UK 1/26 £5($8. 1)

Cantab received a three-year, $8. 1M investment-from Celtic Pharma Holdings Advisors LLP

CornerstonePharmaceuticalsInc.

Cranbury, N.J. 1/27 $6. 18 Cornerstone raised $6. 18M in a Series B-4 private equity financing; C.W. Downer & Co. served as the placement agent, with Althea Partners LLC leading the investment

ElevationPharmaceuticalsInc.

San Diego 1/22 $30 Elevation raised $30M in a Series A round; inves-tors were TPG Growth, Care Capital and Mesa Verde Venture Partners, as well as Canaan Partners

EribisPharmaceuticalsAB

Stockholm, Sweden

1/27 ND Eribis received an undisclosed amount of financ-ing from Karolinska Development AB

EyeGatePharma Inc.

Waltham, Mass. 1/11 $22.6 EyeGate raised $22.6M in a Series D financing; investors were Ventech, Innoven Partners and Medicis Capital, along with Natixis Private Equity and Emerging Capital

F-star Biotech-nologischeForschungs-undEntwicklungsgesmbH

Vienna, Austria 1/6 E8($11 .5)

F-star raised $11 .5M in a third closing of a Series A round; investors were MP Healthcare Venture Management, Merck Serono Ventures, Atlas Venture, Aescap Venture, Novo Ventures and TVM Capital

GlobeImmuneInc.

Louisville, Colo.

1/19 $17.5 GlobeImmune raised $17.5M in a Series E round; investors were Generali Financial Holding and BSI SA

InterceptPharmaceuticalsInc.

New York 1/26 $25 Intercept raised $25M in Series B funding from Genextra SpA


VentureCapitalAndOtherInvestmentsInPrivateBiotechnologyCompanies


Company Location Date Amt. (M) Details

Kolltan PharmaceuticalsInc.

New Haven, Conn.

1/21 $10 Kolltan raised $10M in a Series B round led by Celtic Therapeutics Holdings LP

LiquidiaTechnologiesInc.

Research TrianglePark, N.C.

1/20 $20 Liquidia raised $20M through the Series C round led by Canaan Partners

MolecularBiometricsInc.

Norwood, Mass.

1/13 $12.5 Molecular Biometrics completed a $12.5M Series B financing led by Atlas Venture; other participating investors included Safeguard Scientifics Inc. and Oxford Bioscience Partners

Ohr Pharma-ceutical Inc.

Dover, Del. 1/20 $1 Ohr raised $1M through the private placement of common stock and new warrants to holders of its Series F warrants

PhaseBioPharmaceuticalsInc.

Research TrianglePark, N.C.

1/8 $25 PhaseBio raised $25M in a Series B round; inves-tors were New Enterprise Associates, OSI Investment Management, Hatteras Venture Partners, Johnson & Johnson Development Corp. and Fletcher Spaght Ventures

ProChonBiotech Ltd.

Woburn, Mass. 1/21 $3.95 ProChon closed a $3.95M convertible bridge loan from ProChon Holdings BV and the Musculo-skeletal Transplant Foundation

ProFibrix BV Leiden, theNetherlands

1/8 E5($7.4)

ProFibrix secured a loan from SenterNovem

PrometheusLaboratoriesInc.

San Diego 1/8 $210 Prometheus executed a $260M senior secured credit facility consisting of a $210M term loan and a $50M revolving credit line

SymBioPharmaceuticalsLtd.

Tokyo 1/29 $7.7 SymBio completed a $7.7M second tranche of its Series D round of financing

TerpenoidTherapeuticsInc.

Coralville, Iowa 1/27 $1 .5 Terpenoid raised $1 .5M through a Series A financ-ing from a group of Iowa investors led by Iowa First Capital Fund II LP

VentiRxPharmaceuticalsInc.

San Diego 1/12 $25 VentiRx raised $25 in an extension to its Series A round; investors ARCH Venture Partners, Domain Associates and Frazier Healthcare Ventures partic-ipated; it was led by MedImmune Ventures Inc.

FEBRUARYAdvancedCancerTherapeutics

Louisville, Ky. 2/24 $0.25 Advanced Cancer received $250,000 from the Kentucky Economic Development Partnership Board’s Commonwealth Seed Capital group

BioscienceVaccines Inc.

Indianapolis 2/22 $0.4 Bioscience received $400,000 from the Bio-Crossroads Indiana Seed Fund

CancerGuideDiagnosticsInc.

Durham, N.C. 2/5 $10.5 CancerGuide completed the first part of a $10.5M round

CornerstonePharmaceuticalsInc.

Cranbury, N.J. 2/8 $6.2 Cornerstone closed a Series B-4 private equity financing of $6.2M

DiffusionPharmaceuticalsLLC

Charlottesville, N.C.

2/1 $5.9 Diffusion closed on $5.9M in additional private financing, which was a combination of private equity and convertible notes to existing investors




DirevoIndustrialBiotechnologyAG

Cologne, Germany

2/3** E6($8.4)

Direvo raised $8.4M in a second funding round led by TVM Capital GmbH and NRW Bank

Eleven Bio-therapeuticsInc.

Cambridge, Mass.

2/17 $35 Eleven raised $35M in a Series A financing co-led by Flagship Ventures and Third Rock Ventures

EUSA PharmaInc.

Doylestown, Pa.

2/5 $25 EUSA secured a $25M credit facility from Oxford Finance Corp.

GlidePharmaceuticalTechnologiesLtd.

Oxfordshire, UK

2/11 £2.7($4.3)

Raised $4.3M in its fourth financing round; inves-tors were Hygea VCT plc and Oxford Technology

ImmuneTargetingSystems Ltd.

London 2/18 £8.65($13.66)

Immune Targeting raised $13.66M in a Series A financing; investors were HealthCap, London Technology Fund, Novartis Venture Fund and Truffle Capital (2/18)

Merus BV Utrecht, theNetherlands

2/3 E21 .7($30.3)

Merus raised $30.3M in a Series B round; investors were Novartis, Pfizer Inc., Bay City Capital, Life Sciences Partners and Aglaia Oncology Fund

MirrxTherapeuticsAS

Copenhagen, Denmark

2/5 ND Mirrx closed on a seed financing round

OxfordNanoporeTechnologiesLtd.

Oxford, UK 2/2 £17.4($27.8)

Oxford raised $27.8M from existing investors, including Lansdowne Partners, IP Group and Invesco Perpetual

PearlTherapeutics Inc.

Redwood, Calif.

2/2 $15 Pearl raised $15M through a convertible loan facili-ty set to convert to equity at the time of a $40M Series C financing expected to close in the third quarter; investors were Clarus Ventures, New Leaf Venture Partners and 5AM Ventures

PolyTherics Ltd. London 2/18 £3($4.74)

PolyTherics raised $4.74M in a financing round led by Imperial Innovations Group, Longbow Capital and The Capital Fund

Sistemic Ltd. Glasgow, Scotland

2/5 $1 Sistemic closed a Series A round with ChimeraBio and the Scottish Enterprise Co-Investment Fund

SomnusTherapeutics

Bedminster, N.J.

2/12 $15 Somnus raised $15M in a Series A preferred stock financing led by CTI Life Sciences Fund with the participation of Care Capital LLC

TiogaPharmaceuticalsInc.

San Diego 2/18 $18 Tioga raised $18M in its second round; investors were Genesys Capital Partners, Forward Ventures, New Leaf Venture Partners and BB Biotech Ventures

Viroblock SA Geneva, Switzerland

2/4 ND Viroblock raised an undisclosed amount of Series B funding

MARCHAffectisPharmaceuticalsAG

Martinsried, Germany

3/23 E3.3($4.48)

Affectis raised $4.48M in the first part of a Series D financing; investors were LSP, Aescap Venture, KfW, Bayernkapital and EMBL Ventures




AntisensePharma GmbH

Regensburg, Germany

3/17** E13($17.8)

Antisense raised $17.8M from existing investors, including MIG Verwaltungs AG, GA Global Asset Fund GmbH and Co., as well as management and private investors

AquapharmBiodiscovery Ltd.

Oban, Scotland 3/24 £4.2($6.3)

Aquapharm raised $6.3M from Aescap Venture, Tate & Lyle Ventures, Highlands and Islands Enterprise and NESTA

ArchimedesPharma Ltd.

London 3/3 £65($96.9)

Archimedes Pharma raised $96.9M in a round led by new investor Novo Growth Equity; other inves-tors were Warburg Pincus

Bone BiologicsInc.

Thousand Oaks,Calif.

3/11 ND Bone Biologics received an undisclosed invest-ment for preferred shares from the Musculo-skeletal Transplant Foundation, which now owns 51% of the company; MTF also will provide a line of credit

Eureka Genomics Corp.

Hercules, Calif. 3/11 $3.7 Eureka raised $3.7M from angel investors and other private individuals

GenetixPharmaceuticalsInc.

Cambridge, Mass.

3/12 $35 Genetix raised $35M in a Series B round; investors were Third Rock Ventures, Genzyme Ventures, TVM, Forbion and Easton

Genticel S/A Toulouse, France

3/10 E13. 1($17.7)

Genticel raised $17.7M in a round led by AGF Private Equity; other investors were the Institut Regional de Devloppement Industriel, Amundi Private Equity Funds, Edmond de Rothschild Investment Partners and FSI France Investment’s InnoBio fund

MyotecTherapeuticsLtd.

Cambridge, UK 3/2 E5.6($7.6)

Myotec received a $7.6M investment from Imperial Innovations Group plc and Invesco Perpetual

NGM Biopharma-ceuticals Inc.

South San Francisco

3/16 $51 NGM raised $51M in a Series B round; investors were the Column Group, Tichenor Ventures LLC, Prospect Partners, Rho Ventures and other new and existing investors

OmtheraPharmaceuticalsInc.

New York 3/9 $6.5 Omthera closed a $6.5M Series A round led by Sofinnova Partners

OriGeneTechnologiesInc.

Rockville, Md. 3/19 $16 OriGene raised $16M in a Series B financing led by IDG-Accel, SBI & TH Venture Capital Enterprise and Zero2IPO; other investors were Morningside Venture Investments and President International Development Corp.

PhicoTherapeuticsLtd.

Cambridge, UK 3/30** £1 .8($2.7)

Phico raised $2.7M from institutional investors and business angels

PromediorInc.

Malvern, Pa. 3/16 $12 Promedior raised $12M in a Series C financing led by Forbion Capital Partners, with participation from Morgenthaler Ventures, HealthCare Ventures, Polaris Venture Partners and Easton Capital

RhythmPharmaceuticals

Boston 3/16 $21 Rhythm raised $21M in a Series A equity financing




SaladaxBiomedicalInc.

Bethlehem, Pa. 3/8 $8.4 Saladax raised $8.4M through a Series C preferred offering led by Excel Venture Management; other investors were Ben Franklin Technology Partners and the Life Sciences Greenhouse of Central Pennsylvania, as well as a number of angel inves-tors

Scancell Holdings plc

Nottingham, UK

3/30** £2.31($3.5)

Scancell raised $3.5M in a placing and open offer of 5. 1M shares

SpePharmHolding BV

Amsterdam, theNetherlands

3/5 E11($15)

SpePharm raised $15M in a financing through an investment from Paladin Labs Inc., as well as TVM Capital, Signet Healthcare and Paul Capital Healthcare

Ubiquigent Ltd. Dundee, Scotland

3/4 $4.5 Ubiquigent received $4.5M in start-up funding from Stemgent Inc.

Vaxart Inc. San Francisco 3/5 $12.5 Vaxart closed a $12.5M Series B financing led by Care Capital LLC

APRILAchaogen South San

Francisco4/8 $56 Achaogen raised $56M in a Series C financing

AiCuris GmbH& Co.

Wuppertal, Germany

4/15 E50($75)

AiCuris raised $75M through an investment from German businessmen Andreas and Thomas Strungmann, of Santo Holding

AffimedTherapeuticsAG

Heidelberg, Germany

4/30 E20($26.48)

Affimed raised $26.48M in a Series C financing led by aeris Capital, BioMedInvest, LSP Life Sciences Partners, Novo Nordisk A/S and Orbimed

AltheaDx Inc. San Diego 4/14 $6 AltheaDx raised $6M in a Series A financing led by Telegraph Hill Partners

Altheos Inc. South San Francisco

4/6 $20 Altheos raised $20M in a Series A round led by Bay City Capital; other investors were Novo A/S, Canaan Partners, Life Science Angels and Atheneos Capital

AmplyxPharmaceuticalsInc.

San Diego 4/9 $1 .5 Amplyx completed its initial round of $1 .5M Series A preferred financing with investments from Golden Seeds LLC, Life Science Angels and Tech Coast Angels

AragonPharmaceuticalsInc.

San Diego 4/23 $22 Aragon raised $22M in a Series B financing with Aisling Capital, OrbiMed Advisors and the Column Group

Biocartis SA Lausanne, Switzerland

4/9 E30($41 .3)

Closed a Series B equity financing round raising $41 .3M from its current shareholder base and new investors that included the Debiopharm Group and Johnson & Johnson Development Corp.

BioProteinTechnologies

Jouy-en-Josas, France

4/29 E0.52($0.686)

BioProtein raised $686,378 from existing share-holders

CatabasisPharmaceuticalsInc.

Cambridge, Mass.

4/22 $39.6 Catabasis raised $39.6M in a Series A round led by SV Life Sciences, Clarus Ventures and MedImmune Ventures; Advanced Technology Ventures also participated

CellularDynamicsInternationalInc.

Madison, Wis. 4/28 $40.6 Cellular Dynamics closed on a $40.6M Series B pri-vate equity round




FoundationMedicine Inc.

Cambridge, Mass.

4/15 $25 Foundation raised $25M in a Series A financing from Third Rock Ventures

Gemin XPharmaceuticalsInc.

Malvern, Pa. 4/21 $16 Gemin X raised $16M in a Series D round; investors were Caxton Advantage Life Sciences Fund LP and Sanderling Venture Partners

HemaQuestPharmaceuticalsInc.

Boston 4/22 $12 HemaQuest raised $12M in a Series B financing round led by new investor, Aberdare Ventures

HunterImmunologyLtd.

Sydney, Australia

4/1 A$9.2($9. 1)

Hunter Immunology is raising up to $9. 1M in a round led by the IB Australian Bioscience Fund and Soho Pharmaceuticals

Immunovov BV S-Hertogen-bosch, the Netherlands

4/28 ND Immunovo was formed from seed funding from Biox Biosciences BV and Lupus Ventures BV

Lycera Corp. Cambridge, Mass.

4/29 $11 Lycera raised $11M in a second tranche of a Series A financing

MGBBiopharmaLtd.

Glasgow, Scotland

4/28** £2($3. 1)

MGB received $3. 1M in start-up funding from an angel syndicate led by Archangel Informal Investments Ltd., TRI Cap Ltd., Barwell plc and the Scottish Co-Investment fund

Mirina Corp. Seattle 4/27 ND Mirina closed a Series A-1 round led by Versant Ventures; other investors were Alexandria Real Estate Equities, ARCH Venture Partners, OVP Venture Partners and WRF Capital

NautilusNeurosciencesInc.

Bridgewater, N.J.

4/14 ND Nautilus received an undisclosed amount of financing from Galen Partners

OncosTherapeuticsLtd.

Helsinki, Finland

4/30 E4($5.5)

Completed a $5.5M investment from HealthCap

Rheonix Inc. Ithaca, N.Y. 4/22 $12.6 Rheonix raised $12.6M in a Series A financing

SagentPharmaceuticals

Schaumburg, Ill.

4/9 $40 Sagent raised $40M through two tranches of a strategic Series B financing; a $10M investment was made by Zhejiang Hisun Pharmaceutical Co. Ltd. and the remaining $30M was contributed by an unnamed China-focused private equity invest-ment fund

SelectaBiosciences

Watertown, Mass.

4/6 $15 Selected completed a $15M Series C financing; investors were Polaris Venture Partners, Flagship Ventures, NanoDimension and Timothy A. Springer

Virxsys Corp. Gaithersburg, Md.

4/20 $9.8 Virxsys raised $9.8M of a planned $45M venture round

Xenome Ltd. Brisbane, Australia

4/23 A$10($9.28)

Xenome completed a convertible note financing for $9.28M from funds associated with Queens-land BioCapital Fund and GBS Venture Partners

MAYAgneBio Inc. Indianapolis 5/13 $0.3 AgneBio raised $300,000 from BioCrossroads’

Indiana Seed Fund




AlvinePharmaceuticalsInc.

San Carlos, Calif.

5/27 ND Abbott Biotech Ventures Inc. joined InterWest Partners, Panorama Capital, Prospect Venture Partners, Sofinnova Ventures, Black River Asset Management and Flagship Ventures in a Series A extension round

Aposense Ltd. Petach Tikva, Israel

5/25 $3 Aposense is raising $3M from existing sharehold-ers

ArchBiopartnersInc.

Toronto 5/10 $0.7 Arch raised $700,000 by issuing 1 .4M shares at 50 cents each

CaprotecBioanalyticsGmbH

Berlin 5/17 �4($5. 1)

Caprotec closed a $5. 1M Series B round with exist-i n g i n v e s t o r s C r e a t h o r Ve n t u r e , I B B Beteiligungsgesellschaft, ERP Startfonds and pri-vate investors

Cardoz AB Stockholm, Sweden

5/11 SEK100($13.3)

Cardoz closed a Series A round led by Forbion Capital Partners with new investor Ysios Capital Partners and existing investors HealthCap

CureVac GmbH

Tubingen, Germany

5/11 �27.6($35.25)

CureVac raised $35.25M in a round with dievini Hopp BioTech Holding GmbH & Co. KG

ExosomeDiagnostics Inc.

New York 5/19** $20 Exosome raised $20M in a Series A round co-led by NGN Capital and Forbion Capital Partners

FunxionalTherapeuticsLtd.

Cambridge, UK 5/27 £10($12.2)

Funxional completed a Series B round from Ventech, Index Ventures and Novo A/S

LogicalTherapeuticsInc.

Waltham, Mass. 5/28 $16.9 Logical closed on a $16.9M Series C round led by SV Life Sciences and including Burrill & Co., Novo A/S and Novitas Capital

NeuroThera-peutics PharmaInc.

Chicago 5/21 $43 NeuroTherapeutics raised $43M in a Series B round; investors were Fidelity Biosciences, MPM Capital, SR One and Pfizer Inc., as well as Novo Ventures and Thomas McNerney & Partners

NormOxys Inc. Wellesley, Mass.

5/25 $17.5 NormOxys raised $17.5M in a Series B-1 financing; investors were Index Ventures and Care Capital

NoxxonPharma AG

Berlin 5/28 �33($40.8)

Noxxon closed a $40.8M Series D round led by NGN Capital, with participation from TVM Capital, Sofinnova Partners, Edmond de Rothschild Investment Partners, Seventure Partners, VC Fonds Technologie Berlin GmbH, Dow Venture Capital, F C P O P M e d i c a l B i o H e a l t h Tr e n d s , I B G Beteiligungsgesellschaft SachsenAnhalt mgH, the Dieckell Group and others

OxfordImmunotecLtd.

Oxford, UK 5/3 $26 Oxford Immunotec closed the second tranche of a $26M investment by New Leaf Venture Partners; other investors of the Series D financing included Kaiser Permanente Ventures, Clarus Ventures, Wellington Partners, National Technology Enterprises Co., SPARK Ventures, DFJ Esprit, Oxford University and The Dow Chemical Co.

PaciraPharmaceuticalsInc.

Parsippany, N.J. 5/12 $11 .25 Pacira received a $11 .25M credit facility from GE Capital, Healthcare Financial Services




Pro-CureTherapeuticsLtd.

York, UK 5/25 £0.7($1)

Pro-Cure received further funding of more than $1M as a follow-on to a late 2008 investment; investors were Yorkshire Cancer Research and the Yorkshire & Humber Equity Fund managed by YFM Venture Finance Ltd.

Pronota NV Ghent, Belgium 5/19 �1 .3($1 .59)

Pronota raised $1 .59M in its Series B financing from MP Healthcare Venture Management Inc.

StratatechCorp.

Madison, Wis. 5/4 $3 Stratatech closed a $3M round of funding com-prised of convertible notes from current investors

T2 Biosystems New York 5/26 $15 T2 Biosystems raised $15M in a Series C financing led by Physic Ventures; other investors are Arcus Ventures, RA Capital, Camros Capital and WS Investments, plus Flagship Ventures, Polaris Venture Partners, Flybridge Capital Partners and Partners Healthcare

Tesaro Inc. Boston 5/27 $20 Tesaro raised $20M in a Series A led by New Enterprise Associates and company management, and there’s another $40M from NEA in reserve for future investment rounds

TPP GlobalDevelopment

Edinburgh, Scotland

5/20 £9.6($13.8)

TPP raised $13.8M through investors that included Scottish Venture Fund

ValcorTherapeuticsInc.

Vancouver, BritishColumbia

5/26 ND Valcor received an undisclosed amount of seed financing from GrowthWorks Capital Ltd.

JUNEAblexis LLC San Francisco 6/2 $12 Ablexis raised $12M in a Series A round led by

Third Rock Ventures, with an additional invest-ment from Pfizer Venture Investments

Action PharmaAS

Holte, Denmark

6/4 E5($6.25)

Action Pharma raised $6.25M in the round

AgileTherapeuticsInc.

Princeton, N.J. 6/16 $45 Agile raised $45M through a Series B preferred stock financing co-led by Investor Growth Capital and Care Capital, with participation from ProQuest Investments

AkebiaTherapeuticsInc.

Cincinnati 6/17 $5 Akebia raised $5M in the second tranche of its $16M Series A round

AquinoxPharmaceuticalsInc.

Vancouver, BritishColumbia

6/18 $25 Aquinox raised $25M in a Series B financing led by Ventures West Capital

AndromedaBiotech Ltd.

Yavne, Israel 6/18 $17.5 Teva Pharmaceutical Industries Ltd. decided to exercise its option to invest in Andromeda at a company per-money valuation of $170M

BINDBiosciencesInc.

Cambridge, Mass.

6/29 $12.4 BIND raised $12.4M in a Series C-1 round; investors were Endeavour Vision, Polaris Venture Partners, Flagship Ventures, ARCH Venture Partners, NanoDimension and DHK Investments

Bio-PathHoldings Inc.

Houston 6/8 $7 Bio-Path signed an equity purchase agreement for up to $7M with Lincoln Park Capital Fund LLC

Complix NV Hasselt, Belgium

6/4 E5($6.25)

Complix completed a Series A round led by Vesalius Biocapital and LRM, with CRP Sante, plus existing investors and management also partici-pating




CorridorPharmaceuticalsInc.

Baltimore 6/18 $15 Corridor raised $15M through a Series A round led by Quaker Bioventures, and including Domain Associates, Quaker BioVentures, MedImmune Ventures, NewSpring Capital, Maryland Health Care Product Development Corporation, Ben Franklin Technology Partners, Acidophil LLC and Red Abbey Venture Partners

Cytheris SA Paris 6/8 $15 Cytheris completed a $15M Series D financing; investors were CDC Entreprises, Bioam Gestion France, Caisse de depot et Placement du Quebec, CDC Innovation, Credit Agricole Private Equity and Forbion Capital Partners

ConstellationPharmaceuticalsInc.

Cambridge, Mass.

6/2 $22 Constellation raised $22M in a Series B round led by SR One and including Third Rock Ventures, the Column Group, Venrock and Altitude Life Science Ventures

EnsyceBiosciences Inc.

Houston 6/14 $1 .5 Ensyce raised $1 .5M in funding from the State of Texas Emerging Technology Fund

FerroKinBioSciences Inc.

San Francisco 6/18 $12 FerroKin closed a $12M financing round from existing investors Burrill & Co., Celgene Corp., Clarus Ventures and MP Healthcare Venture Management and new investor Healthcap Ventures

FoldRxPharmaceuticalsInc.

Cambridge, Mass.

6/16 $29 FoldRx raised $29M in venture funding; investors were Novo Ventures and Morgenthaler Ventures, which joined HealthCare Ventures, Fidelity Biosciences, TPG Biotechnology, Alta Partners and Novartis Venture Funds

GaleraTherapeuticsLLC

St. Louis 6/16 ND Galera completed a Series 1 financing led by BioGenerator, with participation from Galera Angels LLC and Analytical Bio-Chemistry Laboratories Inc.

Igenica Inc. Burlingame, Calif.

6/11 $24 Igenica raised $24M in a Series B financing led by The Column Group, OrbiMed Advisors and 5AM Ventures

InclineTherapeuticsInc.

San Diego 6/23 $43 Incline raised $43M through a Series A round led by Frazier Healthcare Ventures and including par-ticipation from 5AM Ventures, Technology Partners, Adams Street Partners, Saints Capital Partners and Emergent Medical Partners

InotekPharmaceuticalsInc.

Beverly, Mass. 6/14 $18 Inotek raised $18M through a financing led by Devon Park Bioventures; other investors were Rho Ventures, Care Capital, Pitango Venture Capital, MedImmune Ventures and Bio*One Capital

Mucosis BV Groningen, theNetherlands

6/2 E3($3.7)

Mucosis received a credit line of $3.7M from Agentschap NL

NereusPharmaceuticalsInc.

San Diego 6/23 $20 Nereus raised $20M through a round led by HBM BioVentures and included Alta Partners, Forward Ventures, Gimv, Advent International, Pacific Venture Group, Roche Venture Fund and Astellas Venture Management

NeurokinePharmaceuticalsInc.

Vancouver,British Columbia

6/3 $0.2 Neurokine raised $200,000 in connection with the re-appointment of Hassan Salari to the company’s board




Otonomy Inc. San Diego 6/11 $10 Otonomy raised $10M in a Series A round from Avalon Ventures

Pacific Biosciences

Menlo Park, Calif.

6/21 $50 Pacific Biosciences received $50M through an investment from Gen-Probe Inc.

Pharnext SAS Paris 6/10 E4.8($5.8)

Pharnext raised $5.8M in a Series A round with Truffle Capital

PrecisionTherapeuticsInc.

Pittsburgh 6/21 $35 Precision raised $35M in a Series D financing led by Bain Capital Ventures and includes partici-pation by The Hillman Co., Adams Capital Man-agement, Quaker BioVentures, Longitude Capital, Birchmere Ventures and TVM Capital (6/21)

PredictiveBiosciences

Sunnyvale, Calif.

6/17 $25 Predictive raised $25M through a Series C round with ProQuest Investments, Flybridge Capital Partners, Highland Capital Partners, Kaiser Permanente Ventures and New Enterprise Associates

PTCTherapeuticsInc.

South Plainfield, N.J.

6/8 $5.4 PTC received a $5.4M Seeding Drug Discovery Award from The Wellcome Trust

QuarkPharmaceuticalsInc.

Fremont, Calif. 6/11 $10 Quark raised $10M in venture funding from exist-ing investors including SBI Holdings Group

QR Pharma Inc. Radnor, Pa. 6/3 $0.5 QR Pharma received a $500,000 investment from BioAdvance and additional funding from angel investors, closing a seed round of $2.4M

TetraphasePharmaceuticalsInc.

Watertown, Mass.

6/2 $45 Tetraphase raised $45M in its latest round, led by Excel Venture Management, with participation from existing investors CMEA Ventures, Fidelity Biosciences, Flagship Ventures, Mediphase Venture Partners and Skyline Ventures

Veracyte Inc. South San Francisco

6/11 $28 Veracyte raised $28M in a Series B financing led by Domain Associates, with participation from Kleiner Perkins Caufield & Byers, TPG Biotech and Versant Ventures

Zymeworks Inc. Vancouver, BritishColumbia

6/30 C$3.2($3)

Zymeworks raised $3M in venture funding led by CTI Life Sciences Fund LP

JULYAdvanced Cancer Therapeutics LLC

Louisville, Ky. 7/2 $10 Advanced Cancer secured $10M in investments from high net-worth individuals and institutions

Agennix AG Planegg/Munich, Germany

7/26 �15 ($19.3) Agennix entered an agreement with shareholder dievini Hopp BioTech holding GmbH & Co. KG for a $19.3M loan at an interest rate of 6% per annum

Biosystems International SAS

Paris 7/20 $2.7 Biosystems closed a $2.7M round of funding

Calistoga Pharmaceuticals Inc.

Seattle 7/1 $40 Calistoga raised $40M in a Series C financing led by Quogue Capital LLC, along with Alta Partners, Amgen Ventures, Frazier Healthcare, Three Arch Partners and Latterell Venture Partners

Calithera Biosciences Inc.

San Francisco 7/9 $40 Calithera raised $40M in a Series A round led by Morgenthaler Ventures, with participation from U.S. Venture Partners, Advanced Technology Ventures, Delphi Ventures and Mission Bay Capital




Cara Therapeutics Inc.

Shelton, Conn. 7/22 $15 Cara raised $15M in a Series D round led by Rho Ventures, with participation from Alta Biopharma, Ascent Biomedical Ventures, CT Innovations, Devon Park BioVentures, Healthcare Private Equity, Mitsubishi International Corp. and MVM Life Science Partners

Cerenis Therapeutics SA

Toulouse, France

7/27 �40 ($51 .9) Cerenis raised $51 .9M in a Series C round led by Fund for Strategic Investment

CMP Therapeutics Ltd.

London 7/30 �1 .5 ($1 .96) CMP raised $1 .96M through a convertible loan from Inventages Venture Capital

Euthymics Bioscience Inc.

Cambridge, Mass.

7/22 $24 Euthymics raised $24M in a Series A round from Novartis Venture Fund and Venture Investors as well as Hambrecht & Quist Capital Management LLC, GBS Venture Partners and the State of Wisconsin Investment Board

Excelimmune Woburn, Mass. 7/8 $4.5 Excelimmune raised $4.5M in a new financing

HemaQuest Pharmaceuticals Inc.

Seattle 7/29 $4 HemaQuest raised $4M in a Series B by Latterell Venture Partners, bringing the total to $16M; other investors were Aberdare Ventures, De Novo Ventures, Forward Ventures and Lilly Ventures

Immune Design Corp.

Seattle 7/27 $32 Immune Design raised $32M in Series B funding led by ProQuest Investments and including the Column Group, Versant Ventures and Alta Partners

InVasc Therapeutics Inc.

Atlanta 7/12 $3. 15 InVasc raised $3. 15M in an initial closing of its first institutional financing led by Trois I Investments Industriels Internationaux SA

iPierian Inc. South San Francisco

7/9 $22 iPierian raised $22M in a Series B equity financing led by new investor Google Ventures; other inves-tors were Kleiner Perkins Caufield & Byers, Highland Capital Partners, MPM Capital and FinTech Global Capital

Kymab Ltd. London 7/13 £20 ($30. 1) Kymab raised $30. 1M in a first round from the Wellcome Trust

Metamark Genetics Inc.

Cambridge, Mass.

7/14 $22 Metamark completed a $22M Series B round

Nitric BioTherapeutics Inc.

Bristol, Pa. 7/16 $6 Nitric closed a $6M financing led by inside inves-tors

Pacific Biosciences Menlo Park, Calif.

7/15 $59 Pacific Biosciences raised $109M in a Series F financing, including a $50M investment by Gen-Probe Inc., which was disclosed in June

Pantec Biosolutions AG

Ruggell, Liechtenstein

7/21 CHF20 ($19) Pantec raised $19M in two private financing rounds with StemCell Holding AG as lead investor

Poxel SA Lyon, France 7/9 �16 ($20.2) Poxel raised $20.2M in a Series A round led by Edmond de Rothschild Investment Partners and including the InnoBio fund, which is managed by CDC Entreprises and Credit Agricole Private Equity

Reata Pharmaceuticals Inc.

Irving, Texas 7/12 $78 Reata added $78M in a Series G round led by CPMG Inc. and Novo A/S




Tethys Bioscience Inc.

Emeryville, Calif.

7/22 $33 Tethys raised $33M, of which $23M was venture funding and $10M was a working capital loan; investors were Greenspring Associates Inc., Paul Capital Investments and current investors; the loan was provided by Oxford Finance Corp. and Silicon Valley Bank

Trevena Inc. King of Prussia, Pa.

7/14 $35 Trevena raised $35M in a Series B round led by New Enterprise Associates and Polaris Venture Partners; it also included Alta Partners, Healthcare Ventures and Yasuda Economic Development Corp.

Vicept Therapeutics Inc.

Malvern, Pa. 7/1 $16 Vicept secured $10M to complete a total $16M Series A led by Vivo Ventures, Sofinnova Ventures and Fidelity Biosciences

Zogenix Inc. San Diego 7/14 $40 Zogenix secured a $35M debt facility led by Oxford Finance Corp., which included Silicon Valley Bank; the facility consists of a $25M term loan and a $10M revolving line of credit; in addi-tion to the $25M loan, the company is now getting a $15M investment from Clarus Ventures, Domain Associates, Scale Venture Partners, Thomas, McNerney & Partners, Abingworth Management and Chicago Growth Partners

AUGUSTAnchor Therapeutics

Cambridge, Mass.

8/23 $10 Anchor raised $10M in an initial close of its Series B financing; investors were Novartis Option Fund, TVM Capital and HealthCare Ventures

Cardioxyl Pharmaceuticals Inc.

Chapel Hill, N.C.

8/3 $15 Cardioxyl raised $15M in funding from Aurora Funds and New Enterprise Associates

CeNeRx Biopharma Inc.

Research Triangle Park, N.C.

8/16 $13 CeNeRx raised $13M in a Series C round with investors Perseus Soros BioPharmaceutical Fund, L Capital Partners and Pappas Ventures

Complete Genomics Inc.

Mountain View, Calif.

8/20 $39 Complete Genomics raised $39M in its Series E financing; Sands Capital led the round and was joined by existing investors Essex Woodlands, OVP Venture Partners, Prospect Venture Partners, OrbiMed Advisors, Highland Capital Management and Enterprise Partners

Dicerna Pharmaceuticals Inc.

Watertown, Mass.

8/12 $25 Dicerna raised $25M in Series B financing led by Domain Associates LLC with existing investors Oxford Bioscience Partners, Skyline Ventures and Abingworth LLP participating

Endocyte Inc. West Lafayette, Ind.

8/31 $10 Endocyte entered into a loan and security agree-ment with MidCap Financial and Silicon Valley Bank for access to up to $15M; it received the first tranche of $10M and the rest comes based on mile-stones

Jennerex Inc. San Francisco 8/20 $8.6 Jennerex completed a fully subscribed private placement financing with existing stockholders and new investors




Lineagen Inc. Salt Lake City 8/31 $5 Lineagen raised an additional $5M in a Series A round, bringing the total raised to $10.8M; inves-tors were PrairieGold Venture Partners, Sanderling Ventures, vSpring Capital and Mesa Verde Venture Partners

Mercator Therapeutics Inc.

Wellesley, Mass.

8/13 $2 Mercator raised $2M in seed financing from eight unnamed investors

Otonomy Inc. San Diego 8/30 $38.5 Otonomy raised $38.5M in a Series B round led by Novo Ventures and RiverVest Venture Partners, who were joined by Domain Associates and TPG Biotech

Pathway Therapeutics Ltd.

San Francisco 8/11 $4.5 Pathway raised $4.5M as the fourth tranche of its Series A private equity placement led by GBS Venture Partners and CM Capital Investments, with co-investors the Breast Cancer Research Trust, the Trans-Tasman Commercialisation Fund and the New Zealand Venture Investment Firm

Swift Biosciences Inc.

Ann Arbor, Mich.

8/13 $3 Swift raised $3M in a Series A financing led by the venture firm DFJ Mercury; other investors were several Michigan-based individual investors who helped launch the company in January 2010

Syndax Pharmaceuticals Inc.

Waltham, Mass. 8/12 $6 Syndax raised $6M by offering convertible notes and warrants to its Series A venture investors

Taligen Therapeutics Inc.

Cambridge, Mass.

8/24 $10 Taligen closed a $10M tranche of its Series B round from existing investors Clarus Ventures, Alta Partners, Sanderling Ventures and High Country Ventures

Tetralogic Pharmaceuticals Inc.

Malvern, Pa. 8/11 $32 Tetralogic raised $32M in a Series C financing led by Clarus Ventures; other investors were Hatteras Venture Partners, Amgen Ventures, Healthcare Ventures, Latterell Venture Partners, Novitas Capital, Quaker Bioventures and the Vertical Group

SEPTEMBERAccumetrics Inc. San Diego 9/2 $7 Accumetrics raised $7M in the second half of its

first financing round, bringing the total raised to $23.5M

Alethia Biotherapeutics Inc.

Montreal 9/8 C$9.6 ($9.2) Alethia raised $9.2M in a Series A financing; inves-tors were AgeChem Venture Fund, BDC Venture Capital, GO Capital and Epicentre Technologies Corp.

Cardoz AB Stockholm, Sweden

9/16 $3.7 Cardoz raised another $3.7M in a second close of a Series A financing, bringing the total to SEK124M ($17M); it was led by Forbion Capital Partners and included Ysios Capital Partners and HealthCap

Celator Pharmaceuticals Inc.

Princeton, N.J. 9/2 $20 Celator raised $20M in a Series D round led by Thomas, McNerney & Partners; other investors were Domain Associates, Ventures West Capital, Quaker BioVentures, TL Ventures, GrowthWorks Capital and BDC Venture Capital




Cylene Pharmaceuticals

San Diego 9/24 $12 Cylene raised another $12M in its Series C round; investors were Sanderling Ventures, HBM BioVentures (Cayman) Ltd., Novartis BioVenture Fund, BioVentures Investors, Lilly Ventures, Mitsui & Co. and Morningside Venture Investments Ltd.

CytomX Therapeutics

Santa Barbara, Calif.

9/23 $30 CytomX raised $30M in a Series B round led by Third Rock Ventures and including VC Roche Venture Fund

DecImmune Therapeutics Inc.

Cambridge, Mass.

9/28 $1 DecImmune secured a $1M equity investment from Astellas Venture Management, Amgen Ventures and HealthCare Ventures

Good Start Genetics Inc.

Boston 9/14 $18 Good Start completed an $18M Series A round led by OrbiMed Advisors, Safeguard Scientifics Inc. and SV Life Sciences

Horizon Discovery Ltd.

Cambridge, UK 9/29 £6.25 ($9.88) Horizon has closed a $9.88M Series C financing led by DFJ Esprit; other investors were Roche Venture Fund, Jonathan Milner and David Evans

Immatics Biotechnologies GmbH

Tubingen, Germany

9/22 E53.8 ($70.6) Immatics raised $70.6M in a third private round; investors were MIG AG, AT Impf, dievini Hopp Biotech Holding, Wellington Partners and other shareholders

Immune Targeting Systems Ltd.

London 9/16 $9.04 Immune Targeting added Esperante Ventures to its Series A syndicated, boosting the total raised to $22.7M

iPierian Inc. South San Francisco

9/9 $6 iPierian raised an additional $6M in the second close of its Series B round, bringing the total to $28M; SR Once, Biogen Idec New Ventures and undisclosed additional ventures participated

NeurAxon Inc. Toronto 9/30 $14 NeurAxon closed a debt financing of debentures convertible into existing class B preferred shares for a total of about $14M; investors include CTI Life Sciences Fund, the Ontario Capital Growth Corp., Delphi Ventures, OrbiMed Advisors LLC, Ventures West Capital Ltd., H.I.G. Ventures, BDC Venture Capital, NeuroVentures Fund and NeurAxon CEO Lawrence Bloch

NewBridge Pharmaceuticals FZ-LLC

Dubai, United Arab Emirates

9/21 $12 NewBridge closed a $12M Series B financing, bring-ing the total amount raised to date to $16M; the round was led by Kuwait Life Sciences Co., with participation by Burrill Life Sciences Capital Fund III LP

Okairos Basel, Switzerland

9/15 E16 ($20.8) Okairos completed a Series B private financing round totaling $20.8M; it was led by Versant Ventures and joined by the Boehringer Ingelheim Ve n t u r e F u n d ; a l l e x i s t i n g i n v e s t o r s - BioMedPartners, LSP and Novartis Venture Funds - also participated in the round

OpGen Inc. Gaithersburg, Md.

9/28 $17 OpGen raised $17M in a Series B round led by jVen Capital; other investors were CHL Medical Partners, Highland Capital Partners, Mason Wells Biomedical and Versant Ventures

Pevion Biotech Ltd. Bern, Switzerland

9/8 CHF10 ($9.9) Pevion raised $9.9M in venture funding from BZ Bank, BB Biotech Ventures and Core Capital




Phenex Pharmaceuticals AG

Ludwigshafen, Germany

9/22 E17.2 ($22.4) Phenex closed a Series C round, raising a total of $22.4M

Protagen AG Dortmund, Germany

9/8 E10 ($12.7) Protagen raised $12.7M in its second round; inves-tors were NRW Bank, MIG Fonds, S-Capital, S-Venture Capital and KfW

Q Chip Ltd. Cardiff, Wales 9/14 E2 ($2.57) Q Chip closed a $2.57M round

Relypsa Inc. Santa Clara, Calif.

9/14 $70 Relypsa raised $70M in its new Series B financing led by OrbiMed Advisors LLC, with participation from existing Relypsa investors New Leaf Venture Partners, 5AM Ventures, Delphi Ventures, Sprout Group and Mediphase Venture Partners

Rhythm Pharmaceuticals Inc.

Boston 9/9 $19 Rhythm raised a total of $40M in a Series A financ-ing, with $21M of the total being accounted for in March; the first closing was led by MPM Capital and New Enterprise Associates, with Third Rock Ventures joining in the expanded round

S*BIO Pte Ltd. Singapore 9/24 $5 S*BIO received a $5M investment by Mitsui Ventures

Sorbent Therapeutics Inc.

Sunnyvale, Calif.

9/14 $21 .8 Sorbent closed a $21 .8M Series B round; investors were AgeChem, CMEA Capital, ARCH Venture Partners, Sofinnova Ventures and the Dow Chemical Co.

Stratos Genomics Inc.

Seattle 9/8 $4 Stratos raised $4M in a Series A round led by Fisk Ventures and including Stratos Group LLC

TetraLogic Pharmaceuticals Corp.

Malvern, Pa. 9/29 $5 TetraLogic added $5M to its previously announced $32M Series C; Pfizer Ventures joined the syndicate of existing investors led by Clarus Ventures

Tigris Pharmaceuticals Inc.

Bonita Springs, Fla.

9/29 $6.5 Tigris raised $6.5M in a Series C convertible pre-ferred stock round led by Neil Flanzraich; other investors were Wexford Spectrum Investors LLC and Sonostar Capital Partners LLC; Riverbank Capital Securities Inc. acted as placement agent

Tobira Therapeutics Inc.

Manalapan, N.J. 9/30 $31 Tobira raised $31M in a Series B round led by Novo A/S; other investors were Domain Associates LLC, Frazier Healthcare Ventures, Montreux Equity Partners and Canaan Partners

Zyngenia Inc. Gaithersburg, Md.

9/9 $15 Zyngenia raised $15M through New Enterprise Associates in a Series A extension round

OCTOBERAmsterdam Molecular Therapeutics Holding NV

Amsterdam, the Netherlands

10/6 E15 ($20.75) Amsterdam raised $20.75M in an equity offering with Advent Venture Partners, Gilde Healthcare Partners, Credit Agricole Private Equity and Forbion Capital Partners

aTyr Pharma Inc. San Diego 10/26 $23 aTyr raised $23M in a Series C round led by Domain Associates and including Alta Partners, Polaris Venture Partners and Cardinal Partners

Cerenis Therapeutics SA

Toulouse, France

10/22 $13.9 Cerenis raised $13.9M in a second close of its Series C led by IRDI-IXO; other investors were Strategic Investment Fund and all previous inves-tors




Convergence Ltd. Cambridge, UK 10/5 $35.4 Convergence raised $35.4M after being spun out by GlaxoSmithKline plc; investors were Apposite Capital, New Leaf Venture and SV Life Sciences

ContraFect Corp. New York 10/27 $14.2 ContraFect closed a $2.2M Series A financing, led by Equity Source Partners LLC, and a $12M Series B financing, led by Maxim Group LLC

Dicerna Therapeutics Inc.

Watertown, Mass.

10/22 $4 Dicerna raised $4M in a second closing of its Series B round, raising a total of $29M from exist-ing investors Oxford Bioscience Partners, Skyline Ventures, Abingworth and Domain Associates and new investor SR One

Dipexium Pharmaceuticals LLC

New York 10/20 $1 .4 Dipexium raised $1 .4M in an offering of its Class A Member Interests in a multiple-closing transaction starting July 23

Innovacell Biotechnologie AG

Innsbruck, Austria

10/7 E4.3 ($6) Innovacell received $6M through its shareholders

Metabolic Solutions Development Co.

Kalamazoo, Mich.

10/22 $23.5 Metabolic Solutions raised $23.5M in a Series D round led by Hopen Life Sciences with support from Southwest Michigan First Life Science Fund

Noxxon Pharma AG Berlin 10/13 $2.8 Noxxon raised another E2M ($2.8M) in a Series D round, bringing the total raised to E35

Pathwork Diagnostics Inc.

Redwood City, Calif.

10/7 $30 Pathwork closed a $30M Series C financing led by Alta Partners, with participation from existing investors Abingworth, Advent Venture Partners, Novus Ventures, Propsect Venture Partners and Venrock

Pearl Therapeutics Inc.

Redwood City, Calif.

10/19 $69 Pearl raised $69M in a Series C financing; inves-tors were Vatera Healthcare Partners, Clarus Ventures, New Leaf Venture Partners and 5AM Ventures

Prolong Pharmaceuticals LLC

South Plainfield, N.J.

10/13 $30 Prolong secured $30M in funding from an undis-closed investor

Regulus Therapeutics Inc.

La Jolla, Calif. 10/29 $10 Regulus received a $10M equity investment from partner Sanofi-Aventis Group SA as part of their microRNA-based drugs for fibrosis deal

Synosia Therapeutics

Basel, Switzerland

10/13 $30 Synosia raised $30M in a third round with partner UCB leading the financing with a $20M invest-ment; other investors were Versant Ventures, 5AM Ventures, Novo A/S, Aravis Venture, Investor Growth Capital and Swiss Helvetia Fund

NOVEMBERAires Pharma-ceuticals Inc.

San Diego 11/15 $20 Aires raised $20M in a Series B round led by MPM Capital, and including ProQuest Investments

Beech Tree Labs Inc.

Providence, R.I. 11/17 $7 Beech Tree raised $7M in a Series B round

Biodesix Inc. Broomfield, Colo.

11/11 $7. 1 Biodesix raised $7. 1M through existing investors

Ceregene Inc. San Diego 11/12 $11 .5 Ceregene closed a Series D round worth $11 .5M in preferred stock; it was led by Hamilton BioVentures and Alta Partners with MPM Capital and Investor Growth Capital participating




Cerulean Pharma Inc.

Cambridge, Mass.

11/16 $24 Cerulean raised $24M in a Series C round led by Lilly Ventures, and including Polar Venture Partners, Venrock, Lux Capital and Bessemer Venture Partners

Coronado Biosciences Inc.

New York 11/5 $21 .6 Coronado raised $21 .6M through a financing led by Paramount BioCapital Inc.

Delenex Therapeutics AG

Zurich, Switzerland

11/15 CHF13.5 ($14.8) Delenex secured $14.8M in a Series A round led by SV Life Sciences, HBM BioCapital, HBM BioVentures, BioMedInvest and VI Partners

Helix Therapeutics LLC

Newhaven, Conn.

11/24 $2.5 Helix raised $2.5M through an investment from Canaan Partners and Connecticut Innovations

Hutchison MediPharma Holdings Ltd.

London 11/9 $12.5 Hutchison raised $12.5M via a private investment from Mitsui & Co. Ltd.

Karyopharm Therapeutics Inc.

Newton, Mass. 11/4 $20 Karyopharm raised $20M through a Series A financing from Chione Ltd.

Mind-NRG SA Geneva, Switzerland

11/3** E1 .5 ($2. 1) Mind-NRG raised $2. 1M in an initial investment from Index Ventures

Mtm Laboratories AG

Heidelberg, Germany

11/9 E7 ($9.7) Mtm raised an additional $9.7M in its Series C round led by HBM BioVentures Ltd., Wellington Partners and Gilde Healthcare Partners, with a con-sortium including National Technology Enterprises Co., Heidelberg Innovation and private investors

RedHill Biopharma Ltd.

Tel Aviv, Israel 11/9 $10 RedHill raised $10M in a private placement

Sutro Biopharma Inc.

San Francisco 11/18 $36.5 Sutro raised $36.5M in a Series C led by Skyline Ventures; other investors were the corporate ven-ture arms of Eli Lilly and Co. and Amgen Inc., SV Life Sciences and Alta Partners

Syntaxin Ltd. Oxford, UK 11/12 £18 ($29) Syntaxin closed a $29M financing that included Abingworth, SROne, LSP, Johnson & Johnson Development Corp. and Quest, as well as Lundbeckfond Ventures and Ipsen and Seventure

Verastem Inc. Boston 11/17 $16 Verastem closed a $16M Series A round led by Longwood Founders Fund; Bessemer Venture Partners, Cardinal Partners and MPM Capital joined in the financing

Xention Ltd. Cambridge, UK 11/24 £8 ($12.7) Xention raised $12.7M in a Series D financing led by Seroba-Kernel Life Sciences Ltd., and including existing investors Forbion Capital Partners, Credit Agricole Private Equity, MVM and BTG International

DECEMBERAarden Pharmaceuticals Inc.

Indianapolis 12/27 $0.25 Aarden received $250,000 from BioCrossroads Indiana Seed Fund

Ablaris Therapeutics Inc.

Pasadena, Calif. 12/21 $3 Ablaris received $3M in start-up money and may receive an additional $500,000 from its founder Arrowhead Research Corp.

Bellicum Pharmaceuticals Inc.

Houston 12/22 $3 Bellicum raised $3M in convertible note funding from new and existing investors; the notes will convert to Series B preferred stock




BioRelix Inc. New Haven, Conn.

12/28 $2.4 BioRelix raised $2.4M through the sale of promis-sory notes and warrants

Capricor Inc. Los Angeles 12/20 $2 Capricor received a $2M investment from Broadview Ventures and private individual inves-tors

Catabasis Pharmaceuticals Inc.

Cambridge, Mass.

12/9 $14.5 Catabasis raised $14.5M in a second tranche in its Series A financing from current investors, which include SV Life Sciences, Clarus Ventures, MedImmune Ventures and Advanced Technology Ventures

Covagen AG Zurich, Switzerland

12/1** CHF6.3 ($6.3) Covagen raised $6.3M in a Series A round led by Seroba Bioventures; other investors were Edmond de Rotschild Investment Partners, MP Healthcare Venture Management Inc., Novartis Venture Fund and Ventech

DBV Technologies Paris 12/20 E2 ($2.6) ALK-Abello invested $2.6M in DBV for the develop-ment of a peanut allergy vaccine

Histogen Inc. San Diego 12/1 $4.65 Histogen completed its $10M Series A round from Secure Medical, Leonard Lavin, Lordship Ventures and Angus Mitchell; the initial $5.35M was raised in May 2008

Hutchison MediPharma Holdings Ltd.

London 12/22 $7.7 Hutchison raised $7.7M in private funding from SB China Venture Capital Ltd.

Noscira Madrid, Spain 12/30 E19 ($25. 1) Noscira raised $25. 1M through the sale of 3.8M shares to existing and new investors

NovImmune SA Geneva 12/20 $20.6 NovImmune raised $20.6M additional in its Series B round

Provesica Ltd. Cambridge, UK 12/17 £4 ($6.2) Provesica received $6.2M from Forbion Capital Partners and Seroba Kernal Life Sciences Ltd.

PsiOxus Therapeutics Ltd.

London 12/16 £3.6 ($5.8) PsiOxus, formed through the merger of Myotec Therapeutics Ltd. and Hybrid BioSystems Ltd., raised $5.8M in a financing led by Imperial Innovations

Regenesance BV Amsterdam, the Netherlands

12/1 ND Regenesance raised an undisclosed amount of seed financing from Life Sciences Fund

SuppreMol GmbH Martinsried, Germany

12/2 $20.3 SuppreMol closed its $20.3M Series C round led by MIG AG and BioMedPartners AG

Notes:

** Denotes the date the item ran in BioWorld International.


Currency conversions reflect values at the time of a deal’s announcement.

Milestone Payments From Corporate Partners in 2010TOTAL: $713. 14MCompany(Symbol)#*

Partner(Country)

Amt.(M)

Details (Date)

JANUARYAlnylamPharmaceuticalsInc. (ALNY)

Roche Group(Switzerland)

ND For the initiation of pre-investigational new drug applica-tion studies for an RNAi therapeutics product candidate (1/7)

A.P. PharmaInc. (APPA)

Affiliate of PaulCapital Healthcare

$2.5 As part of an October 2005 agreement to sell its royalty rights to Retin-A Micro and Carac to the affiliate (1/12)

AstexTherapeutics*(UK)

AstraZeneca plc(UK)

ND For the selection of a protein kinase B inhibitor clinical candidate from Astex’s collaborative program with Cancer Research and Cancer Research Technology Ltd. (1/8)

BioCrystPharmaceuticalsInc. (BCRX)

Shionogi & Co. Ltd.(Japan)

$7 For marketing and manufacturing approval for intrave-nous peramivir to treat patients with influenza in Japan (1/14)

BioFocus DPI*(UK)

Janssen Pharma-ceutica NV

E1 .6($2.3)

For achieving success in its oncology target discovery col-laboration with Ortho Biotech Oncology Research & Development (1/13)

EmisphereTechnologiesInc. (EMIS)

Novo Nordisk AS(Denmark)

$2 For the start of a Phase I trial with a long-acting oral gluca-gon-like peptide-1 (NN9924) for Type II diabetes (1/14)

IderaPharmaceuticalsInc. (IDRA)

Merck KGaA(Germany)

$4.3 For the start of a Phase II study of EMD 1201081 in combi-nation with Erbitux in squamous cell carcinoma of the head and neck patients (1/20)

LigandPharmaceuticalsInc. (LGND)

NV Organon(subsidiary ofMerck & Co. Inc.)

$1 For achieving a discovery milestone through a research collaboration that expired on Dec. 31 (1/11)

NovaBayPharmaceuticalsInc. (AMEX:NBY)

Galderma SA(Switzerland)

$3.75 For the completion of formulation feasibility studies withNovaBay’s aganocide compounds for topical use, and for completing an exploratory clinical study for the treatment of adult acne (1/12)

PerseidTherapeuticsLLC (subsidiaryof Maxygen Inc.;MAXY)

Astellas PharmaInc. (Japan)

$5 For the achievement of a preclinical milestone under their collaboration to co-develop and commercialize next-gen-eration CTLA4-Ig therapeutics (1/20)

SpectrumPharmaceuticalsInc. (SPPI)

Allergan Inc.(NYSE:AGN)

$1 .5 For achieving its enrollment target in the second of two Phase III trials of apaziquone for non-muscle invasive bladder cancer (1/13)

FEBRUARYAradigm Corp.(OTC BB:ARDM)

Zogenix Inc.* $4 For the first commercial sale in the U.S. of Sumavel DosePro injection needle-free delivery system (2/5)

Bioniche LifeSciences Inc.(Canada; TSX:BNC)

EndoPharmaceuticalsHoldings Inc.(ENDP)

$8 For the licensing of rights to develop and market its non-muscle-invasive bladder cancer product in North America(2/16)

CelldexTherapeuticsInc. (CLDX)

TopoTarget A/S(Denmark; CSE:TOPO)

$3 Related to TopoTarget’s $350M deal with Spectrum Pharmaceuticals Inc. for lymphoma drug belinostat; Celldex stands to receive 10% of TopoTarget’s sublicense income on the drug, up to $6M (2/17)


MilestonePaymentsFromCorporatePartners


Company(Symbol)#*

Partner(Country)

Amt.(M)

Details (Date)

ChemoCentryxInc.*

GlaxoSmithKlineplc (UK)

$10 For the start of a Phase I trial of CCX168, an oral small mol-ecule designed to treat autoimmune diseases by targeting the C5a receptor (2/1)

Five PrimeTherapeuticsInc.*

Centocor Research& Development Inc.

ND For the selection of a therapeutic that will be pursued for immunology-related indications (2/25)

Nabi Biopharma-ceuticals Inc.(NABI)


$8 For completing the manufacture and transfer of specifiedmaterials associated with the sale of the PentaStaph vac-cine candidate (2/9)


Nippon KayakuCo. Ltd. (Japan)and HandokPharmaceuticalsCo. Ltd. (South Korea)

$16 In connection with a collaboration with Nippon for apazi-quone, it received $15M, and for a separate deal in South Korea with Handok, it received $1M (2/1)

TargetedGenetics Corp.(PK:TGEN)

AmsterdamMolecularTherapeutics BV*(the Netherlands)

$0.75 For filing for European marketing approval of Glybera (2/10)

MARCHAffymax Inc.(AFFY)

TakedaPharmaceuticalCo. Ltd. (Japan)

$5 For the start of Phase III testing of Hematide to treat ane-mia in chronic renal failure patients (3/11)

AlnylamPharmaceuticalsInc. (ALNY)


$20 For the achievement of certain predefined objectives in the transfer of Alnylam’s platform technology to Takeda for the development of RNAi therapeutics (3/24)

CBio Ltd.(Australia;ASX:CBZ)

Novo NordiskA/S (Denmark)

$1 For the recruitment of the 75th patient into the current 150-patient Phase II trial of XToll to treat autoimmune dis-eases such as rheumatoid arthritis (3/12)

Cel-Sci Corp.(AMEX:CVM)

ByronBiopharma LLC*

$0. 125 As part of a licensing agreement that granted Byron exclu-sive rights to market and distribute Cel-Sci’s Multikine in the Republic of South Africa (3/11)

CombinatoRxInc. (CRXX)

Covidien plc(NYSE:COV)

$40 For the FDA approval of Exalgo to treat moderate to severe pain in opioid-tolerant patients (3/3)

Eli Lilly and Co.and Shionogiand Co. Ltd.(Japan)

AntheraPharmaceuticalsInc. (ANTH)

$3.5 Related to the initiation of the VISTA-16 trial for A-002 (3/8)

IsisPharmaceuticalsInc. (ISIS)

Bristol-MyersSquibb Co.

$6 For the acceptance of initial regulatory filings to begin Phase I studies for BMS-PCSK9Rx (3/9)

Lpath Inc.(OTC BB:LPTN)

Merck KGaA(Germany)

$2 For Phase I Asonep data that showed lymphocyte counts in the vascular space were reduced in a dose-related fash-ion in cancer patients (3/31)


AstraZeneca plc(UK)

$2.5 For the completion by Palatin of certain tasks this quarterrelating to a program focused on compounds that target melanocortin receptors to treat obesity and related indica-tions (3/24)

Seattle Genetics Inc.(SGEN)

Genentech Inc.(NYSE:DNA)

ND For Genentech’s submission of an investigational new drug application for an ADC using Seattle Genetics’ tech-nology for the treatment of cancer (3/4)



Company(Symbol)#*

Partner(Country)

Amt.(M)

Details (Date)

Vernalis plc(UK; LSE:VER)

Novartis AG(Switzerland)

$3 For the first dosing in a Phase II proof-of-concept clinical trial of AUY-922, an Hsp90 inhibitor, in a range of solid tumors (3/17**)

APRILAVEOPharmaceuticalsInc. (AVEO)

Biogen IdecInternational GmbH(subsidiary ofBiogen Idec Inc.;BIIB)

$5 For the selection of the first humanized antibody develop-ment candidate from its ErbB3 program (4/15)


StrativaPharmaceuticals(subsidiary of ParPharmaceutical Cos.Inc.)

$20 For the FDA approval of Oravig to treat oropharyngeal candidiasis in adults (4/19)

CipherPharmaceuticalsInc. (Canada;TSX:DND)

RanbaxyPharmaceuticalsInc.

$2 For reaching the enrollment midpoint in its Phase III safety study of CIP-Isotretinoin, the company’s formulation ofisotretinoin, which is used in the treatment of severe nod-ular acne (4/2)

ClevelandBioLabs Inc.(CBLI)

Biomedical AdvancedResearch andDevelopmentAuthority of theDepartment of Healthand Human Services

$1 .93 For the exercise of milestone-based options on an exist-ing contract for selected tasks in the advanced develop-ment of Protectan CBLB502 (4/30)

Micromet Inc.(MITI)

Bayer ScheringPharma AG(Germany)

ND For the achievement of preclinical proof of concept for a BiTE antibody to treat solid tumors (4/22)

OsirisTherapeuticsInc. (OSIR)

JCR PharmaceuticalsCo. Ltd. (Japan)

$1 For development progress made advancing the stem cellproduct Prochymal for the treatment of acute graft-vs.-host disease in Japan (4/29)

XOMA Ltd.(XOMA)


$1 For achieving a pre-established preclinical milestone under the companies’ 2006 antibody collaboration agree-ment (4/16)

MAYAbbott Biogen Idec Inc.

(BIIB)$30 For the start of a Phase III trial comparing daclizumab to

Avonex in relapsing-remitting multiple sclerosis (5/25)

BioInventInternationalAB (Sweden;SSE:BINV) andThromboGenicsNV (Belgium;BR:THR)

Roche AG(Switzerland)

E10($12.38)

For the start of an imaging study with the antibody TB-403 in patients with metastatic, treatment-refractory, colorectal and ovarian cancer (5/18)

Evotec AG(Germany;FSE:EVT)

BoehringerIngelheim GmbH(Germany)

E2($2.5)

For the advance of a compound for neuropathic pain intoPhase I testing (5/20)

ImmunomedicsInc. (IMMU)

Nycomed A/S(Denmark)

$5 As part of the 2008 collaboration to develop and commer-cialize subcutaneous veltuzumab in all noncancer indica-tions (5/26)

Merck KGaA(Germany)

Clinical Data Inc.(CLDA)

E12.5($15.6)

For the FDA’s acceptance of the NDA filing for vilazodone to treat major depressive disorder (5/25)



Company(Symbol)#*

Partner(Country)

Amt.(M)

Details (Date)

Pozen Inc.(POZN)

AstraZeneca plc(UK)

$20 For the FDA’s approval of Vimovo, the gastric-friendly non-steroidal inflammatory candidate (5/3)

Vectura Groupplc (PK:VEGPF) andSosei Group Corp.


$7.5 For the start of two Phase III trials combining NVA237 with QAB149 for chronic obstructive pulmonary disease (5/11)

JUNEAffymax Inc.(AFFY)

TakedaPharmaceuticalCo. (Japan)

$30 Affymax received $30M in development milestone pay-ments from Takeda as part of their exclusive global agree-ment to develop and commercialize Hematide to treat anemia in patients with chronic renal failure (6/23)

AVEOPharmaceuticalsInc. (AVEO)

Merck & Co. Inc. $8.5 For the start of a Phase II trial evaluating SCH 900105 to treat non-small-cell lung cancer (6/8)

CombinatoRxInc. (CRXX)

Sanofi-AventisGroup SA (France)

$0.5 For the start of a Phase IIb trial testing Prednisporin in patients with persistent allergic conjunctivitis (6/8)



E2.5($3.09)

For the selection of a candidate compound for predevel-opment studies in an oncology program (6/18)

GW Pharma-ceuticals plc(UK; LSE:GWP)

Bayer ScheringPharma AG (Germany)

£10($14.8)

For the UK approval of Sativax to treat spasticity due to multiple sclerosis (6/22)

MorphoSysAG (Germany;FSE:MOR)

Centocor OrthoBiotech Inc.

ND For the start of a Phase I trial of a HuCAL-derived antibody in the therapeutic area of inflammatory and autoimmune diseases (6/23)

VitaePharmaceuticalsInc.*


$14 For Boehringer’s move into Phase I testing with a small-molecule 11bta-HSD-1 inhibitor (6/30)

JULYAlgeta ASA (Norway; OSLO:ALGETA)

Bayer Schering Pharma AG (Germany)

�5 ($6.4) For signed manufacturing and supply agreements for future commercial sale of Alpharadin to treat bone metas-tases (7/23)

Amira Pharmaceuticals Inc.*

GlaxoSmithKline plc (UK)

ND For the successful progression of an Amira-discovered 5-lipoxygenase-activating protein inhibitor into Phase II development in patients with asthma (7/20)

Cipher Pharmaceuticals Inc. (Canada; TSX:DND)

Kowa Pharmaceuticals America Inc.

$1 For reaching a cumulative sales milestone for its fenofi-brate product Lipofen (7/8)


Biomedical Advanced Research and Development Authority

$4. 1 For exercising an option regarding the development of Protectan; it supports the manufacturing process of the compound and three additional registration batches of the drug, plus additional animal studies (7/30)

Curis Inc. (CRIS) Debiopharm SA (Switzerland)

$3 For the start of a Phase I trial of Debio 0932, a small-mole-cule heat shock protein 90 inhibitor being tested for advanced solid tumors or lymphoma (7/7)

Isis Pharmaceuticals Inc. (ISIS)


$5 Related to the designation as a development candidate of a drug to treat an undisclosed rare and serious disease; Isis will develop the drug to Phase II proof of concept, at which time GSK has the option to license it (7/30)

MorphoSys AG (Germany; FSE:MOR)

Novartis AG (Switzerland)

ND For the start of a Phase I trial testing a HuCAL-derived fully human antibody for musculoskeletal diseases (7/2)



Company(Symbol)#*

Partner(Country)

Amt.(M)

Details (Date)

Optimer Pharmaceuticals Inc. (OPTR)

Cempra Pharmaceuticals Inc.

$0.5 As a result of the continuing development of CEM-101 , a macrolide under investigation as a treatment of respirato-ry infections (7/9)

Perseid Therapeutics LLC (subsidiary of Maxygen Inc.; MAXY)

Astellas Pharma Inc. (Japan)

$5 As part of a collaboration to co-develop and commercial-ize CTLA4-lg therapeutics (7/8)

XOMA Ltd. (XOMA) AVEO Pharmaceuticals Inc.

$0.75 For the start of a Phase II trial to evaluate its AV-299 anti-body for the treatment of non-small-cell lung cancer (7/27)

AUGUSTEvotec AG (Germany; FSE:EVT)

Boehringer Ingelheim GmbH (Germany)

E2.5 ($3.29)

For the selection of a candidate compound for pre-devel-opment studies in an inflammation and immunology pro-gram (8/5)

Idera Pharmaceuticals Inc. (IDRA)

Merck KGaA (Germany)

E3 ($3.8) For the start of a Phase Ib trial of IMO-2055 in combination with cisplatin, fluorouracil and Erbitux in first-line squa-mous-cell carcinoma of the head and neck (8/30)



ND For the start of a Phase I trial of a HuCAL-derived antibody in the area of ophthalmology (8/3)

SEPTEMBERCardiome Pharma Corp. (Canada; CRME)

Merck & Co. Inc. $30 For the European approval of Brinavess, or intravenous vernakalant, for use in converting recent onset atrial fibril-lation patients to normal sinus rhythm (9/3)

Depomed Inc. (DEPO) Covidien plc (Ireland; NYSE:COV)

$0.5 For the first acetaminophen/opioid analgesic formulation entering clinical development under their worldwide license agreement (9/29)

GenVec Inc. (GNVC) Novartis AG (Switzerland)

ND GenVec achieved the first milestone in its $213.6M collabo-ration with Novartis to develop treatments for hearing loss and balance disorders (9/15)

ImmunoGen Inc. (IMGN)

Sanofi-Aventis Group (France)

$1 For the start of testing of SAR566658, a treatment for can-cer (9/22)

Lipoxen plc (UK; LSE:LPX)

Baxter International Inc.

$2 For the filing of an investigational new drug application of a lead polymer polysialic acid-FVIII candidate (9/17)

Neovacs SA (France; Paris:ALNEV)

OSEO (French state innovation agency)

E0.963 ($1 .2)

For its contract aimed at developing a TNF-Kinoid in rheu-matoid arthritis (9/14)

Rigel Pharmaceuticals Inc. (RIGL)

AstraZeneca plc (UK) $25 For the start of a Phase III program for oral Syk inhibitor fostamatinib in rheumatoid arthritis (9/30)

Seattle Genetics Inc. (SGEN)

Agensys Inc. (affiliate of Astellas Pharma Inc.; Japan)

ND For Agensys’ initiation of a Phase I trial with AGS-16M8F, an antibody-drug conjugate for cancer (9/3)


Bayer Innovation GmbH (Germany)

ND For the agreement under which Stellar supplies Keyhole Limpet Hemocyanin (9/14)

OCTOBERAblynx NV (Belgium; BR:ABLX)


E3 ($4. 1) For the companies alliance to develop and commercialize Nanobodies (10/4)

Astex Therapeutics Ltd.* (UK)

AstraZeneca plc (UK) ND For AstraZeneca’s selection of a candidate drug from the collaborative program aimed at identifying small-mole-cule inhibitors of beta-secretase, a key enzyme implicated in the progression of Alzheimer’s disease (10/26)



Company(Symbol)#*

Partner(Country)

Amt.(M)

Details (Date)

Depomed Inc. (DEPO) Janssen Pharmaceutica N.V. (subsidiary of Johnson & Johnson)

$5 For the delivery of a formulation of canagliflozin and met-form (10/25)

Flamel Technologies SA (France; FLML)

Merck KGaA (Germany)

E3 ($4. 1) As part of the companies’ partnership for the develop-ment of an extended-release formulation of interferon beta-1a (10/20)

Incyte Corp. (INCY) Eli Lilly and Co. $19 For the start of a Phase IIb trial evaluating INCB28050 for the treatment of rheumatoid arthritis (10/21)

Prosensa Therapeutics BV* (the Netherlands)


£7.5 ($11 .9) For the successful safety review in its Phase II open-label, extension trial of GSK2402968 for Duchenne’s muscular dystrophy (10/14)

Sucampo Pharmaceuticals Inc. (SCMP)

Abbott Japan Co. Ltd. (Japan)

$5 For the submission of a marketing application to Japanese authorities for approval of Amitiza in chronic idiopathic constipation (10/8)

Vernalis plc (UK; LSE:VER)

Les Laboratoires Servier (France)

E0.75 ($1 .045)

As part of a three-year oncology drug discovery collabora-tion initiated in May 2009; for achieving the desired potency and selectivity criteria in the program (10/7)

Xencor Inc.* Boehringer Ingelheim GmbH (Germany)

ND For the regulatory submission of a monoclonal antibody for cancer developed under a 2007 licensing agreement (10/13)

NOVEMBERBioniche Life Sciences Inc. (Canada; TSX:BNC)

Endo Pharmaceuticals Inc. (ENDP)

$4 For Urocidin, a product of non-muscle-invasive bladder cancer that is refractory to current first-line therapy, attaining a contractual efficacy goal from a Phase III FDA registration trial (11/18)

Depomed Inc. (DEPO) Merck & Co. Inc. $2.5 For the development of sitagliptin and extended-release metformin (11/3)

Idenix Pharma-ceuticals Inc. (IDIX)

Viiv Healthcare LLC (UK)

$20 For the initiation of Phase IIb trials of GSK2248761 in HIV/AIDS (11/24)

Incyte Corp. (INCY) Novartis AG (Switzerland)

$50 For the start of Phase III trials of INCB18424 to treat polycy-themia vera (11/3)

Inspiration Biopharmaceuticals Inc.*

Ipsen SA (France) $50 For the start of a Phase II/III study of its intravenous recombinant porcine factor VIII product, OBI-1 , for hemo-philia (11/22)

Ironwood Pharma-ceuticals Inc. (IRWD)

Almirall SA (Spain) $20 For positive results from a European Phase III trial of lina-clotide for irritable bowel syndrome with constipation (11/8)

Micromet Inc. (MITI) Bayer Schering Pharma AG (Germany)

E2.5 ($3.5)

For the move of Micromet’s BiTE antibody MT112/BAY 2010112 into formal preclinical development for solid tumors (11/9)

NovaDel Pharma Inc. (OTC BB:NVDL)

Mist Acquisition LLC $0.5 Pursuant to a 2009 agreement between the two compa-nies to manufacture and commercialize NitroMist in North America (11/5)

Pharming Group NV (the Netherlands; Amsterdam:PHARM)

Swedish Orphan Biovitrum AB (Sweden; PK:SWTUY)

E5 ($7) For the European Commission approval of Ruconest in acute attacks of hereditary angioedema (11/3)

Pozen Inc. (POZN) AstraZeneca plc (UK) $25 For the granting of marketing and pricing approvals for Vimovo in the UK (11/15)



ND For the FDA’s acceptance of an investigational new drug application for an influenza vaccine produced in EB66 cells (11/30)



Company(Symbol)#*

Partner(Country)

Amt.(M)

Details (Date)

XOMA Ltd. (XOMA) Kaketsuken Chemo-Sero-Therapeutic Research Institute (Japan)

$2 As part of a November 2009 collaboration involving mul-tiple XOMA antibody research and development technolo-gies (11/2)

DECEMBERArray BioPharma Inc. (ARRY)

Celgene Corp. (CELG) $10 For plans to start a Phase I cancer trial with cFMS inhibitor ARRY-382 in the first quarter of 2011 (12/1)

Benitec Ltd. (Australia; ASX:BLT)

Tacere Therapeutics Inc.*

$0. 162 For Benitec’s equity stake in Tacere in relation to a licens-ing agreement for gene silencing technology for hepatitis C (12/27)

Catalyst Bioscience Inc.*

Pfizer Inc. $4 Under the terms of their collaboration to develop improved recombinant human Factor VIIa variants for hemophilia and other bleeding disorders (12/17)

Clinical Data Inc. Santen Pharmaceutical Co. (Japan)

$2 For Santen’s filing of an investigational new drug applica-tion for ATL313, an adenosine A2A agonist for primary open angle gluacoma and ocular hypertension (12/23)

Envoy Therapeutics Inc.*

Merck and Co. Inc. ND For executing its bacTRAP technology in diabetes-relevant tissues (12/16)

Icagen Inc. (ICGN) Pfizer Inc. $1 For Pfizer’s selection of a compound targeting the sodium ion channel Nav1 .7 to treat pain and related disorders (12/1)

Ligand Pharmaceuticals Inc. (LGND)

Pfizer Inc. $1 For Pfizer’s sublicensing of Tanaproget, a nonsteroidal progesterone receptor agonist contraceptive (12/23)


Centocor Ortho Biotech LP (unit of Johnson & Johnson)

ND For the filing of an application for a Phase I trial of a HuCAL-derived antibody for inflammatory and autoim-mune diseases (12/23)

Orexo AB (Sweden; SSE:ORX)


E6.5 ($8.6)

For the selection of a development candidate from the firms’ 2005 collaboration focused on pain and inflamma-tory diseases (12/17)

Silence Therapeutics plc (UK; LSE:SLN)

Quark Pharmaceuticals Inc.* and Novartis AG (Switzerland)

$1 .5 In relation to the option agreement between Quark and Novartis for QPI-1002 (12/22)

Zealand Pharma AS (Denmark; CSE:ZEAL)

Helsinn Healthcare SA (Switzerland)

E0.5 ($0.662)

As part of their November 2008 license agreement to develop ZP1846 to treat chemotherapy-induced diarrhea (12/10)

Notes:

# Unless otherwise indicated, shares are traded on the Nasdaq exchange; * Private company. Currency conversions are based on exchange rates at the time of the deal.


ND = Not disclosed. ** Denotes the date the item ran in BioWorld International.

AMEX = American Stock Exchange; ASX = Australian Stock Exchange; CDNX = Canadian Venture Exchange; CSE = Copenhagen Stock Exchange; FSE = Frankfurt Stock Exchange; LSE = London Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; PK = Pink Sheets; SSE = Stockholm Stock Exchange; TSX = Toronto Stock Exchange.

Grants and Awards Given to Biotech Companies in 2010Company* (Country; Symbol)

Funding Institution

Amount (US$M) Type Details (Date)

FIRST QUARTER 2010Ablynx NV(Belgium; BR:ABLX)

Flemish agencyfor Innovation byScience andTechnology

|1 .2($1 .6)

Grant To support preclinical and clinical work with ALX-0061 for autoimmune and inflammatory diseases (2/22)


National Instituteof Allergy andInfectious Disease

ND Phase I SBIR grant

To study and characterize a back-up series of compounds to the antibiotic ACH-702 for tuberculosis (3/19)

AdeonaPharmaceuticalsInc. (AMEX:AEN)

American Recovery and ReinvestmentAct

$0.86 Grant For the ongoing Phase II/III trial of Trimesta for multiple sclerosis (1/11)

Affiris AG* (Austria) Austrian ResearchPromotion Agency

|1 .2($1 .6)

Grant For a hypertension vaccine that will use Affiris’ Affitome technology to target angiotensin II, a peptide that can cause narrowing of the blood vessels (2/26)

AmsterdamMolecularTherapeutics*(the Netherlands)

Dutchgovernment

|4($5.7)

Innovation credit

To support the development of its g e n e t h e r a p y t r e a t m e n t f o r Duchenne’s muscular dystrophy (1/7)

ArcadiaBiosciences Inc.*

National Instituteof Diabetes andDigestive and Kidney Diseases and the AmericanRecovery and Re-investment Act

$0.856 STTR grant To help fund Phase II development of wheat varieties with reduced celiac disease-causing proteins (2/17)

AVI BioPharma Inc.(AVII)

CureDuchenne andthe Foundation toEradicate Duchenne

$0.5 Grants To support research and devel-opment of the company’s exon-skip-ping drug candidates for the treatment of Duchenne’s muscular dystrophy (2/17)

Carmot TherapeuticsInc.*, OpsonaTherapeutics Ltd.*(Ireland), InterMedDiscovery GmbH*(Germany), FoldRxPharmaceuticals Inc., Pfizer Inc.and EnvivoPharmaceuticals Inc.

Michael J. FoxFoundation forParkinson’sResearch

$2. 1 Grants For preclinical projects focused on neuroprotective therapeutic targets for Parkinson’s disease, including Carmot, Opsona and Intermed’s focus on inflammation and oxidative stress, FoldRx and Pfizer’s focus on alpha-synuclein, plus Envivo’s pro-gram looking at inhibitors of histone deacetylase (1/20)

Celsion Corp.(CLSN)

Center forTranslationalMolecular Medicine

ND Grant For magnetic resonance imaging-guided high intensity-focused ultra-s o u n d t o i m p r o v e c a n c e r chemotherapy (2/23)

DeveloGen AG*(Germany)

Juvenile DiabetesResearch Foundation

$0.5 Grant For research of mechanisms for the protection of beta cells (2/24)


GrantsandAwardsGiventoBiotechCompanies


Company* (Country; Symbol)

Funding Institution


GeneGo Inc.* National Instituteof General MedicalSciences

$0.336 Phase I SBIR grant

For creating a type of predictive sig-nature for drug resistance (1/13)

Hepregen Corp.* National ScienceFoundation

$0.5 Phase II SBIR grant

To support its work developing a human liver platform for high-throughput screening of drug-induced liver injury and drug-drug interaction (1/15)

Horizon DiscoveryLtd.* (UK)

University ofTorino (Italy)

$0.5 Eurostars grant

To research a novel class of inherited and somatic noncoding cancer-relat-ed single-nucleotide polymorphisms (2/17)

Intellikine Inc.*and TragaraPharmaceuticals Inc.*

Multiple MyelomaResearchFoundation

$1 Biotech InvestmentAward grant

To fund the early stage drug develop-ment of compounds and approaches that show potential in treating multi-ple myeloma (3/30)

Isotechnika PharmaInc. (Canada;TSX:ISA)

National ResearchCouncil

C$0.237($0.23)

Industrial ResearchAssistance Programgrant

For its non-immunosuppressive cyclosporin analogue molecules pro-gram (3/5)

MirnaTherapeuticsInc.*

Texas EmergingTechnology Fund

$5 Grant To develop miRNA therapeutics for multiple cancers (1/12)

NeurAxon Inc.* Michael J. FoxFoundation forParkinson’sResearch

$0.267 Grant To fund research exploring neuronal nitric oxide synthase inhibitors as a potential treatment paradigm in Parkinson’s research (1/12)

OncoTek DrugDiscovery Inc.(subsidiary ofReceptor Thera-peutics Inc.*; Canada)

Ontario Institutefor CancerResearch

ND Grant For preclinical development of PoLi-PTX, an intraperitoneal ovarian can-cer therapy (3/25)

OrphagenPharmaceuticalsInc.*

NationalInstitutes ofHealth

$1 .2 Phase II SBIR grant

To further characterize a class of small-molecule drugs that have the potential to treat circadian rhythm sleep disorders and psychiatric ill-nesses such as anxiety, depression orpsychosis (2/2)

Pangu BioPharma(Hong Kong; subsid-iary of aTyr Pharma Inc.*)

Hong KongUniversity ofScience andTechnology

ND Grant To fund research it is performing with the university in the identifica-tion and characterization of naturally occurring splice variants of human tRNA synthetases (3/2)

PDS BiotechnologyCorp.*

National CancerInstitute


To complete studies required for an investigational new drug application for its lead human papillomavirus-cancer product (3/3)

Pronota NV*(Belgium)

Institute for thePromotion ofInnovation byScience andTechnology(Belgium)

|1 .4($2)

Grant To further validate and develop bio-markers for the management of heart failure (1/13)




Funding Institution


Sirion BiotechGmbH* (Germany)and HelmholtzZentrum Munchen(Germany)

Federal Ministryfor Economicsand Technology(Germany)

|0.5($0.674)

Two-year grant

To d e v e l o p n e w t h e r a p e u t i c approaches against lymphoid tumors (3/30)

Targacept Inc.(TRGT)


$0.304 Grant To fund a project on development of an alpha6-selective neuronal nicotin-ic receptor imaging agent as a Parkinson’s disease biomarker (2/9)

TerpenoidTherapeutics Inc.*

NationalInstitutes ofHealth

$0.946 Phase II STTR grantand a Phase I SBIR grant

To advance cancer drug candidates toward commercialization (1/27)

Transposagen BiopharmaceuticalsInc.*

National CancerInstitute andKentucky economicdevelopmentoffice

$0.412 SBIR grant For its work developing a rat model of human colorectal cancer (1/26)

Zyngenia Inc.* State of Marylandand MontgomeryCounty

$2.5 Bioscience Strategygrant

To support the new life sciences company that has 14 employees (3/12)

SECOND QUARTER 2010AestusTherapeuticsInc.*

National Instituteof NeurologicalDisorders andStroke

$2 SBIR grant To fund clinical trials of Aestus’ treat-ment for chronic neuropathic pain (6/10)

AmarantusTherapeuticsInc.* andBiodesy LLC*

The Michael J.Fox Foundationfor Parkinson’sResearch

$3 Grant More than $3M was split among the two companies and 15 university pro-grams (4/26); Amarantus reported it received $350,000 from the founda-tion to study the efficacy of mesen-cephalic astrocyte-derived neuro-trophic factor (4/29)

American LifeScience Pharma-ceuticals Inc.*

Alzheimer’s DrugDiscoveryFoundation

$0.248 Grant To allow for the manufacture of its lead drug candidate for preclinical toxicology testing in preparation for Phase I trials (5/25)

AmicusTherapeuticsInc. (FOLD)

Alzheimer’s DrugDiscoveryFoundation

$0.21 Grant To evaluate small-molecule, orally delivered pharmacological chaper-one compounds to treat Alzheimer’s disease (5/10)

AvaxiaBiologics Inc.*

National Instituteof Diabetes andDigestive andKidney Diseases


To support development of a novel antibody therapeutic for inflammato-ry bowel disease (4/2)

BioMarker Strategies*


$1 Phase II SBIR grant

To develop the SnapPath live tumor cell testing system (5/4)




Funding Institution


Ceregene Inc.*,Biovail Corp. (Canada;TSX:BVF) and Med-Genesis TherapeutixInc.* (Canada)

Michael J. FoxFoundation

$4.6 Grants Ceregene received $2.5M for Phase II testing of CERE-120, and Biovail and MedGenesis received the rest to develop a glial cell line-derived neu-rotrophic factor (6/23)

CLC Bio* (Denmark),Ion Torrent andAarhus UniversityHospital

Danish NationalAdvanced Tech-nology Foundation

$2 Grant For a three-year project to develop an integrated software and hardware solution for molecular diagnostics to more quickly and precisely diagnose patient DNA samples through advanced software (6/16)

Critical OutcomeTechnologies Inc.(Canada)

National ResearchCouncil of CanadaIndustrial ResearchAssistance Program

$0.3 Grant To support development of multiki-nase targets against acute myeloge-nous leukemia (6/30)

Evotec AG(Germany; FSE:EVT)

German FederalMinistry ofEducation andResearch

|1 .5($1 .98)

Grant To advance its H3 receptor antago-nist program into the clinic (4/28)

Five PrimeTherapeuticsInc.*

Fast Forward LLC,a subsidiary of theNational MultipleSclerosis Society

$1 Grant To develop a preclinical MS drugthat targets the innate immunesystem (5/26)

Inovio BiomedicalCorp. (AMEX:INO),Drexel University,Cheyney Universityand the Universityof Pennsylvania

State ofPennsylvania

$2.8 Grant To develop a DNA vaccine to treat hepatitis C virus (4/12)

IPierian Inc.* California Instituteof RegenerativeMedicine

$1 .5 Basic Biology Award

To provide valuable insights into the biological pathways and molecular targets involved in inducing pluripo-tent stem cells (5/3)

Lentigen Corp.* National Institutesof Health

ND STTR grant For a program on Lentiviral gene therapy for mucopolysaccharidosis (5/19)

Leonardo Biosystems*

Texas EmergingTechnology Fund

$2.5 Grant For a multistage drug delivery plat-form to improve the effectiveness of drug therapy, particularly for cancer (6/8)

Living CellTechnologies Ltd.(Australia; BE:LHI)

Juvenile DiabetesResearchFoundationInternational

$0.5 Grant For its ongoing Phase II trial of Diabecell in New Zealand (4/28)

MirnaTherapeuticsInc.*

Cancer Preventionand ResearchInstitute of Texas

$10.3 Grant To advance its microRNA mimic dis-covery platform and a pipeline of cancer drug candidates (6/22)

MitoSciences Inc.* National Institutesof Health

$0.59 Grant To support the development of com-panion diagnostic tests for antiviral drugs (5/14)




Funding Institution


NanoBio Corp.*and University ofMichigan

National Institutesof Health

ND Phase I TechnologyTransfer award

To evaluate a potential therapeutic intranasal vaccine for the treatment of hepatitis B (4/21)

Neoprobe Corp.(OTC BB:NEOP)

Ohio’s ThirdFrontier Commission

$1 Grant To fund ongoing development of its Lymphoseek radiopharmaceutical initiative (6/25)

Oragenics Inc.(AMEX:ONI)

National ScienceFoundation

$0.5 Grant To support the company’s DPOLT Lantibiotic Synthesis Platform (6/15)

PluristemTherapeuticsInc. (PSTI)

Office of theChief Scientist atthe Ministry ofIndustry, Tradeand Labor ofIsrael

$2.5 Grant For research and development of PLX-PAD in critical limb ischemia and moderate-severe claudication (6/29)

PolyMedix Inc.(OTC BB:PYMX)

National ScienceFoundation

$0. 15 Grant To support the development of anti-microbial sutures (5/28)

Prolor Biotech Inc.(Israel; AMEX:PBTH)

Israeli Office of the Chief Scientist

$1 .6 Grant To support development of hGH-CTP, a longer-acting version of human growth hormone (4/13)

Protalix Bio-Therapeutics Inc.(Israel; AMEX:PLX)

Office of the ChiefScientist of Israel’sMinistry of Industry,Trade and Labor

$4. 1 Grant Up to $2.9M of the funds are for the advancement of early stage pipeline product candidates, and up to $1 .2M is for further development of taliglu-cerase alfa (5/18)

Protein PotentialLLC*

National Instituteof Allergy andInfectious Diseases

$3 Phase II SBIR grant

To support translational research to develop a vaccine for the prevention of malaria caused by the parasite Plasmodium vivax (4/20)

Q TherapeuticsInc.* and JohnsHopkins University

Maryland Stem CellResearch Fund

$1 Grant To enable further study of Q’s human neural glial cell product Q-Cells in preclinical models of demyelinating disease (6/3)

RegeneRx Bio-pharmaceuticalsInc. (AMEX:RGN)

National Institutesof Health’s NationalHeart, Lung andBlood Institute

$3 Grant To support clinical development of RGN-352 for patients who have suf-fered an acute myocardial infarction (5/14)

Savara Inc.* Texas EmergingTechnology Fund

$1 .9 Grant For the commercialization of its dry-powder technology for treating asth-m a , l u n g c a n c e r a n d o t h e r lung-based diseases (6/16)

SignumBiosciences Inc.*

Alzheimer’sDrug DiscoveryFoundation

$0.27 Grant To evaluate small-molecule, orally delivered protein phosphatase 2a-modulatory compounds as dis-ease-modifying therapeutics for AD (4/1)

Sirnaomics Inc.* National CancerInstitute andNational Instituteof Allergy andInfectiousDiseases

ND SBIR grants For multitargeted siRNA therapeutics using its nanoparticle-enhanced delivery technologies, with programs in cancer, respiratory infections and scarless wound healing (6/30)




Funding Institution


SorrentoTherapeuticsInc. (OTC BB:SRNE)

National Instituteof Allergy andInfectiousDiseases

$0.3 Phase I AdvancedTechnology STTR grant

To help generate and develop anti-body therapeutics and vaccines against Staphylococcus aureus infec-tions (5/24)

Synedgen Inc.* U.S. Army $2.73 Grant To develop treatments for drug-resis-tant bacteria that affect troops injured in battle (5/13)

TriLink BioTech-nologies Inc.*


$0.725 Phase II SBIR grant

To continue the firm’s work on devel-oping reagents to enhance the speci-ficity of DNA ligase (6/23)

ZenBio Inc.* National Institutesof Health

ND Phase I SBIR grant`

To establish novel human cell-based models of nonalcoholic fatty liver disease useful for basic research and as a potential drug development platform (4/22)

THIRD QUARTER 2010A&G Pharmaceutical Inc.*

National Cancer Institute


To develop a neutralizing therapeutic antibody against GP88, a glycopro-tein that plays a critical role in the development of human cancers (9/29)

AcordaTherapeutics Inc.(ACOR)

National, Heart,Lung, and BloodInstitute

$1 Grant To support research on glial growth factor 2, an investigational agent to treat heart failure (7/21)

Addex Pharmaceuticals Ltd. (Switzerland; SWX:ADXN)

Michael J. Fox Foundation

$0.9 Grant To help fund a Phase II study of ADX48621 to treat Parkinson’s dis-ease levodopa-induced dyskinesia (9/9)

Advanced Targeting Systems*


$3 Grant To advance its investigational drug SP-SAP for cancer pain into clinical trials (9/24)

Aeterna Zentaris Inc. (Canada; TSX:AEZ)

National Institutes of Health

$1 .5 Grant NIH awarded University of Southern California professor Jacek Pinski a three-year grant to conduct a Phase I/II study of AEZS-108 in patients with refractory prostate cancer (8/6)

AgeneBio Inc.* Alzheimer’s Drug Discovery Foundation

$0.24 Grant To develop a new class of small mol-ecules aimed at treating amnestic mild cognitive impairment (8/27)

Applied Genetic Technologies Corp.*

FDA $1 Grant To fund a Phase II trial of alpha 1 anti-trypsin deficiency with recombinant adeno-associated virus vectors at higher doses (9/17)

ArGEN-X BV (the Netherlands)

Institute for the Promotion of Innovation by Science and Technology (Belgium)

|1 .5 ($2) Grant To accelerate preclinical develop-ment of lead program ARGX-109 and two further therapeutic monoclonal antibody programs (9/28)

Asklepios Biopharmaceutical Inc.

Epilepsy Foundation $0.2 Grant As part of the Epilepsy Therapy Project to advance its preclinical gene therapy for medically refractory epilepsy (8/24)




Funding Institution


Biodel Inc. (BIOD),Stanford Universityand Oregon Health& Science University

Juvenile DiabetesResearchFoundation

$0.407 Research grants

To evaluate the use of VIAject rapid-acting injectable human insulin in the treatment of diabetes (7/13)

Bionovo Inc. (BNVID) and the University of California at Berkeley

National Center for Complementary and Alternative Medicine

ND STTR grant To fund the first phase in a planned multiphase study to evaluate the company’s plant-derived tissue selective estrogen receptor modula-tors for preventing obesity and meta-bolic syndrome (9/3)

Bolder BioTechnology Inc.*

National Institute of Allergy and Infectious Diseases


To demonstrate the feasibility of using the company’s long-acting interleukin-11 analogue to accelerate platelet recovery and improve sur-vival in a mouse model of acute radi-ation syndrome (8/19)

Celsion Corp. (CLSN) National Institutes of Health


To support the company’s efforts to develop its heat-activated liposomal technology in combination with che-motherapy drug carboplatin in col-laboration with Duke University (9/3)

Cognition Therapeutics Inc.*

Alzheimer’s Drug Discovery Foundation

$0.229 Grant To develop small-molecule drugs that block the action of toxic oligo-mers thought to be responsible for Alzheimer’s disease (8/19)

Compendia Bioscience Inc.*


$1 .3 SBIR Fast Track grant

To compile microRNA data into the Oncomine platform, a compendium of cancer genomic profiles for target discovery and validation (9/1)


Michael J. FoxFoundation forParkinson’s Research

ND Grant To test selected compounds from its Ampakine platform for their ability to restore brain function in animal mod-els of Parkinson’s disease (7/7)

Cytokinetics Inc.(CYTK)

National Instituteof NeurologicalDisorders and Stroke

$2.9 Grant To study CK-2017357 for myasthenia gravis (7/27)

DecImmune Therapeutics Inc.*


$2.2 SBIR grant To work on reducing tissue damage in ischemic reperfusion injury (9/28)

DynavaxTechnologiesCorp. (DVAX)

NationalInstitutes of Health

$0.6 Grant To explore the feasibility of develop-ing a universal vaccine to prevent infection by human papillomavirus (7/8)



$17.6 Five-year grant

To take a systems biology approach to study the differences between individuals who do or do not respond to vaccination against the hepatitis B virus (9/1)

Edge TherapeuticsInc.*

New JerseyEconomicDevelopmentAuthority

$0. 1 Grant To further develop treatments for preventing secondary brain damage that occurs after hemorrhagic stroke or traumatic brain injury (7/14)




Funding Institution


GeneGo Inc.* National Institute on Drug Abuse

ND SBIR grant To develop an integrated systems biology platform for research into the causes and treatment of tobacco dependence, nicotine addiction, smoking cessation and tobacco/nic-otine withdrawal (9/23)

ImmuneRegen Biosciences Inc.*

National Institute of Allergy and Infectious Disease

$15 Five-year, continuation grant

For studies at the University of Rochester Medical Center of a num-ber of drugs and other countermea-sures, including Homspera, for their effectiveness against radiation-induced injury (8/30)

Lentigen Corp.* National Institutes of Health

ND Phase II SBIR grant

To develop an experimental immu-notherapy for melanoma (8/10)

MabVax Therapeutics Inc.*


$1 . 1; and $0. 15 Phase II STTR grant; and an SBIR grant

To support continued development of the company’s project focused on the characterization of human anti-bodies to sialyl-Lewis A, or sLeA (8/11); and to support the manufac-ture and testing of the company’s sarcoma vaccine (8/18)

MacroGenics Inc.* National Institutesof Health

$9.8 Grants To help advance its Dual-Affinity ReTargeting, or bispecific antibody scaffold platform, as well as its port-folio of infectious disease product candidates (7/16)

MorphoSys AG(Germany; FSE:MOR)

German FederalMinistry ofEducation andResearch

|1($1 .25)

Grant To advance the anti-CD38 antibody MOR202 into clinical development for multiple myeloma and to explore relevant biomarkers (7/7)

Orphagen Pharmaceuticals Inc.*



To develop a new class of small-mol-ecule drugs for the treatment of adrenocortical and prostate cancers (8/11)

Oxford BioMedicaplc (UK; LSE:OXB) andVIB* (Belgium)

UK Motor NeuroneDisease Association

|0.255($0.3175)

Research grant

To support the further preclinical evaluation of MoNuDin as a treat-ment for amyotrophic lateral sclero-sis (7/2)

Pluristem Therapeutics Inc. (PSTI)

European Commission

ND Grant from its Seventh Framework Program

To study its PLX cell therapy product, derived from human placenta, to treat diastolic heart failure (8/31)

PolyMedix Inc.(OTC BB:PYMX)


$0.5 Grant To support the development of defensin-mimetic antimicrobial com-pounds for the treatment of malaria (7/8)

PTC Therapeutics Inc.*

FDA’s Office of Orphan Products Development

$1 .6 Grant To support an ongoing Phase III study of ataluren in patients with nonsense mutation cystic fibrosis (9/22)

Repligen Corp. (RGEN)

Friedreich’s Ataxia Research Alliance and Go Friedreich’s Ataxia Research

$0.436 Grants To support its research program to develop HDAC inhibitors for neuro-degenerative diseases (8/3)




Funding Institution


RXi PharmaceuticalsCorp. (RXII)

National Instituteof Allergy andInfectious Diseases

ND SBIR grant For preclinical development of RNAi therapeutics using RXi’s therapeutic platform, which includes both novel RNAi compounds and advanced delivery technologies (7/14)

SangamoBioSciences Inc.(SGMO)


$0.9 Grant To support studies in nonhuman pri-mates for the development of a ZFP therapeutic in Parkinson’s disease (7/2)

Selecta Biosciences Inc.*

National Institute on Drug Abuse

$3 Grant To advance a therapeutic nicotine vaccine for smoking cessation and relapse prevention (8/17)

Sernova Corp. (Canada; CDNX:SVA)

National Research Council of Canada Industrial Research Assistance Program

C$0.275 ($0.267) Grant To support study of the potential islet-sparing effect and optimal dose of islets to provide a long-term treat-ment for diabetics using the compa-ny’s Cell Pouch System in preclinical allograft models of diabetes (9/14)

Signum Biosciences Inc.*

National Institute of Arthritis and Musculoskeletal and Skin Diseases

$0.684 SBIR Phase I grants

To develop G-protein coupled recep-t o r m o d u l a t i n g t h e r a p e u t i c s designed to treat common skin dis-orders (9/21)

Soligenix Inc. (OTC BB:SNGX)

FDA’s Office of Orphan Products Development

$1 .2 Three-year clinical research grant

For its ongoing confirmatory Phase III trial of orBec in acute gastrointestinal graft-vs.-host disease (8/24)

Tocagen Inc.* National Brain Tumor Society

ND Grant To develop its investigational treat-ment for glioblastoma multiforme, which is designed to deliver a pro-drug-activator gene to brain cancer cells (8/5)

YM BioSciences Inc. (Canada; AMEX:YMI) and Pulmokine Inc.*


$0.65 SBIR grants To help develop treatments for pul-monary arterial hypertension using compounds originating from YM’s small-molecule library (9/30)

FOURTH QUARTER 20104SC AG (Germany; FSE:VSC), Anaxomics Biotech* (Spain) and a number of European universities

European Union $7.6 Grant To investigate the link between peri-odontal disease and rheumatoid arthritis (12/23)

Acadia Pharmaceuticals Inc. (ACAD)

The Michael J. Fox Foundation

$0.3 Grant For the development of Nurr1-RXR agonists for the treatment of Parkinson’s disease (11/10)

Adolor Corp. (ADLR) Michael J. Fox Foundation for Parkinson’s Research

$0.363 Grant To support the development of selec-tive centrally acting mu opioid recep-tor antagonists for the treatment of I-DOPA-induced dyskinesia associat-ed with Parkinson’s disease (11/5)

Affiris AG (Austria) Michael J. Fox Foundation

$0.475 Grant For preclinical development of a vac-cine, PD01 , against Parkinson’s dis-ease (12/17)




Funding Institution


Agenta Biotechnologies Inc.*

National Institutes of Health and National Institute of Dental and Craniofacial Research

$1 . 1 SBIR grant To develop a biologically activated membrane to improve healing after oral surgery (11/11)

AiCuris GmbH & Co. (Germany), Squarix (Germany) and the Universities of Bochum, Dusseldorf and Bonn

Ministry of Innovation, Science and Research of North Rhine-Westphalia

$1 . 1 Research grant

Three-year grant to support the proj-ect “Innovative Antibiotics made in NRW” aimed at development of new antibiotics effective against life-thre-aning multiresistant bacteria such as the hospital agent MRSA (11/30)

Allon Therapeutics Inc. (Canada; TSX:NPC)

Michael J. Fox Foundation for Parkinson’s Research

$0.625 Grant To conduct preclinical research that will help determine the potential of the company’s lead neuroprotective drug, davunetide (12/1)

Altravax Inc.* National Institute of Allergy and Infectious Diseases

$1 .2 SBIR grants For research on antibody-inducing vaccines against HIV-1 (10/6)

Amicus Therapeutics Inc.


$0.5 Grant For the development of a next-gener-ation pharmacological chaperone to treat Parkinson’s disease (12/10)

Aphios Corp.* National Institute of Aging

ND Phase I Fast Track SBIR grant

To support preclinical development of PKC activator APH-0703 for Alzheimer’s disease (12/1)

Athersys Inc. (ATHX) Michael J. Fox Foundation for Parkinson’s Research

$0. 14 Grant To advance research and develop-ment of its MultiStem product plat-form as a potential treatment for Parkinson’s disease (11/5)

Avid Biotics Inc.* National Institutes of Health

$1 Grant For the development of the compa-ny’s Avidocin platform for narrow spectrum antibacterial proteins (10/15)

Beech Tree Labs Inc.*

U.S. Quality Therapeutic Discovery Project program

$0. 164 Grant To fund a third program in nicotine craving (11/17)

Bexion Pharmaceuticals LLC*



To identify and select optimized SapC-DOPS formulations and treat-ment methods for glioblastoma mul-tiforme for advancement toward clinical testing (10/11)

BioAlliance Pharma SA (France)

French state Research National Agency, ANR, and Medicen Paris Region and Atlanpole

ND Grant For two new applications of its muco-adhesive Lauriad technology (12/16)

BrainStorm Cell Therapeutics Inc.

Office of the Chief Scientist (Israel)

$0.75 Grant For its adult stem cell therapy pro-gram (12/21)




Funding Institution


Complix NV* (Belgium)

Agency for Innovation by Science and Technology (Flanders)

|1 .6 ($2. 1) Grant To accelerate development of thera-peutic Alphabodies (12/22)

Depomed Inc. (DEPO)


ND Grant To support development of a gastric-retentive extended-release tablet of levodopa/carbidopa that targets constant blood levels of levodopa (10/12)

Discovery Laboratories Inc. (DSCO)


$0.58 Phase I Fast Track SBIR grant

To support work on aerosolizing KL4 surfactant for neonatal respiratory distress syndrome (12/17)

Embera NeuroTherapeutics Inc.* and Louisiana State University Health Sciences Center


$3.9 Grant To fund the next stages of develop-ment of EMB-001 for cocaine depen-dence (10/4)

Genfit SA (France; Paris:ALGFT)

EuroTransBio |1 .2 ($1 .6) Grant To generate new drug candidates as part of a program to identify hits for an orphan nuclear receptor with anti-inflammatory properties (12/21)

Hybrigenics SA (France; Paris:ALHYG)

Oseo Innovation $1 Refundable grant

To allow Hybrigenics to complete Phase IIa studies of oral inecalcitol for hormone-refractory prostate can-cer (12/3)

InDanio Bioscience* (Canada)

Ontario Genomics Institute

ND Grant For its screening system for the com-plete human nuclear hormone recep-tor family (10/14)

Insight Genetics Inc.*



To develop a companion diagnostic for lung cancer patients (11/10)

InteRNA Technologies BV (the Netherlands)

Dutch government |1 .3 ($1 .77) Innovation credit

To support the development of miR-NA-based therapeutics for the treat-ment of melanoma (11/17)

LifeGen Technologies LLC*

National Institute on Aging


To identify a panel of genes in adi-pose tissue that are regulated by a calorie-restricted diet (10/22)

MorphoSys AG (Germany; FSE:MOR) and Proteros Biostructures GmbH* (Germany)

German Federal Ministry of Education and Research

|0.85 ($1 . 18) Grant To support the establishment of a new technology platform for efficient structural characterization of anti-body-antigen complexes (10/13)

NanoBio Corp.* Bill & Melinda Gates Foundation

$6 Grant To develop an intranasal vaccine for respiratory syncytial virus (11/30)

NanoBio Corp.* and University of Michigan Medical School

Department of Defense

$1 .5 Grant To study the use of nanoemulsion-based therapies for protection against burn and wound infections (10/13)

NeuroDerm Ltd.* (Israel)


$1 Grant To support the next clinical study with ND0611 , a dermal patch to treat Parkinson’s disease (10/7)




Funding Institution


Neurokin SA (France) Agence Nationale de la Recherche

$0.46 Grant To help support the Strokinin project aimed at improving the development of NK-102, a neuroprotective drug to treat stroke (11/30)

Oligomerix Inc.* National Institute on Aging

$1 .6 SBIR Phase II grant

For a program to discover small mol-ecules and antibodies targeting tau protein oligomers for development of disease-modifying therapeutics against Alzheimer’s disease (11/12)

Omeros Corp. (OMER)


$3.6 Grant For clinical studies of the company’s addiction program (10/15)

Optivia Biotechnology Inc.* and University of California, San Francisco



To develop a system for characteriz-ing the role transporter proteins play in the disposition of drugs by the liver (11/17)

Oramed Pharmaceuticals Inc. (Israel; OTC BB:ORMD)

Office of the Chief Scientist at the Ministry of Industry, Trade and Labor of Israel

NIS2.9 ($0.807) Grant To support development of Oramed’s oral insulin and oral GLP-1 analogue for diabetes (12/27)

PolyMedix Inc. (OTC BB:PYMX) and the University of Massachusetts, of Amherst

U.S. Army Research Office

$0.75 Phase II STTR grant

To conduct further testing on antimi-crobial compounds (11/17)

Prana Biotechnology ltd. (Australia; PRAN) and the Mental Health Research Institute

Victorian Labor Government in Australia

A$15 ($15. 14) Grant To begin a large-scale trial of PBT2, an investigational treatment for Alzheimer’s disease and Huntinton’s disease (11/9)

Precision BioSciences Inc.*

National Institute of Standards and Technology, the Treasury Department, the National Institutes of Health and the state of North Carolina

$3 Grants To accelerate development of its Directed Nuclease Editor genome engineering technology (12/17)

Profectus BioSciences Inc.*

National Institutes of Health, Division of AIDS; National Institute of Allergy and Infectious Diseases

$6.25 SBIR grants For the development of Transition State Vaccine technology for an HIV vaccine (10/6); to optimize the com-pany’s portfolio of genetic adjuvants (10/8)

Progenics Pharmaceuticals Inc. (PGNX)


$4. 1 Grant To support development of monoclo-nal antibodies against Clostridium difficile infection (10/7)

ProtAffin AG* (Austria)

Austrian Forschungs-Forderungs-Gesellschaft

|2.7 ($3.7) Grant For the preclinical development of lead anti-inflammatory product PA401 , a modified form of interleu-kin-8, in respiratory disease (11/16)




Funding Institution


Pulmatrix Inc. Defense Advanced Research Projects Agency of the U.S. Department of Defense

$5.7 Grant To support formulation development and preclinical studies to evaluate the spectrum and efficacy of lead iCALM drug candidates (12/15)

Repligen Corp. Muscular Dystrophy Association

$1 .4 Research grant

To support the ongoing development of RG3039, an inhibitor of an RNA processing enzyme that targets increased production of survival motor neuron, a protein of deficient levels in patients with spinal muscu-lar atrophy (12/16)

RFS Pharma LLC* National Institute of Allergy and Infectious Diseases of the National Institutes of Health

$0. 15 Grant To develop nucleoside reverse tran-scriptase inhibitors with efficacy and safety profiles against drug-resistant HIV-1 (11/9)

Rockland Immunochemicals Inc.*



To develop biosimilar antibodies (10/27)

Sangart Inc.* Department of Defense

$1 . 1 Grant To support the development of its product platform based on the MP4 molecule designed to enhance the perfusion and oxygenation of oxy-gen-deprived tissues and provide targeted oxygen delivery to the cap-illaries (10/7)

Sirona Biochem Corp. (Canada; CDNX:SBM)

Canada’s Global Commerce Support Program

ND Grant To cover expenses related to its sodi-um glucose transporter inhibitor col-laboration with TFChem SARI (11/30)

Stratatech Corp.* Defense Department’s Armed Forces Institute of Regenerative Medicine

$3.95 Grant To fund the company’s Phase IIb trial of its flagship StrataGraft living human skin substitute tissue (10/8)

Stratatech Corp.* National Institute of Allergy and Infectious Diseases

$3.5 SBIR grant To expand the development of its anti-infective living human skin sub-stitute (11/17)

SuppreMol GmbH* (Germany)

German Federal Ministry of Education and Research

|1 .6 ($2. 12) Grant To support a research project to explore the therapeutic potential of SM101 in systemic lupus erythemato-sus (12/7)

Synta Pharmaceuticals Corp. (SNTA)

U.S. Department of Defense

$1 Grant To fund clinical development of STA-9584, a vascular disrupting agent (11/19)

Taiga Biotechnologies Inc.*


$1 .7 SBIR grants To further develop an antibody pro-gram in the context of neutralizing antibodies to influenza, and to fur-ther develop a universal donor blood stem cell line to treat AIDS; other grants are to scale up and character-ize its blood pharming technology and to test its immune enhancer in the context of HIV vaccines (10/22)




Funding Institution


Tekmira Pharmaceuticals Corp. (Canada; TSX:TKM) and University of Texas Medical Branch


$2.4 Grant To support research to develop RNAi therapeutics to treat Ebola and Marburg hemorrhagic fever viral infections using Tekmira’s lipid nanoparticle delivery technology (10/14)

Trophos SA (France) European Union |6 ($8) Grant To support MitoCare, which will investigate the efficacy and safety of TRO40303 in a Phase II study to treat cardiac ischemia-reperfusion injury in acute myocardial infarction patients (12/15)

World Health Organization


$10.4 Grants To assist developing countries with pandemic influenza vaccine manu-facturing infrastructure, training on influenza vaccine manufacturing, and development and distribution of certain technologies for pandemic influenza vaccines (10/4)

XenoPort Inc. (XNPT) The Michael J. Fox Foundation for Parkinson’s Research

$0. 194 Grant To support a preclinical study of the safety and efficacy of a prodrug of acamprosate for L-dopa-induced dys-kinesia in Parkinson’s disease (11/24)

Notes:

* Indicates a privately held company.

** Denotes the date the item ran in BioWorld International.


Currency conversions reflect values at the time of a deal’s announcement.

SBIR = Small Business Innovation Research; STTR = Small Business Technology Transfer.

Unless otherwise indicated, symbols listed are on the Nasdaq market.

AMEX = American Stock Exchange; BE = Berlin Stock Exchange; BR = Brussels Stock Exchange; CDNX = Canadian Venture Exchange; FSE = Frankfurt Stock Exchange; LSE = London Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SWX = Swiss Stock Exchange; TSX = Toronto Stock Exchange.


BioWorld®

C O R P O R AT E

D E A L S


CorporateDeals

“No big deal.” That describes the sluggish pace of merger, acquisition

and collaboration activity in 2010 as well as any phrase. By just about every measurement, 2010 was slower than the previous year and lacked a genuine mega deal, like Roche AG’s $46.8 billion acquisition of Genentech Inc. in 2009.

There were fewer M&As for less money – 93 for $29.4 billion in 2010 compared to 98 for $62.3 billion in 2009. (See the 2010-2009 M&As table, below.)

There were fewer biotech-pharma collaborations for less money – 322 for $31 .9 billion in 2010 compared to 332 for $39.8 billion in 2009. (See the 2009-2010 Biotech-Pharma Collaborations table, below.)

And there were fewer biotech-biotech collaborations for less money – 270 for $8.3 billion in 2010 compared to 318 for $9. 1 billion in 2009. (See the 2009-2010 Biotech-Biotech Collaborations table, below.)

Taken together, that’s a total of 685 deals in 2010 compared to 748 in 2009. The 2010 deals totaled $69.6 billion compared to $111 .2 billion for 2009.

The source of these numbers and other lists in this article is BioWorld Snapshots; a complete listing for 2010

follows. The totals listed include only transactions involving at least one biotechnology firm that were completed during 2010 or 2009. (Big pharma consolidation deals like 2009’s $68 billion Pfizer acquisition of Wyeth and Merck’s $41 billion merger with Schering-Plough are not included, for example.) Dollar figures include up-front and any milestone amounts. And because the financial details of transactions often are not disclosed, the dollar totals do not account for every transaction.

But based on the information made public for the past two years, deal-making slowed down in 2010.

What happened? Analysts like Geoffrey Meacham and Cory Kasimov of J.P.

Morgan said it wasn’t expected to be that way. In their “2011 Global Biotech Outlook,” they wrote earlier this year that analysts and investors anticipated an uptick in M&A activity in 2010 “given that the digestion from the mega deals in 2009 was likely over and pharma was/is still inching closer to a number of major patent expiries.”

But the uptick didn’t materialize. Meacham and Kasimov point out likely causes as “. . . the acute focus on the pricing environment in the U.S. and EU from healthcare reform and austerity measures as well as a higher perception of risk at both the FDA and CMS.”

Nor does the pace appear to be picking up as this is written at the close of the first quarter of 2011 . There were 22 completed M&As – which projected over the full year would be fewer than in 2010 – for about $3.2 billion – again, if projected over a full year, less than 2010. The big completed deal so far in 2011 has been Amgen Inc.’s $1 billion pickup of BioVex Group Inc., although pending deals like the long, long, long awaited $20. 1 billion purchase of Genzyme Corp. by Sanofi-Aventis SA and Valeant Pharmaceuticals International Inc.’s hostile $5.7 billion takeover bid of Cephalon Inc. could boost the total substantially, when and if completed.

2010 Biotech M&As and Collaborations: ‘No Big Deal’By Tom WallStaff Writer

stAte of the industry: CorporAte deAls


2010-2009 M&As

2010 2009Total M&As 93 98M&As w. value 68 65Total value $29,414,810,000 $62,365,583,000 Average value $432,570,735 $959,470,508 Mean value $108,500,000 $40,900,000 $10B+ 0 1$1B-$10B 4 3$500M-$1B 11 7$200-$500 11 8

2009-2010 Biotech-Biotech Collaborations

2010 2009Total Collaborations 270 318Collaborations w. value 60 82Total value $8,348,332,000 $9,169,565,000 Average value $139,138,867 $111,823,963 Mean value $21,400,000 $20,000,000 $10B+ 0 0$1B-$10B 2 0$500M-$1B 1 5$200-$500 8 14

2009-2010 Biotech-Pharma Collaborations

2010 2009Total Collaborations 322 332Collaborations w. value 112 139Total value $31,992,760,000 $39,882,831,000 Average value $285,649,643 $286,926,842 Mean value $181,000,000 $145,000,000 $10B+ 0 0$1B-$10B 6 12$500M-$1B 15 13$200-$500 34 35


CorporateDeals

Mergers and AcquisitionsDespite the slow pace, 2010 produced its share of

memorable M&A moments. (See the 2010 Top 10 M&As table, below.)

One was Tokyo-based Astellas Pharma Inc.’s acquisition of Melville, N.Y.-based OSI Pharmaceuticals Inc. After an unsuccessful $3.5 billion, or $52 per share, hostile takeover attempt, Astellas raised its offer to $4 billion and OSI agreed to a friendly buyout.

The deal boosted Astellas’ oncology franchise by adding OSI’s blockbuster cancer drug Tarceva (erlotinib) as well as a U.S. sales force, a pipeline of small molecules and discovery capabilities.

Another was the relatively quiet $3.3 billion merger of Aliso Viejo, Calif.-based Valeant Pharmaceuticals International Inc. and Biovail Corp., of Mississauga, Ontario, to form a combined company called Valeant Pharmaceuticals International Inc. with corporate headquarters in Mississauga. Valeant stockholders received 1 .7809 Biovail common shares for each share of Valeant common stock outstanding. Shareholders also received a one-time dividend of $16.77 per share of common stock. This year Valeant initiated a hostile

$5.7 billion takeover of Cephalon Inc.And Celgene Corp., of Summit, N.J., acquired take-out

target Abraxis BioScience, Inc., of Los Angeles, in a $2.9 billion cash and stock deal that gave the big biotech rights to Abraxis’ nanoparticle albumin bound-based drug pipeline, including star cancer drug Abraxane. The total up-front part of the deal values Abraxis at about $72 per share, a 17 percent premium, with Celgene agreeing to pay about $2.4 billion in cash plus an additional $565 million in Celgene stock.

Celgene was a major “double-dealer” in 2010, in addition to Abraxis picking up Gloucester Pharmaceuticals Inc. for $640 million. So was Abbott, which paid more than $7 billion for Solvay Pharmaceuticals Inc. ($6.6 billion) and Facet Biotech ($430 million.) Other pharmas with two deals were Eli Lilly and Co. (Alnara Pharmaceuticals Inc., $380 million), Avid Radiopharmaceuticals Inc., $300 million) and Merck & Co. Inc., (Avecia Biologics, $180 million and SmartCells Inc., $500 million.)

But the most active deal-maker of 2010 was self-proclaimed “transaction junkie” Cephalon Inc., which paid more than $1 billion in three deals: Mepha AG ($615 million); Ception Inc., ($350 million); and, BioAssets Development Corp. ($42.5 million).

2010 Top 10 M&As Company Acquired Acquired By Or Merged

WithValue Terms/Details

Solvay Pharmaceuticals Inc.

Abbott $6.6B Abbott paid $6.6B to acquire Solvay, plus $440M if certain milestones are met

OSI Pharmaceuticals Inc. (OSIP)

Astellas Pharma Inc. $4.0B Astellas offered $4B to acquire OSI, up from an original $3.5B offer

Valeant Pharmaceuticals International Inc. (NYSE:VRX)

Biovail Corp. (Canada; TSX:BVF)

$3.3B The merged company will assume Valeant's name, but retain BioVail's corporate structure and Canadian headquarters

Abraxis BioScience Inc. (ABII)

Celgene Corp. (CELG) $2.9B Celgene acquired Abraxis for $2.9B in cash and stock

Genzyme Genetics (unit of Genzyme Corp.; GENZ)

Laboratory Corp. of America (NYSE:LH)

$925 M LabCorp acquired Genzyme Genetics for $925M in cash

ZymoGenetics Inc. (ZGEN) Bristol-Myers Squibb Co.

$805 M Bristol-Myers acquired ZymoGenetics for $9.75 per share, with 82.6M shares validly tendered

Gloucester Pharmaceuticals Inc.

Celgene Corp. (CELG) $640 M Celgene paid $340M in cash and will owe $300M to Gloucester shareholders for Istodax's development and approval in the peripheral T-cell lymphoma indication

Corthera Novartis AG (Switzerland)

$620 M Novartis acquired Corthera for $120M, plus up to $500M in milestone payments

Mepha AG Cephalon Inc. (CEPH) $615 M Cephalon purchased Mepha for $615.4M

Movetis NV (Belgium; BR:MOVE)

Shire plc (UK) $564 M Shire offered $564.6M for Movetis and share-holders had tendered 99. 18% of the company's shares during the initial acceptance period


CorporateDeals

Biotech-Pharma CollaborationsLocation, location, location: that’s what pops when you

look at the top 10 Biotech-Pharma collaborations of 2010. All of the pharmas involved are from outside the U.S., with nine of the 10 from Europe. (See the 2010 Top 10 Biotech-Pharma Collaborations table, below.)

But break down all of last year’s 322 collaborations and you find that Pfizer Inc. of New York was most active, with 22 deals. Pfizer was followed by Novartis (18); GlaxoSmithKline

(15); Merck (14); and, Sanofi-Aventis (12.)The most active collaborator on the biotech side was

Evotec AG, of Hamburg, Germany. The company showed up in five separate deals, including a potential $345.2 million deal with AstraZeneca plc subsidiary MedImmune for a biologic beta cell regeneration program. The other deals were with Vifor Pharma Ltd. (Switzerland); Merck KGaA (Germany); Shionogi & Co. Ltd. (Japan); and, Zhejiang Jingxin Pharmaceutical Co. Ltd. (China).

2010 Top 10 Biotech-Pharma CollaborationsBiotech Company

Pharma Company

Type/Product Area Terms/Details Value

MacroGenics Inc.


Deal to discover, develop and com-mercialize antibody-based therapeutics based on Macro-Genics’ Dual-Affinity ReTargeting platform

The agreement is worth $2. 16B, including $60M within the first three years and $210M for each of the 10 DART programs

$2. 16B



Option agreement involving RNA drug discovery

Isis gets $35M up front, which it will amor-tize over the five-year agreement and could get up to another $155M in pre-licensing milestones; after Phase II, GSK has the option to license the drug for further develop; total deal could be worth $1 .5B

$1 .5B

Rigel Pharmaceuticals Inc. (RIGL)

AstraZeneca plc (UK)

Licensing agreement for worldwide rights to R788, a spleen tyrosine kinase inhib-itor

Rigel gets $100M up front, along with $25M in milestones this year; Rigel is eligible for up to $345M in development, regulatory and initial sales milestones, plus up to $800M in commercial milestones and a stepped, double-digit royalty

$1 .27B

Aileron Therapeutics Inc.

Roche AG (Switzerland)

Deal to develop ther-apeutics based on Aileron’s stapled pep-tides platform aimed at targets previously considered undrug-gable

Roche will pay Aileron at least $25M up front and $1 . 1B in milestone payments based on achieving drug candidates against five undisclosed targets

$1 . 12B

Orexigen Therapeutics Inc. (OREX)

Takeda Pharmaceuticals Co. Ltd. (Japan)

Partnership to market Orexigen’s Contrave in North America for obesity

Takeda agreed to pay $50M up front for the right to copromote the drug, if approved, plus more than $1B in milestone payments and a tiered double-digit royalty

$1 .05B

OncoMed Pharmaceuticals Inc.


Deal to develop drugs targeting the Wnt signaling path-way

An agreement that brings $40M up front, with the potential for more than $1B in future milestones; the deal calls for up to five compounds and up to $387.5M per compound in development, regulatory and sales milestones, plus double-digit royal-ties and certain co-development options

$1 .04B


CorporateDeals

Biotech Company

Pharma Company


Transgene SA (France; Paris:TNG)


Exclusive option agreement for Transgene's lung can-cer vaccine TG4010

Novartis is paying $10M, plus up to $955.9M in development, regulatory and commercial milestones if it opts to move forward with the product; Transgene also is eligible for royalties on worldwide prod-uct sales and retains co-promotion rights in certain countries, including France and China

$965M

Avila Therapeutics Inc.

Sanofi-Aventis SA (France)

Collaboration to design targeted cova-lent drugs against six signaling proteins with relevance in oncology, with Sanofi moving forward five of the drugs and Avila retaining rights to one

Sanofi-Aventis paid $40M up-front in cash and committed to as much as $770M in milestones

$810M

Regulus Therapeutics Inc.

Sanofi-Aventis Group SA (France)

Partnership aimed at discovering microR-NA-based drugs against four fibrosis targets

The deal is worth $750M, including $25M up front, as well as a $10M equity invest-ment, plus $650M in milestone payments and royalties

$750M

Synosia Therapeutics

UCB Pharma (Belgium)

Agreement to devel-op two lead drugs for treating Parkinson's disease

UCB is leading the company's third round with $20M and is making an undisclosed up-front payment; the deal includes $725M in milestones

$745M

Biotech-Biotech CollaborationsWhile in a given year there are almost as many biotech-

biotech collaborations as biotech-pharma collaborations, they are much smaller – with total value in 2009 and 2010 about one quarter of the biotech-pharma type and average deal value less than half. That said, last year’s three largest deals exceeded or pushed the $1 billion mark, albeit with milestone payments making up the bulk of the value. (See the 2010 Top 10 Biotech-Biotech Collaborations tables, next page.)

Demonstrating that it does more than acquisitions, Cephalon, of Frazer, Pa., put together one of the largest regenerative medicine transactions ever with partner Mesoblast Ltd., of Melbourne, Australia. The companies agreed to a potential $1 .92 billion deal in which Cephalon got exclusive worldwide rights to products based on Mesoblast’s stem cell technology. Cephalon paid $130 million up front, bought about 20 percent of Mesoblast shares for $220 million, and added more than $1 .5 billion in milestones. Was it worth it? In January 2011 the companies reported that each of the 45 patients in a Phase II trial who received a single injection of Revascor into damaged heart muscle have had less cardiac events, deaths and hospitalizations during the

follow-up period to date than control patients. Another potential billion-dollar collaboration was a

$1 .4 billion agreement – one of the largest target-based RNAi deal ever closed – between Dicerna Pharmaceuticals Inc., of Watertown, Mass., and Kyowa Hakko Kirin Co. Ltd., of Tokyo, to discover, develop and commercialize drug delivery systems and siRNA medications using Dicerna’s Dicer Substrate Technology for oncology targets. Dicerna got only $4 million in up-front cash, but could get as much as $120 million in research funding and milestones for each oncology target, with an option for as many as 10 targets.

Pushing the $1 billion mark was a $912 million collaboration between Genentech Inc., of South San Francisco, a unit of Roche AG, and Seattle Genetics Inc., of Bothell, Wash. Genentech paid $12 million up front to apply Seattle Genetics’ ADC platform to specific targets. Potential milestones and maintenance fees could add $900 million.

The most active 2010 biotech-biotech collaborator, with five separate deals, was International Stem Cell Corp., of Carlsbad, Calif. Right behind with four deals each were Biogen Idec, of Weston, Mass.; San Diego-based Cypress Bioscience Inc.; Genentech; Immunovaccine Inc., of Halifax, Nova Scotia; and, Worcester, Mass.-based RXi Pharmaceuticals Corp.


CorporateDeals

2010 Top 10 Biotech-Biotech CollaborationsBiotech Company

Biotech Company


Cephalon Inc. (CEPH)

Mesoblast Ltd. (Australia; ASX:MSB)

Deal for exclusive worldwide rights to products based on Mesoblast’s stem cell technology

Cephalon will pay $130M for the rights, plus milestones that could boost the deal’s value to $1 .7B; Cephalon also will buy 19.99% of Mesoblast’s outstanding shares for a total of about $220M

$1 .92B

Dicerna Pharmaceuticals Inc.

Kyowa Hakko Kirin Co. Ltd. (Japan; FSE:KY4)

Partnership to dis-cover, develop and commercialize drug delivery systems and siRNA medications using Dicerna’s Dicer Substrate Technology for undisclosed oncology targets

The deal potentially could garner Dicerna more than $1 .4B and includes a $4M up-front cash payment; Dicerna stands to gain up to $120M in research funding and devel-opment and commercial milestones for one oncology target, with the firms having the option to expand the collaboration for up to 10 targets under similar terms

$1 .4B

Genentech Inc. (NYSE:DNA)


Deal for Genentech applying Seattle Genetics’ ADC plat-form to an undis-closed number of specific targets

Terms call for Genentech to pay $12M up front, with potential milestones and main-tenance fees that could exceed $900M

$912M

Infinity Pharmaceuticals Inc. (INFI)

Intellikine Inc. Global licensing deal for Intellikine’s pre-clinical phos-phoinositide-3 kinase delta and gamma inhibitors

The deal includes lead compound INK1197 for inflammatory diseases, and is worth $488.5M, including $13.5M up front and two years of research funding, as well as $25M in development milestones and $450M in regulatory and sales milestones

$488M

Biogen Idec Inc. (BIIB)

Neurimmune Holding AG (Switzerland)

Biogen Idec acquired three preclinical immunotherapy pro-grams focused on Parkinson’s disease, Alzheimer’s disease and amyotrophic lat-eral sclerosis

Biogen will pay $32.5M up front and as much as $395M in contingent payments to Neurimmune for a subsidiary that includes the worldwide rights to the programs

$427M

Cypress Bioscience Inc. (CYPB)

BioLineRx Ltd. (Israel; TASE:BLRX)

Deal for the exclusive North American development and commercialization rights to its antipsy-chotic compound CYP-1020 to treat schizophrenia

Cypress is paying BioLineRx $30M up front and potentially $335M in milestones

$365M

Spectrum Pharmaceuticals (SPPI)

TopoTarget A/S (Denmark; CSE:TOPO)

Codevelopment and commercialization deal for belinostat

Spectrum licensed the rights for North America and India in exchange for $30M up front, $320M in milestones and 1M shares of Spectrum based on milestones

$350M

Knopp Neurosciences Inc.


Deal to develop a Phase III drug candi-date for amyotrophic lateral sclerosis

Knopp will receive $80M in initial pay-ments and $265M in potential milestones, while Biogen Idec takes over development and potentially commercialization of KNS-760704 in global markets

$345M


CorporateDeals

Biotech Company

Biotech Company


Agios Pharmaceuticals Inc.


Preclinical collabora-tion in the area of cancer metabolism

The deal will bring Agios $130M up front, including an equity investment; Agios also could receive up to $120M in milestones, as well as royalties on sales

$250M

Immune Design Corp.

MedImmune Inc. Licensing agreement for GLA, a toll-like receptor 4 agonist, to be used by MedImmune as a component in vac-cines against infec-tious diseases

IDC gets an undisclosed up-front fee and is entitled to up to $212M in milestones plus royalties on any future product sales

$212M

Biotech Mergers And Acquisitions In 2010Company Acquired* (Country; Symbol)

Acquired By Or Merged With* (Country; Symbol)

Date Reported

Date Compl.

Value (M)@

Terms/Details

JANUARYAkaRx Inc. Eisai Co. Ltd.

(FSE:EII)12/18/09 1/7 $255 Eisai acquired AkaRx for $255M

Biotest AG’s diag-nostic businesses

Bio-Rad Laboratories Inc. (NYSE:BIO)

10/23/09 1/6 E45 ($67.6)

Bio-Rad acquired certain diagnostic busi-nesses of Biotest AG

DMI Life Sciences Inc.

Imagine Media Ltd. (OTC BB:IMLE)

1/27 1/27 ND Imagine acquired DMI in a deal that gave DMI shareholders 90.52% of the combined company

Specialty pharma-ceutical business of Enzon Pharmaceuticals Inc. (ENZN)

Sigma-Tau Pharmaceuticals Inc.

11/9/09 1/28 $327 Enzon sold its business to Sigma-Tau for $300M plus up to an additional $27M based on milestones

ESE GmbH (Germany)

Qiagen NV (the Netherlands; QGEN)

1/12 1/12 $19 Qiagen acquired ESE for $19M in cash

GL Biochem Commonwealth Biotechnologies Inc. (CBTE)

9/3 1/4 ND Commonwealth agreed to acquire the par-ent of GL Biochem and its associated busi-nesses



12/7 1/15 $640 Celgene paid $340M in cash and will owe $300M for Istodax’s development and approval in the peripheral T-cell lymphoma indications

Humalys SAS (France)

Vivalis (France; Paris:VLS)

1/11 1/11 E10.4 ($15. 1)

Vivalis acquired Humalys for $15. 1M through several installments

Intradigm Corp. Silence Therapeutics plc (UK; LSE:SLN)

12/16 1/6 £20 ($32.6)

Silence issued about 79.6M shares to acquire the entire share capital of Intradigm

Metabasis Therapeutics Inc. (MBRX)

Ligand Pharmaceuticals (LGND)

10/27 1/28 $3.2 Ligand bought it for $3.2M, plus milestone payments

Minster Pharmaceuticals plc (UK; LSE:MPM)

Proximagen Neuroscience plc (UK; LSE:PRX)

1/4 1/4 £4.3 ($6.9)

Proximagen offered 6 pence (10 cents) in cash for each share

Swedish Orphan International AB

Biovitrum AB (Sweden; SSE:BVT)

11/10 1/14 SEK3.656 ($533. 1)

Biovitrum issued SEK1 .7B worth of stock to fund 48% of the purchase, and paid th e rest in cash

Symphony Dynamo Inc. (joint venture between Dynavax and Symphony Capital)


11/10 1/4 $20.4 Dynavax acquired the joint venture, regaining rights to the HCV and cancer programs, in exchange for about 13M shares

FEBRUARYArgenta Discovery Ltd. (UK)


2/2 2/2 E16.5 ($23)

Galapagos is paying $23M to acquire Argenta



BiotechnologyMergersAndAcquisitions

Company Acquired* (Country; Symbol)


Date Reported

Date Compl.

Value (M)@

Terms/Details

Avecia Biologics (UK; part of Avecia Investments Ltd.)

Merck & Co. Inc. 12/17 2/1 $180 Merck agreed to acquire the biologics busi-ness for $180M

BioForm Medical Inc. (BFRM)

Merz-Pharma Group (Germany)

1/5 2/17 $243.6 Merz acquired BioForm for $5.45 per share in cash

BioSeek Inc. Asterand plc (UK; LSE:ATD)

11/18 2/18 $14 Asterand acquired BioSeek for $14M, with $1M payable by the issuance of Asterand shares and $13M payable in 2011 depending on the level of sales growth achieved by BioSeek in the 12 months ended Dec. 21 , 2010

Ception Inc. Cephalon Inc. (CEPH)

1/14/09 2/23 $350 Cephalon paid $100M for an option to acquire and then another $200M when it exercised the option

Corthera Inc. Novartis AG (Switzerland)

12/23/09 2/3 $620 Novartis acquired Corthera for $120M, plus up to $500M in milestone payments

Cytopia Ltd. (Australia; ASX:CYT)

YM BioSciences Inc. (AMEX:YMI)

10/6 2/1 C$10 ($9.44)

YM BioSciences bought Cytopia in a 7.2M-share deal worth $9.44M

Histostem Co. Ltd. (South Korea)

Stem Cell Therapy International Inc. (OTC BB:SCII)

10/29 2/1 ND The companies merged with Histostem acquiring a 60% controlling interest in SCLL and SCLL acquiring a 90% interest in Histostem

Lead Therapeutics Inc.

BioMarin Pharmaceuticals Inc. (BMRN)

2/5 2/5 $100 BioMarin acquired Lead for $100M, includ-ing $18M up front

Pharmacos Exakta SA de CV (Mexico)

OPKO Health Inc. (AMEX:OPK)

2/18 2/18 ND OPKO acquired Pharmacos for an undis-closed cash payment and shares of its common stock

Serica Technologies Inc.

Allergan Inc. (NYSE:AGN)

2/4 2/4 ND Allergan acquired Serica for an undis-closed amount

Solvay Pharmaceuticals Inc.

Abbott 9/28 2/16 $6.6B Abbott paid $6.6B to acquire Solvay, plus $440M if certain milestones are met

Topigen Pharmaceuticals Inc. (Canada)

Pharmaxis Ltd. (Australia; ASX:PXS)

1/12 2/9 $20 Pharmaxis acquired Topigen in an all-stock transaction that included the issuance of 3.2M Pharmaxis shares on closing with an additional 5M shares issued upon achieve-ment of milestones

MARCHApaTech (UK) Baxter

International Inc.3/1 3/1 $330 Baxter acquired all of the outstanding

equity of ApaTech for total consideration of up to $330M, including $240M up front and $90M in sales milestones

Ariston Pharmaceuticals Inc.

Manhattan Pharmaceuticals Inc. (OTC BB:MHAN)

3/12 3/12 ND Manhattan completed a merger with Ariston that involves 7.06M shares up front, and up to $24.7M shares more depending on milestone achievements





Date Reported

Date Compl.

Value (M)@

Terms/Details

Chay Enterprises Inc. (OTC BB:CHYE)

DMI Life Sciences Inc.

3/5 3/5 ND T h e y m e r g e d t o f o r m A m p i o Pharmaceutical Inc.

Dragon Pharmaceutical Inc. (Canada; TSX:DDD)

Chief Respect Ltd. (Hong Kong; created by Dragon’s CEO and Chairman Yanlin Han)

1/25 3/27 $58 Han proposed to acquire the company for 80 cents per share; Han currently owns 39% of the company; he later offered 82 cents per share in cash and created the entity Chief Respect

The discovery and preclinical busi-ness of MDS Pharma Services

Ricerca Biosciences LLC

3/8 3/8 ND Ricerca finalized its acquisition of the MDS business

Novexel SA AstraZeneca plc (UK)

12/23 3/3 $505 AstraZeneca acquired Novexel

APRILArbor Pharmaceuticals

Investment group led by Jason Wild of JW Asset Management LLC and Edward Schutter

4/13 4/13 ND The investment group acquired Arbor, naming Wild board chairman and Schutter CEO

Facet Biotech Corp. (FACT)

Abbott 3/10 4/20 $430 Abbott offered $27 per share to acquire Facet Biotech; the value of $430M is net of cash held by Facet

GeneSeek Inc. Neogen Corp. (NEOG)

4/2 4/2 $13.8 Neogen purchased all the outstanding shares of GeneSeek for about $13.8M

Haemacure Corp. (Canada; TSX:HAE)

Angiotech Pharmaceuticals Inc. (ANPI)

3/23 4/7 ND Haemacure obtained authorization from the Superior Court of the Province of Quebec to sell its assets to Angiotech

Mepha AG Cephalon Inc. (CEPH)

2/1 4/9 CHF662.4 ($615.4)

Cephalon purchased Mepha for $615.4M

Nitec Pharma AG (Switzerland)

Horizon Therapeutics Inc.

4/1 4/1 ND The companies merged and will be called Horizon Pharma Inc.; the deal was an all-stock transaction

SGM Biotech Inc. Mesa Laboratories Inc. (MLAB)

4/29 4/29 $12 Mesa has acquired all outstanding shares of SGM for $12M in cash

Varian Inc. (VARI) Agilent Technologies Inc. (NYSE:A)

7/27 4/30 $1 .5B Agilent agreed to pay $1 .5B in cash to acquire bioanalytical tools company Varian

Verio Therapeutics Inc. (Canada)

Fate Therapeutics Inc.

4/8 4/8 ND Fate acquired Verio, which will become a Canadian subsidiary

MAYAton PharmaInc.*


5/27 5/27 ND Valeant acquired Aton for an undisclosed amount





Date Reported

Date Compl.

Value (M)@

Terms/Details

ES CellInternationalPte Ltd.* (Singapore)

BioTime Inc.(AMEX:BTIM)

4/30 5/4 $10.8 BioTime acquired ES Cell for 1 .38M com-mon shares valued at $10.8M, plus 300,000 warrants to purchase additional shares

MacuClear Inc.* Healthcare ofToday Inc.*

5/5 5/5 ND Healthcare completed an acquisition of MacuClear

OSIPharmaceuticalsInc. (OSIP)

Astellas PharmaInc.

3/1 5/18 $4B Astellas offered $52 per share, but the OSI board rejected the offer, causing Astellas to take the bid straight to shareholders; the OSI board later said it would review the unsolicited tender offer, but it again reject-ed it; Astellas extended the offer to April 23 and then again to May 17; Astellas raised the offer from $3.5B to $4B and OSI agreed to a friendly buyout

PhageBiotechnologyCorp.*

New Technologies Holdings Pte Ltd. (Singapore) and Phage Pharmaceuticals Inc.

5/25 5/25 ND Phage and New Technologies acquired all the assets of Phage Biotechnology, a debt-or-in-possession in proceedings under Chapter 11 bankruptcy, including a manu-facturing facility

Worldwidecoagulation business ofTrinity Biotechplc (Ireland;TRIB)

Stago Group*(France)

3/12 5/6 $90 Stago acquired the business for $90M, including $67.5M at closing, $11 .25M on the first anniversary of closing and the remain-ing $11 .25M on the second anniversary

JUNE Activus Pharma Ltd.* (Japan)

Sosei Group Corp. (Japan)

6/22 6/22 500 yen ($5.5)

Sosei acquired Activus in an all-stock transaction

Arginetix Inc.* Immune Control Inc.*

6/18 6/18 ND Arginetix and Immune Control merged to become Corridor Pharmaceuticals Inc., which received a $15M Series A endow-ment from Quaker Bioventures and other investors

BexPharm* CrystalGenomicsInc.* (South Korea)

6/1 6/1 ND CrystalGenomics merged with BexPharm, a hospital specialty pharmaceutical compa-ny that imports and distributes foreign market approved drugs in Korea

ProBioGen AG* (Germany)

Minapharm Pharmaceuticals* (Egypt)

6/17 6/17 E30.4 ($37.4)

Minapharm completed the acquisition of 95% of the share capital of ProBiogen

JULYAlnara Pharmaceuticals Inc.*

Eli Lilly and Co. 7/6 7/22 $380 Lilly acquired Alnara in an all-cash deal of $180M up front and a potential $200M later based on regulatory and commercial mile-stones

CequentPharmaceuticalsCorp.*

MDRNA Inc.(MRNA)

4/2 7/21 $46 MDRNA acquired Cequent for $46M





Date Reported

Date Compl.

Value (M)@

Terms/Details

CGI Pharmaceuticals Inc.*

Gilead Sciences Inc. (GILD)

6/28 7/8 $102. 1 Gilead bought CGI for $102. 1M

DiaDexus Inc.* VaxGen Inc.(OTC BB:VXGN)

4/15 7/30 $21 .7 VaxGen issued about 19.96M shares to cer-tain diaDexus stockholders and officers, as part of a transaction that gives BaxGen a total of 53M shares outstanding, of which diaDexus stockholders own 38% and VaxGen stockholders own 62%

DMI BiosciencesInc.*

AmpioPharmaceuticalsInc. (OTC BB:AMPE)

4/22 7/27 ND Ampio acquired DMI for an undisclosed amount

DOV Pharmaceutical Inc. (OTC BB:DOVP)

Euthymics Bioscience Inc.*

2/16 7/22 $2 Euthymics acquired DOV for $2M

HealthTronicsInc. (HTRN)

EndoPharmaceuticalsInc. (ENDP)

5/7 7/12 $214.8 Endo acquired HealthTronics for $214.8M

JavelinPharmaceuticalsInc. (AMEX:JAV)

Hospira Inc.(NYSE:HSP)

6/4 7/2 $145 Hospira completed its tender offer to pur-chase all outstanding shares of Javelin's common stock for $2.20 per share, or $145M

Millipore Corp.(NYSE:MIL)

Merck KGaA(Germany)

3/1 7/16 $7B Merck acquired Millipore for $7B

TargeGen Inc.* Sanofi-Aventis Group SA (France)

7/1 7/1 $560 Sanofi-Aventis acquired TargeGen for $75M up front and $485M in milestones

AUGUSTAlcon Inc.(NYSE:ACL)


1/4 8/25 $10.2B Novartis offered $180 per share in cash for the 156M shares of Alcon held by Nestle SA; Novartis now owns 77% of Alcon; in December, Novartis offered $168 per share for Alcon’s remaining shares

BioGAL Ltd.* (Israel)

XTL Biopharma-ceuticals Ltd. (Israel; TASE:XTL)

8/6 8/6 ND XTL acquired BioGAL, including the exclu-sive license for the rights to a use-patent on erythropoietin for the treatment of mul-tiple myeloma patients

Blue Heron Biotechnology*

OriGene Technologies Inc.*

8/16 8/16 ND OriGene acquired Blue Heron for an undis-closed amount

Idun Pharmaceuticals Inc.* (subsidiary of Pfizer Inc.)

Conatus Pharmaceuticals Inc.*

8/2 8/2 ND Conatus acquired Idun for an undisclosed sum

MiddlebrookPharmaceuticalsInc. (PK:MBRKQ)

Victory PharmaInc.*

5/18 8/4 $17.3 Victory acquired all assets of Middlebrook and assumed trade sales and other liabili-ties

Solstice Neurosciences Inc.*

US WorldMeds LLC*

8/16 8/16 $35 US WorldMeds acquired Solstice for $35M





Date Reported

Date Compl.

Value (M)@

Terms/Details

ZyStor Therapeutics Inc.*

BioMarin Pharmaceutical Inc. (BMRN)

8/19 8/19 $115 BioMarin paid $22M up front, and could pay another $13M once the first patient is enrolled in a Phase III study, and another $80M based on regulatory milestones

SEPTEMBERBioniche Pharma Holdings Ltd.* (Ireland)

Mylan Inc. (MYL) 7/16 9/8 $550 Mylan acquired Bioniche for $550M in cash

Cyto Pulse Sciences Inc.

Cellectis SA (France; Paris:ALCLS)

9/10 9/10 $2.2 Cellectis acquired Cyto Pulse for $2.2M in cash

DeveloGen AG* (Germany)

Evotec AG (Germany; FSE:EVT)

7/16 9/3 E26 ($33.3)

Evotec acquired DeveloGen for $33.3M in cash, stock and earn-outs

Penwest Pharmaceuticals Co. (PPCO)

Endo Pharma-ceuticals Inc. (ENDP)

8/11 9/20 $147.6 Endo acquired all of Penwest's stock for $5 per share in cash

Sinuwave Technologies Corp.*

Ondine Biopharma Corp. (Canada; TSX:OBP)

9/16 9/16 ND Ondine completed the sale of a majority interest in Sinuwave for an undisclosed cash payment

Valeant Pharmaceuticals International Inc. (NYSE:VRX)

Biovail Corp. (Canada; TSX:BVF)

6/22 9/28 $3.3B The companies merged with Valeant stock-holders receiving a one-time cash dividend of $16.77 per share and 1 .7809 shares of Biovail common stock in exchange for their holdings; Biovail stockholders own about 50.5%, and Valeant stockholders own about 49.5% of the combined entity, which will assume Valeant's name, but retain Biovail's corporate structure and Canadian headquarters

VaxDesign Corp.*

Sanofi Pasteur (France)

9/28 9/28 $60 Sanofi bought VaxDesign for $55M up front and another $5M contingent on fur-ther development of the MIMIC technology

OCTOBERAbraxis BioScience Inc. (ABII)


7/1 10/15 $2.9B Celgene acquired Abraxis for $2.9B in cash and stock

AngioblastSystems Inc.*

Mesoblast Ltd.(Australia; ASX:MSB)

5/13 10/21 $164 Angioblast stockholders voted unanimous-ly in favor of becoming a wholly owned subsidiary of Mesoblast, which paid $164M in stock for the remaining 60% of Angioblast it did not already own

BioAssetsDevelopmentCorp.*

Cephalon Inc.(CEPH)

10/26/09 10/25 $42.5 Cephalon paid $30M up front for an option to acquire BioAssets and paid another $12.5M to buy the outstanding stock

FoldRx Pharmaceuticals Inc.

Pfizer Inc. 9/2 10/7 ND Pfizer bought FoldRx with an up-front fee and additional milestone payments

Ion Torrent Systems Inc.*

Life Technologies Corp. (LIFE)

8/19 10/5 $375 Life acquired DNA sequencing firm Ion Torrent for $375M in cash and stock





Date Reported

Date Compl.

Value (M)@

Terms/Details

Movetis NV (Belgium; BR:MOVE)

Shire plc (UK) 8/4 10/1 E428 ($564.6)

Shire offered $564.6M for Movetis and shareholders had tendered 99. 18% of the company's shares during the initial accep-tance period

PregLem Holding SA (sub-sidiary of Ipsen SA; Paris:IPN)

Gedeon Richter plc (Hungary; FSE:RIG1)

10/12 10/12 CHF6 ($6.22)

Gedeon acquired all of the shares to PregLem from Ipsen SA and PregLem's other shareholders; Ipsen received $6.22M from the transaction

ZymoGenetics Inc. (ZGEN)

Bristol-Myers Squibb Co.

9/9 10/11 $805.35 Bristol-Myers acquired ZymoGenetics for $9.75 per share, with 82.6M shares validly tendered

NOVEMBERAdnaGen AG (Germany; subsid-iary of OncoVista Innovative Therapies Inc.; OTC BB:OVIT)

Unnamed buyer 11/12 11/12 $83 OncoVista divested its majority holding of AdnaGen, selling shares for $10M up front and $73M in potential milestone payments

Biocompatibles plc (UK; LSE:BII)

BTG plc (UK; LSE:BGC)

11/22 11/22 £177.2 ($284.5)

BTG acquired Biocompatibles for $284.5M

Biocontrol Ltd. (UK)

Targeted Genetics Corp. (PK:TGEN)

11/15 11/15 ND The companies merged with Biocontrol becoming a subsidiary

NeoPharm Inc. (NEOL)

Insys Therapeutics Inc.*

11/2 11/11 $135 Insys is accessing the public markets via a reverse merger with NeoPharm, which is issuing 19.5M shares of common stock, plus 14.9M shares of preferred stock convertible into 35 shares of common stock apiece; Insys holds about 95% of the combined com-pany

Osteotech Inc. (OSTE)

Medtronic Inc. (NYSE:MDT)

8/18 11/12 $123 Medtronic offered $6.50 a share cash to acquire Osteotech

Trubion Pharmaceuticals Inc. (TRBN)

Emergent BioSolutions Inc. (NYSE:EBS)

08/16 11/1 $135.5 Emergent bought Trubion for $96.8M up front, plus a potential $38.7M in mile-stones, for a total value of $135.5M

DECEMBERAvid Radiophar-maceuticals Inc.*

Eli Lilly and Co. 11/9 12/22 $300 Lilly paid $300M to buy Avid, which could earn $500M more based on a milestone


Laboratory Corp. of America (NYSE:LH)

9/14 12/2 $925 LabCorp acquired Genzyme Genetics for $925M in cash

GTC Biotherapeutics Inc. (OTC BB:GTCB)

LFB Biotechnologies SAS* (France)

10/20 12/7 $18.3 LFB took GTC private paying 30 cents per share, or $18.3M

GTI Diagnostics* Gen-Probe Inc. (GPRO)

12/17 12/17 $53 Gen-Probe acquired GTI Diagnostics for $53M in cash





Date Reported

Date Compl.

Value (M)@

Terms/Details

Hybrid BioSystems Ltd.* (UK)

Myotec Therapeutics Ltd.* (UK)

12/16 12/16 ND Myotec and Hybrid merged to form PsiOxus Therapeutics Ltd.

SmartCells Inc.* Merck & Co. Inc. 12/3 12/3 $500 Merck acquired SmartCells in a deal poten-tially worth $500M

Sucampo AG (Switzerland) and Sucampo AG Japan

Sucampo Pharmaceuticals Inc. (SCMP)

12/30 12/30 $80 Sucampo Pharmaceuticals paid $80M to acquire Sucampo AG and its subsidiary Sucampo AG Japan from majority share-holders Ryuji Ueno and Sachiko Kuno

Notes:

# This chart is intended to include not only mergers and acquisitions of entire businesses, but also of divisions or subsidiaries of those businesses, where appropriate. In general, it does not include acquisitions of single products or of manufacturing facilities.

For those deals that are pending, and for which the acquiring company is issuing stock, the value of the transaction was calculated based on the closing price prior to the first announcement. For stock-based deals that have been completed, the final value was calculated based on the closing price before the merger’s completion was announced.

* Private companies are indicated with an asterisk. ** Denotes the date the item ran in BioWorld International.

@ Conversions of non-U.S. currencies are calculated using the rate on the date the transaction closed, or for pending deals, on the date it was announced.

ND = Not disclosed

Unless otherwise indicated, shares are traded on the Nasdaq exchange.

AMEX = American Stock Exchange; ASX = Australian Stock Exchange; BR = Brussels Stock Exchange; FSE = Frankfurt Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SWX = Swiss Stock Exchange; TSX = Toronto Stock Exchange.

Biotechnology Company Deals With Pharmaceutical Companies In 2010



Type/Product Area Terms/Details (Date)

JANUARY Alize PharmaSAS (subsidiaryof Alize PharmaSAS)

Eli Lilly and Co. Research collaboration and license option agreement regard-ing Alize Pharma’s AZP-01 pro-g r a m f o c u s e d o n t h e development of unacy-lated ghrelin agonists for the treat-ment of Type II diabetes

Lilly will pay an undisclosed up-front fee and both companies will collaborate on Alize’s AZP-1 proj-ect; in return, Lilly will be granted an exclusive option to license the program according to predefined terms (1/26)

AlteaTherapeuticsCorp.*

KAI PharmaceuticalsInc.

Partnership for the preclinical and clinical develop-ment of cer-tain KAI peptides using Altea’s PassPort transdermal delivery system

Altea also granted KAI an option to receive a worldwide technology license for further development and commercialization of those transdermal products, whichwould make Altea eligible for license payments, milestones and royalties (1/14)

AnaptysBioInc.*

F. Hoffmann-LaRoche Ltd.(Switzerland)

Deal for the development of anti-body therapeutics

AnaptysBio will generate antibod-ies using its somatic hypermuta-tion platform, and Roche will receive a worldwide license to d e v e l o p t h o s e p r o d u c t s ; AnaptysBio will receive a signing fee and is eligible formilestones and royalties (1/12)

ArteryTherapeuticsInc.*


Partnership of its preclinical ApoA-1 peptide mimetic, AT5261 , with Roche

The companies will jointly devel-op the cardiovascular product through Phase I, at which point Roche may exercise an option to acquire worldwide rights (2/16)

B3 bio Inc.* Roche HoldingsAG (Switzerland)

Agreement to source and devel-op early stage technologies

Roche will have certain rights for further development and/or com-mercialization of such technolo-gies; Roche will increase its equity investment in b3 bio as well as providing development funds (1/22)

BioCrystPharmaceuticalsInc. (BCRX)

Merck Serono(Switzerland);Hikma Pharma-ceuticals plc (UK)

Agreement for stockpiling oppor-tunities for BioCryst’s influenza antiviral peramivir in Europe, Russia, Canada and Singapore; the deal with Hikma is for the Middle East and the North African region, excluding Israel

In October 2009, the FDA granted emergency use authorization for certain hospitalized patients with swine flu (1/12)

Cellectis SA(France; Paris:ALCLS)

Bayer HealthCare(subgroup ofBayer AG; Germany)

Licensing agreement for use of C e l l e c t i s ’ p a t e n t f a m i l y WO9011354 covering homologous recombination aimed to intro-duce new features into the genome

The global license includes the use of the Institut Pasteur technol-ogy relating to homologous recombination to obtain and use certain transgenic animals in pharmaceutical research in all countries, including Japan (1/13)



BiotechnologyCompanyDealsWithPharmaceuticalCompanies




Crystal-Genomics Inc.*

AstraZeneca plc(UK)

Research collaboration to discov-er and develop an anti-infective for use as a potential antibacteri-al agent

CrystalGenomics will receive r e s e a r c h f u n d i n g f r o m AstraZeneca for two years and will be eligible for future milestones and royalty payments associated with development and commer-cialization of a drug candidate (1/14)

DebiopharmGroup*(Switzerland)

Pfizer Inc. Agreement to co-develop tremeli-mumab, an anti-CTLA4 antibody from Pfizer Inc.

Debiopharm will conduct a new trial, while Pfizer will be responsi-ble for commercialization; they will share any sales revenues (1/8)

EdisonPharmaceuticalsInc.*

Centocor R&DInc.

Licensing agreement for CNTO-530 for clinical evaluation in rare mitochondrial and other neglect-ed diseases

Financial terms were not disclosed (1/6)

EnsembleDiscovery Corp.*

Pfizer Inc. Strategic alliance to discover and develop drug candidates against a number of pharmaceutical tar-gets using Ensemble’s drug dis-covery platforms and Ensemblin compound libraries

Pfizer will provide up-front and research payments and will have the right to develop and commer-cialize any products arising from the collaboration; Ensemble will receive development milestones plus royalties (1/7)

EnvoyTherapeuticsInc.*

Merck & Co. Inc. Diabetes and obesity drug dis-covery collaboration

Envoy will use its bacTRAP plat-f o r m t o i d e n t i f y p r o t e i n s expressed in certain cell types, and Merck will develop com-pounds to modulate the protein targets; Envoy gets an up-front fee, research funding, milestone payments and royalties (1/27)

Evolva HoldingSA (Switzerland;SWX:EVE)


Agreement to create compounds for oncology and anti-infective targets using Evolva’s technology platform

Roche will pay Evolva an undis-closed up-front technology access fee and ongoing research fees; Roche will take forward any com-pounds discovered and will poten-tially pay Evolva research and clinical milestone fees as well as royalties (1/5)

Galapagos NV(Belgium; BR:GLPG)

F. Hoffmann La-Roche Ltd.(Switzerland)

Deal for small-molecule and anti-body treatments for chronic obstructive pulmonary disease

Agreement is worth $579.6M (1/13)

GenVec Inc.(GNVC)


Deal to discover and develop treatments for hearing loss and inner ear-related balance disor-ders based on GenVec’s adeno-vector technology

GenVec is receiving $5M up front, with the potential to bank more than $206M in milestones plus undisclosed royalties; Novartis also has purchased $2M in GenVec common stock (1/20)






InspirationPharmaceuticalsInc.*

Ipsen SA(France)

Agreement for clinical develop-ment of the two lead products, including Ipsen’s OBI-1 to treat congenital hemophilia A and Inspiration’s IB1001 to treat acute bleeding in patients with hemo-philia A

Ipsen will invest $259M to fund clinical development; it will make an up-front pay-ment of $85M for 20% of Inspiration; for each mile-stone payment, Ipsen will beentitled to receive more equity; if all are reached, Ipsen will own 47% of Inspiration (1/22)

IntrinsicBioprobes*

Ortho-ClinicalDiagnostics Inc.

Licensing agreement for two novel biomarkers for diabetes

No financial terms were disclosed (1/22)

KaloBiosPharmaceuticalsInc.*

Sanofi Pasteur(France)

Partnership for Humaneered anti-body fragment targeted against Pseudomonas aeruginosa infec-tions

Deal is worth $290M, including $35M up front and $255M in mile-stones, plus royalties (1/12)

KinaxoBiotechnologiesGmbH* (Germany)

RocheDiagnosticsGmbH (Germany)

Col laborat ion under which Kinaxo will apply its phosphopro-t e o m i c s t e c h n o l o g y PhosphoScout to support target-ed treatment approaches under development at Roche


MonoSol Rx* StrativaPharmaceuticals(division of ParPharmaceuticalCos. Inc.)

Licensing and development agreement that gives Strativa the option to license exclusive U.S. commercial-ization rights for the three additional oral soluble film products to be developed using the PharmFilm technology

The new option agreements are an extension of the strategic rela-tionship between MonoSol Rx and Strativa, initiated in June 2008 (1/6)

OncoMethylomeSciences SA(Belgium; BR:ONCOB)


Agreement for MGMT gene pro-moter methylation testing in a Phase III trial of Avastin in newly diagnosed glioblastoma patients


Priaxon AG* BoehringerIngelheim(Germany)

Research deal to study mdm2/p53 inhibitors for treating cancer

Priaxon also would be eligible to receive $122.7M in milestone pay-ments (1/20)

ReataPharmaceuticalsInc.*

Kyowa HakkoKirin Co. Ltd.(Japan)

Agreement focused on Nrf2-targeting bardoxolone

Deal includes $35M up front as part of $132M in development milestones, about half of which will be paid before the drug gains FDA clearance, plus $140M in sales milestones and escalating double-digit royalties (1/11)

FEBRUARY Abbott(NYSE:ABT)

Pierre Fabre SA Exclusive, worldwide licensing deal to develop and commercial-ize h224G11 in cancer indications

Pierre will receive an initial $25M up-front payment and research funding; Abbott will lead develop-ment and commercialization; terms also include milestones androyalty payments (2/2)

AdamisPharmaceuticalsCorp. (OTC BB:ADMP)

ColbyPharmaceuticalsCo.

Agreement to acquire exclusive license agreements for CPC-100, CPC-200 and CPC-300, for the potential treatment of human prostate cancer

Colby gains shares of Adamis stock (2/26)






AnaptysBioInc.*

Merck & Co. Inc. Strategic collaboration to devel-op novel antibody therapeutics to a specified disease target

AnaptysBio will generate antibod-ies using its somatic hypermuta-tion technology platform; Merck will receive worldwide rights to develop and commercialize anti-bodies optimized by AnaptysBio, which has received an up-front sum and is eligible to receive mile-stone payments and royalties (2/9)

ApeironBiologics AG*


Licensing agreement for APN01 , a recombinant form of human angiotensin converting enzyme 2

Deal is valued at up to $329.4M, plus it includes double-digit royal-ties (2/4)

Ariana Pharma*(France)

Fovea Pharma-ceuticals SA (France)

Fee-for-service collaboration deal under which Ariana will use its KEM decision support platform to carry out systemic analysis of Fovea’s Prednisporin Phase II data


BasileaPharmaceutica AG (Switzerland;SWX:BSLN)

Astellas PharmaInc.

Partnership for the late-stage antifungal product isavuconazole

Basilea will get $69.6M in an up-front payment in exchange for worldwide rights, except for Japan, though the pharma holds a six-month option to add that terri-tory; there is a potential for CHF478M ($443.3M) more in development and sales mile-stones, plus significant double-digit, tiered royalties (2/25)

BG MedicineInc.*

Merck & Co. Inc. Research collaboration for the development and valid-ation of a novel biomarker with potential application in the management of lipid disorders

BG Medicine is eligible for certain payments upon achievement of established milestones; financial terms were not disclosed (2/18)

DebiopharmGroup*(Switzerland)


Exclusive license deal for the development, manufacture and commercialization of Debio 025

In exchange for granting Novartis worldwide rights, except for Japan, Debiopharm is entitled to receive an up-front fee, develop-ment and sales milestones, plus royalties (2/10)

DelcathSystems Inc.(DCTH)

ChiFu Trading Co. Ltd. (Taiwan)

Research, distribution, sales and marketing agreement for its Percutaneous Hepatic Perfusion System, granting ChiFu rights to sell the system in Taiwan for use in hepatic malignancies in infec-tious disease upon Taiwan regu-latory approval

Delcath is eligible for milestone payments up to $1M, with the total value of the deal expected to be at least $10M (2/10)


Vifor Pharma Ltd.(Switzerland)

Agreement under which Evotec will provide integrated biology, chemistry and preclinical devel-opment activities for the project

The deal is worth more than $7.68M (2/3)






Merus BV*(the Netherlands)


License option agreement for a preclinical oncology program

The deal includes an equity com-ponent in which Novartis partici-pated in Merus’ $30.3M Series B round; all told, the deal is worth more than $200M in up-front and milestone payments (2/3)

NanoViricidesInc. (OTC BB:NNVC)

TheraCourPharma Inc.

Licensing agreement for nanoviri-cides drug candidates against dengue viruses, West Nile virus, Japanese encephalitis virus, epi-demic kerato-conjunctivitis-caus-ing viruses, Ebola and Marburg viruses

Up-front compensation was paid in restricted, preferred stock, which is convertible into shares of common stock only in the event of a change of control of the compa-ny (2/24)

NasVax Ltd.(Israel; TASE:NSVX)


Joint research and option for a license agreement to investigate the feasibility of developing improved vaccines by incorporat-ing its adjuvant technology, VaxiSome

NasVax also granted Novartis an option to acquire a nonexclusive license to use VaxiSome in con-nection with certain Novartis vac-cines (2/23)

Optomagic Co.Ltd.* (South Korea)

Shenogen PharmaGroup (China)

Drug discovery collaboration to create small molecules targeting modulators of ER-alpha 36, a membrane-associated estrogen receptor


Qiagen NV(the Netherlands;QGEN)

Pfizer Inc. Agreement to develop a compan-ion diagnostic test kit for PF-04948568 for glioblastoma multiforme


QRxPharma Ltd.(Australia; PK:QRXPF)

China AoxingPharmaceuticalCo. Inc. (China)

Agreement for development and marketing of MoxDuoIV and MoxDuoIR in China


RegulusTherapeuticsInc.*


Deal to develop an miR-122 antag-onist in hepatitis C virus

Deal is worth $150M-plus, includ-ing an up-front investment, plus a convertible note that converts into equity and milestone pay-ments (2/26)

RicercaBiosciences LLC*

MDS PharmaServices

Agreement to acquire the discov-ery and preclinical business of MDS

Ricerca will acquire assets related to biochemical, cellular, tissue, organ and animal assays for use in profiling the specificity and selec-tivity of drug compounds and in understanding their po-tential for adverse events (2/11)

RigelPharmaceuticalsInc. (RIGL)

AstraZenecaplc (UK)

Licensing agreement for world-wide rights to R788, a spleen tyrosine kinase inhibitor

Rigel gets $100M up front, along with $25M in milestones this year; Rigel is eligible for up to $345M in development, regulatory and ini-tial sales milestones, plus up to $800M in commercial milestones and a stepped, double-digit royal-ty (2/17)






SanBio Inc.* Teijin Ltd. (Japan) Exclusive licensing agreement to develop and sell in Japan SB623 for recovery of lost function after a stroke

Teijin has taken an equity position in SanBio as part of the agreement (2/8)

StarpharmaHoldings Ltd.(Australia; ASX:SPL)

Eli Lilly and Co. A g r e e m e n t u n d e r w h i c h Starpharma’s dendrimer drug delivery technology will be applied to enhance compounds in Lilly’s pharmaceutical portfolio

Lilly will fund an R&D program with the aim of creating improved drugs incorporating Starpharma’s delivery technology, to be com-mercialized by Lilly (2/2)

ViametPharmaceuticalsInc.*

Novartis OptionFund

Deal to discover and develop metalloenzyme inhibitors of interest to Novartis

Deal is worth more than $200M (2/23)

Vivalis (France;Paris:VLS)

Kyoto BikenLaboratories Inc.(Japan)

Rights agreement for Kyoto to evaluate its duck embry-onic stem cell-derived EB66 cell line for the production of viral vac-cines


MARCH 4-Antibody AG*(Switzerland)


Antibody discovery deal under which 4-Antibody will use its platforms to discover the anti-bodies against Boehringer’s tar-gets in various diseases

The deal is worth $243M (3/17)

Allergan Inc.(NYSE:AGN)


Exclusive worldwide rights agreement to develop, manufac-ture and commercialize AGN-209323

BMS is paying $40M up front in exchange for rights to AGN-209323 and backup compounds; the deal also includes develop-ment and regulatory milestones up to $373M, in addition to royal-ties on worldwide sales; ExonHit Therapeutics SA stands to gain $36M total from the deal (3/4)

AmarilloBiosciences Inc.(OTC BB:AMAR)

IntasPharmaceuticalsLtd. (India)

Executed a license and supply agreement and plans to launch a Phase III trial of ABI’s orally administered interferon-alpha lozenges in India by the end of March

The study will include up to 520 patients with clinical signs and symptoms of influenza; Intas will pay a royalty on net sales in India and Nepal (3/5)

AnaptysBioInc.*

Undisclosedpharmaceuticalcompany

Strategic collaboration to gener-ate antibody therapeutics to a specified disease target

The company will be responsible for generating antibodies using its somatic hypermutation technolo-gy platform; the pharma company gets worldwide rights to develop and commercialize the antibodies generated, and AnaptysBio gets an up-front sum and is eligible to receive milestone payments and royalties (3/2)

BioSeek LLC* Ono Pharma-ceutical Co. Ltd.(Japan)

Multiyear drug discovery collabo-ration for BioSeek to apply its BioMAP platform to a specific Ono drug target

Deal includes research funding and milestone payments; Ono retains worldwide rights to devel-op and sell all discovered prod-ucts (3/24)








Licensing deal on the Euro-pean patents to obtain, breed and use animal models in pharmaceutical research throughout Europe

The license covers an Institut Pasteur technology for introduc-ing new features in genomes, for which Cellectis has an exclusive license (3/26)

Cellzome Ltd.* GlaxoSmithKlineplc (UK)

Collaboration to apply the epi-genetics platform technology in the discovery of oral small-mole-cule drugs for treating immuno-inflammatory diseases

T h e d e a l i s w o r t h | 4 7 5 M ($644.3M), including |33M up front (3/10)


WatsonPharmaceuticalsInc.

Agreement for exclusive U.S. rights to its bioadhesive proges-terone gel products

Watson is buying 11 .2M shares of Columbia stock and will pay a roy-alty on its sales of the gel product and any next- generation products (3/5)

Medivir AB(Sweden;SSE:MVIRB)

DaewoongPharmaceuticalCo. Ltd. (SouthKorea)

Licensing agreement for its hepa-titis B virus polymerase inhibitor drug lagociclovir valactate

Daewoong will assume develop-ment and marketing rights in South Korea, Japan and China, including Taiwan, Macao and Hong Kong, while Medivir has retained rights in the rest of the world; Medivir is entitled to an up-front payment and milestones, plus double-digit royalties (3/12)

MorphogenesisInc.*


Licensing agreement for one of its cancer immunotherapies to Novartis’ animal health division

Morphogenesis will receive mile-stones and royalties on dog and cat products (3/25)

NeurOp Corp.* Bristol-MyersSquibb Co.

Agreement to develop small mol-ecules for depression and other central nervous system disor-ders, using NeurOp’s platform targeted at the N-methyl-D-aspartate receptor

NeurOp gets $1 .5M up front, research funding for two years and up to $74M in potential mile-stones (3/31)

NiCox SA(France; Paris:COX)

Bausch & LombInc.

Deal for the development of the glaucoma and ocular hyperten-sion drug NCX 116

NiCox is banking an initial license payment of $10M, and it eventually could earn up to $169.5M more in development, regulatory and com-mercial milestones (3/4)

OdysseyThera Inc.*

Lonza(Switzerland)

Agreement to make Odyssey’s protein-fragment complementa-tion assay technology available to life science and drug discovery researchers

Lonza also gains an option to cer-tain exclusive global technology licenses; Odyssey will receive an equity investment, development funding and milestones (3/10)

Omeros Corp.(OMER)

Asubio PharmaCo. Ltd. (unit ofDaiichi SankyoCo. Ltd.; Japan)

Licensing agreement for a pre-clinical phosphodiesterase-7 pro-gram for movement disorders

Exclusive deal involves milestones and royalties (3/10)

PrometheusLaboratoriesInc.*

Bayer ScheringPharma AG(Germany)

Research collaboration and non-exclusive license agreement with Bayer to partner its oncology diagnostic platform with Bayer’s oncology pipeline

Prometheus will receive an up-front payment, R&D support and testing fees and potential mile-stones, with total payments up to $160M (3/18)






QuatrxPharmaceuticalsCo.*

Shionogi PharmaInc.

Licensing agreement for ospemi-fene, which is being developed for postmeno-pausal vulvovagi-nal atrophy

Quatrx will receive an up-front payment of $25M and is eligible to receive in excess of $100M in development and regulatory mile-stone payments (3/3)

Syntarga BV*(the Netherlands)

Two undisclosedpharma companies

Research collaborations involv-ing its antibody-drug conjugate program, bringing its total phar-ma collaborations to five

ADCs will be evaluated based on various linker-Drug chemistries and a variety of antibodies (3/4)

TekmiraPharmaceuticalsCorp. (Canada;TSX:TKM)

Pfizer Inc. Research collaboration to evalu-ate Tekmira’s stable nucleic acid-lipid particle technology to deliver small interfering RNA molecules provided by Pfizer

Tekmira will be responsible for preparing the formulations, and Pfizer will evaluate the formula-tions in preclinical models (3/17)

To-BBB*(the Netherlands)


Research collaboration to evalu-ate the brain delivery of treat-ments enhanced with To-BBB’s G-Technology

The technology is designed to enhance transport of medicines across the blood-brain barrier by encapsulating those compounds into proprietary glutathione-coat-ed liposomes (3/4)

Transgene SA(France; Paris:TNG)


Exclusive option agreement for Transgene’s lung cancer vaccine TG4010

Novartis is paying $10M, plus up to $955.9M in development, regula-tory and commercial milestones if it opts to move forward with the product; Transgene also is eligible for royalties on worldwide prod-uct sales and retains co-promo-tion rights in certain countries, including France and China (3/11)

TransitionTherapeuticsInc. (Canada;TTHI)

Eli Lilly and Co. Rights agreement for preclinical compounds in the area of diabe-tes

Lilly will receive an up-front pay-ment of $1M and will retain an option to reacquire rights to the compounds up until the end of Phase II; if Lilly exercises those rights, Transition would be eligi-ble for up to $250M in milestone payments and up to low double-digit royalties; otherwise, it gets low single-digit royalties (3/4)

TraversaTherapeutics*

Sanofi-Aventis SA(France)

Research agreement for the vali-dation and development of Traversa’s RNAi delivery technol-ogy PTD-DRBD

The companies will study short interfering RNA complexed to PTD-DRBD, with the ultimate goal of developing drugs (3/26)

APRIL AMAGPharmaceuticalsInc. (AMAG)

TakedaPharmaceuticalCo. Ltd.

Deal for iron replacement therapy Feraheme

The $280M deal includes $60M up front; Takeda will be responsible for commer-cialization in Europe, C a n a d a , T u r k e y , t h e Commonwealth of Independent States and the Asia Pacific coun-tries, excluding Japan, China and Taiwan (4/2)






AntaresPharma Inc.(AMEX:AIS)

Uman Pharma(Canada)

Strategic alliance to develop and commercialize Antares’ Vibex MTX to treat rheumatoid arthritis and related autoimmune condi-tions

Antares retained rights to com-mercialize it outside of Canada, while Uman received an exclusive license to commercialize the prod-uct in Canada (4/28)

Array BioPharma Inc.(ARRY)


Collaboration for MEK inhibitors The deal includes $45M up front, plus $422M in milestones; Array will co-develop ARRY-162 in one or more specific indications and fund a portion of development costs; the deal provides Array with dou-ble-digit royalties outside the U.S., and a higher royalty rate for U.S. sales (4/21)

Biocortech*(France)

Marco PoloPharmaceuticals(Luxembourg)

Licensing agreement to develop BC-19 in treatment-resistant depression

Marco Polo takes responsibility for all further clinical development of BC-19 and for eventual commer-cialization or out-licensing; finan-cial terms were not disclosed (4/2)


Undisclosed largemultinationalpharmaceuticalcompany

Option agreement to obtain a non-exclusive worldwide license for BioSante’s 2A/Furin technolo-gy in the expression of antibod-ies


CelticTherapeutics*(U.S. VirginIslands)

Bellus Health(Canada)

Agreement in which Celtic will acquire and license worldwide rights related to the Phase III product Kiata for AA amyloidosis

The deal includes up-front pay-ments of $10M, and will fund 100% of Kiata’s development costs through its confirmatory Phase III study and other development activities, estimated at $20M (4/30)

ClovisOncology Inc.*

Ventana MedicalSystems Inc.

Collaboration to develop a com-panion diagnostic to CP-4126 for clinical and commercial use


Crucell NV(the Netherlands;CRXL)

GlaxoSmithKlineBiologicals SA(Belgium)

Binding letter of agreement to collaborate on developing a sec-ond generation malaria vaccine candidate

Crucell will contribute its recombi-nant malaria vaccine candidate, Ad35-CS, and GSK will contribute its late-stage malaria vaccine can-didate RTS,S/AS (4/7)

CureDM LLC* Sanofi-Aventis(France)

Deal for CureDM’s approach to treating diabetes by stimulating the body’s production of insulin-producing islet cells

The deal is worth $335M in up-front and milestone payments, plus royalties (4/9)

EyeGatePharma Inc.*


Research collaboration to evalu-ate the delivery of several GSK therapies to the anterior and pos-terior tissues of the eye using the EyeGate II delivery system

Specific terms were not disclosed (4/30)








Option agreement involving RNA drug discovery

Isis gets $35M up front, which it will amortize over the five-year agreement and could get up to another $155M in pre-licensing milestones – averaging about $20M for each of the five pro-grams; after Phase II, GSK has the option to license the drug for fur-ther development; the deal could be worth a total $1 .5B (4/1)

MDRNA Inc.(MRNA)

Pfizer Inc. C o l l a b o r a t i o n t o e v a l u a t e MDRNA’s di-alkylated amino acids platform and UsiRNA con-structs for RNA interference

MDRNA will formulate Pfizer’s oli-gonucleotides in DiLA2 formula-tions for in vivo preclinical evaluation to be performed at Pfizer (4/6)

MersanaTherapeuticsInc.*

TevaPharmaceuticalsLtd.

Agreement for XMT-1107, a preclin-ical revival of the old antiangio-genic drug fumagillin

Teva agreed to pay $334M in up-front and milestone payments, as well as royalties, for rights to XMT-1107 worldwide except in Japan; Teva also is covering all develop-ment costs except those specific to Japan (4/13)

Metabolex Inc.* Takeda Pharma-ceutical Co. Ltd.(Japan)

Research collaboration on the evaluation and validation of pro-tein targets

Metabolex will provide protein targets discovered through the use of its target discovery tech-nologies; financial terms were not disclosed (4/14)

MicuRxPharmaceuticalsInc.* andCumencorPharmaceuticalsInc.*

Pfizer Inc. Collaboration to discover novel therapeutic agents to treat multi-drug-resistant tuberculosis

Pfizer will provide an up-front payment, funding for the discov-ery and preclinical development, and payments linked to the devel-opment and commercialization of any antibiotics developed through the collaboration (4/7)

PregLem*(Switzerland)

HRA Pharma(France)

Agreement giving PregLem rights to develop and commercialize ulipristal acetate for benign gyne-cological disorders in North America


ProximagenNeuroscience plc (UK; LSE:PRX)

Upsher-SmithLaboratoriesInc.

Development, license and subli-cense agreement for tonabersat, which was recently acquired by Proximagen through its acquisi-tion of Minster Pharmaceuticals plc

Upsher-Smith will undertake development, filing and commer-cialization of tonabersat for epi-lepsy in North America, and Proximagen will be entitled to roy-alty-free use of the data when developing tonabersat for Europe, where it is retaining full rights (4/14)

SerenityPharmaceuticalsLLC*

Allergan Inc. Deal for worldwide rights to Ser-120, a Phase III nasal spray for nocturia







Stemgent Inc.* Pfizer Inc. Collaboration and research licensing agreement to develop certain research reagents and make them available to the global research community

Pfizer and Stemgent will form a joint research committee to review and evaluate the progress and handle other tasks (4/19)

MAY AndroScienceCorp.*

OrientEuropharmaCo. Ltd. (Taiwan)

Strategic partnership centering on the clinical development and commercialization of ASC-J9, a topical acne product

OEP is responsible for clinical study expenses related to the Phase IIb trial slated to start in September and will secure rights as exclusive commercialization partner for Taiwan, Hong Kong, South Korea, New Zealand, Australia and other select markets through Asia Pacific (5/24)

Asterand plc(UK; LSE:ATD)

Eisai Co. Ltd.(Japan)

Two-year collaboration under which BioSeek will apply its BioMAP platform to advance Eisai discovery projects in oncology and inflammation

The agreement encompasses sci-entific projects at Eisai sites in the U.S. and Japan (5/5)

BioDeliverySciencesInternationalInc. (BDSI)

Kunwha PharmaceuticalCo. Ltd. (SouthKorea)

License and supply agreement to develop and commercialize BEMA Fentanyl in South Korea

Terms call for potential milestone payments to BDSI of up to nearly $1 .3M, including an up-front pay-ment of $300,000; BDSI also will receive an ongoing royalty based on net sales (5/28)

CardioDx Inc.* GE Healthcare Strategic alliance to advance and co-develop genomic-based diag-nostic technologies to improve the care and management of patients with cardiovascular dis-ease

The GE Healthymagination Fund invested $5M in CardioDx as part of a Series D round (5/14)

Clavis PharmaASA (Norway;OSLO:CLAVIS)

Ventana MedicalSystems Inc.

License agreement for exclusive access to Clavis’ monoclonal anti-body targeting human nucleoside transporter 1 and to the hybrid-oma cell line that produces the antibody

Specific financial terms were not disclosed (5/3)

Clinical DataInc. (CLDA)

SantenPharmaceuticalCo. Ltd. (Japan)

Exercised option to license Clinical Data’s ATL313 for certain ophthalmic diseases

Santen will pay $2M up front, and possibly milestone payments and royalties on sales (5/4)

ElexoPharmGmbH* (Germany)

Merck & Co. Inc.(Germany)

Agreement to develop com-pounds for cardiovascular diseas-es

Deal is worth up to $41 .65M, including $1 .85M up front (5/18)

EpigenomicsAG (Germany;FSE:ECX)

Warnex MedicalLaboratories(division of WarnexInc.; Canada)

Nonexclusive licensing agree-ment for Epigenomics’ colorectal cancer biomarker Septin9

Warnex has obtained the rights to establish a laboratory-developed test for Septin9 and offer colorec-tal cancer blood testing services in Canada (5/4)

ErgoNexPharma GmbH*(Switzerland)

Pfizer Inc. Licensing agreement for the Phase II pulmonary arterial hyper-tension drug terguride

ErgoNex will receive milestone payments and royalties, while Pfizer will support development and have worldwide rights out-side of Japan (5/13)






GlenmarkPharmaceuticalsSA (subsidiaryof GlenmarkPharmaceuticalsLtd.; India;BOMBAY:GLPHA)

Sanofi-AventisGroup SA (France)

Agreement for rights to develop and commercialize its vanilloid receptor antagonist molecules, including GRC 15300, which is in Phase I for various pain condi-tions, including diabetic neuro-pathic pain and osteo-arthritic pain

Sanofi is paying $20M up front to Glenmark, which also could bank an additional $325M based on achieving certain milestones, plus tiered double-digit royalties on sales; Sanofi will have exclusive marketing r ights for North America, European Union and Japan, subject to Glenmark’s right to co-promote the products in the U.S. and five Eastern European countries (5/4)

Grifols SA(Spain; PK:GIFLF)

Pharmalink AB(Sweden)

Agreement to acquire various forms of intellectual property associated with the treatment of post-polio syndrome

The acquisition includes Swedish regulatory approvals under the trade name Xepol, as well as U.S., European and Japanese patents that give Grifols exclusive rights to the treatment method (5/21)

IntelGenx Corp.(Canada; CDNX:IGX)

CaryPharmaceuticalsInc.

Deal acquiring full rights to, and ownership of, CPI-300, a high-strength formulation of bupropi-on hydrochloride

Cary has assigned to IntelGenx all rights and interest in the regulato-ry approvals and IntelGenx will be responsible for the costs going forward (5/12)

Labopharm Inc. (Canada; DDSS)

Gruppo Angelini SpA (Italy)

Completed transaction to estab-lish a joint venture with Gruppo Angelini

Named Angelini Labopharm, the J V w i l l l a u n c h O l e p t r o , Labopharm’s once-daily formula-tion of trazodone indicated for major depressive disorder, in the third quarter (5/24)

Micromet Inc. (MITI) Boehringer Ingelheim (Germany)

Global agreement to research, develop and commercialize a new BiTE antibody to treat multi-ple myeloma

Micromet retained U.S. co-promo-tional rights for the product; it will receive $6.6M cash up front, and could bank an additional $66M; Micromet also is eligible for a roy-alty comparable to profit split on U.S. product sales and a low dou-ble-digit royalty on ex-U.S. sales (5/6)

Peregrine Pharmaceuticals Inc. (PPHM)

Stason Pharmaceuticals Agreements granting Stason cer-tain exclusive development and commercialization rights to Peregrine’s tumor necrosis thera-py technologies

Peregrine’s lead TNT product can-didate is Cotara (5/4)

Polyphor Ltd.* (Switzerland)


Drug discovery collaboration to use Polyphor’s Protein Epitope Mimetics drug discovery technol-ogy to identify compound candi-dates against targets of interest

Novartis is paying Polyphor an undisclosed up-front payment, research funding and milestone payments, plus royalties (5/7)






Protox Therapeutics Inc. (Canada; TSX:PRX)

Kissei Pharmaceutical Co.

Agreement to develop and com-mercialize injectable PRX302 in Japan for enlarged prostate and other prostate diseases

The deal includes $3M up front; Protox also is eligible for a near-term milestone payment of $5M, as well as progressive payments of up to $67M upon achievement of specific development, regulato-ry and commercial milestones; Protox also would receive a dou-ble-digit royalty plus a drug sup-ply fee based on product sales (5/3)

Quintiles Transnational Corp.*

Nycomed GmbH (Switzerland)

A g r e e m e n t u n d e r w h i c h Nycomed has transferred a UK-based Healthcare Solutions Team to Quintiles

The transfer follows Nycomed’s decision to out-license a product to another pharmaceutical compa-ny in the UK (5/21)

Response Genetics Inc. (RGDX)


Nonexclusive license agreement granting GSK certain rights to its PCR analysis technology and diagnostic expertise to assess BRAF gene mutations in human tumor samples

The BRAF gene encodes B-Raf pro-tooncogene serine/threonine-pro-tein kinase; financial details were not disclosed (5/12)

Tekmira Pharmaceuticals Corp. (Canada; TSX:TKM)


Multiyear, target validation deal, giving Bristol-Myers access to small interfering RNA molecules formulated by Tekmira in stable nucleic acid- lipid particles to silence target genes of interest

BMS will pay Tekmira $3M at sign-ing (5/11)

Xanodyne Pharmaceuticals Inc.*

Ferring Pharmaceuticals Inc. (Switzerland)

Agreement divesting global rights for approved menorrhagia drug Lysteda

The rights were bought for undis-closed terms (5/11)

JUNE Aestus Therapeutic Inc.*


Exclusive, worldwide rights agreement for FK614 to treat postherpetic neuralgia


Ascenta Therapeutics Inc.*


Collaboration for an early stage cancer program that include two preclinical candidates designed to target the p53 protein

The deal includes up to $398M in up-front and milestone payments, plus tiered royalties on any prod-ucts that make it to market (6/7)

BioWa Inc.* GlaxoSmithKline plc (UK)

Two agreements, one amending a 2007 deal to provide GSK with extended access to BioWa’s Potelligent Technology platform for research, development and commercialization of antibody therapeutics with enhanced anti-body-dependent cellular cytotox-icity

The second agreement provides GSK with access to BioWa’s Complegent Technology for enhancing the complement-dependent cytotoxicity of select GSK therapeutic antibodies; BioWa will receive up-front and annual fees, development milestone pay-ments and royalties on any mar-keted products (6/24)






Diamyd Medical AB (Sweden; PK:DMYDY)

Ortho-McNeil-Janssen Pharmaceuticals Inc. (unit of Johnson & Johnson)

Deal to develop and commercial-ize its recombinant glutamic acid decarboxylase-65 antigen-based immuno-therapy to treat and pre-vent Type I diabetes

Ortho-McNeil is paying Diamyd $45M up front, plus up to $580M in development and sales mile-stone payments; the companies will equally share development costs, and it includes royalties (6/23)

Durect Corp. (DRRX) Hospira Inc. Deal to develop and market Posidur

The companies will jointly fund remaining development costs, and Hospira holds commercialization rights in the U.S. and Canada; Hospira will make an up-front pay-ment of $27.5M and could pay up to $185M in milestone payments, as well as a royalty on product sales (6/9)

Dyax Corp. (DYAX) Sigma-Tau SpA (Italy) Partnership to develop and com-mercialize ecallantide to treat hereditary angioedema through-out Europe, North Africa, the Middle East and Russia

Sigma Tau will pay Dyax $2.5M up front and will purchase $2.5M in equity shares at a 50% premium above market value; Dyax also is eligible for more than $100M in development and sales mile-stones, and royalties equal to 41% of net sales (6/22)

Eisai Inc. (FSE:EII) Helsinn Healthcare SA (Switzerland)

Licensing agreement for U.S. commercialization rights to its fixed-dose combination product in both oral and IV forms contain-ing netupitant and palonosetron, which is under investigation to prevent chemotherapy-induced nausea and vomiting


EnGen Bio Inc.* Dyadic International Inc.

Nonbinding term sheet for an outl icense on an exclusive worldwide basis of Dyadic’s C1 platform technology

Dyadic is eligible to receive a sub-stantial equity stake in EnGen Bio (6/10)

Entelos Inc.* Pfizer Inc. Nonexclusive, perpetual license that gives access to Entelos’ Metabolism Physiolab platform

The platform is designed to com-bine physiology and individual behavior to support research on obesity and diabetes (6/25)

Essen BioScience Inc.*

Nycomed A/S (Switzerland)

Joint discovery agreement to identify small-molecule ion chan-nel modulators as pain therapeu-tics

The companies will collaborate to screen, optimize and develop modulators of voltage-gated ion channels (6/22)

Ikano Therapeutics Inc.*

Upsher-Smith Laboratories Inc.

Agreement to obtain exclusive global rights to ITI-111 , Ikano’s nasal midazolam

Upsher-Smith will assume all fur-ther development, testing and clinical study of nasal midazolam to manage acute repetitive sei-zure in patients with epilepsy (6/29)

Marcadia Biotech Inc.*

Eli Lilly and Co. A glucagon analogue partnership Terms were not disclosed, but Lilly gets worldwide commercializa-tion rights to lead preclinical can-didate MAR531 as well as related backup compounds (6/29)






Marionomed Biotechnologie GmbH* (Austria)


Licensing agreement extending the marketing of the antiviral nasal spray to treat the common cold to all of Europe (except Austria and UK), Russia and CIS, South America, parts of Asia and Australia

Marionomed will receive an undis-closed up-front payment in the million Euro range, in addition to milestone payments and royalties (6/29)

Metabolex Inc.* Ortho-McNeil-Janssen Pharmaceuticals Inc. (unit of Johnson & Johnson)

Deal to discover and develop compounds for Type II diabetes and other disorders

Metabolex will receive an undis-closed up-front payment and could be eligible to receive devel-opment, regulatory and commer-cial milestones up to $330M; Metabolex also is eligible for roy-alties (6/23)

Metabolex Inc.* Sanofi-Aventis SA (France)

Collaboration for the research, development, manufacture and commercialization of small mole-cules that modulate the G-protein coupled receptor 119

The deal is worth $375M (6/28)

miRagen Therapeutics Inc.*

Santaris Pharma A/S (Denmark)

Alliance to develop microRNA-targeted medicines to treat car-diovascular disease

MiRagen will gain access to Santaris’ Locked Nucleic-Acid plat-form to develop and commercial-ize single stranded LNA-based product; Santaris will receive a minority equity interest in miRa-gen and is eligible for undisclosed milestone payments plus royalties (6/24)

Neurocrine Biosciences Inc. (NBIX)

Abbott Exclusive worldwide deal to develop and commercialize elagolix to treat endometriosis-related pain

The deal is worth more than $575M, including $75M up front (6/17)

Neurocrine BioSciences Inc. (NBIX)


Research and development deal for small-molecule GPR119 ago-nists to treat Type II diabetes and o t h e r i n d i c a t i o n s u s i n g Neurocrine’s technology platform SiNERG

The deal is worth more than $235M, including $10M up front, plus royalties (6/18)

OncoMed Pharmaceuticals Inc.*

Bayer Schering Pharma AG

Deal to develop drugs targeting the Wnt signaling pathway

An agreement that brings $40M up front, with the potential for more than $1B in future mile-stones; the deal calls for up to five compounds and up to $387.5M per biotherapeutic, or up to $112M per small molecule, in develop-ment, regulatory and sales mile-stones, plus double-digit royalties and certain co-development options (6/18)


Ortho-McNeil-Janssen Pharmaceuticals Inc. and Janssen Pharmaceutica NV

Alliance to develop two of its pre-clinical programs that target pathways involved in arachidonic acid metabolism

Orexo will get an up-front pay-ment of $10M and will get another $11 .5M in research funding (6/2)






Regulus Therapeutics Inc.*


Partnership aimed at discovering microRNA-based drugs against four fibrosis targets

The deal is worth $750M, includ-ing $25M up front, as well as a $10M equity investment, plus $650M in milestone payments and royalties (6/23)

Saladax Biomedical Inc.*


Multiyear development and com-mercialization agreement for the development of certain clinical diagnostic tests to be used in conjunction with the develop-ment of certain therapeutic com-pounds in the BMS pipeline

Companies will collaborate glob-ally on development and regulato-ry approvals; Saladax received exclusive global rights to com-mercialize the assays it develops (6/22)

TransTech Pharma Inc.*

Forest Laboratories Inc. Partnership to develop and com-mercialize a new class of glu-cose-lowering agents to treat diabetes

TransTech is receiving a $50M up-front payment and is eligible to receive royalties on worldwide sales; Forest is responsible for all development and commercializa-tion costs (6/9)

Tranzyme Pharma Inc.*

Norgine BV (the Netherlands)

Exclusive rights agreement to develop and commercialize Tranzyme’s ghrelin agonist, uli-morelin in several ex-U.S. regions

Norgine gains rights to the Phase III compound, being developed in gastrointestinal dysmotility condi-tions in acute care settings, in Europe, Australia, New Zealand, the Middle East, South Africa and North Africa; Tranzyme retains development rights in the U.S. and Asian countries; Norgine also will make an undisclosed equity investment in Tranzyme (6/17)

Uluru Inc. (AMEX: ULU) & Strakan International Ltd.* (Scotland)

Crawford Healthcare Ltd. (UK)

Deal under which Uluru and Strakan have divested their inter-est in acne drug Zindaclin

Crawford will pay up to $5. 1M for the product, which will be shared equally by Strakan (6/29)


Sanofi-Aventis Group (France)

License agreement for the Humalex antibody platform

Vivalis will receive an up-front payment of $3.6M, plus another potential €35M in milestone pay-ments, as well as royalties (6/9)

WisTa Laboratories Ltd.* (subsidiary of TauRx Pharmaceuticals)


Collaboration to develop specific markers designed to aid in the diagnostics and management of tau protein-related Alzheimer’s disease using brain-imaging tech-nology

TauRx will use its technology plat-form of ligands, specialized tau-directed assays and its animal models to optimize the develop-ment of ligands; diagnostic prod-ucts arising from the deal will be developed by Bayer, while com-pounds with therapeutic potential will be developed by TauRx (6/4)

JULYAdimab Inc.* Novartis AG

(Switzerland)An antibody discovery partner-ship that involves Adimab’s yeast-based platform

Details were not disclosed but most of Adimab’s deals involve up-front fees, milestone payments and royalties, typically in the mid-single-digits (7/12)






Aestus TherapeuticsInc.*

Eisai Co. Ltd. (Japan) Multiyear collaboration for the research and development of treatments for psychiatric disor-ders


Biolex Therapeutics Inc.*

Merial Ltd. Research and development col-laboration to produce veterinary vaccines

The collaboration will combine Biolex’s Lemna expression system with Merial’s expertise and com-mercial presence in veterinary vaccines (7/19)

Biotica Technology Ltd.* (UK)


Agreement for Biotica to acquire intellectual property of bioengi-neering techniques for use in lead optimization

It provides additional product opportunities in new polyketide chemical classes and enhances capabilities in manufacturing development (7/9)

EUSA Pharma Inc.* (UK)

Ohara Pharmaceutical Co. Ltd. (Japan)

Japanese development and com-mercialization rights for the can-cer drug Erwinase

EUSA will receive an up-front fee and royalties (7/7)

Hawaii Biotech Inc.* Merck & Co. Inc. Licensing agreement for Hawaii Biotech’s dengue vaccine pro-gram

Hawaii received an up-front pay-ment and will not collect further milestones or royalties (7/22)

ImmunoVaccine Inc. (Canada; CDNX:MIV)

Merck KGaA (Germany) Licensing agreement for EMD 640744, a survivin-targeted anti-gen-based cancer vaccine

The product also will be incorpo-rated into its liposome delivery platform; terms were not dis-closed (7/13)

Itero Biopharmaceuticals Inc.*

Watson PharmaceuticalsInc.

Itero exclusively licensed world-wide rights to its biosimilar recombinant follicle stimulating hormone for infertility

Watson will cover all future costs and pay Itero a licensing fee, mile-stone payments and royalties (7/16)

Nitto Denko Corp.(Japan; FSE:ND5)

Quark Pharmaceutical Inc.

Collaboration and license agree-ment for the development of siRNA therapeutics for the treat-ment of fibrotic diseases

The collaboration is designed to develop siRNA drugs using RNAi technologies and structures by Quark and Nitto Denko’s drug delivery technologies for thera-peutic concepts (7/19)

OctoPlus NV(the Netherlands;Amsterdam:OCTO)


Agreement relating to the use of OctoPlus’ controlled-release tech-nology

OctoPlus will develop, up to in vivo feasibility, a controlled-release formulation of an undis-closed compound using its drug delivery technology PolyActive (7/1)

Qiagen NV(the Netherlands; QGEN)

Roche AG (Switzerland) Licensing agreement for intellec-tual property covering the devel-opment of phosphoinositide 3-kinase, or P13K, assays


Vastrata Ltd.*(UK)

Mitovie Pharma Ltd. (UK)

Exclusive, worldwide licensing deal covering VAS005/MVP009 for an undisclosed indication in the field of women’s health

Vastrata will receive payments linked to commercial success of the project (7/6)

X-Chem Inc.* Roche AG (Switzerland) Multiyear deal to apply X-Chem’s platform to the discovery of drug candi-dates against several Roche targets

Roche will make up-front and research payments, plus success-based discovery milestones and technology access fees; X-Chem also is eligible for development milestones and royalties (7/2)






AUGUSTAileron Therapeutics Inc.*

Roche AG (Switzerland) Deal to develop therapeutics based on Aileron's stapled pep-tides platform aimed at targets previously considered undrugga-ble

Roche will pay Aileron at least $25M up front and $1 . 1B in mile-stone payments based on achiev-ing drug candidates against five undisclosed targets (8/25)

Alectos Therapeutics Inc.*

Merck & Co. Inc. Collaboration to study a potential non-amyloid approach to treat Alzheimer's disease

Alectos will receive up to $289M in an up-front fee and milestone payments; Merck gets worldwide, exclusive rights to research, develop and commercialize com-pounds that modulate the enzyme O-linked N-acetylglucosaminidase (8/12)

Amplimmune Inc.* GlaxoSmithKline plc (UK)

Strategic alliance for AMP-224, an Fc-fusion protein of the B7-DC ligand, which targets PD-1

The deal is worth $23M up front and as much as $485M in later payments (8/5)

FivePrime Therapeutics Inc.*


Drug discovery alliance giving G S K e x c l u s i v e a c c e s s t o FivePrime's drug discovery plat-forms, specifically in the areas of sarcopenia, cachexia and other skeletal muscle disorders

FivePrime will receive about $15M in 2010 from an up-front fee, the purchase of FivePrime equity by GSK and payments related to the research program (8/5)

Immunomedics Inc. (IMMU)

GE Healthcare License and collaboration agree-ment for the evaluation of label-ing technologies based on Immunomedics' patented fluo-rine-18 peptide labeling method

Terms were not disclosed, but GE Healthcare will fund all costs relat-ed to the collaboration (8/19)

Impax Laboratories Inc. (APXL)

Perrigo Co. Collaboration to develop and commercialize two extended topi-cal drug products

The products and terms of the agreement were not disclosed (8/6)

Nabi Biopharmaceuticals Inc. (NABI)

GlaxoSmithKline Biologicals SA (Belgium)

Completed a technology transfer of program know-how associated with the sale of the PentaStaph vaccine candidate

Nabi is eligible to receive another $8M under the $46M deal for the pentavalent S. aureus vaccine and related assets (8/11)

NextWave Pharmaceuticals Inc.*

Tris Pharma Inc. Partnership to apply Tris' drug delivery technology to Next Wave's central nervous system portfolio, and to develop another three CNS products

Terms of the deal were not dis-closed (8/13)

Osteologix Inc. (OTC BB: OLGX)

Servier Research Group (France)

Osteologix granted Servier an exclusive royalty-bearing license to develop and commercialize NB S101 to treat postmenopausal osteoporosis, other bone and joint disorders and dental indica-tions

The rights are worldwide, except in the U.S.; Osteologix will receive up to $15.8M in up-front and mile-stone payments; Osteologix is eli-gible to receive up to $39.5M in minimum royalty payments cred-itable against royalties on sales (8/3)






Phylogica Ltd. (Australia; ASX:PYC)

AstraZeneca plc (UK) Deal with AstraZeneca under which its MedImmune biologics unit will search Phylogica’s pep-tide library for compounds that are active against Pseudomonas aeruginosa

The deal is worth $1 .5 million over the next 12 months for the screen-ing work, plus a further $98 mil-lion in milestones against the development of any product (8/25**)

PregLem SA* Merck Serono SA Worldwide, exclusive licensing agreement for Bentamapidmod, an orally active Jun Kinase inhibitor, for an undisclosed amount

PregLem will develop the com-pound for the prevention of post-surgical abdominal adhesions and endometriosis in patients with tubal ligation or comparable effec-tive contraception (8/12)

Quark Pharmaceuticals Inc.*


Deal granting Novartis an option to obtain an exclusive worldwide license to develop and commer-cialize QPI-1002, a p53 temporary inhibitor siRNA drug

Quark stands to bank $680M, including $10M up front (8/19)

SureGene LLC* Medco Research Institute LLC (subsid-iary of Medco Health Solutions Inc.)

Research collaboration to evalu-ate whether variation in genetic biomarkers previously identified by SureGene can help predict drug response for widely pre-scribed antipsychotic drugs in patients with serious mental ill-ness

Terms were not disclosed (8/25)

Vectura Group plc (UK; LSE:VEC)


Worldwide, nonexclusive agree-ment to license some of its dry powder drug formulation patents in relation to two late-stage development compounds in GSK's respiratory product pipe-line

Vectura will receive up to $31 .9M in up-front and milestone pay-ments, plus royalties (8/9)

Xcellerex Inc.* SK Chemicals Co. Ltd. (South Korea)

Memorandum of understanding for an alliance to develop and commercialize SK-developed vac-cines with Xcellerex’s FlexFactory biomanufacturing platform

Specific terms will be defined at a later time (8/27)

SEPTEMBER Acceleron Pharma Inc.*

Shire plc (UK) Agreement to develop drugs for rare muscle disorders, including ACE-031 for Duchenne’s muscular dystrophy

The deal is worth a potential $498M, including $45M up front, plus royalties (9/10)

Acucela Inc.* Otsuka Pharmaceutical Co. Ltd. (Japan)

Agreement to co-develop and co-promote OPA-6566, an adenosine A2a receptor agonist to treat glaucoma in the U.S.

Specific terms were not disclosed (9/28)

Anchor Therapeutics Inc.*

Ortho-McNeil-Janssen Pharmaceuticals Inc.

Development and commercializa-tion deal focused on Anchor’s program targeting gpr39, a GPCR involved in metabolic diseases

The deal is worth $480M in devel-opment and regulatory mile-stones, plus an undisclosed up-front fee (9/10)






Asklepios BioPharmaceutical Inc.*

Pfizer Inc. License agreement for certain gene-delivery platform technolo-gies developed by AskBio for use in developing therapies for hepa-titis C virus

AskBio is developing gene thera-py-based clinical programs (9/14)

Concordia Pharmaceuticals Inc.*

Ono Pharmaceutical Co. Ltd. (Japan)

Exclusive rights deal to develop and commercialize salirasib in Japan in exchange for an undis-closed up-front payment

Concordia is eligible to receive additional payments based on milestones, plus royalties on sales in Japan (9/2)

Kinaxo Biotechnologies GmbH* (Germany)

Daiichi Sankyo Co. Ltd. (Japan)

Long-term partnership in cancer research under which Daiichi will employ Kinaxo’s technology plat-form to support the development of its targeted cancer drugs


Kythera Biopharmaceuticals Inc.*

Intendis (unit of Bayer HealthCare)

Rights agreement to develop, manufacture and commercialize ATX 101 outside the U.S. and Canada for reduction of submen-tal fat

Kythera will receive $43M up front with a potential $330M in mile-stone payments, plus royalties (9/1)

Ligon Discovery Inc.*


Partnership for Ligon to apply its s m a l l - m o l e c u l e m i c r o a r r a y screening platform to discover candidates for new disease tar-gets



Unnamed U.S.-based pharmaceutical com-pany

Feasibility agreement relating to the use of OctoPlus’ controlled-release technology

OctoPlus will develop a con-trolled-release formulation of an undisclosed compound using its d r u g d e l i v e r y t e c h n o l o g y PolyActive (9/21)

OncoMethylome Sciences Inc. (BR:ONCOB)

GlaxoSmithKline Biologicals SA (subsid-iary of GSK plc; UK)

Collaboration in which GSK will use OncoMethylome’s DNA meth-ylation-specific PCR biomarkers in its immunotherapy develop-ment program

Financial details were not dis-closed (9/24)

Onyx Pharmaceuticals Inc. (ONXX)

Ono Pharmaceutical Co. Ltd. (Japan)

Licensing agreement for Japanese regional development and com-mercialization rights for carfilzo-mid and another proteasome inhibitor, ONX 0912

The deal calls for Onyx to receive about $59M up front, $280M in potential milestones and double-digit royalties on Japanese sales (9/9)

Pepscan Therapeutics* (the Netherlands)

Tibotec Pharmaceuticals Ltd. (unit of Johnson & Johnson)

Research and license agreement to develop therapeutic peptides against an undisclosed target

Pepscan will receive undisclosed R&D funding and could receive payments on the achievement of research and clinical milestones, as well as royalties (9/15)

Pieris AG* Sanofi-Aventis Group (France)

Licensing agreement for rights for up to six drug targets using Anticalin technology from Pieris

Sanofi-Aventis and Sanofi Pasteur will receive $4.7M up front for two initial targets, plus research fund-ing and preclinical, regulatory and commercial milestone payments totaling $35.3M for the first thera-peutic application, and $24.4M in commercial milestones, plus roy-alties (9/29)






Prima BioMed Ltd. (Australia; ASX:PRR)

Bioceros BV (the Netherlands)

Licensing agreement for the development of a Cripto-1 cancer monoclonal antibody

The deal is a 70:30 project split with Prima taking the larger por-tion (9/8)

reMYND* (Belgium) Roche AG (Switzerland) Agreement to develop two class-e s o f c o m p o u n d s a g a i n s t P a r k i n s o n ’ s d i s e a s e a n d Alzheimer’s disease

The total deal is worth as much as $637M as milestones are met (9/8)

Santarus Inc. (SNTS) Pharming Group NV (the Netherlands)

Deal for North American rights to Rhucin to treat acute attacks of hereditary angioedema and other future indications from Pharming

Santarus will pay $15M up front, plus an additional $5M milestone payment upon FDA acceptance of a BLA; Santarus also may pay mile-stones (9/14)

Santhera Pharmaceuticals AG (Switzerland; SWX:SANN)

Ipsen Group SA European partnering deal for its Parkinson’s drug Fipamezole

Santhera wil l receive E 13M ($16.6M) up front, with up to E128M ($163.2M) in development, regulatory and commercial mile-stones (9/7)

OCTOBER Ablexis LLC* Pfizer Inc. and four

other pharmaceutical companies

Partnership with a consortium that will work to develop and use Ablexis’ AlivaMab transgenic mouse platform for the discovery of antibody therapeutics

Each consortium member will make a nonrefundable “seven-fig-ure” payment to become part of the consortium; Ablexis gets an “eight-figure payment” in return for granting specified nonexclu-sive rights to use the technology in antibody discovery programs (10/26)

BioRelix Inc.* Merck & Co. Inc. Partnership aimed at identifying new candidates for treating bac-terial infections

BioRelix will apply its riboswitch platform and gets an up-front fee and research funding, as well as milestones and royalties (10/4)

Cell Cure Neurosciences Ltd.* (Israel)

Hadasit Bio-Holdings Ltd. (Israel) and Teva Pharmaceutical Industries Ltd. (Israel)

Exclusive license option agree-ment to develop and commercial-ize Cell Cure’s OpRegen product for the treatment of age-related macular degeneration

Cell Cure will be entitled to mile-stone payments and royalties (10/12)

Cytos Biotechnology Ltd. (Switzerland; SWX:CYTN)

Science Applications International Corp.

Subcontract agreement to sup-port the U.S. National Institutes of Health with the preclinical devel-opment of a malaria vaccine

Cytos will provide its virus-like particle based vaccination tech-nology and expertise while the NIH will contribute malaria anti-gen candidates; vaccines generat-ed will be tested in preclinical models of malaria disease by NIH and SAIC (10/22)

Envoy Therapeutics Inc.*

Takeda Pharmaceutical Co. Ltd. (Japan)

Three-year research alliance aimed at discovering drugs for schizophrenia

Takeda will make a $3M up-front payment, will provide $2.25M per year in research funding and fees and will pay undisclosed mile-stones and royalties on any prod-ucts that advance (10/11)






Evotec AG (Germany; FSE:EVTA)

Shionogi & Co. Ltd. (Japan)

Multiple-target drug discovery collaboration to identify small-molecule modulators of various protein-protein interaction tar-gets

Evotec will use its integrated frag-ment-based discovery platform to investigate targets selected by Shionogi; financial terms were not disclosed (10/6)

Evotec AG (Germany; FSE:EVTA)

Zhejiang Jingxin Pharmaceutical Co. Ltd. (China)

License and collaboration agree-ment for EVT 201 to treat insom-nia

The agreement grants Jingxin exclusive rights to develop and market the drug candidate in China; Evotec will receive a small up-front payment, plus commercial milestones and royalties (10/29)

Exelixis Inc. (EXEL) Bristol-Myers Squibb Co.

Agreements for exclusive world-wide licenses to develop and commercialize small-molecule TGR5 agonists and ROR antago-nists

Exelixis will receive an initial pay-ment of $60M, and it will be eligi-ble for potential development and approval milestone payments of up to $250M on the TGR5 pro-gram and $255M on the ROR pro-gram (10/12)

Genmab AS (Denmark; CSE:GEN)

H. Lundbeck AS (Denmark)

Partnership to create and develop human antibody therapeutics for central nervous system disorders

Genmab will receive an up-front payment of $10.47M; if all mile-stones are met, the total value is $53.5M, plus single-digit royalties (10/14)

GenVec Inc. (GNVC) SAIC-Frederick Inc. Option agreement under a four-year contract for the develop-ment of influenza and HIV vaccines

GenVec will receive up to about $3.5M for the second year of activities under the SAIC contract, and that funding increases the total value of the contract to up to $24M (10/7)

ImmunoGen Inc. (IMGN)


Partnership for i ts Tumor-Activated Prodrug technology, which combines a tumor-target-ed antibody with a cell-killing agent

The deal includes $45M up front for ImmunoGen and up to $200.5M in milestone payments for each target that becomes a cancer drug; Novartis gets the right to apply the technology to antibodies against an undisclosed number of products (10/12)

InterMune Inc. (ITMN)

Hoffmann-La Roche Inc. and F. Hoffmann-La Roche Ltd. (Switzerland)

Deal for worldwide development and commercialization rights to danoprevir

Roche gained the rights for $175M in cash, and the October 2006 col-laboration between the two par-ties was terminated (10/7)

Laboratorio Teuto Brasileiro SA* (Brazil)

Pfizer Inc. Deal to develop and commercial-ize genetic medicines

Pfizer will acquire a 40% stake in Teuto, and the firms will enter into a series of commercial deals (10/21)

MacroGenics Inc.* Boehringer Ingelheim GmbH (Germany)

Deal to discover, develop and commercialize antibody-based t h e r a p e u t i c s b a s e d o n MacroGenics ’ Dual -Aff in i ty ReTargeting platform

The agreement is worth $2. 16B, including $60M within the first three years and $210M for each of the 10 DART programs; they are working in multiple therapeutic areas, including immunology, oncology, respiratory, cardiometa-bolic and infectious diseases (10/27)






MacroGenics Inc.* Pfizer Inc. Dual-Affinity ReTargeting plat-form agreement for two undis-closed cancer targets

MacroGenics will get an up-front cash payment, research funding, milestone payments and tiered royalties on resulting products (10/27)

MingSight Pharmaceuticals Inc.*

Pfizer Inc. Exclusive worldwide rights to develop, manufacture and com-mercialize two preclinical stage new chemical entities aimed at treating eye diseases

MingSight has agreed to pay Pfizer an undisclosed up-front fee, as well as development and sale-related milestone payments, and royalties (10/12)

Myriad Genetics Inc. (MYGN)

Abbott Agreement to conduct BRCA1 and BRCA2 mutation testing on patients for enrollment in a Phase III study of an undisclosed drug for metastatic breast cancer

Myriad will use its BRACAnalysis test to identify the presence of germline mutations in breast can-cer patients and determine their mutation status (10/28)

ProteoTech Inc.* Tasly Pharmaceutical Co. Ltd. (China)

Development deal for ProteoTech’s Exebryl-1 for the treatment of mild-to-moderate Alzheimer’s disease

Terms include an up-front pay-ment, development costs and research funding (10/5)

SanBio Inc.* Dainippon Sumitomo Pharma Co. Ltd.

Option agreement to co-develop a new cell therapy for stroke recovery

DSP received an option for exclu-sive U.S. and Canadian marketing rights to SB623 (10/5)

Synosia Therapeutics*

UCB Pharma Agreement to develop two lead drugs for treating Parkinson’s disease

UCB is leading the company’s third round with $20M and is making an undisclosed up-front payment; the deal includes $725M in milestones (10/13)

Synthetic Genomics Vaccines Inc.*


Deal for SGVI to provide synthetic genomics tools and technologies to develop a bank of synthetic influenza seed viruses for vac-cine production

The ready-to-use viruses could advance the six- to nine-month vaccine production schedule by as much as two months (10/11)


Undisclosed partner Agreement to evaluate the EB66 cell line for the production of sev-eral undisclosed therapeutic pro-teins

The results of the feasibility study would result in an EB66 cell line commercial license to the partner (10/6)

NOVEMBER Amicus Therapeutics Inc. (FOLD)


Partnership for Fabry disease drug Amigal

Amicus will get $60M up front in the potential $230M partnership; GSK is paying $30M in cash and will take a 19.9% equity stake for about $31M, and Amicus is eligible for up to $170M in milestones, plus tiered, double-digit royalties (11/1)

Aposense Ltd. (Israel; TASE:APSN)

Roche AG (Switzerland) Nonexclusive agreement to use the Earl iTest solution with Roche’s oncology program

Roche will fund the clinical trials and pay Aposense undisclosed license and milestone fees (11/10)

Archemix Inc.* Baxter International Inc.

Agreement to sell Archemix’s hemophlia-related assets to Baxter

Baxter will pay $30M up front and possibly $285M in milestone pay-ments; Baxter gains ARC19499 and related intellectual property assets (11/22)






Biovista Inc.* Pfizer Inc. Research collaboration to seek new indications for Pfizer drug candidates in development using a bioinformatics technology plat-form developed by Biovista

Terms include the identification of up to three new indications for each drug; Biovista will receive an undisclosed up-front payment and success milestone payments (11/10)

Forma Therapeutics Inc.*

Eisai Inc. (unit of Eisai Co. Ltd.; Japan)

Drug discovery deal that focuses on difficult-to-treat drug targets

Forma gets up-front payments and committed funding of $20M over three years, plus additional milestone payments and royalties on future products that Eisai com-mercializes (11/18)

f-star Biotechnologische GmbH* (UK)


Partnership to apply its modular antibody technology to discover antibodies and/or antibody frag-ments against seven targets nominated by Boehringer

f-star gets an up-front fee, research funding and milestone payments; the deal could be worth $245.4M (11/23)

Guangdong Techpool Bio-Pharma Co. Ltd.* (China)

Nycomed A/S (Switzerland)

Nycomed acquired a majority stake in Guangdong by purchas-ing 51 .4% of its shares

The two companies operate as seperate entities; Nycomed will ben-efit from Techpool’s protein drug assets and its market presence in China (11/2)

Simcere Pharmaceutical Group (China; NYSE:SCR)


Deal to co-develop BMS-817378, a preclinical small-molecule MET/VEGFR-2 inhibitor, to treat cancer

Simcere gains exclusive rights to develop and commercialize the product in China, while BMS retains rights in all other markets (11/4)

Spencer Pharmaceuticals Inc. (PK:SPPH)

National Pharmaceutical Corp.

Agreement to develop central nervous disease treatments for Alzheimer’s and Parkinson’s dis-eases using Spencer’s drug deliv-ery platform

The companies will swap 20M restricted shares, subject to a final agreement (11/2)

Valeant Pharmaceuticals International Inc. (Canada; NYSE:VRX)

Kadmon Pharmaceuticals LLC

Agreement granting Kadmon an exclusive worldwide license to taribavirin, excluding Japan; and a deal for exclusive rights to its dos-age forms of ribavirin in Poland, Hungary, Czech Republic, Slovakia, Romania and Bulgaria

Valeant gained an up-front pay-ment of $5M plus development milestones and royalties in the range of 8% to 12% of future net sales; in the second deal, Valeant paid $7.5M for exclusive rights (11/2)

DECEMBER Adamis Pharmaceuticals Corp. (OTC BB:ADMP)

Beximco Pharmaceuticals Ltd. (Bangladesh)

Partnership to introduce four sep-arate drugs in the area of allergy and asthma in the U.S. over three years

The two companies also will co-develop other drugs (12/2)

Anaphore Inc.* Mitsubishi Tanabe Pharma Corp.

Partnership for Anaphore’s Atrimer protein engineering plat-form

The deal is worth up to $345M, including $5M up front for the ini-tial autoimmune target and $110M in milestones, plus the possibility of two additional targets under the same terms; the deal also includes tiered royalties on future sales (12/13)






Apexigen Inc.* Johnson & Johnson Worldwide antibody discover and development deal

Apexigen will generate and screen antibodies to several targets spec-ified by Centocor; terms were not disclosed (12/8)


Ascentage Pharma Group Corp. Ltd. (China)

Collaboration to develop cancer candidates AT-101 and AT-406 from Ascenta’s pipeline

AT-101 and AT-406 trigger apopto-sis through pan-Bcl-2 inhibition and multi-IAP inhibition, respec-tively (12/2)

Asupex Pharmaceuticals Inc.*

Teva Pharmaceutical Industries Ltd. (Israel)

Deal involving a deuterium-con-taining drug


Avila Therapeutics Inc.*


Collaboration to design targeted covalent drugs against six signal-ing proteins with relevance in oncology, with Sanofi moving for-ward five of the drugs and Avila retaining rights to one

Sanofi-Aventis paid $40M up-front in cash and committed to as much as $770M in milestones (12/21)

Biological Mimetics Inc.*

GlaxoSmithKline plc Research collaboration to focus on applications of its Immune R e f o c u s i n g Te c h n o l o g y t o develop vaccines


Cancer Targeted Technology*


Research and license option agreement to optimize a PET imaging agent based on its inhib-itor scaffold that recognizes a validated cancer enzyme bio-marker


CardioVascular BioTherapeutics Inc. (PK:CVBT)

Merck & Co. Inc. Exclusive licensing agreement for clinical and scientific data regard-ing the therapeutic use of human fibroblast growth factor-1 to treat diabetic wounds

CVBT plans to use the data to advance its FGF-1 diabetic wound healing drug candidate, CVBT-141B, to a pivotal Phase III trial (12/1)

Champions Biotechnology Inc.*

Teva Pharmaceutical Industries Ltd. (Israel)

Partnership to use its Tumorgraft platform to evaluate an anti-angiogenic drug from Teva


Cytori Therapeutics Inc. (CYTX)


Strategic equity deal for Astellas to purchase 1 .43M unregistered shares of Cytori common stock for $7 each

Astellas gets a two-year rights of first refusal on Cytori’s adipose stem cell products for use in liver disease as well as a nonvoting board of director’s seat and a sci-entific advisory board seat (12/8)


Pfizer Inc. Agreement for an explorative R&D collaboration to identify bio-markers in early stages of A lzheimer ’s d isease us ing DiaGenic’s patented gene expres-sion technology and its blood samples from ongoing clinical studies

The agreement gives Pfizer a non-exclusive, worldwide license to use DiaGenic’s MCI test and AD tests in their research and drug development programs (12/20)






Emisphere Technologies Inc. (OTC BB:EMIS)

Novo Nordisk A/S (Denmark)

Oral diabetes drug delivery deal Emisphere will receive $5M up front and a potential $52.5M in milestones to use its Eligen tech-nology to develop oral formula-tions of Novo’s insulin products (12/22)

EpiTherapeutics Aps* (Denmark)

Abbott Deal to discover small-molecule inhibitors of epigenetic oncology targets


Epitomics Inc.* SAIC Frederick Inc. Contract to develop several dozen rabbit monoclonal anti-bodies to support the Clinical Proteomic Technol-ogies for Cancer program

The goal is to develop high affini-ty and renewable reagents to cap-ture tryptic peptides derived from human plasma protein biomark-ers, and then use the captured peptides to quantify the biomark-ers (12/16)

Evotec AG (Germany; FSE:EVT)

AstraZeneca plc (UK) subsidiary MedImmune

Partnership for a biologic beta cell regeneration program

The deal is worth $345.2M, with $6.6M at signing, and 30% of the up-front and milestone payments are owed to DeveloGen sharehold-ers; Evotec acquired DeveloGen in July (12/16)

Galenica AG (Switzerland; SWX:GALN)

Fresenius Medical Care AG & Co. KGaA (Germany)

Deal to create renal pharmaceuti-cal company Vifor-Fresenius Medical Care Renal Pharma Ltd.

Galenica will give the newco intra-venous iron products Venofer and Ferinject for use in the dialysis and pre-dialysis market as well as rights to a Phase II iron-based phosphate binder (12/2)

GenVec Inc. (GNVC) Sanofi-Aventis Group SA’s Merial animal health division

Deal to use GenVec’s adenovector technology to develop and sell a vaccine for foot-and-mouth dis-ease

Specific financial terms were not disclosed (12/30)

Gruenenthal GmbH* (Germany)

Forest Laboratories Inc. Licensing agreement for Phase II small-molecule analgesic GRT 6005 and follow-on compound GRT 6006 to Forest Laboratories

Forest will pay an up-front fee, milestones and royalties in exchange for U.S. and Canadian rights and a co-promotion option in Europe (12/7)

Gruenenthal GmbH* (Germany)

Forest Laboratories Inc. Agreement selling the rights to colistin, an antibiotic for cystic-fibrosis-related bacterial infections, and Colobreathe, a delivery device for colistin

Financial terms were not dis-closed

LPath Inc. (OTC BB:LPTN)

Pfizer Inc. Deal covering lead antibodies iSONEP for ophthalmology and ASONEP for cancer

The deal calls for Pfizer to pay LPath $14M up front as well as share half the costs of two planned iSONEP trials; if Pfizer exercises its worldwide option on iSONEP, LPath will get an option fee, up to $497.5M in milestone payments and tiered double-digit royalties, plus a right of first refus-al on ASONEP (12/21)






Merrion Pharmaceuticals plc (Ireland; PK:MNHPF)

Undisclosed pharma-ceutical company; Novo Nordisk AS (Denmark)

D e a l t o e v a l u a t e w h e t h e r Merrion’s GIPET drug delivery technology can boost the bio-availability of three of the phar-ma’s drugs

Terms were not disclosed (12/7); the second deal is to see if the GIPET technology can boost oral bioavailability with an undis-closed Novo Nordisk compound; Merrion issued warrants for up to $1 .96M in Merrion shares at $3.92 per share (12/23)

Novogen Ltd. (Australia; NVGN)

Marshall Edwards Inc. Deal for Marshall Edwards to acquire isoflavone-based intellec-tual property

Novogen will receive $4M in con-vertible preferred stock; each of 1 ,000 shares of Class A preferred stock is convertible to a minimum of 4,827 shares of common stock (12/23)

PhenoMatriX* SRI International Collaboration on the develop-ment of platin-based chemother-apies

Platin-based drugs such as cisplat-in and related analogues are used to treat a variety of cancers with solid tumors and other difficult-to-treat cancers; SRI will receive roy-alties and an equity stake once R&D milestones are met (12/6)

Philochem AG* (Switzerland)

Merck Serono (division of Merck KGaA; Germany)

Deal in which Philochem will supply specific monoclonal antibodies to Merck Serono, to be used in the search for molecular biomarkers of oocyte and embryo quality for a test to be used by physicians



Pfizer Inc. Collaboration and licensing deal to discover peptide-based vac-cines

Phylogica will use its Phylomer drug discovery platform, and will receive $500,000 up front and is eligible to receive a commercial license payment, plus milestone payments of up to $134M, as well as royalties (12/21)

Proximagen Ltd. (UK; LSE:PRX)


Exclusive agreement to acquire the global rights to two drug development programs that tar-get diseases of the central ner-vous system


Serodus A/S* (Norway)

Roche AG (Switzerland) License deal for a selective sero-tonin-4 antagonist for potential treatment of heart failure

Roche will receive an undisclosed up-front payment and will be enti-tled to development, regulatory and commercial milestones, plus royalties (12/13)

Sirnaomics Inc.* Undisclosed Chinese pharmaceutical compa-ny

Partnership for development of its small interfering RNA thera-peutic STP705 for scarless wound healing

The partnership specifically cov-ers the regulatory development and sale of STP705 in the greater China market (12/3)






Sloning BioTechnology GmbH (subisidary of MorphoSys AG; Germany; BE:MOR)

Pfizer Inc. Nonexclusive license and tech-nology transfer deal covering the installation, training and use of Sloning’s Slonomics platform for fabrication of highly diverse gene and protein libraries and Pfizer’s subsidiary, Rinat NeuroScience Corp.

Terms call for Sloning to receive an up-front payment this year, with annual license fees due over the patent lifetime (12/13)


Bayer Innovations Exclusive, irrevocable, worldwide sublicensable and royalty-free license to the technology devel-oped through a collaboration between the two

The license includes a carve-out by BIG for use of the technology in its non-Hodgkin lymphoma vac-cine, which is currently under development (12/8)

Tesaro Inc.* OPKO Health Inc. Deal to acquire rights to nausea drug rolapitant and one other drug from OPKO

Terms entail $121M in up-front and milestone payments, plus double-digit, tiered royalties and a 10% equity position (12/15)

Vernalis plc (UK; LSE:VER)

H. Lundbeck A/S (Denmark)

Partnership to use vernalis’ frag-ment- and structure-based plat-form against LRRK2

Vernalis will receive undisclosed fees and a potential share in the downstream success of the prod-uct in the form of milestones and royalties (12/17)

Zenobia Therapeutics Inc.*

H. Lundbeck A/S (Denmark)

Research collaboration to use Zenobia’s expertise in protein expression and X-ray crystallog-raphy for the Parkinson’s disease target LRRK2

Zenobia will complete X-ray crys-tal structures of wild-type and the Parkinson’s-associated mutant, G20195, in complex with Lundbeck compounds (12/17)

Notes:

* Private companies are indicated with an asterisk.


Unless otherwise noted, stock symbols listed are on the Nasdaq market.

AMEX = American Stock Exchange; ASX = Australian Stock Exchange; BE = Berlin Stock Exchange; BR = Brussels Stock Exchange; CDNX = Canadian Venture Stock Exchange; CSE = Copenhagen Stock Exchange; FSE = Frankfurt Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; PK = Pink Sheets; SSE = Stockholm Stock Exchange; SWX = Swiss Stock Exchange; TASE = Tel Aviv Stock Exchange; TSX = Toronto Stock Exchange.

Modified Deals Between Biotechs and Pharmas in 2010Company* (Country; Symbol)



JANUARY BioMimeticTherapeuticsInc. (BMTI)

NovartisVaccines andDiagnostics Inc.(Switzerland)

Amended manufacturing and supply agreement for the supply of bulk rhPDGF-BB to BioMimetic

The contract was extended by three years with succes-sive three-year evergreen extension periods (1/8)

ChemoCentryxInc.*


Exercised option for an exclusive license for devel-opment and worldwide com-mercialization of Traficet-EN to treat inflammatory bowel diseases, including Crohn’s disease

The option includes two b a c k u p c o m p o u n d s ; ChemoCentryx will receive an option exercise fee of $35M and may be eligible for further regulatory mile-stone payments (1/12)

Gentium SpA(Italy; GENT)

Sigma-TauPharmaceuticalsInc.

Amended license and supply and cost-sharing agree-ments to develop and com-mercialize defibrotide in North America, Central America and South America

Gentium will retain exclu-sive rights to defibrotide in Europe and the rest of the world, while Sigma-Tau will gain a license for the intra-venous formulation of defib-rot ide as a preventive therapy for veno- occlusive disease in the Americas (1/12)

HalozymeTherapeuticsInc. (HALO)

Roche HoldingsAG (Switzerland)

Roche is investing about CHF190M ($182.4M) to manu-facture a patient- friendly device that would allow for self-administration of bio-logics

The companies have been collaborating on a subcuta-n e o u s f o r m u l a t i o n o f Herceptin (1/22)

Hologic Inc.(HOLX)

KV PharmaceuticalInc.

Amended asset purchase agreement allowing KV to secure the full U.S. and worldwide rights to Gestiva to treat preterm birth

Specific terms were not dis-closed (1/12)

MorphoSys AG(Germany;FSE:MOR)

Shionogi & Co.Ltd. (Japan)

Expanded research license t o c o v e r t h e u s e o f MorphoSys’ HuCAL Platinumtechnology in drug discov-ery

Shionogi will have the right to use the technology for research at one of its sites; MorphoSys wil l receive increased annual user fees (1/28)

FEBRUARY Active BiotechAB (Sweden;SSE:ACTI)

Teva Pharma-ceutical IndustriesLtd. (Israel)

Amended marketing and distribution agreement for oral laquinimod

Teva extended its marketing and distribution rights to include the Nordic and Baltic regions, and Active Biotech will receive a higher royalty rate for sales in these terri-tories compared to the roy-alty rate set under the original licensing agreement signed in 2004 for sales in the rest of the world (2/9)



ModifiedDealsBetweenBiotechsandPharmas




BAC BV*(the Netherlands)

GE Healthcare Extended collaboration to alpha-1 antitrypsin from blood plasma, recombinant cell culture or transgenic sources

Financial terms were not dis-closed (2/18)

Benitec Ltd. (Aust-ralia; ASX:BLT) and Tacere Thera-peutics Inc.*

Pfizer Inc. Exercised option to further develop and commercialize Tacere’s hepatitis C virus compounds

The option was granted in a collaboration and license agreement announced in January 2008 (2/8)

Curis Inc.(CRIS) andChugai Pharma-ceutical Co. Ltd.(Japan)

F. Hoffmann-La Roche Ltd.(Switzerland)

Chugai exercised its right of first refusal for the develop-ment and commer-cializa-tion in Japan of GDC-0446, a Hedgehog pathway inhibi-tor, under an agreement with Roche

GDC-0449 is being devel-oped by Roche’s Genentech Inc. subsidiary under the companies’ 2003 collabora-tion; Chugai will lead devel-o p m e n t a n d commercialization efforts in Japan (2/19)

KineMed Inc.* Bristol-MyersSquibb Co.

Expanded collaboration in the area of Alzheimer’s dis-ease and other neurodegen-erative conditions

Further details were not dis-closed (2/9)

Obecure Ltd.*(Israel)

Gunenthal GmbH(Germany)

Extended license and supply agreement for Histalean

O b e c u r e i s s t u d y i n g Histalean for the reduction of side effects associated with antipsychotics (2/17)

TacereTherapeuticsInc.*

Pfizer Inc. Exercised option to further develop and commercialize Tacere’s hepatitis C virus compounds

The option was part of a $145M collaboration and license agreement, and in-volves a lead agent that con-tains three separate RNAi elements, simultaneously targeting three different sites of the virus (2/12)

MARCH Actelion Ltd.(Switzerland;FSE:ACT)

InvidaPharmaceuticalHoldings Pte.Ltd. (Singapore)

Extended partnership for continued Asian commercialization of Tracleer for pulmonary arterial hypertension

The contract runs through 2015 and covers Thailand, M a l a y s i a , P h i l i p p i n e s , Vietnam and Hong Kong (3/29)

BG Medicine Inc.* Abbott Extended development and commercialization deal to include the development of a galectin-3 test for Abbott Point of Care’s i-STAT System

Abbott will be responsible for the development, and both companies will support regulatory filings and stud-ies for acute decompensat-ed heart failure (3/10)






GTX Inc. (GTXI) Ipsen Group SA(France)

Expanded partnership for toremifene

GTx will receive $58M in milestones tied to a second Phase III trial of toremifene 80 mg in reduction of bone fractures associated with prostate cancer androgen deprivation therapy; Ipsen will receive co-promotion rights or a double-digit roy-alty in the U.S. (3/24)


DainipponSumitomoPharma Co. Ltd.(Japan)

Expanded their ongoing small interfering RNA deliv-ery collaboration

The deal was entered into in August 2009 (3/31)

APRIL MethylGeneInc. (Canada;TSX:MYG)

Otsuka Pharma-ceutical Co. Ltd.(Japan)

Extended the companies’ funded research collabora-tion for an additional six months

The collaboration is to develop small-molecule kinase inhibitors for the local delivery and treatment of ocular diseases (4/26)


AstraZeneca plc(UK)

Agreement for a one-year extension of their ongoing small interfering RNA deliv-ery collaboration

The companies are using a number of Silence’s lipid delivery and targeting tech-nologies to develop new delivery approaches for RNA interference therapeutics (4/22)

SwedishOrphanBiovitrum AB*(Sweden)

Merck KGaA(Germany)

Expanded agreement for the distribution of Cyanokit

The distribution territories will include Ireland, the UK and the Netherlands in addi-tion to the existing territo-ries of the Nordic and Baltic countries (4/2)

Warner Chilcottplc (Ireland; WCRX)

Sanofi-AventisSA (France)

Amended Actonel global col-laboration with respect to the U.S. and Puerto Rico

Warner Chilcott will take full operational control over the promotion, marketing and R&D decisions for Actonel in the U.S. and Puerto Rico, and will assume responsibility for all associated costs (4/6)

MAY Ablynx NV(Belgium;BR:ABLX)

Pfizer Inc. Research collaboration that forms part of its license agreement for Nanobodies to tumor necrosis factor alpha was extended for another year

The original deal was signed in November 2006 and had a potential value of $212.5M plus royalties (5/21)

AriadPharmaceuticals(ARIA)

Merck & Co.Inc.

Restructured deal for Merck to shoulder all of the devel-opment costs of Ariad’s pipeline cancer drug ridafo-rolimus going forward and acquire rights to the drug

Merck will provide retroac-tive funds to cover $19M in costs so far, and Ariad will get a $50M cash infusion up front (5/6)







Merck KGaA(Germany)

Renewed license and supply agreement for Crinone (pro-gesterone gel) for an addi-tional five-year term

Merck Serono has marketing rights worldwide, except the U.S. (5/19)



Broadened chronic obstruc-tive pulmonary disease col-laboration

The amplified deal could garner Galapagos an addi-tional $190.4M on top of the original $580M value (5/12)

Targacept Inc.(TRGT)

AstraZeneca plc(UK)

Expanded 2005 collabora-tion to develop TC-561 , add-i n g a t t e n t i o n d e f i c i t /hyperactivity disorder and Alzheimer’s disease to the deal

The original deal was for cognitive dysfunction in schizophrenia; AstraZeneca will make an $11M payment to Targacept and maintain its option to license TC-5619 (5/4)

JUNE PainTherapeuticsInc. (PTIE)

King PharmaceuticalsInc.

Strategic alliance for ex-U.S. Remoxy has been modified

They modified a royalty term because the pain mar-ket in Europe is smaller than the U.S.; Pain will receive a flat royalty rate of 10% on net sales of Remoxy outside the U.S., plus a one-time pay-ment of $5M from King in July (6/29)

Prosensa BV*(the Netherlands)


Initiated two further pro-grams under their alliance covering RNA-based treat-ments for Duchenne’s mus-cular dystrophy

GSK made two initial pay-ments to Prosensa, which is now eligible for further pre-option milestone payments based on research progress (6/24)

JULY Anacor Pharmaceuticals Inc.*

GlaxoSmithKline plc (UK) Exercised option to obtain an exclusive l icense to GSK2251052, a systemic antibiotic derived from Anacor's boron chemistry platform

The option triggers a $15M exercise fee under the com-panies' 2007 collaboration, and Anacor is eligible for further development and commercialization mile-stone payments plus royal-ties (7/30)

Genmab A/S (Denmark; CSE:GEN)

GlaxoSmithKline plc (UK) Amended licensing agree-ment for rights to ofatu-mumab

Genmab will get $136.7M up front in exchange for fore-going development mile-stones and the first two sales milestones in autoim-mune indications; it remains eligible for a double-digit royalty; in oncology funding is capped at £145M total (7/2)






Elusys TherapeuticsInc.*

Lonza AG (Switzerland) Extended agreement for scale-up and commercial production of Anthim, a monoclonal antibody for inhaled anthrax

Elusys landed a $143M gov-ernment contract for the program late last year (7/16)

Genzyme Corp.(GENZ)

Hospira Worldwide Inc. Expanded manufacturing agreement to provide fill and finish manufacturing servic-es for Cerezyme, Fabrazyme, M y o z y m e , L u m i z y m e , Thryogen, Thymoglobulin, Campath and certain other Genzyme product candidates

The agreement is set to expire June 30, 2015, or at the end of the last agreed-on order (7/9)

MethylGene Inc. (Canada;TSX:MYG)

Otsuka PharmaceuticalCo. Ltd. (Japan)

Extended a research collabo-ration to develop small-mol-ecule kinase inhibitors for the local delivery and treat-ment of ocular diseases, excluding cancer, to the end of June 2011

The new extension provides for an additional $1 .27M in research funding; the deal also includes up to $50.5M in milestone payments, plus royalties (7/1)

Regeneron Pharmaceuticals Inc. (REGN)

Astellas Pharma Inc. (Japan) Expanded its nonexclusive deal through 2023 for its VelocImmune mouse anti-body platform

The deal includes $165M up front (7/29)

Silence Therapeuticsplc (UK; LSE:SLN)

AstraZeneca plc (UK) Extended research and development collaboration for the identification and optimization of five novel siRNA therapeutic molecules addressing respiratory and oncology indications

The collaboration is extend-ed for a year (7/15)

SEPTEMBER Cytori Therapeutics Inc. (CYTX)

GE Healthcare (UK) Renegotiated an existing agreement to extend the term through the end of 2011 , and to assign shared rights to certain products

GE Healthcare and Cytori will share sales rights for C e l u t i o n S y s t e m a n d StemSource products with different terms for cosmetic surgery and research mar-kets in Europe and the U.S. (9/17)

Hana Biosciences Inc. (OTC BB:HNABD)

Tekmira Pharmaceuticals Corp. (Canada)

Amended license agreement for three chemotherapy can-didates

Hana agreed to make a $5.75M payment to Tekmira in consideration for reduc-ing certain future payments (9/22)

Icagen Inc. (ICGND) Pfizer Inc. Expanded worldwide collab-oration to discover, develop and commercialize com-pounds that modify specific sodium ion channels as new treatments for pain and related disorders

The deal has been extended through December 2011 , and Pfizer is providing $5M in committed funding, with Icagen eligible to receive about $359M in milestone payments, plus tiered royal-ties (9/24)






NicOx SA (France; Paris:COX)

Merck & Co. Inc. Agreement to expand the scope of their 2006 world-wide partnership, which fol-lows the discovery of a new approach to nitric oxide donation during the course of the joint research pro-gram

The approach may be used to develop new classes of NO-donating new molecular entities designed to offer a different mechanism for controlling the delivery of NO while retaining the potential therapeutic bene-fits (9/16)

Progenics Pharmaceuticals Inc. (PGNX)

Wyeth Extended agreement to con-tinue Wyeth’s commercial-i z a t i o n o f R e l i s t o r subcutaneous injection in the U.S. through at least Dec. 31

The agreement was termi-nated in October 2009, but is being extended to allow Progenics to conclude dis-cussions with companies interested in partnering (9/28)

OCTOBER Ablynx NV (Belgium; BR:ABLX)

Merck Serono SA (Switzerland)

Expanded relationship for a second agreement to co-dis-cover and co-develop nanobod-ies against an inflammatory disease target

The first agreement was for two targets in oncology and immunology; Ablynx will receive $13.8M up front and be responsible for all costs, excluding manufacturing, up to the delivery of a pre-clinical package, which could result in $20.8M in milestone payments; Ablynx can continue with Merck on a 50-50 basis and share the resulting profits, or make it a licensing deal with mile-stone payments and royal-ties (10/12)

ArQule Inc. (ARQL) Daiichi Sankyo Co. Ltd. (Japan)

Expanded research, devel-opment and license agree-ment for the discovery of novel kinase inhibitors in the field of oncology

The expanded agreement establishes a third therapeu-tic target, with an option for a fourth, in the field of oncology, and it includes a two-year extension based on the application of the ArQule Kinase Inhibitor Platform technology (10/13)

BioFocus (division of Galapagos NV; Belgium; BR:GLPG)

Chiesi Farmaceutici SpA (Italy)

Expanded collaboration to provide medicinal chemistry and biology services for an undisclosed Chiesi thera-peutic program

The total value for the 2009 col laborat ion has now reached $3.5M (10/15)


Purdue Pharmaceutical Products LP and Mundipharma International Corp. Ltd. (UK)

Exercised option for Purdue and Mundipharma to assume worldwide development and commercialization activities for Infinity’s fatty acid amide hydrolase program under the 2008 agreement







Paion AG (Germany; FSE:PA8)

H. Lundbeck A/S (Denmark) Expanded desmoteplase license agreement

L u n d b e c k i s g r a n t e d research rights and poten-tial desmoteplase follow-on compounds; Paion receives $2. 1M and is eligible for up to $34.6M in milestones, plus royalties; the new deal also raises the milestones for desmoteplase to up to $94. 1M (10/19)

TaiGen Biotechnology Co. Ltd.* (Taiwan)

Warner Chilcott plc (Ireland) Amended license agreement for the development and c o m m e r c i a l i z a t i o n o f nemonoxacin

The companies will cross-license respective patent rights relating to nemonoxa-cin; TaiGen received an up-front payment and is eligible for milestone payments, as well as a royalty (10/15)

NOVEMBER Protein Sciences Corp.* UMN Pharma Inc. (Japan) Expanded 2006 agreement

to which it licensed exclu-sive rights to commercialize F l u B l o k a n d Pa n B l o c k , t o g e t h e r w i t h P r o t e i n Sciences’ influenza vaccines for the Japan market

Protein Sciences gets part of an up-front payment and is entitled to milestones and double-digit royalties on sales (11/11)

DECEMBER BioInvent International AB (Sweden; SSE:BINV)

Undisclosed Japanese phar-maceutical group

Extended collaboration to take a lead candidate into preclinical development in the area of inflammation

BioInvent will do stable cell line and process develop-ment and clinical manufac-turing of the candidate, while the partner will fund a l l d e v e l o p m e n t w o r k (12/22)

Dicerna Therapeutics Inc.*

Kyowa Hakko Kirin Co. Ltd. (Japan)

Expanded research collabo-ration into the new thera-peutic area of immunologic and inflammatory diseases

Dicerna will receive a cash payment for exercise by Kyowa Hakko Kirin of an option to bring an additional target into the collaboration (12/8)

Hemispherx Biopharma Inc. (AMEX:HEB)

GP Pharm SA (Spain) Amended its June 2010 sales, marketing, distribution and supply agreement to imme-diately include Mexico

GP Pharm will be responsi-ble for gaining regulatory approval and commercializ-ing Ampligen to treat chron-ic fatigue syndrome (12/10)


Mundipharma International Corp. Ltd. (unit of Purdue Pharmaceutical Products LP)

Expanded deal to develop and commercialize IPI-926, plus candidates arising from its P13K and discovery programs

The deal means an addition-al $110M in 2012 for Infinity, on top of $65M banked this year and the $85M anticipat-ed in 2011 (12/14)






Prometheus Laboratories Inc.*

AstraZeneca LP (UK) Extended distribution agree-ment for the exclusive mar-keting, sales and distribution of Entocort EC capsules in the U.S. until Dec. 31 , 2011

Entocort EC is the only FDA-approved drug for the induction and maintenance of clinical remission in mild to moderate Crohn’s disease involving the ileum and/or the ascending colon (12/2)

Protein Sciences Corp.* UMN Pharma Inc. (Japan) Expanded 2006 agreement to which it licensed exclu-sive rights to commercialize F l u B l o k a n d Pa n B l o c k , t o g e t h e r w i t h P r o t e i n Sciences’ influenz vaccines for the Japan market

Protein Sciences gets part of an up-front payment and is entitled to milestones and double-digit royalties on sales (11/11)

Unigene Laboratories Inc. (OTC BB:UGNE)

GlaxoSmithKline plc (UK) Amended and restated exclusive, worldwide deal to develop and commercialize an oral formulation of a recombinantly produced parathyroid hormone ana-logue for osteoporosis in postmenopausal women

Unigene will conduct the Phase II trial and will be eli-gible to up to $142M in mile-stone payments (12/14)

Notes:





Terminated Deals Between Biotechs and Pharmas in 2010Company* (Country; Symbol)



JANUARY AnacorPharmaceuticals*

Merck & Co. Inc. Merck returned the full worldwide development andcommercialization rights forAN2690, a topical antifungaltherapy

Anacor entered the agree-ment in 2007 with Schering Corp., now a subsidiary of Merck (2/16)

ArenaPharmaceuticalsInc. (ARNA)

Merck & Co. Inc. Terminated deal for MK-1903to treat atherosclerosis

Merck’s decision came after evaluating the results of a Phase IIa trial in patients with dyslipidemia (12/24)

BasileaPharmaceuticaAG (Switzerland;SWX:BSLN)

Johnson & Johnson Terminated deal for global rights to Zevtera, the cepha-losporin antibiotic ceftobip-r o l e , w h i c h i s i n development for complicat-ed skin and soft tissue infec-tions

Basilea launched arbitration proceedings against J&J, seeking to recover mile-stone payments plus an unspecified amount of dam-ages because of delays in the approval process (2/22)

MARCHGTx Inc.(GTXI)

Merck and Co. Inc. Discontinued agreement to develop the Phase II muscle loss drug Ostarine/MK-2866

Details were not disclosed (3/5)

Vectura Groupplc (UK; LSE:VEC)

Novartis AG’sSandoz unit(Switzerland)

Terminated agreement for U.S. control of the asthma drug candidate, VR315

Sandoz will continue to be responsible for the product in Europe (3/19)

APRILBiota HoldingsLtd. (Australia;BE:BZK)


Concluded the 2006 collab-oration and license agree-ment for the development of nucleoside drugs for the treatment of hepatitis C infections

Boehringer Ingelheim cited lack of progress on identify-ing a suitable preclinical candidate as the key reason for the decision (4/21)

Biotie TherapiesOyj (Finland;BE:F8S)

Roche Holding AG(Switzerland)

Terminated agreement after Roche decided not to exer-cise an option on BTT-1023 for rheumatoid arthritis

Roche has had two major setbacks in rheumatoid arthritis, contributing to its decision (4/28)

Numerate Inc.* PresidioPharmaceuticalsInc.

Concluded their two-year collaboration to discover compounds targeting hepa-titis C virus

Presidio said it has opted not to pursue further devel-opment of the compounds “for internal reasons” (4/26)

Phenomix Corp.*

ForestLaboratories Inc.

Terminated development and commercialization dealfor the DPP-4 inhibitor PHX1149 (dutogliptin) for Type II diabetes

Analysts said the commer-cial opportunity did not jus-t i f y t h e s i z e a b l e investments, calling it a “me too” drug (4/21)


TerminatedDealsBetweenBiotechsandPharmas





JUNE CaprotecBioanalyticsGmbH* (Germany)


Completed a research col-laboration using Caprotec’scapture compound mass spectrometry technology to analyze the binding charac-teristics and interaction of one undisclosed drug candi-date with its human target proteins


Exelixis Inc.(EXEL)


Terminated deal to develop XL184, a small- molecule MET inhibitor

Exelixis regained full rights after the firms could not agree on the scope, breadth and pace of the ongoing clinical development; BMS is paying $17M in connection with the return (6/22)

JULYGTC Biotherapeutics Inc.(OTC BB:GTCB)

Lundbeck AS (Denmark) GTC regained U.S. commer-cialization rights to ATryn from Lundbeck

Lundbeck will earn a royalty on net sales beginning in two years, with a predefinedcumulative maximum (7/19)

AUGUSTCypress Bioscience Inc. (CYPB)

Forest Laboratories Inc. Cypress is discontinuing its rights under an agreement with Forest to copromote Savella for fibromyalgia

Forest has agreed to pay Cypress a one-time payment of $2M to help facilitate the transition (8/5)

SkyePharma plc (UK; SKYE; LSE:SKP)

Abbott Respiratory LLC Terminated U.S. rights agree-ment to Flutiform for asth-ma

The FDA said in January that further clinical trials were n e e d e d f o r r e g u l a t o r y approval (8/23)

SEPTEMBERAlnylam Pharmaceuticals Inc. (ALNY)

Novartis AG (Switzerland) Novartis declined a $100M option to extend its partner-ship with Alnylam for the development of new RNAi therapeutics

The deal was valued at $700M when it began in 2005 (9/27)

Celldex Therapeutics Inc. (CLDX)

Pfizer Inc. Terminated agreement for rights to brain cancer vac-cine CDX-110

The original deal, signed in 2008, included $40M up front and $10M in equity investments; Pfizer dropped the product due to a reprior-itization of its pipeline (9/7)

OCTOBER AVEO Pharmaceuticals Inc. (AVEO)

Merck & Co. Inc. Terminated agreement that gives back to AVEO world-wide development and com-mercialization rights to Phase II anticancer candi-date AV-299

Merck decided to repriori-tize its portfolio (10/1)

TerminatedDealsBetweenBiotechsandPharmas





Cortex Pharmaceuticals Inc. (OTC BB:CORX)

Merck & Co. Inc. Cortex regained worldwide rights to develop and com-mercialize its ampakine compounds for schizophre-nia and depression

NV Organon discontinued development of Ampakine due to its acquisition by Merck and a subsequent reorganization (10/4)

CyDex Pharmaceuticals Inc.*

Prism Pharmaceuticals Inc. Companies mutually decid-ed to terminate their joint development agreement for novel Captisol -enabled intravenous formulations of clopidogrel

CyDex gains full develop-ment and commercialization rights to the product candi-date (10/13)

Human Genome Sciences Inc. (HGSI)

Novartis AG (Switzerland) Terminated agreement to develop Zalbin in Hepatitis C virus

The decision came after the FDA issued a complete response letter (10/6)

NOVEMBER Arena Pharmaceuticals Inc. (ARNA)

Ortho-McNeil-Janssen Pharmaceutical Inc.

Terminated collaboration for APD597 to treat Type II diabetes

Arena regains all rights (11/8)

Kuros Biosurgery AG* (Switzerland)

Baxter International Inc. Terminated deal for a num-ber of selected wound care and trauma clinical candidates

Kuros regained rights to KUR-212, KUR-213 and KUR-112 (11/9)

DECEMBER Adolor Corp. (ADLR) Pfizer Inc. Terminated a 2007 collabo-

ration to develop Adolor’s delta opioid receptor ago-nists, ADL5859 and ADL5747

The deal was originally val-ued at up to $265M, but Phase II results did not deliv-er proof of efficacy and mul-tiple indications; Adolor is discontinuing the program (12/23)

Notes:





Manufacturing/Supply/Distribution Deals Between Biotechs and Pharmas in 2010




JANUARY Anteis SA*(Switzerland)

Sanofi-Aventis(France)

Supply and distribution part-nership for Succeev, a hyal-uronic acid-based dermal filler

Succeev includes three for-mulations for correcting rin-kles and lip augmentation (1/6)

BioTheranostics* Ferrer inCode(Spain)

Three-year, exclusive agree-ment to commercialize bio-T h e r a n o s t i c s ’ T h e r o s CancerType ID molecular cancer classifier in Spain, P o r t u g a l , G r e e c e a n d Venezuela

No financial terms were dis-closed (1/12)

Genzyme Corp.(GENZ)

HospiraWorldwide Inc.

Material definitive agreement to perform fill and fin-ish manufacturing services for Genzyme’s Cerezyme, Fabrazyme, Myozyme and Thyrogen


OraSureTechnologiesInc. (OSUR)

Roche Diagnostics(Switzerland; unitof Roche AG)

Agreement for the worldwide commercialization of homogeneous fully automated oral fluid drugs of abuse assays with OraSure’sIntercept oral specimen col-lection device

The oral fluid assays use Roche’s kinetic interaction of microparticles in solutiontechnology and are being jointly developed under an a g r e e m e n t p r e v i o u s l y signed by the parties (1/21)

PrometheusLaboratoriesInc.*


Agreement for Prometheus to acquire exclusive rights from Novartis to distribute, promote and sell Proleukin in the U.S. to treat metastatic melanoma and metastatic kidney cancer

Novartis received an undis-closed up-front fee and will receive royalties on net U.S. sales of Proleukin; Novartis also is eligible to receive potential sales milestone payments (1/27)

FEBRUARYOrexo AB(Sweden; SSE:ORX) andKyowa HakkoKirin Co. Ltd.(Japan)

HisamitsuPharmaceutical Co.Ltd. (Japan)

Joint distribution agreementfor the cancer pain drug KW-2246

Kyowa is responsible for the approval process in Japan, and KW-2246 will be jointly distributed by the two Japanese companies once the manufacturing and sales approval is obtained (2/3)

MARCH Acrux Ltd.(Australia;ASX:ACR)

Eli Lilly and Co. Licensing deal for Axiron, a treatment for hypogonad-ism

Acrux is receiving a $50M up-front payment and could receive a further $87M upon FDA approval (3/17)

AxiogenesisAG (Switzerland;BE:AI8)

Lonza CologneAG (Germany)

Worldwide, exclusive distri-bution deal that includes Axiogenesis’ product and service portfolio

It includes the CorAt mouse embryonic stem cell-derived cardiomyocytes (3/4)



Manufacturing/Supply/DistributionDealsBetweenBiotechsandPharmas




Solasia PharmaKK* (Japan)


License and supply agree-ment that provides Kyowa Hakko Kirin Co. with an exclusive right to market and sell SP-01 extended-release transdermal granise-tron patch sold under the trade name Sancuso in T a i w a n , H o n g K o n g , Singapore and Malaysia

Solasia will receive up-front, regulatory and sales mile-stones (3/4)


SpearPharmaceuticalsInc.

Agreement for rights to commercialize Refissa, a prescription-based topical tretinoin cream used to diminish fine wrinkles and fade irregular pigmentation due to sun damage

Valeant will pay Spear $12M up front, and the two com-panies will share net profits (3/2)

APRIL AveciaBiotechnologyInc.*

Pfizer Inc. Agreement for commercial supply of a component of wet age-related macular degeneration drug Macugen



Therabel Group(France)

A g r e e m e n t g r a n t i n g Therabel the European com-mercialization rights of Loramyc and Setofilm

The deal is worth |48.5 ($68.9M), including |6.5M up front (4/7)

Cangene Corp.(Canada; TSX:CNJ)

BaxterHealthcare Corp.

Agreement under which Cangene assumes the com-mercialization rights to WinRho SDF in the U.S.

The companies terminated a distribution agreement, and Cangene will begin distri- buting the product June 1 (4/22)

InternationalStem Cell Corp.(OTC BB:ISCO)

Veritas Corp.(Japan)

Distribution agreement to distribute its human cell cul-ture products throughout Japan

Further terms were not dis-closed (4/1)

Ipsen SA(France; Paris:IPN)

Invida Group(Singapore)

Distribution and promotion-al agreement for Diphereline2.75 mg and 11 .25 mg, Somatuline Autogel and Increlex in selected coun-tries in SouthEast Asia

The agreement is for five years with an option to renew for five years (4/28)

Labopharm Inc.(Canada; DDSS)

Gruppo AngeliniSpA (Italy)

Agreement to establish a 50-50 joint venture in the U.S. to commercialize Olepto

Labopharm will receive up to $92M, with $52M paid upon completion of the transaction and $40M paid on the drug achieving cer-tain sales milestones (4/30)






LabopharmInc. (Canada;DDSS)

Nippon ShinyakuCo. Ltd. (Japan)

Licensing and distribution agreement for once-daily tramadol

Labopharm will receive an undisclosed up- front pay-ment on signature and is eli-gible to receive additional payments related to the achievement of certain regu-latory and commercializa-tion milestones in exchangefor its once-daily tramadol product in Japan (4/9)

MediGeneAG (Germany;FSE:MDG)

MeditrinaPharmaceuticals

License and supply agree-ment for the supply and c o m m e r c i a l i z a t i o n o f Veregen in Greece and Cyprus

Meditrina will promote and distribute Veregen to treat genital warts, and MediGene will be entitled to payments totaling $1 .2M; MediGene will supply the finished product and will receive double-digit royalties on net sales (4/2)

Medinox Inc.* Orient EuropharmaCo. Ltd. (Taiwan)

Deal for Asian rights to the Phase I antihypotensive drug, NOX-100

Terms were not disclosed, but Orient Europharma picked up rights in Taiwan, China, Korea, Australia, New Zealand and Southeast Asia (4/13)

NapoPharmaceuticals(LSE:NAPU)

Luye PharmaGroup Ltd.

Finder’s agreement for cro-felemer

They will seek to combat dehydration due to diarrhea by joining with pharmaceu-tical companies that have a presence in China and expertise in the manufac-ture and commercialization of gastrointestinal products (4/27)

Nycomed A/S*(Denmark)

Merck & Co. Inc. Agreement to copromote the chronic obstructive pul-monary disease drug Daxas in Canada and certain European countries

Nycomed received an up-front fee and is eligible for milestone payments (4/27)

ProteomeSciences plc(UK; LSE:PRM)

Sigma-AldrichCorp.

Nonexclusive license deal for Sigma-Aldrich to contin-ue selling products under P r o t e o m e ’ s t r a d e m a r k ProteoPrep in Europe, Japan and Australia

The license gives Proteome an undisclosed signature fee and royalties on ProteoPrep sales in those territories (4/12)

Swedish OrphanBiovitrum*

Pharming GroupNV (the Netherlands)

Exclusive 10-year agreementto distribute Rhucin, a recombinant human C1 inhibitor for the acute treat-ment of hereditary angio-edema attacks, in 24 EU countries, Norway, Iceland and Switzerland

Swedish Orphan will pay Pharming an undisclosed up-front payment, a regula-tory approval milestone and a s u p p l y p r i c e , w h i c h includes t iered perfor-mance-based royalties (4/16)






XanodynePharmaceuticalsInc.*

FerringPharmaceuticalsInc.

Co-promotion deal for Zipsor liquid-filled capsules

Ferring’s orthopedic sales force will promote Zipsor to certain physicians in the U.S., and Ferring will receive a royalty on Zipsor sales gen-erated by a predefined tar-get prescriber base (4/5)

MAY KemPharm Inc.* Johnson Matthey

Inc.Exclusive supply agreement to manufacture the active pharmaceutical ingredient for KP201 , a hydrocodone prodrug for acute pain

KemPharm will be responsi-ble for drug product, pre-clinical and clinical studies, and regulatory filings, while Johnson Matthey is respon-sible for manufacturing (5/19)

MediGene AG(Germany;FSE:MDG)

GC-RisePharmaceuticalCo. Ltd. (China) andJS Bio Pharm Co. Ltd. (South Korea)

License and supply agree-ments for the commercial-ization and marketing of Veregen ointment

The first deal involves GC-Rise, which will conduct a clinical trial in genital warts in China and handle all regulatory procedures, in return for a one-time pay-ment, plus further mile-stones to MediGene; the other deal involves JS Bio handling regulatory proce-dures and the promotion and distribution of Veregen in the South Korean market; MediGene will receive royal-ties and a milestone pay-ments (5/11)

MillenniumPharmaceuticalsInc.* (unit ofTakedaPharmaceuticalCo. Ltd.; Japan)

Janssen PharmaceuticalKK (Japan)

Co-promotion deal for multi-ple myeloma drug Velcade

Takeda gains a percentage of sales as a co-promotion fee (5/11)

NovalarPharmaceuticalsInc.*

H.A. SystemsDental ImportsLtd. (Israel)

Agreement to distribute OraVerse in Israel and Palestinian territories


PromosomeLLC*

Recopharma AB(Sweden)

Licensing agreement for its Tr a n s l a t i o n E n h a n c i n g E l e m e n t s a n d Re-Engineering of the mRNA Primary Structure technolo-gies


StellarPharmaceuticalsInc. (Canada;OTC BB:SLXCF)

Medac GmbH(Germany)

License agreement for the distribution and sale of Uracyst, a treatment of interstitial cystitis-painful b l a d d e r s y n d r o m e , i n Germany and Austria

Medac will pay Stellar an undisclosed up-front fee, in addition to a specified trans-fer price (5/7)






JUNE Almirall SA(Spain; LSE:OKWR)

BasileaPharmaceuticaAG (Switzerland)

Distribution agreement for Toctino, a once-daily oral treatment for severe chronichand eczema unresponsive to topical corticocosteroids, in selected European mar-kets and Mexico

Basilea will be eligible for up-front and milestone pay-ments totaling $33.3M (6/16)

Biovail Corp.(Canada; NYSE:BVF)


License deal to acquire U.S. and Canadian rights to com-mercialize products contain-ing istradefylline to treat Parkinson’s disease

BLS paid an up-front fee of $10M and could pay up to $20M in development mile-stones through FDA approv-al and up to an additional $35M in sales-based mile-stones; BLS also will make tiered royalty payments of up to 30% on net commer-cial sales (6/4)

SirionTherapeuticsInc.*

Bausch + Lomb Agreement acquiring U.S. rights to Zirgan, which was approved in 2009 as a topi-cal antiviral against acute hepatic keratitis


TalecrisBiotherapeuticsHoldings Corp.(TLCR)


Co-promotion deal to jointly m a r k e t a n d s e l l t h e i r respective post-exposure rabies products


JULYAlgeta ASA (Norway;OSLO:ALGETA)

Bayer Schering Pharma AG (Germany) and Oslo’s Institute for EnergyTechnology (IFE)

Two agreements for the manufacture and supply for future commercial sale of Alpharadin to treat bone metastases

Under the agreement with Bayer, Algeta will be the e x c l u s i v e s u p p l i e r o f Alpharadin; the deal with IFE entails Algeta paying for a new manufacturing facility to supply the commercial demand (7/23)

Arena PharmaceuticalsInc. (ARNA)

Eisai Inc. Marketing deal for obesity drug lorcaserin

Eisai is giving Arena $50M right away and another $90M upon approval of lor-caserin and delivery of com-mercial supply; Eisai will buy it for a price that starts at 31 .5% of Eisai’s annual net product sales; the price will rise to as high as 36.5% on the portion of annual net sales that go beyond $750M (7/2)

Human Genome Sciences Inc. (HGSI)

Lonza AG (Switzerland) Deal for commercial manu-facturing of lupus drug Benlysta (belimumab)

The drug is partnered for marketing and commercial-ization with GlaxoSmith-Kline plc (7/14)






Laboratory Corp. of America Holdings (NYSE:LH)

Merck & Co. Inc. Nonexclusive license agree-ment for the commercializa-tion of a genetic test to predict the response of patients with hepatitis C virus infection to peginter-feron alpha-based therapy


MediGene AG (Germany;PK:MDGEF)

Astellas Pharma Inc. (Japan) Deal to sell the full European marketing and distribution rights to Eligard to treat hor-mone-dependent prostate cancer

MediGene sold the rights for $32.6M in cash and undis-closed royalties to Astellas Pharma Europe Ltd. , of London (7/20)


Daewoong Pharmaceutical Co. Ltd. (South Korea)

D i s t r i b u t i o n d e a l f o r Xerclear in South Korea

Daewoong will be responsi-ble for gaining regulatory approvals, and Medivir will receive up-front and mile-stone payments, plus royal-ties (8/25)

Oramed PharmaceuticalsInc. (OTC BB:ORMP)


Agreement under which Sanofi will supply specified quantities of recombinant human insulin to be used by Oramed for its U.S. clinical trials


Raptor PharmaceuticalCorp. (RPTP)

Uni Pharma Co. Ltd. (Taiwan) Exclusive agreement to commercialize Convivia in Taiwan


Uluru Inc. (AMEX:ULU) Jiangxi Aiqilin Pharmaceuticals Group

Deal for the marketing of Altrazeal in China

Uluru will get up-front and milestone payments as well as royalties (7/1)

United TherapeuticsCorp. (UTHR)

Lee’s PharmaceuticalHoldings Ltd. (Hong Kong)

Exclusive agreement for the distribution of Remodulin injection in China

Lee’s will be responsible for obtaining all necessary authorizations to market Remodulin in China; upon receipt of marketing authori-zation and pricing approval, L e e ’ s w i l l p u r c h a s e Remodulin from United (7/6)

AUGUSTGenVec Inc. (GNVC) Novartis AG (Switzerland) Supply agreement to manu-

facture clinical trial material for up to two candidates

GenVec could receive about $13M over four years (8/9)

Kamada Ltd. (Israel; TASE:KMDA)

Baxter International Inc. Partnership to distribute and m a n u f a c t u r e Ka m a d a ' s alpha-1 antitrypsin protein therapeutic, Glassia, for alpha-1 antitrypsin deficiency

Baxter will provide an up-front payment of $20M with milestone payments that could total as much as $110M in the f irst f ive years ; Kamada also will receive royalty payments (8/25)

Noven Pharmaceuticals Inc. (FSE:NV5; subsidiary of Hisamitsu Pharmaceutical Co. Inc.)

Shire plc (UK) Agreement for Noven to acquire global rights to Daytrana

The product is approved for attention deficit hyperactivity disorder and was originally developed by Noven (8/12)






Somaxon Pharmaceuticals Inc. (SOMX)

Proctor & Gamble Co. Deal for Proctor & Gamble to copromote the S i lenor insomnia drug in the U.S.

Each party will pay for its own sales force; P&G will be paid a fixed fee and a per-centage of net sales in the form of a fixed royalty that do not exceed 15% of total revenue generated in the U.S. (8/30)

SEPTEMBER Access Pharmaceuticals Inc. (OTC BB:ACCP)

RHEI Pharmaceuticals Inc. and Jian An Pharmaceuticals Ltd. (China)

S u p p l y a g r e e m e n t f o r MuGard

Access signed a $30M sup-ply deal for MuGard, a ready-to-use mucoadhesive oral wound rinse and coating for the management of oral mucositis; the deal includes a sublicense between RHEI and Jian to leverage Jian An’s sales, marketing and regula-tory infrastructure for the launch of MuGard in China and Taiwan (9/22)

Dendreon Corp. (DNDN) GlaxoSmithKline plc (UK) Development and supply agreement covering the commercial production and supply of the antigen used in the manufacture of pros-t a t e c a n c e r v a c c i n e Provenge

The deal includes an initial order by Dendreon for about $8.3M of antigen, for deliv-ery in August 2011 (9/22)

Elite Pharmaceuticals Inc. (OTC BB:ELTP)

Mikah Pharma LLC D e a l t o a c q u i r e t h e approved abbreviated new drug application for naltrex-one hydrocholoride 50-mg tablets

Elite is entitled to sell the drug in the U.S. and its terri-tories, including Puerto Rico, and has licensed the right to sell the drug in the remain-der of the world to Mikah (9/2)

Generex Biotechnology Corp. (GNBT)

Merck KGaA (Germany) Long-term marketing and distribution agreement for Glucose RapidSpray in Mexico

Merck will market the prod-uct as Diabion GlucoShot (9/8)

Genzyme Corp. (GENZ) Teijin Pharma Ltd. (Japan) Deal for Japanese commer-cialization rights to Synvisc for osteoarthritis

Teijin will pay Genzyme cer-tain milestones and a prede-termined supply price for Synvisc (9/21)

Orexigen Therapeutics Inc. (OREX)

Takeda Pharmaceuticals Co. Ltd.

Pa r t n e r s h i p t o m a r k e t Orexigen’s Contrave in North America for obesity

Takeda agreed to pay $50M up front for the right to co-p r o m o t e t h e d r u g , i f approved, plus more than $1B in milestone payments and a tiered double-digit royalty (9/3)






Reata Pharmaceuticals Inc. *

Abbott Laboratories Agreement for ex-U.S. com-mercialization of Reata’s chronic kidney disease drug bardoxolone

Abbott offered $450M in up-front and near-term cash payments; the deal excludes the U.S. and certain Asian territories; Abbott also will gain a minority equity stake in Reata, which is entitled to milestones and royalties as well (9/24)

Stallergenes SA (France; Paris:GENP)

Shionogi and Co. Ltd. (Japan) Partnership to develop and distribute Actair house dust mite tablets and Japanese cedar pollen tablets

Stallergenes will receive a E24M ($34.44M) up-front payment and up to E46M in milestone payments, plus royalties (9/8)

OCTOBER Biocon Ltd. (India; Bombay:BIOCON)

Pfizer Inc. Marketing partnership for rights to biosimilar versions of insulin

The partnership is worth $ 3 5 0 M - p l u s , i n c l u d i n g $200M up front and $150M in milestones; Biocon is respon-sible for development, manu-facture and supply of all products; Pfizer has commer-cialization rights globally, except for Germany, India and Malaysia, where they will have co-exclusive rights (10/19)

Cepheid Inc. (CPHD) Novartis AG (Switzerland) Collaboration to commercial-ize a test for monitoring the Bcr-Abl gene transcript in peripheral blood specimens from patients diagnosed with Philadelphia chromo-s o m e - p o s i t i v e c h r o n i c myelogenous leukemia


Dyax Corp. (DYAX) CMIC Co. Ltd. (Japan) Marketing deal in Japan for its hereditary angioedema drug Kalbitor

Dyax will get $4M up front and $102M in development and sales milestones, plus royalties in the 20% to 24% range (10/1)

Nautilus Neurosciences Inc.*

Mission Pharmacal Co. Exclusive co-promotion agreement for Cambria to obstetricians, gynecologists and other women’s health medical professionals

Cambria is approved for the acute treatment of migraine with or without aura (10/8)

New American Therapeutics Inc.*

Novartis AG (Switzerland) New American acquired all U.S. rights to manufacture, market and sell the antiviral Denavir owned by Novartis

Denavir is a topical antiviral treatment indicated for recurrent herpes labialis in adults and children 12 years of age and older (10/5)






ProMetic Life Sciences Inc. (Canada; TSX:PLI)

Allist Pharmaceuticals Inc. (China)

Agreement to develop and commercialize PBI-1402 and PBI-4419 in China for chemo-therapy-induced and cancer-related anemia indications and for fibrotic diseases

Allist gains exclusive com-mercia l r ights for the Chinese market , whi le ProMetic will retain rights to use the data generated by Allist for markets outside China; the deal includes $10M up front, $59M in mile-stones and royalties on sales in China (10/20)

Transposagen Biopharmaceuticals Inc.*

Charles River Laboratories Exclusive marketing and dis-tribution agreement for two of Transposagen’s high-val-ue TGEM knockout rat mod-els

Financial terms were not dis-closed; one rate line con-tains a mutation in the p53 gene and another contains a mutation in the Bcrp gene (10/14)

NOVEMBER Shield Holdings AG* (Switzerland)

AOP Orphan Pharmaceuticals AG (Austria)

Commercialization deal for STIO-021 in Central Eastern Europe and the Middle East to treat iron deficiency anemia

Shield gets an up-front pay-ment of E1 .25M ($1 .74M) and further milestone-based payments of up to E1 .75M; AOP gets an equity stake in a Shield subsidiary (11/2)

Specialized Therapeutics Australia Pty Ltd.* (Australia)

Helsinn Healthcare SA (Switzerland)

Exclusive license and distri-bution rights for palonose-tron from Helsinn in the regions of Australia and New Zealand

Palonosetron is a 5-HT3 receptor antagonist labeled for prevention of acute nau-sea and vomiting from che-motherapy (11/2)

DECEMBER Hemispherx Biopharma Inc. (AMEX:HEB)

GP Pharma SA (Spain Agremeent for the market-ing of Alferon N injection in Argentina with an option for other Latin American countries

Financial terms were not dis-c l o s e d ; A l f e r o n N i s approved in the U.S. for sex-ually transmitted diseases (12/21)

Theratechnologies Inc. (Canada; TSX:TH)


Commercialization deal for Egrifta in Latin America, Africa and the Middle East

Theratechnologies wi l l receive a significant per-centage of the drug’s selling price in those regions, while Sanofi will be responsible for all regulatory and com-mercial activities for Egrifta for HIV-associated lipodys-trophy; it has the option to commercialize the drug in those territories for other indications (12/7)

Notes:





Biotechnology Company Deals With Other Biotechnology Companies In 2010




JANUARY Can-FiteBioPharma Ltd.(Israel; TASE:CFBI)

MorningsideAsia VentureLtd. (Hong Kong)

Agreement for a joint venture that will hold an exclusive license to intellectual property relating to CF102 in China, Hong Kong, Macau and Taiwan, and will be responsible for developing it in those markets

The Morningside fund will provide all funding, $7.5M, for preclinical and clinical development through Phase II (1/21)

DicernaPharmaceuticalsInc.*

Kyowa HakkoKirin Co. Ltd.(Japan; FSE:KY4)

Partnership to discover, devel-op and commercialize drug delivery systems and siRNA medications using Dicerna’s Dicer Substrate Technology for undisclosed oncology targets

The deal potentially could garner Dicerna more than $1 .4B and includes a $4M up-front cash pay-ment; Dicerna stands to gain up to $120M in research funding and devel-opment and commercial milestones for one oncology target, with the firms having the option to expand the collaboration for up to 10 targets under similar terms (1/5)


BioAtla LLC* Exclusive, worldwide contract research collaboration agree-ment to develop high-through-put recombinant protein screening libraries directed against targets in oncology, aesthetic dermatology and inflammation

Halozyme will receive exclusive worldwide commercial rights from BioAtla to conditionally active bio-logics that arise from the agreement (1/20)

IdahoTechnologyInc.*

AppliedBiosystemsLLC*

Cross-licensing agreement that covers a broad range of prod-ucts including hardware, soft-ware and reagents

The agreement includes patents relating to real-time polymerase chain reaction methods and instru-mentation, including the 5’ Nuclease process and the use of SYBR Green I in PCR reactions (1/28)

Kenta BiotechLtd.* (Switzerland)

RentschlerBiotechnologieGmbH* (Germany)

Agreement for the develop-ment of a fully human mono-c l o n a l a n t i b o d y a g a i n s t m e t h i c i l l i n - r e s i s t a n t Staphylococcus aureus

Rentschler will develop a manufac-turing process for Kenta’s KBSA301 antibody using single-use bioreactor technology (1/15)

MedGenesisTherapeutixInc.* (Canada)

Amgen Inc.(AMGN)

Exclusive worldwide rights deal for a glial cell line-derived neurotrophic factor protein in central nervous systems and non-CNS indications

Amgen now holds a small equity stake in MedGenesis (1/13)

OncoMedPharmaceuticalsInc.*

Fluidigm Corp.* C o l l a b o r a t i o n t o a p p l y Fluidigm’s microfluidic tools to the analysis of tumor cell het-erogeneity, including cancer stem cells

The deal combines Fluidigm’s plat-form with OncoMed’s cancer stem cell sorting technology to generate tools for analyzing, quantifying and developing treatments directed at a highly tumorigenic cell population (1/7)



BiotechnologyCompanyDealsWithOtherBiotechnologyCompanies




Pacgen Bio-pharmaceuticalsCorp. (Canada;CDNX:PGA)

New SummitBiopharma Co.*(China)

Research and development agreements to develop PAC-113 for oral candidiasis in China

New Summit will work with Pacgen to raise funding and develop the antifungal drug for the Chinese mar-ket (1/29)


AbraxisBioScience Inc.(ABII)

Collaboration to develop and commercialize various applica-tions deriving from ProMetic’s prion capture technology plat-form

Abraxis and ProMetic will equally share in the cost for the develop-ment of new applications as well as the financial rewards (1/6)

TrilliumTherapeuticsInc.*

Biogen Idec Inc.(BIIB)

License agreement granting Biogen Idec exclusive world-wide rights to one of its devel-opment programs

Trillium will receive an up-front pay-ment and is eligible for milestone payments, plus royalties (1/13)

VaxInnateCorp.*

Biological E.Ltd.* (India)

L i c e n s i n g a g r e e m e n t t o VaxInnate’s recombinant H1N1 pandemic swine flu vaccine

Companies are collaborating on the manufacture, clinical development and commer-cialization of the vac-cine in India; terms include initial fees, milestone payments and royal-ties (1/13)

WuXi AppTecInc.* (China)


Partnership to provide integrat-ed single solution for molecu-lar biomarker development, validation and personalized health care targets to their respective client bases

Qiagen will provide a complete port-folio of instrumentation, training and consum-ables, while WuXi AppTec will pro-vide laboratory facilities and staff to execute the services (1/12)

FEBRUARY 3SBio Inc.(SSRX)

AscentagePharma GroupLtd. (China,subsidiary ofAscentaTherapeuticsInc.)

Partnership to research, devel-op and commercialize best-in-c l a s s t a r g e t e d c a n c e r therapeutics focusing on pro-grammed cell death

3SBio will make a $3M equity invest-ment in Ascentage Pharma in exchange for the exclusive right to develop and commercialize cancer therapeutics in China discovered from the programs (2/16)


GCATherapeuticsLtd.*

License agreement for elvu-citabine in both hepatitis B virus infection and HIV

GCA gets exclusive rights to the drug through its Chinese joint ven-ture with Tianjin Institute of Pharmaceutical Research, to develop and commercialize the drug in main-land China, Hong Kong and Taiwan; Achillion will be eligible for develop-ment milestones and double-digit royalties (2/2)

AlexzaPharmaceuticalsInc. (ALXA)

BiovailLaboratoriesInternational SRl(Canada; NYSE:BVF)

Agreement to develop and commercialize Alexza’s inhaled antipsychotic AZ-004 in the U.S. and Canada

The deal is worth $130M, including $40M up front and the rest in mile-stones, plus royalties (2/11)

AltraVax Inc.* Maxygen Inc.(MAXY)

Acquired a vaccine develop-ment technology package from Maxygen, gaining an exclusive license to develop vaccines for infectious diseases

The company has rights to use Maxygen’s MolecularBreeding plat-form; financial terms were not dis-closed (2/19)






CancerGuideDiagnostics Inc.*

Laboratory Corp.of AmericaHoldings (NYSE:LH)

Multiyear, strategic collabora-tion and license agreement for the development and commer-cialization of CancerGuide’s molecular oncology assays

Financial details were not disclosed (2/5)


AdagioPharmaceuticalsLtd.*

Letter of intent granting Cannasat the option to execute an exclusive, worldwide agree-ment to license all intellectual property relating to APL-130277, a reformulation of an approved Parkinson’s drug

The parties are negotiating a deal that would give Cannasat product development and commercialization rights in return for development milestones and royalties, plus shares of Cannasat (2/5)

Genoptix Inc.(GXDX)

HistoRx Inc.* Multiyear licensing agreement under which Genoptix gained exclusive commercial laborato-ry rights in the U.S. to develop and perform three solid tumor assays using HistoRx’s technol-ogy for analysis of fluorescent i m m u n o h i s t o c h e m i s t r y enabling quantitative assess-ment of specific biomarkers for patients with solid tumors

Genoptix also gained nonexclusive rights to use the AQUA technology to measure two additional biomarkers associated with cancer (2/23)

Isogenica Ltd.*(UK)

Phylogica Ltd.(Australia; ASX:PYC)

Agreement to use Isogenica’s CIS display technology to opti-mize the performance of three of Phylogica’s lead compounds targeting CD40 ligand

The CD40 ligand is a key protein involved in many inflammatory dis-eases, such as rheumatoid arthritis and inflammatory bowel disease (2/3)

Novozymes AS(Denmark; CSE:NZYM-B)


Alliance regarding albumin purification technology based upon a synthetic-ligand affinity a d s o r b e n t d e v e l o p e d b y ProMetic ’s UK subsidiar y, ProMetic BioSciences Ltd.

The companies will jointly promote a new synthetic-ligand affinity adsor-bent as a platform approach for the purification of albumin and albumin-fusion proteins (2/3)

PanacorBioscience Ltd.*

3SBio Inc.(SSRX)

L icensing agreement for Chinese development and commercialization rights to its Phase II phosphate binder for hyperphosphatemia, Nephoxil

Panacor will receive $1M up front plus royalties (2/9)

Sequenom Inc.(SQNM)

Optherion Inc.* Exclusive worldwide licensing agreement to develop and commercialize diagnostic tests to predict genetic predisposi-tion to late-stage age-related macular degeneration

The Sequenom Center for Molecular Medicine intends to market a labora-tor y developed test under its SensiGene brand name for genetic tests (2/10)

SunesisPharmaceuticalsInc. (SNSS)

CarmotTherapeuticsInc.*

Exclusive licensing agreement to fragment-based lead discov-ery technology

Carmot will use the technology for identifying promising drug candi-dates for inflammatory, metabolic and neurodegenerative diseases (2/9)







TopoTarget A/S(Denmark; CSE:TOPO)

Co-development and com-mer-cialization agreement for beli-nostat, a histone deacetylase inhibitor

Spectrum licensed the rights for North America and India, and an option for China, in exchange for an up-front cash payment of $30M, potential milestone payments of up to $320M, and 1M shares of Spectrum common stock based on milestones (2/3)

TenX BiopharmaInc.*

Genmab A/S(Denmark;CSE:GEN)

Licensing agreement to acquire exclusive world-wide rights to develop and commercialize zanolimumab from Genmab

Genmab will receive an up-front license fee of $4.5M and will be enti-tled to mile-stones and royalties on sales of zanolimumab (2/5)

ThallionPharmaceuticalsInc. (Canada;TSX:TLN)

LFB Biotech-nologies*(France)

Development and commer-cial-ization deal for Thallion’s Phase II E. coli treatment

The deal is worth C$150M ($140M), including an up-front payment of $2.5M, plus tiered, double-digit roy-alties (2/17)

TransgenomicInc. (OTC BB:TBIO)

IntegraGen SA*(France)

Licensing agreement, on an exclusive U.S. basis, intellectual property that will enable Transgenomic to develop and commercialize a genetic test designed to assess the risk of autism in children who have older siblings diagnosed with an autism spectrum disorder

Transgenomic anticipates launching the test in the second quarter (2/25)

UnitedTherapeuticsCorp. (UTHR)

ImmuneWorksInc.*

Licensing agreement for pre-clinical idiopathic pulmonary f ibrosis drug IW001 from ImmuneWorks

Financial terms were not disclosed, but LungRx has an option to acquire Immune-Works (2/11)

UnitedTherapeuticsCorp. (UTHR)

MondoBiotechAG (Switzerland;SWX:RARE)

Strategic partnership for Aviptadil

It covers Aviptadil’s development in a number of indications, including pulmonary arterial hypertension, sarcoidosis, idiopathic pulmonary fibrosis and acute respiratory dis-tress syndrome (2/4)

MARCH BioInventInternationalAB (Sweden;SSE:BINV)

Human GenomeSciences Inc.(HGSI)

Collaboration to discover, develop and commercialize therapeutic monoclonal anti-bodies, which specifically tar-get antigens discovered by HGS

BioInvent will use its discovery tech-nology to generate and develop monoclonal antibody candidates, ini-tially in the field of inflammation; they will share costs and revenues (3/12)

Biomoda Inc.(OTC BB:BMOD)

Advanced MedicalImaging and Genetics*

Collaboration to advance tech-nology for the early detection of lung and other cancers

Amigenics offers personalized dis-ease risk screening, clinical evalua-tions, genetic counseling and treatment plans for a variety of con-ditions (3/4)

Biovail Corp.(NYSE:BVF)


A g r e e m e n t t o a c q u i r e Ampakine compounds from Cortex for $10M

Biovail also will pay up to $15M in clinical development milestones; it plans to use the compounds to develop treatments for respiratory depression (3/29)






DicernaPharmaceuticalsInc.*

Ipsen SA (France;Paris:IPN)

Exclusive research collabora-tion to use Dicerna’s Dicer Substrate siRNA research and peptide engineering

The companies will develop conju-gates of Dicerna’s DsiRNA molecules and Ipsen’s peptide targeting vectors in the therapeutic areas of oncology and endocrinology (3/31)


Active BiotechAB (Sweden;SSE:ACTI)

Collaboration to identify small-molecule modulators of a pri-ority biological target involved in immune disorders and can-cer


IBio Inc.(OTC BB:IBPM)

G-Con LLC* Licensing agreement for IBio’s technology, the iBio-Launch platform

The deal includes technology trans-fer services for the development and manufacture of plant-expressed influenza vaccines at a new facility being constructed in Bryan, Texas (3/1)

Ikaria HoldingsInc.*

OrphanTherapeutics Inc.*

Agreement for Ikaria to acquire the new drug application and the investi-gational new drug application to Lucassin, assum-ing all future development and ownership of the drug in North America and Australia

Lucassin is being developed for the treatment of hepatorenal syndrome Type I (3/31)

IntelGenxCorp. (Canada;CDNX:IGX)


Letter of intent under which IntelGenx would acquire a 50% stake from Cannasat and an exclusive worldwide license to develop and commercialize Relivar using IntelGenx’s muco-adhesive AdVersa technology to treat various diseases such as neuropathic pain


Ipsen SA(France; Paris:IPN)

RhythmPharmaceuticals*

Licensing agreement for its melanocortin and ghrelin pro-grams for obesity, metabolic diseases and gastrointestinal disorders

Ipsen will receive 17% equity in Rhythm and up to $80M in milestone payments, as well as royalties (3/15)

MDRNA Inc.(MRNA)

ValeantPharmaceuticalsInternational(NYSE:VRX)

Agreement acquiring intel-lec-tual property covering bridged nucleic acids from Valeant


OriGeneTechnologiesInc.*

Essen Instruments Inc.*

Alliance to co-develop ion channel cell lines

They will be co-marketed by the companies (3/16)

OxfordImmunotec Ltd.*(UK)

Scancell Ltd.* Contract to provide support services to Scancell for its Phase I/II trial of SCIB1 , a DNA ImmunoBody vaccine for mela-noma

Oxford Immunotec will use its ELISpot technology to measure T-cell responses to SCIB1 (3/24)






Pfenex Inc.* RanbaxyLaboratories Ltd.(India; PK:RBXZF)

Deal to develop an undisclosed biosimilar therapeutic pro-duced in the Pfenex Expression Te c h n o l o g y p l a t f o r m , a Pseudomonas-based recombi-nant protein expression tech-nology

Pfenex is eligible to receive mainte-nance fees, milestone payments and royalty payments on any products that come out of the deal (3/30)

ProfectusBiosciencesInc.*

Ichor MedicalSystems Inc.*

L o n g - t e r m d e v e l o p m e n t , license and supply agreement, providing Profectus with com-mercial access to Ichor’s TriGrid delivery system for the development of its DNA vac-cine programs

Ichor has an option to co-develop (3/3)

QuestDiagnosticsInc. (NYSE:DGX)

Health DiscoveryCorp. (OTC BB:HDVY)and SmartPersonalizedMedicine LLC

Agreement to develop tests to aid the selection of breast can-cer therapies

Quest will pay Health Discovery a $500,000 up-front development license fee plus $375,000, payable over nine months; Quest also will pay a monthly license maintenance fee of $8,750 for the first year and $17,500 for subsequent years, with the amounts being deducted from royalty payments (3/18)

Repligen Corp.(RGEN)

BioFlash PartnersLLC*

Agreement acquiring assets including a technology plat-form for the production of pre-p a c k e d , p l u g - a n d - p l a y chromatography columns

Repligen paid $1 .8M in the deal that includes a contingent milestone and royalties based on product sales (3/4)

Stem CellInnovationsInc. (PK:SCLL)

Agennix AG(Germany; FSE:AGX)

Master services agreement to provide research and assay s e r v i c e s i n s u p p o r t o f Agennix’s talactoferrin pro-gram


Xenome Ltd.*(Australia)

MedImmune LLC(subsidiary ofAstraZeneca plc;UK)

Licensing agreement under which MedImmune will gain access to Xenome’s xdiscover venom peptide library to exclu-sively screen for drug candi-dates against two undisclosed targets involved in key pain pathways

Xenome will receive an undisclosed up-front cash payment; MedImmune will fund research at Xenome; MedImmune can enter into product licenses on selected peptides, which would trigger milestone and royalty payments (3/24)

ZealandPharma A/S*(Denmark)

PolyThericsLtd.* (UK)

Research collaboration aimed at defining character-istics of pegylated peptides as thera-peutics

Zealand will contribute peptide-based candidates in metabolic, car-diovascular and gastrointestinal indications that are amenable to pegylation, while PolyTherics will contribute its pegylation technolo-gies (3/3)






APRIL AlbanyMolecularResearch Inc.(AMRI)

NavigenPharmaceuticalsInc.*

Research collaboration under which AMRI will provide fully integrated drug discovery ser-vices including assay develop-ment, screening, in vitro ADMET, computer-aided drug discovery and medicinal chem-istry


Agios Pharma-ceuticals Inc.*

Celgene Corp.(CELG)

Preclinical collaboration in the area of cancer metabolism

The deal will bring Agios $130M up front, including an equity invest-ment; Agios also could receive up to $120M in milestones, as well as royal-ties on sales; it also may participate in the development and commercial-ization of certain products in the U.S. (4/16)

AnaptysBioInc.*

VLST Corp.* Collaboration to generate novel multi-antigen specific antibody therapeutics for the treatment of autoimmune and inflammatory disorders

AnaptysBio has receive an up-front payment and is eligible to receive milestone payments and royalties (4/6)

BioMerieux SA(France; Paris:BIM)

Knome Inc.* Strategic agreement to collabo-rate in the develop-ment of next-generation, sequence-based in vitro diagnostics

bioMerieux will have exclusive rights to license Knome’s proprietary genome analysis platform for use in the in vitro diagnostics market; bioMerieux purchased a $5M equity stake in Knome (4/22)

EntestBioMedical Inc.(OTC BB:ENTB)

Medistem Inc.(OTC BB:MEDS)

Agreement for Entest to acquire about 61% of Medistem

Medistem’s technologies include treatments for autism, heart failure, diabetes, erectile dysfunction and multiple sclerosis (4/14)

Galapagos NV(Belgium; BR:GLPG)

CHDI FoundationInc.*

Five-year collaboration focused on discovering novel drugs for Huntington’s disease

Galapagos’ service division BioFocus will perform the research and is eligi-ble to receive $41M in research fees (4/30)

GenOway SA(France; Paris:Algen)

Unnamed bio-pharmaceuticalcompany

Renewed contract for a two-year period to provide geneti-cally modified animals to the unnamed company


Genzyme Corp.(GENZ)

Arecor Ltd.* (UK) Collaboration to develop sta-ble, high-strength formu-lations of labile biomolecules

The agreement comes after a two-year working relationship (4/14)

HuntBiosciences AS*(Norway)

Tissue SolutionsLtd.* (Scotland)

Collaboration to promote the value of the Hunt Study, which has gathered blood samples from the general population of the Nord-Trondelag region in mid-Norway together with detailed phenotype and envi-ronmental data







KytoBiopharma Inc.(OTC BB:KBPH)

TargetedPayloadTherapeuticsInc.*

Agreement under which Kyto provided seed funding, with funds to be reimbursed upon TPT’s completion of a private placement offering, and for R&D work on Kyto’s lead prod-uct

Kyto entered a secondary agreement with TPT, in which it will obtain a per-centage ownership of TPT, as well as a commitment that TPT will spend up to $2M for the R&D work (4/1)

MediGene AG(Germany; FSE:MDG)

Catherex Inc.* MediGene divested its oncolyt-ic herpes simplex virus pro-gram to Catherex

MediGene received a 40% stake in Catherex as well as potential future payments (4/14)

NanoFormCardiovascularTherapeuticsLtd.* (UK)

NanGenex Inc.*(Hungary)

Agreement under the newly created NanoForm acquired all rights to the two Nano-Active formulations

NanoForm will develop and commer-cialize the formulations for cardio-vascular indications (4/14)


ImmuneRegenBioSciences Inc.*

Collaborative research agree-ment under which NeoStem will use its very small embry-onic-like stem cell technology to evaluate ImmuneRegen’s stem cell -activating drug Homspera


Polyphor Ltd.*(Switzerland)

Axxam SpA*(Italy)

Joint discovery agreement in which the two companies will work to discover and develop drug candidates for selected therapeutic areas such as pain, inflammation and metabolic disorders


ProBioGen AG*(Germany)

Virdante Bio-pharmaceuticalsInc.*

Deal under which ProBioGen will contribute producer cell line development and process e n g i n e e r i n g f o r o n e o f Virdante’s proprietary thera-peutic proteins


PSivida Corp.(PSDV)

Alimera SciencesInc. (ALIM)

Licensing agreement for rights to develop Iluvien in diabetic macular edema

PSivida received a $15M note, includ-ing an additional $225,000 in accrued interest, for the license; if Iluvien is approved, PSivida will receive a $25M milestone payment (4/29)

RXiPharmaceuticalsCorp. (RXII)

MiRagenTherapeuticsInc.*

Research collaboration to eval-uate RXi’s rxRNA technology against specific cardiac and neuromuscular miRNA targets of interest to miRagen


RXiPharmaceuticalsCorp. (RXII)

TransDerm Inc.* Collaboration on studying the potential use of RXi’s com-pounds in dermatology models

Each party will contribute technolo-gy and resources to the collabora-tion to evaluate and develop new transdermal RNAi delivery (4/7)






TGen DrugDevelopment*(subsidiary ofthe TranslationalGenomicsResearchInstitute)

HorizonDiscovery Ltd.*

Strategic alliance to advance personalized medicine

The partnership will create a begin-ning-to-end solution for pharmaceu-tical and biotechnology companies to more rationally design and tailor their drugs to specific patient popu-lations based on the unique genetic variations that define a given disease (4/13)

MAY AdeonaPharmaceuticalsInc. (AMEX:AEN)

Meda AB (Sweden;PK:MEABF)

Corporate partnership to develop flupirtine to treat fibromyalgia

Meda was granted an exclusive sub-license to all of the U.S., Canadian and Japanese patents covering the use of flupirtine in exchange for $17.5M, including $2.5M up front and $15M in milestones, plus 7% royalties on sales (5/10)

AgilentTechnologiesInc. (NYSE:A)

SteminaBiomarkerDiscovery Inc.*

Agreement to accelerate S t e m i n a ’ s m e t a b o l o m i c research

Agilent is providing a 1290 Infinity UHPLC system to separate stem cel-lular metabolites, coupled to a 6530 Accurate Mass quadrupole time-of-flight mass spectometer to identify those metabolites (5/26)

AltheaTechnologiesInc.*

AltusPharmaceuticalsInc. (PK:ALTUQ)

Agreement acquir ing the assets and intellectual property portfolio of Altus

The IP portfolio includes Altus’ Cross Linked Enzyme Crystal and con-trolled-release injectable technolo-gies (5/4)

Amorfix LifeSciences(Canada; TSX:AMF)

Epitomics Inc.* Agreement to develop high-affinity monoclonal antibodies against a number of cancer tar-gets


BaroFold Inc.* Nuron Biotech* Exclusive license agreement for Phase I multiple sclerosis drug BaroFeron

Terms were not disclosed, but Nuron gets an exclusive license to PreEMT for use in developing BaroFold and follow-on interferon beta products (5/18)

Clovis Oncology Inc.*

AvilaTherapeuticsInc.*

Oncology partnership to devel-op and commercialize epider-mal growth factor receptor mutant-selective inhibitors to treat non-small-cell lung cancer

The deal is potentially worth $209M in milestone payments, plus an up-front fee and tiered royalties (5/26)

CytosBiotechnologyLtd. (Switzerland;SWX:CYTN)

Intercell AG(Austria; FSE:IJE)

Agreement for Cytos to sell its platform technology for the identification of monoclonal antibodies

Intercell will pay $18.95M to Cytos for the technology (5/7)

Evotec AG(Germany; FSE:EVTA)


Multiyear drug discovery alli-ance to discover small-mole-cule therapeutics

Evotec will apply its platform and disease biology expertise against targets nominated by Genentech (5/11)

GeneticTechnologiesLtd. (Australia;GENE)

Gen-Probe Inc.(GPRO)

L i c e n s e a g r e e m e n t f o r Genetic’s non-coding patents

The license covers the worldwide activities of Gen-Probe in relation to its genetic diagnostics and analysis products (5/4)






Hawaii BiotechInc.*

AdvancedBioScienceLaboratories Inc.*

Partnership for preclinical development of a dengue vac-cine

Hawaii Biotech plans to being a com-pany-sponsored Phase I study with its tetravalent dengue vaccine candi-date later this year (5/26)

ICoTherapeuticsInc. (Canada;CDNX:ICO)


Technology transfer agreement to transfer certain technology related to the manufacture of iCo-007

ICo will issue a warrant to purchase 235,000 shares of iCo’s common stock at an exercise price of 61 cents each (5/26)

LigandPharmaceuticalsInc. (LGND)

GenaeraLiquidating Trust

Purchasing agreement for cer-tain intellectual property and interest in future mile-stones and royalties for MEDI-528, an IL-0 antibody program under development by MedImmune

Ligand paid $2.75M for the antibody in development for asthma; it also entered a separate agreement with Biotechnology Value Fund to share the purchase price andany proceeds from the deal equally (5/24)

Polyplus-transfection SA*(France)

Kempbio Inc.* Licensing agreement allowing Kempbio to use its polyethyl-enimine for the transfection of cells used for the production of recombinant proteins


Q Chip Ltd.*(UK)

ArtesBiotechnologyGmbH* (Germany)

Collaboration to explore the development of new sustained-release formulations of inter-feron alpha2a in chronic hepatitis B and C

The first phase of the collaboration is expected to be completed by the end of the year (5/3)

SagentPharmaceuticalsInc.*

Actavis Inc.* Exclusive collaboration to develop and market a select group of specialty injectable medications for the U.S.

Actavis will develop, obtain FDA approval and supply the products, which Sagent will market in the U.S. (5/5)

Scolr PharmaInc. (AMEX:DDD)

RedHill Biopharma Ltd.*(Israel)

Licensing agreement granting RedHill the worldwide rights to market and sell ondansetron tablet formulations based on Scolr’s extended-delivery tech-nology

RedHill has agreed to make up-front and additional payments to Scolr up to $600,000 based on achievement of certain regulatory milestones (5/7)

Scynexis Inc.* Trevena Inc.* Agreement in which Scynexis will provide medicinal chemis-t r y s e r v i c e s t o s u p p o r t Trevena’s ongoing research activities directed at the dis-covery of biased G protein-cou-pled receptor ligands

Terms of the deal were not disclosed (5/20)

Stemgent Inc.* Miltenyi Biotec* Collaboration for co-develop-ment and commercialization of stem cell research products

Miltenyi Biotec will be responsible for worldwide marketing and sales of Stemgent’s existing stem cell product portfolio outside the U.S., and Stemgent will continue to serve its U.S. customers (5/5)






Swedish OrphanBiovitrum*(Sweden)

Biomodels LLC* Research agreement under which Biomodels will explore the possibility of developing a clinically applicable screening platform to define mucositis risk among patients undergo-ing condit- ioning regimens for hematopoietic stem cell trans-plants

Swedish Orphan Biovitrum will pro-vide funding for the project (5/12)

ValcorTherapeuticsInc.* (Canada)

QLT Inc. (Canada; QLTI)

Licensing agreement for a port-folio of dermatology products from QLT

The portfolio includes the topical photodynamic therapy Lemuteporfin for acne as well as small molecules for atopic dermatitis and vitiligo (5/26)

JUNE AdnaGen AG(subsidiary ofOncoVistaInnovativeTherapies Inc.;OTC BB:OVIT)

KellBenx Inc.* Option agreement to license specific antibodies

KellBenx will secure exclusive, worldwide rights to commercialize the antibodies (6/21)

AdventrxPharmaceuticalsInc. (AMEX:ANX)

Theragence Inc.* Licensing agreement for the folate-based cancer drug CoFactor

The deal includes up to $30M in commercial milestones, plus royal-ties to Adventrx (6/11)

AeternaZentaris Inc.(Canada; TSX:AEZ)

Almac Group*(Northern Ireland)

Collaboration for AEZS-108 aimed at determining LHRH receptor expression through the development of a compan-ion diagnostic tool

AEZS-108 is in Phase II trials for ovari-an and endometrial cancer (6/29)

Affiris AG*(Austria)

ProBioGen AG*(Germany)

Deal for ProBioGen’s Human Artificial Lymph Node technol-ogy as an analytical tool for its Affitome-based vaccination concept

Affiris will evaluate the HuALN tech-nology as a human organoid model to investigate drug-related effects in the context of the human immune system (6/3)

Amorfix LifeSciences Ltd.(Canada; TSX:AMF)

AragenBioscience Inc.*

Deal to develop high-affinity monoclonal antibodies against a number of cancer targets

Amorfix identified several disease-specific epitopes using its ProMIS compu-tational platform discovery technology on misfolded Fas recep-tor, and Aragen will use those epit-opes to generate antibodies (6/1)

AoxingPharmaceuticalsCo. Inc. (AMEX:AXN)

PhoenixPharmaLabs Inc.*

Co-development, manufac-tur-ing and license agreement related to a class of polyrecep-tor active opioid-like drug can-didates targeting pain and substance abuse and addiction treatment

The firms will co-collaborate with the N a t i o n a l I n s t i t u t e o n D r u g Dependence; Aoxing gains exclusive rights for pain management and sub-stance abuse in China, Macau and Hong Kong in exchange for tiered royalties to PPL (6/4)

Applied GeneticTechnologiesCorp.*

Icagen Inc.(ICGN)

Deal to transfer rights to pat-ents relating to the ion channel gene CNGB3, which has been linked to certain disorders of the eye

AGTC will use the technology for gene therapy as a potential treat-ment for achromatopsia (6/25)






AscalonInternationalInc.*

CerRx Inc.* Agreement for an exclusive option to license CerRx’s intra-venous fenretinide product

Ascalon will assume full responsibili-ty for development and commercial-ization for IV fenretinide; CerRx will recieve developmental milestone payments and a share of certain sub-licensee income and royalties (6/7)

CellularDynamicsInternational*

PromegaCorp.*

Research collaboration aimed at combining human cardiomy-ocytes with bioassays to pre-dict toxicity


CypressBioscience Inc.(CYPB)

BioLineRx Ltd.(Israel; TASE:BLRX)

Deal for the exclusive North American development and commercialization rights to its antipsychotic compound CYP-1020 to treat schizophrenia

Cypress is paying BioLineRx $30M up front and potentially $335M in milestones (6/22)

CytosBiotechnologyLtd. (Switzerland;SWX:CYTN)

Intercell AG(Austria; FSE:IJE)

Deal to sell Cytos’ platform technology for the identifi- cat-ion of monoclonal antibodies to Intercell

Intercell is paying $11 .9M this week and more by Jan. 31 , 2011 (6/9)

Emerald Bio-Structures*

FormaTherapeuticsInc.*

Partnership agreement for the structure-based design of can-c e r d r u g c a n d i d a t e s f o r Forma’s pipeline

Financial terms were not disclosed, but will provide funding for multiple full-time employees at Emerald (6/29)

EsperionTherapeutics*

TransGenRx* Deal to produce protein- based therapeutics to be used in the company’s research efforts tar-geting HDL therapies for the treatment of cardiometabolic disease

TransGenRx will coordinate produc-tion of protein-based therapies for a range of research needs using a pro-prietary expression system (6/22)

ExonHitTherapeuticsSA (France;Paris:ALEHT)

Genmab A/S(Denmark; CSE:GEN)

Exclusive agreement for a selection of splice variants that have the potential to be thera-peutic targets for breast cancer

Genmab retains exclusive develop-ment and commercialization rights on 10 events out of a breast cancer database (6/15)

Faron Pharmaceuticals Ltd.* (Finland)

Priaxon AG* Collaboration and commercial-ization agreement to obtain new superior AOC3/ SSAO antagonists

The goal is to create completely new scaffold structures to modify the inter-action and the AOC3 function with orally available drugs (6/15)

ImmunoCellular Therapeutics Inc. (OTC BB:IMUC)

Targepeutics Inc.* Exclusive licensing deal to acquire Targepeutics’ property rights surrounding the IL-13 receptor, alpha 2


Immunovaccine Inc. (Canada; CDNX:IMV)

Oncothyreon Inc.(ONTY)

Agreement to develop ONT- 10, a synthetic MUC1-based liposo-mal glyco-lipopeptide cancer vaccine



Vaxil BioTherapeutics Ltd.* (Israel)

Collaboration to explore the efficacy of Vaxil’s cancer anti-gens in Immuno-vaccine’s DepoVax vaccine enhancement platform


MDRNA Inc. (MRNA) RiboTask ApS* (Denmark)

Exclusive rights to develop, make, use and sell unlocked nucleobase analog-based diag-nostics







Morphosys AG (Germany; FSE:MOR)

Xencor Inc.* Collaboration on a Phase I-ready antibody developed by Xencor that is aimed at chronic lymphocytic leukemia

Xencor will carry the costs through Phase I testing and will receive an up-front payment of $13M plus mile-stone payments and tiered royalties (6/29)

Oramed Pharmaceuticals Inc. (Israel) and its subsid-iary Oramed Ltd. (OTC BB:ORMP)

Laser Detect Systems Ltd. (Israel; TASE:LSDT)

Companies formed a joint ven-ture, Entera Bio Ltd., to use Oramed’s oral drug delivery technology to develop an oral treatment for osteoporosis


Oxygen Healthcare Ltd.* (UK)

Karyopharm Therapeutics Inc.*

Agreement to provide discov-ery services to Karyopharm to advance Karyopharm’s lead s m a l l - m o l e c u l e p r o g r a m toward the nomination of a development candidate


RXi Pharmaceuticals Corp. (RXII)

Philips Electronics (the Netherlands; NYSE:PHG)

Joint research agreement to explore the benefits of combin-ing technologies from both firms for the targeted delivery of RNAi-based therapeutics

The companies will test, in preclini-cal studies, the possibility of using RXi’s sdrxRNA in conjunction with Philips’ ultrasound technology to achieve the targeted delivery and monitoring of RNAi-based com-pounds in cells (6/4)

Sapient Discovery LLC*

Helicon Therapeutics Inc.*

Research collaboration to apply its structural biology platform and expertise to determine the three-dimen-sional structure for targets of interest to Helicon


Scancell Holdings plc* (UK)

Immatics Biotechnologies GmbH* (Germany)

Collaboration to explore the development of Immuno-Body vaccines in colorectal cancer


SymBio Pharmaceuticals Ltd.* (Japan)

Cephalon Inc. (CEPH) License agreement for the development of Rigerimod in Japan

SymBio gains rights to study the drug in a Japan Phase I trial of sys-temic lupus erythematosus patients, with the option to negotiate further product development in Japan upon the attainment of defined clinical outcomes (6/15)

ViroStatics srl* (Italy) Vichem Chemie Ltd.* (Hungary)

Partnership to identify, synthe-size, screen and develop next-g e n e r a t i o n a n t i v i r a l hyperactivation limiting thera-peutics in HIV/AIDS and other chronic diseases


JULY Access Pharmaceuticals Inc. (OTC BB:ACCP)

Unnamed biotech-nology company

Pre-licensing feasibility agree-ment with an unnamed bio-t e c h n o l o g y c o m p a n y t o develop an oral formulation of its currently marketed inject-able drugs

Access will use its Cobalamin oral drug delivery technology to develop oral formulations of the drug for pre-clinical testing; a successful formula-tion will be subject to a full-licensing agreement (7/19)






Amorfix Life Sciences Ltd. (Canada; TSX:AMF)


Licensing agreement for exclu-sive worldwide r ights to Amorfix's lead amyotrophic lat-eral sclerosis monoclonal anti-bodies

The antibodies have shown efficacy in animal models of ALS; Biogen Idec will complete development and pre-pare for clinical trials; Amorfix will receive $1M up front and is eligible for milestones and royalties (7/19)

Ampio Pharmaceuticals Inc. (OTC BB:AMPE)

DMI BioSciences Inc.*

Deal giving Ampio access to all rights, royalties and patents associated with DMI's drugs for male sexual dysfunction, including premature ejacula-tion, and combination drugs to treat premature ejaculation and erectile dysfunction

Ampio also gets Phase III trial data accumulated for the PE drugs; finan-cial terms were not disclosed (7/28)

Aptuit Inc.* Siena Biotech SpA* (Italy)

Strategic partnership in which Siena Biotech will take a minor-ity stake in Aptuit's Italian operations in Verona, Italy

Aptuit will become a provider of choice for Siena Biotech's develop-ment pipeline; they will work in the areas of Alzheimer's disease, Huntington's disease and oncology (7/30)

AquapharmBiodiscoveryLtd.* (Scotland)

Albany MolecularResearch Inc.(AMRI)

Research agreement to identify novel drug-like compounds and scaffolds with antimicrobi-al and anti-inflammatory activi-ty from Aquapharm’s marine natural products library

AMRI will screen Aquapharm’s library against Gram-negative and Gram-positive bacteria and an undis-closed anti-inflammatory target (7/8)

Edge Therapeutics Inc.*

SurModics Inc. (SRDX)

Feasibility agreement to devel-op a biodegradable, site-specif-i c , s u s t a i n e d - r e l e a s e formulation of Edge's NimoGel for treating delayed complica-tions of ruptured brain aneu-rysms or traumatic brain injury

Edge will lead and fund development and commercial izat ion, whi le SurModics provides technical and manufacturing expertise (7/21)

Exact Sciences Corp. (EXAS)

OncoMethylome Sciences SA (Belgium; BR:ONCOB)

Exclusive, worldwide rights deal for up to two DNA methyl-ation biomarkers for use in stool -based detect ion of colorectal cancer

Exact Sciences also gained nonexclu-s i v e a c c e s s t o p a r t o f OncoMethylome's platform technol-ogy; involves milestone payments and royalties (7/28)

InfinityPharmaceuticalsInc. (INFI)

Intellikine Inc.* Global l icensing deal for Intellikine’s preclinical phos-phoinositide-3 kinase delta and gamma inhibitors

The deal includes INK1197 for inflam-matory diseases, and is worth $488.5M: $13.5M up front and two years of research funding, as well as $25M in development milestones and $450M in regulatory/sales mile-stones (7/9)


Insight Bioventures India Private Ltd.* (India)

Letter of intent for funding and establishment of an Indian affiliate of ISCO

The goal is to set up development and manufacturing operations for ISCO in India, including the firm's Lifeline Cell Technology research products and CytoCor (7/21)


Sankara Nethralaya* (India)

Collaboration to develop CytoCor to treat corneal blind-ness and vision impairment







Kerecis* (Iceland) ValaMed* (Iceland) Collaboration on the research of cell growth in various matri-ces

Kerecis is described as an emerging t issue regeneration f irm, and ValaMed is involved in the develop-ment of chemo-sensitivity assays of cancerous tissues (7/16)

Marina Biotech Inc. (MRNAD)

Novosom AG* (Germany)

Marina acquired the intellectu-al property of Novosom for its Smarticles liposomal-based delivery system

It paid $5M in unregistered Marina common stock (7/29)

Midatech GroupLtd.*

Immunotope Inc.* Companies formed Syntara LLC, which will use Midatech’s nanoparticle platform to deliv-er Immunotope’s antigens


Molecular Templates Inc.*

ImClone Systems(IMCL; unit of Eli Lillyand Co.)

Oncology discovery and trans-lation research agreement

Molecular Templates will identify Engineered Toxin Bodies against an undisclosed oncology target select-ed by ImClone, which is responsible for preclinical studies; the compa-nies can then continue development for potential commercialization by Lilly, with Molecular Templates enti-tled to up-front, milestone and royal-ty payments (7/7)

MRC Technology*


Agreement for an exclusive license to a series of small- molecule drug candidates for the potential treatment of neu-rological disease


NovImmune SA* (Switzerland)

Genentech Inc. (NYSE:DNA; unit of Roche AG; Switzerland)

Licensing agreement for a pre-clinical, fully human, anti-IL17 antibody program

The deal includes an up-front pay-ment, as well as milestones and roy-alties (7/27)


The Medicines Co.(MDCO)

Pharmaceutical development and manufacturing contract

OctoPlus will perform process devel-opment and clinical manufacturing for The Medicines Co. related to MDCO-216 (7/13)


Undisclosed U.S.biotechnologycompany

Agreement for the use of itscontrolled-release Poly-Active technology

Companies will work to develop a version of a product currently in clin-ical development (7/9)

ProtAffin AG* (Austria)

CMC Biologics* (Denmark)

Contract for the manufacture of PA401, a glycan-binding decoy protein based on human chemokine IL-8, in develop-ment for chronic obstructive pulmonary disease

The contract will cover manufacture and supply of PA401 for preclinical development and early clinical devel-opment in COPD and related respira-tory indications (7/28)

Selvita sp*(Poland)

Orion Corp.(Finland)

Global collaboration to jointly develop and commercialize SEL103 for Alzheimer’s disease and other cognitive disorders

Selvita will receive receive undis-closed up-front and research fund-ing, plus milestone payments from Orion (7/9)

Strategic Diagnostics Inc. (SDIX)

Banyan Biomarkers Inc.*

Multiyear collaboration to pro-vide products and services for Banyan to conduct discovery work in the detection of trau-matic brain injury







AUGUST Advaxis Inc. (OTC BB:ADXS)

Vibalogics GmbH* (Germany)

Deal to co-develop a room tem-perature stable processing technology for live vaccines original ly engineered for Advaxis


Axiogenesis AG (Germany; FSE:AI8)

iPS Academia Japan Inc. (Japan)

Nonexclusive licensing agree-ment to access its pluripotent stem cell technology for the development of predictive dis-ease models

T h e a g r e e m e n t e x p a n d s Axiogenesis's stem cell portfolio, with assets in both murine and human model systems (8/4)

BrainCells Inc.* Proximagen Group plc (UK; LSE:PRX)

A g r e e m e n t u n d e r w h i c h BrainCells is acquiring sab-comeline, a compound aimed at psychiatric and neurologic disorders

The deal will bring in as much as $51M in up-front and milestone pay-ments, plus royalties (8/5)

Cornerstone Therapeutics Inc. (CRTX)

Alitair Pharmaceuticals Inc.*

License and development a g r e e m e n t u n d e r w h i c h Cornerstone has acquired cer-tain intellectual property

The companies will collaborate to develop one or more products to treat respiratory diseases (8/3)

Cynapsus Therapeutics Inc. (Canada; CDNX:CTH)

Adagio Pharmaceuticals Ltd.* (Canada)

License option agreement granting Cynapsus the option to execute a proposed exclu-sive, worldwide agreement to license all intellectual property relating to APL-130277, a refor-mulation of an approved Parkinson's drug

The firms also finalized an exclusive worldwide license where Cynapsus will assume development and com-mercialization rights in return for milestones and royalties to Adagio (8/10)

Cypress Biosciences Inc. (CYPB)


In-licensing agreement for the Staccato nicotine drug delivery technology from Alexza

The deal is worth $6M, including $5M up front and $1M in milestones (8/27)

Cypress Biosciences Inc. (CYPB)

Marina Biotech Inc. (MRNA)

In-licensing agreement for Marina’s Phase I autism drug candidate carbetocin

The deal is worth $27.75M, including $750,000 up front and the rest in milestones; Cypress also will pay royalties (8/27)


Temasek Life Science Ventures Pte Ltd.* (Singapore)

Deal to form a joint venture, EPIC BIO Pte Ltd., of Singapore, to develop, manufacture and commercia l ize a vaccine against influenza caused by H5 influenza strains

Both companies will contribute cash and intellectual property to the part-nership; Emergent will have 60% ownership, while TLV will hold 40% (8/12)

Genentech Inc. (NYSE:DNA)


Deal for Genentech applying Seattle Genetics' ADC platform to an undisclosed number of specific targets

Terms call for Genentech to pay $12M up front, with potential milestones and maintenance fees that could exceed $900M (8/4)

Isotechnika Pharma Inc. (Canada; TSX:ISA)

3SBio Inc. (China; SSRX)

Development and commercial-ization agreement for voclo-sporin to treat autoimmune disease

Isotechnika will get $6M, including an up-front licensing payment of $1 .5M, with the additional $4.5M invested by 3SBio through a convert-ible debenture; 3SBio gets exclusive rights in China, Hong Kong and Taiwan for all uses, excluding oph-thalmic indications (8/25)






Knopp Neurosciences Inc.*


Deal to develop a Phase III drug candidate for amyotrophic lat-eral sclerosis

Knopp will receive $80M in initial payments and $265M in potential milestones, while Biogen Idec takes over development and potentially commercialization of KNS-760704 in global markets (8/19)


Emergent Product Development Co. GmbH (subsidiary of Emergent BioSolutions Inc.; NYSE:EBS)

Nonexclusive rights agreement to Oxford's Hi-8 PrimeBoost technology patents and subli-cense to poxvirus patents for the development and commer-cialization of vaccines and therapeutics targeting eight infectious diseases

Emergent will pay an up-front licens-ing fee of $1M, potential milestones of up to $20.4M and undisclosed royalties on sales (8/19)


MedImmune Inc. (subsidiary of AstraZeneca plc; UK)

Agreement to test Phylogica's Phylomer peptide library for antimicrobial peptides

Phylogica will receive $750,000 up front, with an additional $750,000 in committed research funding for an initial 12-month term; Phylogica also is eligible to receive development, regulatory and commercial mile-stone payments of up to $98M, plus royalties (8/19)

Proteonomix Inc. (OTC BB:PROT)

Proteonomix Inc. investors

Executed a joint venture agree-ment to create a new stem cell treatment and research facility in the United Arab Emirates

The investment group has commit-ted $5M and the joint venture will be called XGen Medical LLC; it will be owned 51% by Proteonomix and 49% by the investor group (8/18)

PURE Bioscience Inc. (PURE)

FTA Bioscience LLC*

Deal for product-specif ic licenses for development of a silver dihydrogen citrate-based treatment for tinea unguium (nail fungus) and tinea pedis (athlete's foot)


Targacept Inc. (TRGT) Cornerstone Therapeutics Inc. (CRTX)

Licensing deal for rights to nic-otinic receptor-based patents and preclinical compounds tar-geting alpha7, primarily aimed at respiratory diseases

Targacept agreed to pay a $1 .5M up-front fee for the rights; additional payments to Cornerstone could range from $45.6M to up to $74.9M, depending on which of the two lead compounds successfully moves through development (8/4)

Valirx plc (UK; LSE:VAL) Cancer Research Technology Ltd.* (UK)

L icensing agreement for Valirx's anticancer compound VAL201 , which stops growth of hormone-resistant breast and prostate tumors in mice

Valirx will provide milestone pay-ments in exchange for exclusive rights to treat, prevent and diagnose cancer and other diseases (8/13)

SEPTEMBER Artes Biotechnology GmbH* (Germany)

Select Vaccines Ltd. (Australia; ASX:SLT)

D e a l u n d e r w h i c h A r t e s acquired the Anavax virus-like particle technology from Select Vaccines







Asterand plc (PK:ATDPF)

Cellzome AG* (Germany)

Asterand’s subsidiary, BioSeek LLC, signed a two-year agree-ment to apply its BioMAP pre-dictive human disease models to support and advance Cellzome’s discovery projects

The projects are focused on the treatment of inflammatory diseases (9/24)

Champions Biotechnology Inc. (OTC BB:CSBR)

Cephalon Inc. (CEPH) Partnership to test the effec-t i v e n e s s o f C E P- 3 2 4 9 6 , Cephalon’s B-Raf inhibitor, using Champions’ Biomerk Tumorgraft in various cancer indications


DM Corp. (India) ORF Genetics (Iceland)

Joint venture to develop, pro-duce and market human recombinant therapeutic pro-teins and biosimilars

DM brings expertise in management of preclinical research, clinical devel-opment and marketing, while ORF Genetics wil supply expertise in plant genetics and protein biochem-istry (9/2)

Evotec AG (Germany; PK:EVTCY)

Almirall SA (Spain; Madrid:ALM)

Partnership to identify small-molecule ion channel modula-tors for respiratory diseases using Evotec’s screening plat-form

No financial details were disclosed (9/24)

Genmab A/S (Denmark; CSE:GEN)


Partnership giving Genmab rights to use Seattle Genetics’ ADC technology with i ts HuMax-TF antibody targeting the tissue factor antigen, which is expressed on numerous types of solid tumors

Seattle Genetics received an undis-closed up-front payment and has the right to exercise a co-development option for any resulting ADC prod-ucts at the end of Phase I; it will receive research support payments and if it opts into an ADC product, the companies will co-develop and share all future costs and profits on a 50-50 basis (9/15)

HUYA Bioscience International LLC*

Quintiles Transnational Corp.*

Agreement to co-develop a cancer drug, HBI-8000, sourced in China by HUYA


Jennerex Inc.* Transgene SA (France; Paris:TNG)

Overseas deal for its midstage cancer product JX-594

Transgene gains European rights for an undisclosed equity investment and up to $116M in milestones (9/9)


Proximagen Ltd. (UK; LSE:PRX)

Exclusive licensing agreement for a series of compound hits related to the CXCR4 target

Ligand will receive an up-front pay-ment and continue to be entitled to receive potential future milestone and royalty payments (9/20)


Absynth Biologics Ltd.* (UK)

License and collaboration agreement for target molecules associated with Staphylococcus aureus infections

MorphoSys will generate antibodies using its HuCAL Platinum antibody library, which Absynth will test in rel-evant disease models; Absynth will receive an up-front payment, mile-stone payments and royalties (9/3)


Newbridge Pharmaceuticals

Agreement for the licensing and distribution of break-through cancer pain drug Abstral (sublingual fentanyl) in the Middle East and Africa

Specific terms were not disclosed, but included up-front milestone and revenue-sharing payments (9/17)






RedHill Biopharma Ltd.* (Israel)

Giaconda Ltd. (Australia; ASX:GIA); IntelGenx Corp. (Canada; OTC BB:IGXT)

Deal acquiring a clinical-stage drug to treat Crohn’s disease and two additional gastrointes-tinal products from Giaconda; and a deal with IntelGenx to jointly develop a new drug for-mulation for acute migraine


RTI Biologics Inc. (RTIX)

Athersys Inc. (ATHX) Agreement to provide access to its Multipotent Adult Progenitor Cell technologies for RTI to use in certain orthopedic indica-tions

Terms call for Athersys to receive a $3M license fee; it also is eligible for up to $37.5M in development mile-stones and up to $35.5M in sales milestones, plus tiered royalties (9/14)

RXi Pharmaceuticals Corp. (RXII)

EyeGate Pharma Inc.*

Collaboration on the ocular delivery of RNAi therapeutics

EyeGate will contribute its iontopho-resis technology for delivering RXi’s Sd-rx-RNA compounds to the eye in preclinical models (9/23)

Topica Pharmaceuticals Inc.*

Undisclosed part-ner

Subl icense and purchase option agreement with an undisclosed partner to develop luliconazole

The product is a broad-spectrum antifungal (9/22)


Mymetics Corp. (Switzerland; OTC BB:MYMX)

Research license agreement to evaluate the replication of an undisclosed virus in Vivalis’ EB66 cell line for the manufac-turing of human vaccines developed by Mymetics


OCTOBER Aastrom Biosciences Inc. (ASTM)

ATEK Medical Deal to use ATEK’s technology in Aastrom’s cell manufactur-ing processes


ACEA Biosciences Inc.*

Vivo Biosciences Inc.*

Collaboration for the further development of label-free and real-time cell-based assays for the xCELLigence System

The new assays will incorporate Vivo’s HuBiogel platform (10/7)

Ambrilia Biopharma Inc. (Canada; TSX:AMB)

Tournoux Biotech SAS* (France)

Exclusive worldwide licensing agreement for the develop-ment, manufacture and sale of Ambrilia’s MTX and OSK1 tech-nologies

Ambrilia could receive future mile-stone and royalty payments (10/28)

BioDelivery Sciences International Inc. (BDSI)

TTY Biopharm Co. Ltd.*

Partnership to develop and commercialize BEMA Fentanyl in China and Taiwan in a deal potentially worth $1 .3M

The deal includes an up-front pay-ment of $300,000; BEMA Fentanyl is a treatment for breakthrough pain in cancer marketed as Onsolis in the U.S. and Canada (10/8)

Celtic Therapeutics Holdings LP* (U.S. Virgin Islands)

Resolvyx Pharmaceuticals Inc.*

Option agreement relating to Resolvyx’s RX-10045 for dry-eye syndrome and other oph-thalmic conditions

Celtic has an exclusive option to acquire and l icense rights to RX-10045 in all eye indications (10/27)

Cypress Bioscience Inc. (CYPB)

Exagen Diagnostics Inc.*

Asset purchase deal for Exagen to acquire Cypress’ diagnostic business for up to $8M in up-front and milestone payments

Additional payments will come in the form of a 10% royalty on sales (10/12)






ERYtech Pharma* (France)


Collaboration to develop a therapeutic enzyme formula-tion for Genzyme disease indi-cations using technology developed by ERYtech

The agreement lasts for 15 months and will cover studies to evaluate the feasibility of enzyme encapsulation and preclinical studies of that formu-lation (10/13)

Eyetech Inc.* SurModics Pharmaceuticals Inc. (SRDX)

Licensing and development deal to develop an extended-release formulation of age-related macular degeneration drug Macugen using micropar-ticles technology


Fate Therapeutics Inc.*

BD Biosciences (unit of Becton, Dickinson and Co.; NYSE:BDX)

Collaboration and license agreement to help develop and then distribute commercially IPSC tools and technologies for use in both academic and industry R&D efforts

The deal includes an undisclosed up-front payment, research funding and milestones; the company also is eli-gible for royalties (10/14)

Goodwin Biotechnology Inc.*

Unnamed multina-tional biopharma-ceutical client

Agreement to develop the pro-cess to manufacture a mono-clonal antibody conjugate for diagnostic imaging purposes

It will manufacture the conjugate as a kit for radio-labeling for use in clin-ical trials (10/19)

Horizon Discovery Ltd.* (UK)

Cylene Pharmaceuticals Inc.*

Collaboration to use Horizon’s X-MAN human isogenic cancer cell lines to pinpoint patients who will respond best to C y l e n e ’ s C K 2 i n h i b i t o r , CX-4945

The partnership could result in a sig-nificant reduction in research costs and acceleration of timelines for reg-ulatory approval (10/20)

Immune Design Corp.*

MedImmune Inc.* Licensing agreement for GLA, a Toll-like receptor 4 agonist, to be used by MedImmune as a component in vaccines against infectious diseases

IDC gets an undisclosed up-front fee and is entitled to up to $212M in mile-stones plus royalties on any future product sales (10/27)

Immunovaccine Inc. (CDNX:IMV)

IRX Therapeutics Inc.* (Canada)

Partnership to study IRX’s vac-cines IRX-2 and DepoVax in order to determine whether a combination of the two vac-cines is superior in generating an antitumor immune response



Insight Bioventures India Private Ltd. (India)

Agreement to establish an Indian affiliate of ISCO to develop and commercialize ISCO’s stem cell-derived cor-neal tissue products for blind-ness and visual impairment

The new affiliate will assist in the development of cell systems for drug screening and manufacture ISCO’s Lifeline Cell Technology cul-ture media (10/6)

Isogenica Ltd.* (UK) NovaBiotics Ltd.* (UK)

Agreement to fast-track the development of NovaBiotics’ platform peptide anti-infective technology



Venenum Biodesign LLC*

Agreement to sell its combina-torial chemical library and associated technology, includ-ing an ultra-high throughput s c r e e n i n g p l a t f o r m , t o Venenum

Venenum is buying everything for $1 .8M, paying $1M at the close of the transaction and $800,000 over a two-year period, plus 10% of reve-nues from resulting third-party col-laborations for three years (10/8)






Lumiphore Inc.* Algeta ASA (Norway; OSLO:ALGETA)

Global agreement on incorpo-ration of Lumiphore’s Lumi4 complexes in Algeta’s targeted radiotherapeutics and compan-ion diagnostics

Algeta has an option to the exclusive rights to incorporate its technology into future targeted therapeutics for cancer (10/22)

Millennium Pharmaceuticals Inc.*

Therasis Inc. and Takeda Pharmaceutical Co. Ltd. (Japan)

Research collaboration under which Therasis will use its technology, the Therasis Filter, to investigate and identify key properties of a portfolio of Millennium compounds



Sloning BioTechnology GmbH*

Deal to integrate the Slonomics technology into the existing HuCAL antibody platform

Morphosys paid $26.4M in cash to Sloning’s shareholders (10/8)

NeuroVive Pharmaceutical (Sweden; SSE:NVP)

to-BBB* (the Netherlands)

Deal to jointly develop thera-pies for stroke and other acute neurodegenerative diseases


NovaBiotics Ltd.* (UK)

Isogenica Ltd.* (UK) Partnership to develop new applications for NovaBiotics’ anti-infective drugs

NovaBiotics will work with Isogenica on two research projects, one con-cerning peptide selection and the other will be peptide maturation (10/5)

Nuevolution AS* (Denmark)

Consortium with EpiTherapeutics Aps* (Denmark), ExpreS2ion Biotechnologies* (Denmark) and the research group of Kristian Helin of the Biotech Research & Innovation Centre at the University of Copenhagen

D i s c o v e r y c o l l a b o r a t i o n focused on epigenetic disor-ders

As part of the col laboration, Nuevolution will apply its Chemetics technology to screen hundreds of millions of small molecules (10/7)

PBS-Bio* Endece LLC*, Revalesio Corp.* and Unibioscreen* (Belgium)

Partnerships to analyze the mechanism of PBS-Bio’s anti-cancer drug candidates, and identifying biomarkers to develop as companion diag-nostics


Salix Pharmaceuticals Ltd. (SLXP)

Photocure ASA (Norway; OSLO:PHO)

Exclusive worldwide rights agreement outside the Nordic region to Lumacan for the detection of precancerous and cancerous lesions in the colon

Salix paid $4M up front and may pay an additional $126.5M in milestones, plus royalties, for the drug (10/21)

Sirius Genomics Inc.* (Canada)

Golden Helix Inc.* Partnership to develop a com-p a n i o n d i a g n o s t i c f o r Vasopressin and similar drugs

Golden Helix will contribute its sin-gle nucleotide polymorphism and copy number variant analysis tech-nology to Sirius’s pipeline to identify potential genetic markers in septic shock and related disorders (10/13)






Stemedica International SA* (subsidiary of Stemedica Cell Technologies Inc.)

AnC Bio* (South Korea)

Agreement to form a joint ven-ture with AnC Bio

The JV, to be named StemedicaAnC, will manufacture stem cells devel-oped by Stemedica for ischemic stroke and other degenerative disor-ders (10/6)

Vivus Inc. (VVUS) Meda AB (Sweden; SSE:MEDAA)

Agreement to sell Muse, Vivus’ marketed product for erectile dysfunction, to its European partner, Meda

Meda is buying it for $23.5M, includ-ing a $22M up-front payment and a milestone payment of $1 .5M based on future sales of Muse; Vivus employees affiliated with Muse will join Meda (10/5)

NOVEMBER3SBio Inc. (China; SSRX)

EnzymeRx LLC* Worldwide rights agreement for pegsiticase for all indica-tions

3SBio is paying $6.25M for the rights, and intends to develop it in China (11/30)

Alnylam Pharmaceuticals Inc. (ALNY)

Tekmira Pharmaceuticals Corp. (Canada; TSX:TKM)

Licensing agreement for InterfeRx to discover, develop and commercialize an RNAi therapeutic for treating Ebola virus infection

The deal includes royalties on sales of any resulting product (11/5)

Apeiron Biologics AG* (Austria)

Polymun Scientific GmbH* (Austria)

Exclusive rights agreement to recombinant super oxide dis-mutase from Polymun

The deal is for clinical development of a topical formulation to treat cer-tain inflammatory skin conditions such as skin damage related to can-cer radiation therapy (11/5)


Cold Genesys Inc.* Exclusive, worldwide rights deal to develop and commer-cialize its oncolytic virus tech-nology

BioSante gains a 19.9% ownership in Cold Genesys and a $95,000 up-front cash payment; it also is eligible for undisclosed future milestone and royalty payments (11/18)

BioWa Inc. (subsidiary of Kyowa Hakko Kirin Co. Ltd.; Japan)

Agensys Inc. (affili-ate of Astellas Pharma Inc.; Japan)

L icensing agreement for BioWa’s Potelligent technology for antibody discovery


Compugen Ltd. (Israel; CGEN)


Research collaboration covering a Compugen-discovered oncolo-gy target

Seattle Genetics gets an option for an exclusive worldwide milestone and royalty-bearing license for development and commercialization of monoclonal antibody therapeutics addressing the target (11/1)

DiscoveRx Corp.* Ambit Biosciences* Deal for DiscoveRx to acquire the KINOMEscan kinase screen-ing services division from Ambit

The company said it would further strengthen its position in validated GPCR and kinase assays for high-throughput screening and profiling (11/19)

Eden Biodesign Ltd. (UK; unit of Watson Pharmaceuticals Inc.)

Crucell NV (the Netherlands; CRXL)

Nonexclusive vendor network agreement under which Eden wil l offer i ts ser vices to Crucell’s PER.C6 licensees in the field of vaccines and gene therapy

N o f i n a n c i a l t e r m s w e r e disclosed (11/11)






Fabrus LLC* Ambrx Inc.* Research program to discover antibodies with properties that are optimized for use as anti-body drug conjugates

Ambrx gains exclusive rights to commercialize conjugated forms of the antibodies; Fabrus will receive up-front payments and is eligible for milestone payments and a share of certain payments received by Ambrx in the future (11/10)

Horizon Discovery Ltd.*

Mirna Therapeutics Inc.*

Collaboration to test the impact of Mirna’s miRNA mim-ics on a panel of Horizon’s patient-relevant human isogen-ic cancer cell models

Horizon’s X-MAN human cell lines will be used to test the effects of common mutations in cancer patients on the efficacy of Mirna’s miRNA mimics (11/3)

IntelGenx Corp. (Canada; CDNX:IGX)

PediPharm Ltd.*; Cynapsus Therapeutics Inc. (Canada; CDNX:CTH)

Deal acquiring exclusive, worldwide rights to INT0010 for neuropathic pain in multiple sclerosis and chemotherapy-i n d u c e d n a u s e a f r o m PediPharm

PediPharm will get an up-front fee and milestone payments, plus royal-ties; IntelGenx also made an agree-ment with Cynapsus to receive full control and interest in the drug in exchange for debt forgiveness and royalty payments (11/30)


Xenon Pharmaceuticals Inc.* (Canada)

Deal to discover and develop antisense drugs to treat the common disease anemia of inflammation

Isis will get an undisclosed up-front payment in the form of a convertible promissory note from Xenon to dis-cover and develop antisense drugs to the targets hemojuvelin and hep-cidin (11/17)

Isotechnika Pharma Inc. (Canada; TSX:ISA)

Iljin Life Science Co. Ltd.* (unit of the Iljin Group; South Korea)

Development, distribution and license deal for the further clinical and commercial devel-opment of voclosporin for use in transplant indications

Iljin agreed to fund a single Phase III trial in kidney transplantation through a combination of a $5M license fee and the purchase, in three tranches, of common stock; Iljin gains rights for transplant and auto-immune indications for the U.S. and other regions outside of Canada, Israel, South Africa, Europe, China, Taiwan and Hong Kong; Isotechnika retains rights over voclosporin in Europe (11/17)

London Genetics Ltd.* (UK)

Astrimmune Ltd.* (UK)

Deal to plan a biomarker identi-f i c a t i o n p r o g r a m f o r Astrimmune’s early stage pan-creatic cancer vaccine candi-date


Maxygen Inc. (MAXY) Codexis Inc. (CDXS) D e a l t o s e l l M a x y g e n ’ s MolecularBreeding platform technology to Codexis

Codexis is paying $20M in cash; the sale includes the cancellation of all payment and potential royalty obli-gations of Codexis relating to biofu-els and other energy products (11/1)

Merrion Pharmaceuticals plc (Ireland; PK:MNHPF)

Rebel Pharmaceuticals LLC*

A g r e e m e n t t o e v a l u a t e Merrion’s Gipet technology to improve Rebel’s products

Upon completion of the feasibility study, the companies will execute a license agreement (11/24)

Omeros Corp. (OMER) Patobios Ltd.* (Canada)

Completed acquisition of a GPCR assay technology com-prising patents and other intel-lectual property rights from Patobios

The purchase price was C$10.8 ($10.5M), of which C$7.8M was paid in cash and the remaining was paid in 379,039 shares of Omeros com-mon stock (11/24)






SurModics Inc. (SRDX) Edge Therapeutics Inc.*

Collaboration for a feasibility study of SurModics’ NimoGel for delayed cerebral ischemia

Edge will provide funding for devel-opment and commercialization and SurModics will provide technology and manufacturing expertise ; SurModics will receive licensing fees, milestone payments and royalties (11/5)

DECEMBERAdimab Inc.* Genentech Inc.

(NYSE:DNA), Human Genome Sciences Inc. (HGSI) and Eli Lilly and Co.

Adimab initiated three new research collaborations for the use of its antibody discovery platform technology


AltheaDx Inc.* Compendia Bioscience Inc.*

Partnership to jointly discover novel products and services in the area of cancer biomarkers



Bracco SpA* (Italy) Licensing agreement granting Bracco exclusive rights to mar-ket Vitaros, a topical treatment for erectile dysfunction

Apricus will get up to $7.2M in up-front, regulatory and sales mile-stones, plus tiered, double-digit royalties based on Bracco’s sales of the product (12/23)

Biogen Idec Inc. (BIIB) Neurimmune Holding AG* (Switzerland)

Biogen Idec acquired three pre-clinical immunotherapy pro-grams focused on Parkin-son’s disease, Alzheimer’s disease and amyotrophic lateral sclero-sis

Biogen will pay $32.5M up front and as much as $395M in contingent payments to Neurimmune for a sub-sidiary that includes the worldwide rights to the programs (12/22)


Harvard Apparatus (a division of Harvard Bioscience Inc.; HBIO)

License agreement that gives Harvard the worldwide exclu-sive rights to manufacture and sell, for research use, the full line of electroporation-based instruments, which Cellectis gained in its acquisitions of CytoPulse Sciences Inc.

Cellectis will receive a payment of $1 .3M and retains all rights to the use of the products for its own research and development programs (12/3)

Cephalon Inc. (CEPH) Mesoblast Ltd. (Australia; ASX:MSB)

Deal for exclusive worldwide rights to products based on Mesoblast’s stem cell technolo-gy

Cephalon will pay $130M for the rights, plus milestones that could boost the deal’s value to $1 .7B; Cephalon also will buy 19.99% of Mesoblast’s outstanding shares for a total of about $220M (12/9)

iCo Therapeutics Inc. (Canada; CDNX:ICO)

Immune Pharmaceuticals* (Israel)

Deal for an exclusive license for the development and com-mercialization rights to the systemic uses of iCo-008 in inflammatory bowel disease and severe asthma

iCo will retain worldwide exclusive rights to all ocular applications; IMPH will pay iCo an option fee creditable upon conversion against an up-front license fee payment of $1M; iCo may receive $32M in milestone pay-ments, in addition to royalties on net sales (12/10)







OncoTherapy Science Inc.* (Japan)

Collaborative research agree-ment to explore the efficacy of their peptide cancer antigen in Immuno-vaccine’s DepoVax vaccine delivery and enhance-ment platform


Metamark Genetics Inc.*

HistoRx Inc.* Multiyear licensing agreement w i t h H i s t o R x g r a n t i n g Metamark worldwide rights to the AQUA technology for clini-cal commercial izat ion of Metamark’s prognostic assays


miRagen Therapeutics Inc.*

t2cure GmbH* (Germany)

Licensing agreement that pro-vides miRagen with exclusive rights to the technology and intellectual property related to the in vivo use of discoveries made by the University of Frankfurt and licensed by t2cure regarding microRNA 92

miR-92 is a key regulator of neoan-giogenesis as part of ischemic dis-ease, which may be relevant to peripheral arterial disease and other cardiovascular disorders (12/1)

MonoSol Rx* Midatech Group Ltd.* (UK)

Agreement to form a joint ven-ture to develop products for diabetes



Sarasota Medical Products Inc.*

Binding letter of intent to deter-mine the feasibility of pursuing a joint venture in chronic isch-emic wounds based on the combination of Oxygen’s Wundecyte PFC formulation with SMP’s topical medical devices

Wundecyte is designed to deliver oxygen to a wound alone or in com-bination with a specialized oxygen-ating bandage (12/17)

Paladin Labs Inc. (Canada; TSX:PLB)

ProStrakan Group plc (UK; LSE:PSK)

Agreement in which Paladin will get an exclusive license to ProStrakan’s products for cer-tain emerging territories and will acquire, by way of assign-ment, ProStrakan’s existing secured debt facility with the addition of certain conversion rights

The $78M secured facility will be amended, with capital repayment not due until early January 2014 (12/17)

PolyTherics Ltd.* (UK)

MacroGenics Inc.* C o l l a b o r a t i o n t o a p p l y PolyTher ics ’ s i te -speci f ic pegylation technologies to an initial dual-affinity re-targeting protein for evaluation by MacroGenics

MacroGenics has the option to use PolyTherics’ technologies for addi-tional DART candidates in the future and holds an option to license use of the technologies for further develop-ment and commercialization activi-ties (12/7)

Recordati SpA (Italy; Milan:REC)

Nymox Pharmaceutical Corp. (NYMX)

European licensing agreement for the development and com-mercialization of NX-1207, Nymox’s Phase III drug in devel-opment to treat benign prostat-ic hyperplasia

Recordati will receive exclusive rights to develop and market NX-1207 in Europe, including Russia and the CIS, the Middle East, the Maghreb area of North Africa and South Africa (12/20)






Notes:





Biotech–Biotech Collaborations: Modified Agreements for 2010




JANUARY LaureatePharma Inc.*

Selexis SA*(Switzerland)

Expanded collaboration via a joint-marketing relationship

Aimed at generating highly pro-ductive, stable mammalian cells producing gram quantities of recombinant protein materials in as little as eight weeks, post-trans-fection (1/6)

JubilantBiosys Ltd.*(India)

EndoPharmaceuticals(ENDP)

Expanded drug discovery part-nership in oncology following the successful delivery of an early stage milestone

The year-old partnership focused on Jubilant delivering preclinical oncology candidates; details of the expansion were not disclosed (1/28)


Wacker ChemieAG (Germany; PK:WKCMF)

Expanded collaboration in the use of Wacker’s bacterial secre-tion technology Esetec

MorphoSys will be able to use the technology for the production of antigen material in addition to the production of antibodies in both the early development phase of therapeutic projects as well as in the production of diagnostic and research antibodies (1/21)

Repligen Corp.(RGEN)

GE HealthcareBio-Sciences AB*(Sweden)

Extended relationship in a five-year supply deal to supply recombinant Protein A for use in the manufacture of monoclonal antibodies


FEBRUARY Biogen IdecInc. (BIIB)

SwedishOrphanBiovitrum AB*(Sweden)

Restructured collaboration agreement for long-acting, recombinant Factor VIII Fc fusion protein in hemophilia A patients and recombinant Factor IX Fc fusion protein in hemophilia B patients

The amended terms call for Biogen to assume full development responsibilities and costs, as well as manufacturing rights for both programs; Biogen Idec also gains marketing rights for the rest-of-the-world territories, in addition to its existing commercial rights in North America (2/19)

Durect Corp.(DRRX)

Nycomed A/S*(Denmark)

Amended a 2006 development and license agreement that gives Durect final decision-mak-ing authority and funding responsibility over trials intend-ed for U.S. registration of Posidur

Nycomed will oversee develop-ment in the European Union and other countries; the amendment also expands the territories licensed to include China, Hong Kong, Malaysia, the Philippines, Singapore, Taiwan, Vietnam, Thailand, Indonesia, India and Venezuela (2/23)



Biotech–BiotechCollaborations:ModifiedAgreements





CubistPharmaceuticalsInc. (CBST)

Extended research agreement to the end of the year; Evotec will provide additional fragment-based drug discovery expertise using its EVOlution platform, which includes fragment screen-ing, structural biology and pro-tein crystallography

They will work to discover and profile new compounds against additional antibacterial targets selected by Cubist (2/26)


Galapagos NV(Germany; BR:GLPG)

Expanded antibody alliance in bone and joint diseases, adding a fourth antibody target to the alliance

The alliance was created in 2008 to discover and develop therapeu-tics against diseases such as rheu-matoid arthritis, osteoporosis and osteoarthritis (2/19)

APRIL MaxCyte Inc.* Medinet Co. Ltd.*

(Japan)Amended license, develop-ment and supply agreement for expansion of Medinet’s right to use MaxCyte’s cell loading tech-nology in Asia Pacific markets

It allows Medinet to further co-develop new technologies for intractable diseases in addition to cancer, as well as to enhance demand for ImmunoCell Therapy outside of Japan in the Asia Pacific markets (4/12)

RadientPharmaceuticalsCorp. (AMEX:RPC)

GenWay BiotechInc.*

Extended partnership to exclu-sively, market, sell and distrib-u t e O n k o - S u r e i n v i t r o diagnostic cancer test in Russia and the former Soviet Republics

The agreement is for five years (4/12)

MAY S*BIO Pte Ltd.* (Singapore)

Onyx Pharmaceuticals Inc. (ONXX)

Expanded development collabo-ration and option and license commercialization agreement for S*BIO’s JAK2 inhibitors, SB1518 and SB1578

Onyx is providing $20M in funding to broaden and accelerate the existing development program (5/6)

JUNE CelatorPharmaceuticalsInc.*

Cephalon Inc.(CEPH)

Expanded research agree-ment using Celator’s tech-nology in an ongoing drug development and life-cycle management program at Cephalon

No other details were disclosed (6/23)

MonoSol Rx* Midatech Group*(UK)

Expanded deal to develop nanoparticle-based proteins and peptides for therapeutic deliv-ery using pharmaceutical films

MonoSol made an equity invest-ment in Midatech (6/25)

AUGUST Inspire Pharmaceuticals Inc. (ISPH)

Allergan Inc. (NYSE:AGN)

Amended marketing agreement that gives Inspire sole control over future development of Prolacria

The deal runs through Dec. 31 , 2020; Inspire is entitled to receive revenues based on net sales of Restasis and any other human oph-thalmic formulation of cyclospo-rine owned or controlled by Allergan (8/30)






Lexicon Pharmaceuticals Inc. (LXRX)

Symphony Capital LLC*

Lexicon bought back rights to LX6171 for cognitive disorders, LX1031 for irritable bowel syn-drome and LX1032 for gastroin-testinal disorders

Lexicon paid $10M up front and will make deferred payments of $50M, minus a 50% share of the expenses incurred by Lexicon up to an aggregate reduction of $15M, plus contingent payments of up to $30M (8/3)

NsGene AS* (Denmark)


Expanded license and commer-cialization agreement giving Biogen extended rights to Neublastin

Deal secures $6M up front, for NsGene, plus an annual mainte-nance fee of $1 .5M in the years it doesn't receive a development milestone and until acceptance of the first regulatory filing (8/11)

SEPTEMBER Argenta Discover Ltd.* (UK; division of Galapagos NV; BR:GLPG)

Genentech Inc. (NYSE:DNA; unit of the Roche Group)

Contract extension to expand the portfolio of projects in the collaboration

Genentech gains integrated medic-inal chemistry, in vitro biology and ADME services (9/13)

OCTOBER BioAlliance Pharma SA (France; Paris:BIO) and Strativa Pharmaceuticals

Swedish Orphan Biovitrum AB (Sweden; PK:SWTUY)

Amended and restated license and supply agreement covering the European development and commercialization rights of Strativa’s Nascobal (cyanocobal-amin) Vitamin B12 Nasal Spray

Swedish Orphan will conduct and pay for all development activities for European regulatory approval (10/27)

Biogen Idec Inc. (BIIB) Genentech Inc. (NYSE:DNA)

Modified deal for anti-CD20 anti-bodies with Biogen handing off sole responsibility of ocrelizum-ab while upping its co-develop-m e n t p a r t i c i p a t i o n i n next-generation antibody GA101

Genentech will shoulder full devel-opment costs, and Biogen remains eligible for tiered, double-digit roy-alties on U.S. sales of the com-pound; the agreement also clears up profit-sharing arrangements for Rituxan and GA101

Labopharm Inc. (Canada; DDSS)

Paladin Labs Inc. (Canada; TSX:PLB)

Expanded relationship for Paladin to distribute two of Labopharm’s products in certain jurisdictions



Affitech AS (Denmark; CSE:AFFI)

Amended worldwide license agreement for Brazil, Russia and o t h e r c o u n t r i e s o f t h e Commonwealth of Independent States (CIS) to develop a fully human antibody called AT001/r84

Peregrine and Affitech will reinvest their portions of any future mile-stone payments toward the further advancement of the product; if Affitech enters into a licensing deal for AT001/r84 in a major pharma-ceutical market, it will reimburse Peregrine for its milestone pay-ments applied to the program, and Affitech would be eligible for reim-bursement for up to 50% of its development costs (10/1)

NOVEMBER Clavis Pharma ASA (OSLO:Clavis)

Clovis Oncology Inc.*

Expanded partnership for CP-4126 to include Asian coun-tries and the rest of the world

The expansion comes a year after partnering American and European rights to the drug designed to be an improved formulation of che-motherapeutic drug Gemzar (11/12)






Epigenomics AG (Germany; PK:EPGNF)

Predictive Biosciences Inc.*

Extended licensing agreement for the prostate cancer biomark-er GSTP1

Predictive obtained rights to devel-op a prostate cancer test incorpo-rating the DNA methylation biomarker and has now exercised its option to license GSTP1 for com-mercialization of the test, trigger-ing a one-time license fee (11/17)

Swedish Orphan Biovitrum AB (Sweden; LSE:OMTD)

Amgen Inc. (AMGN) Agreement for Swedish Orphan to sell back its co-promotion rights in the Nordic countries for Mipara to treat secondary hyper-parathyroidism in patients with chronic kidney disease on dialy-sis

Swedish Orphan will receive an undisclosed payment from Amgen (11/8)

DECEMBER Amsterdam Molecular Therapeutics BV* (the Netherlands)

Amgen Inc. (AMGN) Amended and restated agree-ment for applications of its glial cell-derived neurotrophic factor gene


BioFocus (UK; services division of Galapagos NV, of Belgium; BR:GLPG)

Amgen Inc. (AMGN) Extended contract for 2011 and 2012, with an expansion to include target discovery and val-idation services

BioFocus will receive $2.6M in research fees for the first year and is eligible to receive payments of access fees and success-based milestones (12/20)

NovaBay Pharmaceuticals Inc. (AMEX:NBY)

Galderma SA* (Switzerland)

Expanded multiyear collabora-tion agreement under which Galderma agreed to exercise its option to advance the clinical development program for Aganocide compounds against impetigo

Galderma will pay a $3.25M contin-uation fee together with additional R&D funding in 2010 and 2011; NovaBay has the potential to receive up to $62M in milestones, as well as escalating double-digit royalties (12/7)

OSI Pharmaceuticals Inc. (subsidiary of Astellas U.S. Holding Inc.; FSE:OS1)

AVEO Pharmaceuticals Inc. (AVEO)

Exercised option under a July 2009 agreement providing the right for OSI to internalize cer-tain elements of AVEO’s technol-ogy platform

OSI will pay AVEO $25M in license expansion fees (12/2)

Transition Therapeutics Inc. (Canada; TTHI)

Elan Corp. plc (Ireland; NYSE:ELN)

Modified collaboration for the development and commercial-i z a t i o n o f E L N D 0 0 5 f o r Alzheimer’s disease

Elan will pay $9M upon signing with potential $11M payment on commencement of the next clinical trial; Transition is eligible for up to $93M in additional milestone pay-ments, plus tiered royalties of 8% to 15% of net sales (12/28)

Notes:





Biotech–Biotech Collaborations: Terminated Agreements in 2010




JANUARY TopigenPharmaceuticalsInc.* (Canada)

NicOx SA(France; Paris:COX)

Terminated collaboration forTPI 1020, which has complet-ed a Phase II asthma trial that fell short of showing statistical significance

The decision was made as a result of Topigen’s proposed acquisition by Pharmaxis Ltd. (1/13)

FEBRUARY AmbriliaBiopharma Inc.(Canada; TSX:AMB)

SurModicsPharmaceuticalsInc. (unit ofSurmodics Inc.;SRDX)

Terminated development and commercialization deal for octreotide

SurModics claimed that Ambrilia, which is in bank-ruptcy and recently halted a Phase III trial of the drug in acromegalic patients, has breached its contract (2/17)


Genoway SA(France; Paris:ALGEN)

Terminated their 2001 sublicense agreement relating to patents and patent appli-cations belonging to the pool WO90/11354

The license included use of homologous recombination for the development of cel-lular and animal models (2/19)

MARCH ExonHitTherapeuticsSA (France;Paris:ALEHT)April

bioMerieux(France; Paris:BIM)

Terminated collaboration in colon cancer

The decision follows a review of data by their sci-entific committee; they con-tinue to collaborate in the field of prostate cancer (3/9)

APRIL FemPharmPty Ltd.*(Australia)

Vivus Inc.(VVUS)

Terminated a 2004 develop-ment and commercialization agreement for Luramist

Vivus said it was returning the rights to FemPharm to focus on developing Qnexa for obesity and avanafil for erectile dysfunction (4/1)

JUNEAlphaRx Inc.(OTC BB:ALRX)

Cypress Bioscience Inc.(CYPB)

AlphaRx is regaining all rights to Indaflex to reduce the symptoms of osteo-arthritis of the knee

AlphaRx originally licensed i t to Proprius Pharma-c e u t i c a l s , w h i c h w a s acquired by Cypress; it intends to find a new part-ner (6/30)

JULYCornerstoneTherapeuticsInc. (CRTX)

MedImmuneLLC*

Cornerstone reacquired all development and commer-cial rights to its high-mobility group box protein 1 related t e c h n o l o g y f r o m MedImmune

Cornerstone plans to find a new partner (7/7)


Biotech–BiotechCollaborations:TerminatedAgreements





AUGUSTCerus Corp. (CERS) BioOne Corp.* (Japan) Ended their commercial

rights agreement for the Intercept Blood System for inactivating bloodborne pathogens in blood transfu-sions

Cerus previously licensed the rights to BioOne for certain Asian markets; Cerus will transfer 1 . 17M shares of Cerus common stock, plus its equity interest in BioOne in order to regain those rights (8/30)

Numerate Inc.* Intellikine Inc.* Completed their research collaboration to discover small-molecule compounds targeting the P13K/mTOR signaling pathway

The collaboration combined Intellikine's capabilities in X-ray crystal structure-guid-ed medicinal chemistry and d r u g d i s c o v e r y w i t h Numerate's computational drug design platform to identify inhibitors of P13 kinase alpha (8/12)

OCTOBERAcadia Pharmaceuticals Inc. (ACAD)

Biovail Laboratories International SRL (subsid-iary of Valeant Pharmaceuticals International Inc.; NYSE:VRX)

Terminated deal to develop and commercialize pima-vanserin in the U.S. and Canada

Acadia has regained all rights to pimavanserin and will receive a one-time cash payment of $8.75M (10/29)



Terminated deal for AZ-004 (Staccato loxapine) to treat agitation in schizophrenic or bipolar patients

Alexza regained U.S. and Canadian rights a week after the FDA issued a complete response letter, citing safety concerns (10/21)

Santhera Pharmaceuticals AG (Switzerland; SWX:SANN)


Terminated deal for U.S. and Canadian rights for fipa-mezole to treat dyskinesia in Parkinson’s disease

Santhera regained the rights due to a shift in strategic focuse of the new Valeant group (10/26)

NOVEMBERBiogen Idec Inc. (BIIB) Cardiokine Inc.* Terminated agreement for

Cardiokine’s hyponatremia drug lixivaptan

Cardiokine received $50M up front from the 2007 col-laboration, but will have to forgo about $170M in mile-stones due to Biogen Idec’s restructuring plan (11/5)

MedGenesis Therapeutics Inc.* (Canada)


Terminated deal for glial cell line-derived neurotrophic factor protein and related C o n v e c t i o n E n h a n c e d Delivery technology

MedGenesis regained all rights to the product and received a one-time cash payment of $5M to acceler-ate development of the drug in Parkinson’s disease (11/9)

Notes:





Manufacturing, Marketing And Distribution Agreements Between Biotech Companies in 2010




JANUARY AgilentTechnologies Inc.(NYSE:A)

Covaris Inc.* Co-marketing agreement in which Covaris S2 DNA shearing technology will be marketed with the Agilent SureSelect Target Enrichment System to streamline next-generation sequencing experiments


Alcon Inc.(Switzerland;NYSE:ACL)

SirionTherapeuticsInc.*

Agreement to purchase U.S. rights for two FDA-approved topical eye care products from Sirion

The products are Durezol and Sirgan; Alcon also acquired the global rights, excluding Latin America, for Zyclorin, in devel-opment to treat dry eye and other ocular surface diseases (1/20)

EpiCept Corp.(EPCT)

Meda AB(Sweden; SSE:MEDAA)

Exclusive commercializationagreement to promote the acute myeloid leukemia drug Ceplene outside the U.S.

EpiCept is getting a $3M fee and an additional $2M upon the first commercial launch of Ceplene in a major European market; it also will get $5M through a regulatory milestone and up to $30M in sales-based milestones (1/12)

Jubilant BiosysLtd.* (India)

DiscoveRx Corp.* Co-marketing agreement to pro-vide screening solutions

The deal allows Jubilant access to DiscoveRx’s PathHunter and cAMPHunter cell lines and EFC chemilumiscent detection tech-nology (1/12)

Movetis NV(Belgium; BR:MOVE)

QuintilesTransnationalCorp.*

Alliance to commercialize Resolor in the UK and Germany


XbraneBiosciences AB*(Sweden)

VaxiionTherapeuticsInc.*

Licensing arrangement granting Xbrane rights to Vaxiion’s protein production system, the Rhamex System

The agreement enables Xbrane to distribute and sell the pro-tein expression system for both research and commercial pur-poses in addition to using the system for their in-house pro-tein production services busi-ness (1/20)

FEBRUARYBTG plc (UK;PK:BTGGF)

PaladinLabs Inc.(Canada; TSX:PLB)

Deal selling exclusive Canadian rights to DigiFab to Paladin Labs

DigiFab is approved in the U.S. and is under review in Canada as an antidote for digoxin tox-icity (2/26)


Manufacturing,MarketingAndDistributionAgreementsBetweenBiotechCompanies






Meda AB(Sweden; SSE:MEDAA)

Commercial ization deal for Medivir’s cold sore product, which will be marketed in North America under the trade name Xerese

Meda gets the exclusive rights to market, sell and distribute Xerese in the U.S., Canada and Mexico for the treatment of cold sores; Meda will pay $5M in up-front and pre-launch mile-stones and double-digit royal-ties (2/17)

MARCH Biocrates LifeSciences AG*(Austria)

Chenomx Inc.*(Canada)

Co-marketing agreement to iden-tify and quantify endogenous metabolites in body fluid or tis-sue samples

The companies will develop them into biomarkers (3/11)

Caleco PharmaCorp. (OTC BB:CAEH)

Natac Biotech SL*(Spain)

Licensing agreement for North and South American rights to five plant-derived compounds for metabolic disease and inflamma-tion

Caleco will pay Natac 5% royal-ties on the drugs (3/18)

Cellceutix Corp.(OTC BB:CTIX)

Formatech Inc.* Agreement to formulate cancer drug Kevetrin for a Phase I study


Pro-Pharma-ceuticals Inc.(AMEX:PRW)

Procaps SA*(Colombia)

Agreement granting exclusive Columbian rights to market and sell Davanat

Pro-Pharmaceuticals is eligible to receive undisclosed pay-ments and royalties (3/30)

Sanofi-AventisDeutschlandGmbH (Germany;Paris:SAN)

NovalarPharmaceuticalsInc.*

Exclusive license and distribution agreement in which Sanofi-Aventis will have the right to commercia l ize and market Novalar’s OraVerse in Germany with options to extend the license to other European countries

Sanofi-Aventis will pay up-front and milestone payments, plus royalties (3/4)

SinovacBiotech Ltd.(China; SVA)

Parenteral BiotechLtd.* (India)

Exclusive license, supply and dis-tribution deal for seasonal flu vaccine Anflu and its pandemic H1N1 flu vaccine Panflu 1


SpePharmHolding BV*(the Netherlands)

Paladin Labs Inc.(Canada; TSX:PLB)

Agreement licensing out rights to Savene for com-mercialization in South Africa and Israel to Paladin

Paladin is making an invest-ment in SpePharm by way of secured convertible debentures (3/5)

SpePharmHolding BV*(the Netherlands)

TopoTarget A/S(Denmark;CSE:TOPO)

Agreement for marketed product Savene, a topoisom-erase II inhib-itor approved in Europe to coun-ter chemo-therapy extravasations

SpePharma also is picking up TopoTarget’s European sales force (3/5)

APRIL BAC BV* LFB Biotech-

nologies* (subsid-iary of LFB SA;France)

Extended license agreementto cover the use of BAC’s antiFac-tor VIIa CaptureSelectaffinity ligand in the large-scale purification of recom-binant human Factor VIIa







CumberlandPharmaceuticalsInc. (CPIX)

AlvedaPharmaceuticalsInc.* (Canada)

Deal to commercialize Caldolor in Canada

Alveda will seek Canadian approval, and Cumberland will be entitled to up-front, mile-stone and royalty payments (4/29)

GTC Biothera-peutics Inc.(OTC BB:GTCB)

Bio Sidus SA*(Argentina)

License agreement for GTC’s ATryn

Bio Sidus will be responsible, including all expenses, for seek-ing sales authorizationsfor the drug in Argentina, Uruguay and Paraguay (4/14)


Avid BioservicesInc.* and Cook PharmicaLLC*

Commercial supply agreements for the production of recombi-nant human hyaluronidase to be used in the manufacture of cur-rent products and partnered products

It includes the manufacture of subcutaneous Herceptin and Gammagard with rHuPH20 (4/6)

MAY International Stem Cell Corp.(OTC BB:ISCO)

AutomationPartnership*

Alliance to automate and scale up the production of stem cell-derived human corneal tissue


OptimerPharmaceuticalsInc. (OPTR)

Biocon Ltd.(India; Bombay:BIOCON)

Long-term supply agreement for the commercial manufacturing of the active pharmaceutical ingre-dient fidaxomicin, Optimer’s lead candidate for Clostridium difficile infection

Terms of the deal were not dis-closed (5/25)

JUNE TrojanTechnologiesUSA*

Trojantec Ltd.*(UK)

Licensing agreement under which Trojan was granted exclusive rights to commer-cialize the Antennapedia protein transduc-tion technology

Trojan can commercialize it in the field of prevention, diagno-sis and/or treatment of infec-tious diseases (6/14)

JULY Access Pharmaceuticals Inc. (OTC BB:ACCP)

BioScrip Inc. (BIOS) Distr ibution agreement for MuGard, an oral wound rinse for the management of oral mucosi-tis

A c c e s s g a i n s a c c e s s t o BioScrip's nationwide distribu-tion platform (7/21)


NerPharMa DS*(Italy)

Manufacturing agreement for CTI’s drug candidate pixantrone

The five-year contract provides for the commercial and clinical supply of pixan-trone, a treat-ment for non-Hodgkin’s lym-phoma (7/15)

ClinuvelPharmaceuticalsLtd. (Australia; ASX:CUV)

Surmodics Inc.(SRDX)

Manufacturing agreement for its photoprotective drug Scenesse (afamelanotide)


GeneNews Ltd.(Canada;TSX:GEN)

GeneDiagnosticsInc.* (South Africa)

Marketing partnership agreement to market ColonSentry in China

ColonSentry is a blood-based test to determine risk for colorectal cancer (7/1)


Sristi Biosciences Ltd.* (India)

Distr ibution agreement for human cell culture products








Genekor SA* (Greece) Exclusive distribution deal for diagnostic tests


Selvita sp* (Poland) Rottapharm Madaus SpA* (Italy)

Services contract to deliver to Rottapharm a set of designed and synthesized compounds


SurModics Inc. (SRDX) EGEN Inc.* Feasibility collaboration focused on long-term controlled release of siRNA complexes

The collaboration is being con-tinued and involves EGEN's TheraSilence nanoparticles in combination with SurModics' Eureka DUET platform (7/28)

SynCo Bio Partners* (the Netherlands)

Versartis Inc.* Collaboration to manufacture its once-monthly human growth hor-mone VRS-317

SynCo also will provide fill and finish services for the manufac-ture, testing and release of for-mulated drug product vials (7/30)

AUGUST Stellar Pharmaceuticals Inc. (Canada; OTC BB:SLXCF)

Laboratorios Inibsa SA* (Spain)

Agreement to distribute Uracyst for painful bladder syndrome in Spain

Inibsa will pay Stellar an up-front license fee and a specified transfer price (8/2)

SEPTEMBER DSM BioSolutions* PolyTherics Ltd.*

(UK)Partnership to manufacture HiPeg IFN alpha-2a

The companies will adapt PolyTherics’ pegylation method to develop a large-scale process for preclinical and clinical development (9/8)

Edimer Pharmaceuticals Inc.*

CMC Biologics A/S* (Denmark)

Manufacturing contract to sup-port the development of EDI200 for the treatment of X-linked hypohidrotic ectodermal dyspla-sia


Nabi Biopharmaceuticals Inc. (NABI)

Diosynth RTP Inc.* Five-year commercial manufac-turing agreement for the manu-facture of a drug substance integral to the production of NicVAX, Nabi’s vaccine to treat nicotine addiction and prevention of smoking relapse


Santarus Inc. (SNTS) S2 Therapeutics Inc.* and VeroScience LLC*

Distribution and license agree-ment granting Sant-arus exclu-sive rights to manufacture and commercialize Cycloset in the U.S.

Santarus is paying $5M up front to S2 and VeroScience and will pay a product royalty of 35% of the gross margin associated with net sales up to $100M of cumulative total gross margin, increasing to 40% therafter (9/10)

Synthecon Inc.* Biomerix Corp.* Distribution agreement for three-dimensional cell culture scaffolds developed using Biomerix’s bio-material technology







OCTOBER Phosphagenics Ltd. (Australia; ASX:POH)

Calzada Ltd. (former-ly Metabolic Pharmaceuticals; Australia; ASX:CZD)

Licensing deal to launch a cosme-ceutical product containing C a l z a d a ’ s o b e s i t y p e p t i d e AOD9604 in combination with TPM delivery technology

Phosphagenics plans to refor-mulate the oral compound into a topical cream (10/20)

ThromboGenics NV (Belgium; BR:THR)

MSD Biologics Ltd.* (UK)

A 10-year supply deal for the pro-duction of microplasmin


NOVEMBER Horizon Pharma Inc.* Mundipharma

International Corp. Ltd.* (UK)

Exclusive distribution and supply agreements for commercializa-tion of Lodotra in Australia, China, Hong Kong, Indonesia, Korea, Malaysia, New Zealand, the Philip-pines, Singapore, South Africa, Taiwan, Thailand and Vietnam

Lodotra is a programmed-release formulation of low-dose prednisone; financial terms were not disclosed (11/8)

Nautilus Neurosciences Inc.*

Tribute Pharmaceuticals* (Canada)

Exclusive license agreement for the commercialization of Cambia in Canada

Cambia is approved in the U.S. for migraine (11/17)

DECEMBER Advanced Cell Technology Inc. (OTC BB:ACTC)

Roslin Cells Ltd.* (Scotland)

Memorandum of understanding to establish a bank of good manu-facturing practice-grade human embryonic stem cell lines using ACT’s single-ceblastomere tech-nique for deriving embyronic stem cells without damage to the embryo


ImVisioN Therapeutics AG* (Switzerland)

IDT Biologika* (Germany)

Partnership for manufacturing of ImVisioN’s immunotherapy prod-uct candidates

Specific financial terms were not disclosed, though IDT plans to make an equity investment in ImVisioN (12/17)

Notes:





Collaborations Between Biotechnology Companies AndGovernment/Nonprofit Institutions In 2010


University/Nonprofit@

Type of Agreement

Product Area Details (Date)

FIRST QUARTER AcetylonPharmaceuticalsInc.*

HarvardUniversity andthe Dana-Farber CancerInstitute

Licensingagreement

To a platform technology and chemical methodology f o r c o n d u c t i n g h i g h -throughput screening and lead optimization for his-tone deacetylase inhibitor compounds, as well as small-molecule selective HDACs

The license includes rights to the first selective inhibi-tor of HDAC6 (3/9)

AC Immune SA(Switzerland)

State Universityof Moscow

Licensingagreement

For an AMPAkine memory enhancer


Advanced CancerTherapeutics*

Department ofMedicine at theUniversity of Louisville’sJames GrahamBrown CancerCenter

Agreement To accelerate the identifica-tion of new clinical candi-dates for the prevention and treatment of cancer


Algeta ASA(Norway; Oslo:ALGETA)

Institute forEnergyTechnology

Collaboration For the manufacture and supply of Alpharadin for future commercial use and clinical trials


Asuragen Inc.* University ofPittsburghMedical Center,Brigham andWomen’sHospital, theH. Lee MoffittCancer Center,Dartmouth’sHitchcock MedicalCenter and theUniversity ofSherbrooke

Researchagreements

To develop a microRNA-based diagnostic test to aid the detection of pancreaticcancer from fine-needle aspirate biopsies

The studies will be used to expand Asuragen’s current pancreatic cancer test pro-gram (2/2)

AvilaTherapeuticsInc.*

Leukemia &LymphomaSociety

Collaboration To support development of AVL-292 for B-cell cancers

The society will provide up to $3.2M (3/30)

Benitec Ltd.(Australia; ASX:BLT)

CommonwealthScientific andIndustrialResearch Organization

Agreement Terminating a previous capi-tal growth agreement and commercial agreement in exchange for pro-viding CSIRO with a 10% equity stake in Benitec

Under the new agreement, 50% of CSIRO shares will be held in escrow for six months and the remaining 50% will be held in escrow for 12 months (1/5)



CollaborationsBetweenBiotechnologyCompaniesAndGovernment/NonprofitInstitutions



Type of Agreement


Biovista Inc.* FDA Licensingagreement

For its technology platform to help analyze, identify and better understand the way certain drugs can cause harmful side effects

The agency will test the Adverse Event Analysis technology, with the goal of predicting which patients may be most likely to expe-rience adverse reactions to certain classes of drugs (1/13)

California StemCell Inc.*

ALS TherapyDevelopmentInstitute

Extendedcollaboration

Aimed at advancing a poten-tial stem cell therapy for amyotrophic lateral sclero-sis

ALS TDI will use CSC’s Motor-Graft, a high-purity line of stem cells, to deliver gene expression modifying payloads to specific loca-tions within the central ner-vous system (2/3)

Celera Corp.(CRA)

University ofCalifornia

Licensingagreement

For Celera’s KIF6 discoveries The gene encodes a kinesin-like protein 6 and studies have shown an association between the gene and car-diovascular risk and statin benefit (1/13)


French NationalInstitute forAgriculturalResearch

Agreement To work together in a num-ber of fields including cell biology, plant and animal biotechnology

The nonexclusive partner-ship will be developed in the field of genome engineering (1/20)

Corgenix MedicalCorp. (OTC BB:CONX)

TulaneUniversity


To combat viral hemorrhag-ic fever

It will generate an additional $800,000 in contract reve-nue for Corgenix over the life of the contract (2/9)

CornerstonePharmaceuticalsInc.*


Collaboration To apply its Emulsiphan can-cer selective delivery nano-technology platform to a class of agents developed at NCI’s Center for Cancer R e s e a r c h N a n o b i o l o g y Program

The collaboration will focus on evaluating the potential of the combined technolo-gies in reducing tumors (3/24)

CreativeAntibioticsSweden AB(Sweden; SSE:CAS)

UniversiteCatholique deLouvain (Belgium)

Materialtransferagreement

For researchers to test the company’s substances on the Pseudomonas bacterium


ERYtech Pharma(France)

M.D. AndersonCancer Center

Collaboration In the field of personalized m e d i c i n e f o c u s e d o n ERYtech’s product, Graspa

ERYtech has identified a can-didate biomarker, aspara-gine synthetase, that may p r e d i c t L - A S P a c t i v i t y against solid tumors (2/17)


CHDI FoundationInc.


Aimed at finding new treat-ments for Huntington’s dis-ease

The collaboration will pro-vide Evotec with up to $37.5M in research funding over the next three years (1/15)





Type of Agreement


FormaTherapeuticsInc.*

Leukemia &LymphomaSociety

Partnership To discover and develop small-molecule compounds against Bcl-6

The collaboration expands upon the partnership previ-ously formed in July, and LLS has committed substantial multiyear funding to sup-port the work as part of its T h e r a p y A c c e l e r a t i o n Program (3/16)

GenoceaBiosciences Inc.*

University ofWashington andthe Fred Hutch-inson CancerResearch Center

Licensingagreement

For 25 pending and issued patents related to herpes simplex virus type 2 anti-gens

The patented antigens will be used in HSV vaccine development; terms were not disclosed (2/24)

GenoceaBiosciences Inc.*

Children’s Hospital Boston

Licensingagreement

F o r a p o r t f o l i o o f Streptococcus pneumoniae antigens

Genocea retains exclusive rights to create vaccines incorporating the antigens for developed countries, while it shares rights with nonprofit PATH for develop-ing countries (3/19)

GenVec Inc.(GNVC)

Department ofHomeland Security

Contract To continue the develop-ment of adenovector-based vaccines against foot-and-mouth disease

GenVec will receive $3.8M in the first year and an addi-tional $700,000 if DHS exer-cises its renewal option under the contract (2/22)

Geron Corp.(GERN)

University ofCaliforniaDiscoveryResearch andTraining Grant

Collaboration To investigate the therapeu-tic potential of Geron’s human embryonic stem cell-based product, GRNOPC1 , for Alzheimer’s disease

GRNOPC1 will be evaluated in models of Alzheimer’s disease to see if memory recovers (1/27)

Health DiscoveryCorp. (OTC BB:HDVY)

Pancreas, Biliaryand Liver SurgeryCenter of NewYork

Exclusiveagreement

To develop new molecular diagnostic tests for the early detection of pancreatic can-cer

The center will provide all specimens from their col-lected specimen banks, specimens on a l l new patients and all associated clinical and outcomes data (2/8)

HorizonDiscovery Ltd.*(UK)

TranslationalGenomicsResearchInstitute

Agreement To develop human disease models for use in TGen’s cancer research

The collaboration and subli-censing deal will allow TGen i n v e s t i g a t o r s t o u s e Horizon’s GENESIS and X-MAN technologies to search for new drug targets, biomarkers and anticancer agents (2/2)

HorizonDiscovery Ltd.*(UK)

University ofMinnesota

Worldwide,exclusiverights agreement

To a panel of human isogen-ic cell models of DNA dam-age repair developed at the university

Those lines will be added to Horizon’s library of X-MAN cell models for drug discov-ery research (3/16)

ImmaticsBiotechnologiesGmbH* (Germany)

Cancer ResearchUK

Collaboration For the further development of Immatics’ therapeutic cancer vaccine IMA950 in glioblastoma

Cancer Research UK will sponsor and conduct a Phase I trial of IMA950 to be carried out at leading glio-ma research centers in the UK (2/17)





Type of Agreement



Fred HutchinsonCancer ResearchCenter

Agreement To conduct clinical trials of adult stem cell compound Homspera for cancer immu-notherapy

The center will raise $30M for the project (2/11)



Agreement To begin studies using ImmuneRegen’s Homspera

The NIH will perform explor-atory studies on Homspera relating to mucosal immuni-ty that might lead to evalua-t ion in models of HIV infection (1/28)

Inovio BiomedicalCorp. (AMEX:INO)

University ofPennsylvania

Expandedlicenseagreement

Adding exclusive worldwide licenses for technology and intellectual property for novel DNA vaccines against pandemic influenza


Isogenica Ltd.*(UK)

UK Ministry ofDefence

Agreement For the development of anti-microbial peptide drugs

The ministry has assigned all patent rights and know-how associated with the antimicrobial peptides for commercial use to Isogenica (2/17)

Kyto BiopharmaInc. (Canada;OTC BB:KBPH)

ResearchFoundation ofthe StateUniversity ofNew York

Licensingagreement

Granting Kyto patent rights to the transcobalamin recep-tor and to an additional broad group of other pat-ents

The patents relate to Kyto’s research and development strategy for the treatment of cancer (3/5)

LifeTechnologiesCorp. (LIFE)

TranslationalGenomicsResearchInstitute andUS Oncology

Collaboration To sequence the genomes of 14 patients afflicted with tri-ple negative breast cancer whose tumors have pro-gressed despite multiple other therapies

The goal is to demonstrate whether genomic sequenc-ing of cancer tissue can pro-vide clues for treatment strategies for those individ-uals (3/8)

MabCure NV(Belgium; subsidiaryof MabCure Inc.)

RamathibodiHospital ofMahidolUniversity(Thailand)

Clinicalresearchagreement

For a study aimed at evaluat-ing the company’s panel of anti-ovarian MAbs in diag-nosing the presence of ovar-ian cancer

Specific terms were not dis-closed (1/7)

Melior DiscoveryInc.*

Rett SyndromeResearch Trust

Collaboration To screen drug candidates in an in vivo model of Rett syn-drome

The disorder is caused by alterations of an X-linked gene, MECP2 (3/31)

NanoViricides Inc.(OTC BB:NNVC)

University ofCalifornia,Berkeley

Research anddevelopmentagreement

To evaluate the effective-ness of nanoviricides drug candidates against various dengue viruses

Cell culture models as well as in vivo animal studies will be employed (2/17)

NellOneTherapeuticsInc.*

Oak RidgeNationalLaboratorycontractorUT-Battelle

Licensingagreement

For patents on inventions based on the Nell-1 gene

The protein therapy treat-ment under development takes advantage of the Nell-1 gene’s cell-signaling path-way that controls tissue growth and maturation in mammalian organs (2/1)





Type of Agreement



University ofMichigan

Sponsoredresearchagreement

To evaluate bone defect repairs using human stem cells

The one-year project will be funded through the pro-ceeds of a $108,746 grant from the National Institutes of Health (3/5)

OPKO HealthInc. (AMEX:OPK)

Centro deInvestigacion yAsistenciaTecnologicaDiseno delEstado deJalisco (Mexico)

Collaboration To develop and manufacture vaccines for flu, dengue fever and West Nile virus


OxfordBioMedica plc(UK; LSE:OXB)

ALS TherapyDevelopmentInstitute


Aimed at advancing the development of Oxford BioMedica’s preclinical gene therapy candidate, MoNuDin

It also will evaluate other gene-based strategies for the treatment of amyo-trophic lateralsclerosis (1/28)

Proteacel LLC* Moffitt CancerCenter

Licensingagreement

F o r t h e P e r f o r a t i o n Optimization and Repair Enhancement gene delivery technology

Proteacel will initially pro-vide contract cell transfec-tion ser vices and later assays (3/19)


Johns HopkinsUniversity

Global andexclusivelicense

For biomarker P13K to devel-op real-time PCR and end-point PCR assays


PharmAthene(AMEX:PIP)

BiomedicalAdvancedResearch andDevelopmentAuthority

Modifiedcontract

To develop its next-genera-tion SparVax anthrax vac-cine

PharmAthene could receive up to an additional $78.4M in government funding (2/24)

Principio Inc.* Johns HopkinsSidney KimmelComprehensiveCancer Center

Exclusivelicense

To several technologies developed at the center, including imaging and radio-therapeutic agents for Epstein-Barr virus-associat-ed tumors and prostate can-cer


RXi Pharma-ceuticals Corp.(RXII)

University ofMassachusettsMedical School

Researchcollaboration

To focus on the application of RXI’s self-delivering RNAi compounds for ocular dis-eases such as age-related macular degeneration

The collaboration aims to further advance the compa-ny’s therapeutic platform by evaluating the delivery and silencing activity of sd-rxR-NAs in preclinical models of ocular disease (1/15)

SeasideTherapeuticsLLC*

VanderbiltUniversityMedical Center

Collaborativeresearchagreement

To discover and develop small molecules targeting neurologic receptors impli-cated in disorders of brain development such as Fragile X syndrome and autism

The targets, muscarinic ace-tylcholine subtype 1 recep-tors, are known to regulate learning and memory (1/7)





Type of Agreement


SIGA Technol-ogies Inc. (SIGA)

Department ofDefense

Contract To support the preclinical development and investiga-tional new drug filing of ST-669, a broad spectrum antiviral that has demon-strated in vitro antiviral activity against several dif-ferent viral families

The contract has option for up to $9.9M; SIGA has received $2.8M through the initial contract (2/26)

Sigma-AldrichCorp. (SIAL)

CommonwealthScientific andIndustrialResearchOrganization(Australia)

Worldwidelicensingagreement

To manufacture and sell reversible addition-fragmen-tation chain transfer agents

Sigma-Aldrich has the rights to manufacture and sell the RAFT agents worldwide for all research and develop-ment applications (3/12)

Sirnaomics Inc.* University ofMarylandMedical School

Licensingagreement

To a patent covering the use of Histidine-Lysine polymer for wound healing and ocu-lar diseases siRNA therapeu-tics


SorrentoTherapeuticsInc. (OTC BB:SRNE)

Scripps ResearchInstitute

Exclusiveworldwidelicensingrights deal

To quorum sensing technol-ogy to develop an antibody t o p r e v e n t a n d t r e a t Staphylococcus aureus infections

Sorrento said it will use its antibody library technology to identify fully human anti-bodies for the neutralization of staph-specific signaling peptides that control bacte-rial virulence (1/12)

StrategicDiagnosticsInc. (SDIX)

Fred HutchinsonCancer ResearchCenter

Collaboration To discover biomarkers for use in the early detection of a variety of cancer, with ini-tial studies focusing on pan-creatic cancer


TapImmune Inc.(OTC BB:TPIV)

Aeras Global TBVaccineFoundation

Letter of intent

To enter an R&D collabora-tion effort aimed at evaluat-ing the efficacy of TAP in concert with vaccine vectors encoding TB immunogens under development at Aeras

The goal is to advance suit-able candidates to clinical development (2/2)

TrilliumTherapeuticsInc.* (Canada)

University HealthNetwork andthe Hospitalfor Sick Children(Toronto)

Worldwiderightsagreement

To immunology programs for hematopoietic stem cell transplantation and cancer


Vical Inc.(VICL)

U.S. Navy Contract To conduct a Phase I trial of its Vaxfectin-formulated DNA vaccine against A/H1N1 pandemic influenza

Vical previously received a Department of Defense con-tract, which brings the total government funding for the project to about $2M (3/23)

ViroPharma Inc.(VPHM)

Sanquin BloodSupply Foundation

Agreement For rights to develop, file regulatory dossiers and commercialize Cinryze for hereditary angioedema and for new indications in cer-tain European and rest-of-world territories

The agreement expands ViroPharma’s rights to com-m e r c i a l i z e C i n r y z e i n regions beyond the original-ly license territories of N o r t h A m e r i c a , S o u t h America and Israel (1/12)





Type of Agreement


SECOND QUARTER Advanced Life Sciences Holdings Inc. (OTC BB:ADLS)

U.S. government Expanded col-laboration

To include the evaluation of Restanza's activity against sexually transmitted infec-tions, such as gonorrhea

Restanza's in vitro activity against Neisseria gonor-rhoeae and other key STI's will be assessed (6/1)


University of Pennsylvania

Patent amend-ment agreement

It allows Advaxis to acquire exclusive licenses for an additional 27 patents relat-ed to the company's Listeria vaccine technology

Advaxis will reimburse UPenn a portion of the licensing fees and all legal expenses and will provide milestone payments and a 1 .5% royalty fee (5/19)

Affomix Corp.* University of Montreal Pharma-cogenomics Center and the Montreal Heart Institute

Collaboration To discover novel biomark-ers that are predictive of drug efficacy and toxicity


Amarantus MA Inc.*

Pioneer Valley Life Sciences Institute

Collaboration To accelerate the develop-m e n t o f A M R S 0 01 f o r Parkinson's disease and ischemic heart disease

PVLSI will work with the company to identify and advance AMRS001 in cell-based models of diabetes (6/28)

AnacorPharmaceuticalsInc.*

Medicines forMalaria Venture

Researchagreement

To explore Anacor’s boron chemistr y platform for malaria drug discovery

MMV will provide malaria expertise and an undis-closed amount of funding (4/27)

Asuragen Inc. Johns Hopkins University

Nonexclusive license agree-ment

To incorporate the BRAF V600E mutation sequence into its molecular diagnos-tics products

The license includes the use of the mutation as a compo-nent of diagnostic test kits and for use in Asuragen's CLIA laboratory for clinical research and patient testing (6/3)

AVI BioPharmaInc. (AVII)

U.S. DefenseThreat Reduc-tion Agency

Agreements To develop one or more of AVI’s nucleotide-based drug candidates targeting the pandemic H1N1 influenza virus; for its RNA-based influenza therapeutic candi-date AVI-7100

AVI secured up to about $4M under the agreement (4/29); DTRA awarded a new contract worth up to $18M to advance development of the drug through to ear ly human safety testing (6/8)

Biovest International Inc. (PK:BVTI)


Contract To supply AutovaxID biore-actors to the DOD for the development and applica-tion in cell culture-based vaccine production

The contract is part of an initiative to develop new biomanufacturing solutions for cost-effective and rapid production of preventive and therapeutic vaccines against infectious diseases and cancer (5/19)

Cangene Corp.(Canada; TSX:CNJ)

BiomedicalAdvancedResearch andDevelopmentAuthority

Extendedagreement

To allow the company addi-tional time to pursue FDA licensure for its botulism antitoxin

The modif ied contract extends from May 2011 to May 2013 (4/1)





Type of Agreement


CatalystPharmaceuticalPartners Inc. (CPRX)

National Instituteon Drug Abuse

Definitiveagreement

To jointly conduct a Phase IIb trial evaluating CPP-109 to treat cocaine addiction

Catalyst expects to pay $2.8M of the $10M trial cost, with NIDA providing sub-stantial resources (4/14)

CellularDynamicsInternationalInc.*

iPS AcademiaJapan Inc.

Nonexclusivelicensingagreement

For the iPSC patent portfolio arising out of the work of Shinya Yamanaka at the Center for iPS Cell Research and Application at Kyoto University

Further terms were not dis-closed (5/10)

Chronix Biomedical*

University ofCalgary

Partnership To develop a commercial version of its serum DNA-based blood test for the early detection of bovine spongiform encephalopathy

Chronix expects to offer BSE testing services to the cattle industry once the commer-cial test is finalized and vali-dated (4/14)

Crucell NV(the Netherlands;CRXL)

UNICEF Contract To supply its pediatric vac-cine Quinvaxem to the developing world

UNICEF awarded Crucell an additional $110M for the con-tract (5/7)

DARABioSciences Inc.(DARA)

Division ofCancer Preventionof the NationalCancer Institute

Clinical trialsagreement

To advance the study of KRN5500 for the treatment of chemotherapy induced peripheral neuropathy in patients with cancer

NCI will fund the studies and DARA wi l l supply KRN5500 and p lacebo (4/28)

DSM Biologics* AustralianGovernments

Partnership To design, build and operate the first major Australia-based mammalian bio-phar-maceutical manufacturing facility

The facility would be locat-ed in Brisbane (5/4)

Esperion Therapeutics*

Cleveland Clinic Collaborative research agree-ment

To advance research target-ing new HDL therapies in cardiovascular disease


FluGen Inc.* Wisconsin Alumni Research Foundation

Agreement For rights to a class of antivi-ral drugs aimed at prevent-ing viral replication

The entry-blocker peptide, a n H A 2 i n h i b i t o r , i s designed for development as a nasal spray or oral for-mulation and has shown effectiveness against the H5N1 flu (6/9)

GenOway SA(France; Paris:ALGEN)

GriffithUniversity(Australia)

Partnership To develop animal models using adult stem cells from the olfactory bulb

Each party will cover its own research costs, and genO-way will retain an exclusive license to use the resulting technologies to create mouse and rat models (5/18)


Moffitt Cancer Center

License agree-ment

Relating to the discovery of the combined relationship of two genes, RRM1 and TS, to patient response to non-small-cell lung cancer

Genzyme plans to develop and market a laboratory test to measure the expression levels of those two com-bined genes (6/11)

HawthornPharmaceuticalsInc.*

University ofPittsburgh

Globallicensing deal

For a series of new monoclo-nal antibodies for cancer

The antibody portfolio tar-gets a variety of cancers through the cell surface chondroitin sulfate proteo-glycan 4 (5/18)





Type of Agreement


IBio Inc.(OTC BB:IBPM)

Fraunhofer USACenter forMolecular Biotechnology

Agreements For the rights to use its iBio-Launch platform in support of a $5.3M government-funded project for the devel-opment of a single vaccine to protect against anthrax and plague; to develop and manufacture global health vaccines for the Bil l & Melinda Gates Foundation

Financial terms were not disclosed (4/8); CMB will use iBio's technology under a nonexclusive, non-royalty-bearing grant to develop and test new vaccines, while iBio will own commercial rights (6/4)

Immatics Biotechnologies GmbH* (Germany)

Center for Cancer Research of the National Cancer Institute

Clinical trial agreement

Covering development of Immatics' therapeutic cancer vaccine IMA950 for glioblas-toma

The center will conduct a Phase I trial (6/3)

Immunetics Inc.* National Heart, Lung and Blood Institute

Contract To develop and supply a new test for HIV aimed at distinguishing infected peo-ple from those who have been immunized with exper-imental HIV vaccines in clini-cal trials

Immunetics will receive $2.8M as part of the con-tract (5/19)

ImmunoCellularTherapeutics Ltd.(OTC BB:IMUC)

University ofPennsylvania

Sponsoredresearchagreement

To support process develop-ment and manufacturing in a Phase II trial of ICT-107

ICT-107 is the company’s dendritic cell-based cancer vaccine product candidate for the treatment of glio-blastoma multiforme (4/22)


RadboudUniversityNijmegenMedicalCentre’sDepartment ofTumorImmunology(the Netherlands)

Collaboration To commence studies utiliz-ing Homspera

Experts will perform studies on Homspera relating to its adjuvant and immunomodu-latory properties for poten-t i a l a p p l i c a t i o n i n experimental cancer vac-cines and immunotherapy for cancer (4/28)

ImmunovaccineInc. (Canada;CDNX:IMV)

Dana-FarberCancer Institute

Collaboration To formulate its HIV protein a n t i g e n s i n I m m u n o -vaccine’s DepoVax vaccine enhancement and delivery platform

The goal is to establish whether the vaccine formu-lation will induce a stronger immune response (4/23)

InNexus Biotechnology Inc. (CDNX:IXS)


Collaboration To research technologies developed by the company

InNexus is working on developing the next genera-tion of antibodies based on its Dynamic Cross Linking technology (5/28)

IRXTherapeutics*

National CancerResearch Center(Japan)

Collaboration To evaluate next-generation peptide-based cancer vac-cines


Lentigen Corp.* AIDS VaccineInitiative

Partnership To design a preventative AIDS vaccine based on Lentigen’s synthetic mimic of HIV






Type of Agreement


Life TechnologiesCorp. (LIFE)

StanfordUniversitySchool ofMedicine

Agreement To discover a genomic com-ponent that plays a key role in promoting breast cancer progression



NortheasternOhio Univer-sitities Collegesof Medicine andPharmacy

Research anddevelopmentagreement

To evaluate the effective-ness of nanoviricide drug candidates against herpes simplex virus 1

Cell culture models, as well as in vivo studies will be used, and the testing is expected to help the compa-ny develop a drug against oral and genital herpes (5/14)


University ofCalifornia,San Francisco

Researchagreement

For in vivo testing of its anti-HIV drug candidates



The Vatican's Pontifical Council for Culture

Alliance For a joint initiative to expand research and raise awareness of adult stem cell therapies


Odyssey Thera Inc.*

Environmental Protection Agency

Contract To use its technology plat-form to profile the toxic effects of compounds in the agency's ToxCast program designed to define the potential impact of chemi-cals on the environment and human health

Odyssey Thera is eligible to receive more than $7M in the first year and $34M over a period of up to five years (6/25)

Onconova Therapeutics Inc.*

Leukemia & Lymphoma Society

Collaboration To support the development of Estybon for patients with high-risk myelodysplastic syndrome

LLS will provide up to $10M to support a trial of Estybon vs. best supportive care (6/2)

Opal Therapeutics Inc.*

Massachusetts General Hospital

Joint develop-ment collabora-tion

To develop an immunother-apy for treating HIV

Opal retains rights to com-mercialize the vaccine glob-ally and will contribute funds, technology, intellec-tual property and commer-cialization expertise to the collaboration (6/8)

Pikamab* UAB Research Foundation

Agreement For exclusive rights to a pat-ent pertaining to the discov-er y that the functional polymorphism in the cyto-plasmic domain of Fc alpha receptor determines the pro-inflammatory potential of serum IgA autoantibodies through cell signaling and production of cytokines


Probactive Biotech Inc.

Dalat Nuclear Research Institute

Agreement To co-develop cancer drugs, using combinations of anti-tumor antibodies and antitu-mor radioactive compounds






Type of Agreement


Proteo Inc. (BE:OTR)

U.S. Army Medical Research Institute of Infectious Diseases

CRADA To provide Elafin and related scientific data for preclinical research on the develop-ment of new therapeutic strategies to combat life-threatening infectious dis-eases

Elafin is a natural human antagonist of elastase and proteinase-3 (6/21)

Proteonomix Inc.(PK:PROT)

Cohen-McNieceFoundation

Licensing agreement

For cellular technology for patients who have suffered myocardial infarctions

The technology involves a method of preparing and using stromal cells for the treatment of cardiac diseas-es (5/5)

QR Pharma Inc.* Massachusetts General Hospital

Collaborative research agree-ment

To conduct preclinical test-ing of its drug candidates for Parkinson's disease

QR's lead Alzheimer's drug, Posiphen, inhibits amyloid precursor protein synthesis and also appears to inhibit the alpha-Synuclein path-way, which is implicated in Parkinson's

Raptor Pharmaceutical Corp. (RPTP)

Weizmann Institute of Science (Israel) and Niigata University (Japan)

Exclusive world-wide license agreement

To intellectual property related to the potential treatment of Huntington's disease

Raptor plans to start a Phase II trial this summer (6/3)

Regulus Therapeutics Inc.*

University of Wuerzburg (Germany)

Exclusive rights agreement

To intellectual property cov-ering methods for modulat-ing microRNA-21

The technology relates to the discoveries that miR-21 is induced in fibroblasts in the failing heart, and the license includes patents covering compositions of matter for various com-pounds targeting miRNA-21 (5/28)

ScancellHoldings plc* (UK)

U.S. NationalInstitutes ofHealth

Worldwidenonexclusivelicensingagreement

For the use of the melanoma antigens TRP-2 and gp100

Scancell has agreed to pay the U.S . Publ ic Heal th Service an undisclosed up-front fee in addition to cer-tain milestone fees and a royalty on future sales of SCIB1 (5/12)

Siena Biotech SpA* (Italy)

Agency forScience, Tech-nology andResearch (Singapore)

Collaboration To discover small molecules for hard to treat cancers and antibodies for osteoporosis


StemCells Inc. (STEM)

Children's Hospital of Orange Count

Agreement To provide the hospital with a royalty-free research license to certain patents a n d a u t h o r i z e s CH O C Children's to proliferate, maintain and use human neural stem cells for non-commercial purposes






Type of Agreement


TapImmune Inc. (OTC BB:TPIV)

Mayo Clinic Exclusive licens-ing option agreement

For clinical development of a breast cancer vaccine tech-nology

The option can be exercised after Phase I trials (6/2)

Trius Therapeutics Inc.*

Defense Department's Defense Threat Reduction Agency

Four-and-a-half-year contract

To develop new antibiotics directed against Gram-negative bacterial patho-gens

The deal is worth $29.5M to Trius (5/20)

Zirus Inc.* Emory Instituteof Drug Discovery

Collaborationand researchagreement

To develop compounds to treat infectious disease

The parties will use Zirus’ method for identifying genes and gene products in host cells (4/1)

THIRD QUARTER Achaogen Inc.* Biomedical

Advanced Research and Development Authority

Two-year con-tract

To further develop the com-p a n y ' s i n v e s t i g a t i o n a l broad-spectrum antibiotic ACHN-490 for use against a bioterrorism attack involv-ing plague or tularemia

The contract is worth $27M (8/31)

Advanced Cancer Therapeutics*

University of Louisville

Exclusive agree-ment

To identify cancer drugs tar-geting PFKFB3 and choline kinase

Both are implicated in can-cer metabolism (8/11)


University of British Columbia

Sponsored research and option agree-ment

To develop several antimi-crobial peptides that have bactericidal properties

Advanced Life Sciences paid the university an up-front fee and will make milestone payments in exchange for an option to acquire exclu-sive worldwide rights to the compounds (7/27)

AnaptysBio Inc.* Defense Advanced Research Projects Agency

Contract To use the company's somatic hypermutation technology platform to gen-erate high-affinity thermally stable antibodies intended to be used by the military in antibody-based biosensors, including those that can detect bioterrorist threats

The contract is worth up to $1 .5M (7/13)

AROS Applied Biotechnology*, CLC bio* (both of Denmark) and Roche AG (Switzerland)

Aarhus University Hospital's Institute of Pathology and the Research Unit for Molecular Medicine

Partnership To develop a solution for large-scale use of formalin fixed, paraffin embedded tissue in molecular analyses

The project is budgeted to $5M, half of which will be funded by the Danish N a t i o n a l A d v a n c e d Technology Foundation (9/9)

Avedro Inc.* Emory University Agreement To combine clinical trial data from Emory with data from Avedro's multisite clinical trials for corneal collagen crosslinking

Both cl inical tr ials are designed to assess the safe-ty and efficacy of riboflavin and ultraviolet-A light for halting the progression of keratoconus and post-LASIK ectasia (9/16)

AVI BioPharma Inc. (AVII)


Contract To develop drugs targeting Ebola and Marburg viruses

The contract is potentially worth $291M (7/19)





Type of Agreement


Biomoda Inc. (OTC BB:BMOD)

Saccomanno Research Institute

Agreement To advance Biomoda's sys-tem for measuring the pho-t o n e m i s s i o n r a t e o f CyPath-stained cells to detect early stage lung cancer


Bioniche Life Sciences Inc. (Canada; TSX:BNC)

University of Ottawa (Canada)

Exclusive, worldwide license agree-ment

To provide Bioniche access to the university's technolo-gy for botanical therapeutics and pharmaceutical com-pounds for treating anxiety and related conditions in animal and human health and aquaculture


Cardium Therapeutics Inc. (AMEX:CXM)

University of Toronto (Canada)

Exclusive rights agreement

To certain supramacromo-lecular polymer complexes enabling regulatable and localized topical delivery of nitric oxide for prolonged periods of one to three weeks


Cellerant Therapeutics Inc.*


Contract To further develop the cellu-lar therapy CLT-008 as a treatment for acute radia-tion syndrome

The contract is worth $63.3M (9/2)


Defense Department

Contract To develop and stockpile CBLB502 as a medical radia-tion countermeasure

The contract is worth $45M, with $14.8M of that amount taking CBLB402 from devel-opment through the FDA approval process (9/20)

Clinical Genomics Pty. Ltd.* (Australia)

Garvan Institute of Medical Research (Australia)

License agree-ment

For biomarkers discovered at Garvan

Clinical Genomics gains worldwide, exclusive rights to cancer-associated meth-ylation DNA biomarkers for the diagnosis and/or treat-ment of colorectal cancer (9/28)

Complete Genomics Inc.*


Agreement To sequence and analyze pediatric tumors for an NCI project seeking therapeutic targets for childhood cancers

Complete Genomics will receive $1 . 1M for its part (9/8)

Cryo-Cell International Inc.

Monash University (Australia)

Collaboration To conduct preclinical studies using Cryo-Cell's C'elle men-strual stem cell technology

It will be used to identify potential future therapies to treat autoimmune diseases such as multiple sclerosis (8/18)

CvergenX Inc.* Moffitt Cancer Center

Exclusive, worldwide rights deal

To a technology platform designed to individualize radiation therapy using gene expression analysis and systems biology






Type of Agreement


CyDex Pharmaceuticals Inc.*

University of Kansas

Licensing agree-ment

For a sulfoakyl ether-alyl ether cyclodextrin derivative

The new Captisol formula-tion is expected to broaden the company's drug delivery platform (8/5)


Singapore's Agency for Science, Technology and Research

Collaboration On a virus-like particle vac-cine

They aim to develop a VLP vaccine to manage influen-za infections (7/16)

Elusys Therapeutics Inc.*


Contract For the advanced develop-ment of Anthin for the pre-vention and treatment of anthrax infection following a biowarfare attack

It is a second contract year o f f u n d i n g v a l u e d a t $40.6M; over five years, the contract could total up to $143M if all options are exer-cised (8/5)


Office of the Biomedical Advanced Research and Development Authority of the Department of Health and Human Services

Contract To develop and obtain regu-latory approval for large-scale manufacturing of BioThrax (anthrax vaccine adsorbed)

The contract is valued at up to $107M (7/15)



Four-year con-tract

To advance the develop-ment of a third-generation anthrax vaccine candidate consisting of the company's BioThrax plus VaxImmune




Contract To develop a new anthrax vaccine using the protective antigen to stimulate a pro-tective immune response that neutralizes the toxins

The contract is worth $51M and could be extended for up to $186.6M over five years (9/20)


University of Bristol

Collaboration Aimed at developing treat-ments for diabetic neuro-pathic pain

Galapagos' service division, BioFocus, will provide hit-to-lead and lead optimization services for a Wellcome Trust-funded program; the total contract is worth $4.26M (7/19)

Geron Corp. (GERN)

Hong Kong University of Science and Technology

Consolidation Of their joint venture, TA Therapeutics Ltd.

TA's small molecule telom-erase activator program will continue as an internal Geron program; the univer-sity gets royalties (7/16)

Geron Corp. (GERN)

University Campus Suffolk (UK)

Collaboration To develop human embry-onic stem cell-derived chon-d r o c y t e s f o r t r e a t i n g cartilage damage and joint disease

The program will be funded jointly by Geron and UCS (9/14)





Type of Agreement


Geron Corp. (GERN)

University of Edinburgh (Scotland)

Worldwide, exclusive deal

Covering technology that allows for the efficient pro-duction of chondrocytes from human pluripotent stem cells


GLG Pharma LLC* Moffitt Cancer Center


For a preclinical platform of STAT3 inhibitors for cancer

Financial terms include commercialization mile-stone and royalty payments to Moffitt (9/17)

Glythera Ltd.* (UK) PATH Research collab-oration

To use its PermaLink tech-nology to produce carbohy-d r a t e - b a s e d c o n j u g a t e vaccines against penumo-coccal disease

Glythera will carr y out research to attach anigenic capsular polysaccharides to carrier proteins as a poten-tial alternative conjugation method (8/4**)

Horizon Discovery Ltd.* (UK)

Institute of Cancer Research

Collaboration A i m e d a t c o m b i n i n g Horizon's panel of 200-plus genetically defined X-MAN cancer models with ICR's expertise in genomewide functional genomics to rap-idly screen for drug targets that selectively kill cancer cells


HUYA Bioscience International LLC*

School of Pharmaceutical Sciences at China's Sun Yat-sen University

Strategic part-nership

Gives access to and first review of certain therapeutic candidates owned or con-trolled by the university

The school gains access to HUYA's expertise in drug development as well as its global network of pharma-ceutical partners (8/31)

InNexus Biotechnology Inc. (CDNX:IXS)


Amended agree-ment

Under which NCI is evaluat-ing the company's technolo-g y a p p l i e d t o c e r t a i n immunotoxins

The amended deal calls for additional immunotoxins for modification in InNexus' facilities to enhance activity and function (7/2)

Inovio Pharmaceuticals Inc. (AMEX:INO)

PATH Malaria Vaccine Initiative

Agreement To provide follow-on fund-ing to continue evaluation and development of Inovio's malaria DNA vaccine candi-date in nonhuman primates

In the study, Inovio's SynCon DNA vaccine platform, which targets sporozoites and the liver stage of the parasite, is delivered using its electroporation delivery technology (9/16)

Intercept Pharmaceuticals Inc.*

National Institute of Diabetes and Digestive and Kidney Diseases

CRADA To evaluate the effects of obeticholic acid in patients with nonalcoholic steato-hepatitis

The trial is set to begin in the fourth quarter, and the NIDDK will provide a majori-ty of the funding (7/29)


Sankara Nethralaya Eye Hospital

Collaboration To develop ISCO's CytoCor stem cell-derived corneal tissue

The goal is to use CytoCor, which consists of transpar-ent human tissue derived from pluripotent human stem cells, to treat corneal blindness and vision impair-ment (7/12)





Type of Agreement


Life Technologies Corp. (LIFE)

University of California at San Diego Moores Cancer Center

Collaboration To use SOLiD 4 genomic anal-ysis technology to study chronic lymphocytic leukemia

Funding will come from the National Institutes of Health (8/6)


Juvenile Diabetes Research Foundation

Agreement For MannKind to provide its ultra rapid-acting insulin, Afrezza, for use in a closed-loop blood sugar monitoring and insulin delivery system being studied by the foun-dation as part of its Artificial Pancreas Project

Affreza was chosen for the study because its pharma-cokinetic profile is closest to the human body's natural insulin (8/24)

Marina Biotech Inc. (MRNAD)

University of Helsinki Biomedicum (Finland)

Extended col-laboration

To identify peptides with preferential hominglike properties that allow them to target specific tissues, including tumors

The collaboration will use Marina's Trp Cage phage display library to evaluate peptides expected to be used with Marina's delivery systems for improving delivery and therapeutic potential of RNAi (7/28)

Medicago USA Inc. (subsidiary of Medicago Inc.; Canada; TSX:MDG)


Contract To demonstrate the scalable manufacturing of its plat-expressed virus-like parti-cles vaccines in the U.S. under a technology invest-ment agreement

Contract is worth $21M (8/11)

Mucosis BV (the Netherlands)

PATH Partnership To develop oral vaccines for diarrhea using Mimopath technology

Positive results in the early trial may lead to further col-laboration (9/29)


Schepens Eye Research Institute and an affiliate of Harvard Medical School

Sponsored research agree-ment

Collaboration focused on the development of thera-pies for both age-related macular degeneration and glaucoma



U.S. Army Medical Research and Material Command Telemedicine and Advanced Technology Research Center

Contract To evaluate the use of topi-cally applied bone marrow-derived adult mesenchymal stem cells for rapid wound healing

The contract is worth $700,000 (7/13)

Novartis Vaccines and Diagnostics, VaxDesign Corp.*, Pfenex Inc.*, Rapid Micro Biosystems*, 3M (NYSE:MMM), Northrop Grumman Security Systems and PATH and the Infectious Disease Research Institute


Contracts To modernize and improve the nation's infrastructure for producing medical counter-measures and reducing the time and cost of develop-ment, testing and production

The contracts totaled $55M for the initial phase and could be expanded to up to $100M over three years (9/22)





Type of Agreement


Numerate Inc.* Defense Threat Reduction Agency

Contract Contract to design and opti-mize biowarfare agents

Numerate was awarded the three-year, $6.75M contract to deliver small-molecule drug leads for treating the hemorrhagic fever virus Ebola, as well as an antibac-terial drug lead with broad-spectrum activity (9/10)

Omni Bio Pharmaceutical Inc. (OTC BB:OMBP)

University of Colorado Denver-Anschutz Medical Campus

Two-year con-tract

To further evaluate the bio-logical activity of alpha-1 antitrypsin and its effects on influenza

Omni Bio will pay UCD about $440,000 under the agreement (8/25)


Naval Medical Research Center

CRADA To conduct preclinical trials to assess the safety and effi-cacy of its Oxycyte perfluo-rocarbon emulsion

Terms were not disclosed (8/3); amended the agree-ment to use swine models to assess the safety and effi-cacy of the product for spi-nal cord injur y due to decompression sickness and for hemorrhagic shock (9/21)


Defense Department

Extended con-tract

To evaluate bavituximab in advanced models of viral hemorrhagic fever

The two-year contract has been extended by s ix months to March 2011 , and includes about $2.4M in additional funding (9/21)

Pfenex Inc.* Department of Health and Human Services' Biomedical Advanced Research and Development Authority

Contract To support the development of a Pfenex Expression Technology for the produc-tion of bulk recombinant protective antigen from anthrax

Contract is worth $18.8M in funding, contingent on mile-stones and options (8/4)

PolyTherics Ltd.* (UK)

Anisur Rahman at the University College London

Collaboration To use its site-specific Pegylation to develop a treatment for antiphospho-lipid syndrome

Rahman and his team were awarded a nearly $1 . 1M five-year grant from Arthritis Research UK to support the work (9/28)


Tarrot Laboratories (business unit of Cedars-Sinai Medical Center)

Collaboration To identify genetic or sero-logic markers associated with response to anti-TNF therapies for Crohn's dis-e a s e , s u c h a s C i m z i a , Humira and Remicade, and subsequent development of diagnostic tests

Tarrot and Prometheus will jointly fund and share tech-nology for research and development; Tarrot will receive milestones pay-m e n t s a n d a r o y a l t y : Prometheus gets rights to intellectual property and diagnostic tests developed (9/20)





Type of Agreement


Sanofi-Aventis SA (France; NYSE:SNY)

Scripps Genomic Medicine (division of Scripps Health)

Partnership To advance research and development initiatives in the field of individualized medicine

Sanofi-Aventis Recherche & Developpement will fund up to three discovery innova-tion grants per year; Sanofi-Aventis will be granted nonexclusive rights to any research tools developed through these grants, as well as preferred access to Scripps labs (8/16)

Scancell Holdings plc (UK; LSE:SCLP)

Cancer Research UK


To use a human antibody known as 105AD7

Scancell gains a worldwide license to use it for develop-ment of new ImmunoBody vaccines for any immuno-therapy indication (8/11)

Sigma-Aldrich Corp. (SIAL)

National Heart, Lung, and Blood Institute and Boston University

Collaboration To develop methods to mea-sure several potential bio-markers of atherosclerotic cardiovascular d isease using plasma samples from the Framingham Heart Study

NHLBI is providing an undis-closed amount of funding to S igma-Aldr ich under a research subaward agree-ment with BU (8/6)

Spherix Inc. (SPEX) University of Kentucky Research Foundation

License agree-ment

Giving the company world-wide rights to international patents filed for Dtagatose as a lipid-lowering agent for prevention and treatment of atherosclerosis, hypertri-glyceridemia and related dyslipidemias

Spherix has been develop-ing the product as an oral treatment for glycemic con-trol in patients with Type II diabetes (7/2)

TapImmune Inc.* Mayo Clinic Research and technology license option agreement

To develop a smallpox vac-cine

They will evaluate novel pep-tide antigens with Tap-Immune's TAP technology (8/5)

TcLand Expression SA* (France)

French National Institute for Health and Medical Research

License agree-ment

For two patents relating to gene expression signatures that can predict responsive-ness to rheumatoid arthritis drugs


Tekmira Pharmaceuticals Corp. (TSX:TKM)


Contract To develop an RNAi-based therapeutic against Ebola

The deal is worth a potential $140M (7/19)

Telormedix SA (Switzerland)

Swiss Tropical and Public Health Institute

Collaboration To study an adjuvant for malaria and Buruli ulcer vac-cine

The adjuvant, TMX-201 , is based on the Toll-like recep-tor molecule (8/4)

TPP Global Development Ltd.* (Scotland)

University of Edinburgh (Scotland)

Five-year collaboration

For the development of pre-clinical intellectual property originated within the univer-sity

The parties will focus on commercialization of prod-ucts in the areas of nervous system disorders, immunol-o g y / i n f l a m m a t i o n a n d oncology (9/1)





Type of Agreement


Vyteris Inc. (OTC BB:VYTR)

Georgia Tech Research Corp. (technology trans-fer arm for the Georgia Institute of Technology

Option for a licensing agree-ment

For thermal ablation and microdevice fabrication technologies for transder-mal drug delivery

Georgia Tech will be entitled to royalty and milestone payments if any products incorporating the technolo-gies make it to market (8/25)

Western States Biopharma-ceuticals Inc.

University of Colorado

License agree-ment

For approaches to inhibiting newly discovered T cell cytokine-inducing surface molecule discovery targets

The goal is to mediate adap-tive immunity while leaving the innate immune system intact (7/9)

FOURTH QUARTER AbD Serotec (research unit of MorphoSys AG; Germany; FSE:MOR)

Research Councils UK Shared Services Centre Ltd.

Two-year con-tract

To supply custom monoclo-nal antibodies

The antibodies are devel-oped using human combina-torial ant ibody l ibrar y technology (10/15)

AbD Serotec (research unit of MorphoSys AG; Germany; FSE:MOR)

Institute of Cancer Research of London

License agree-ment

Providing the company with worldwide exclusive rights t o c o m m e r c i a l i z e a Bromodeoxyuridine anti-body clone for research applications

The agreement covers clone BU1/75, allowing develop-ment in a range of formats suitable for various applica-tions such as ELISA, flow cytometry and immunohis-tochemistry (11/5)


Walter Reed Army Institute of Research

CRADA To allow Walter Reed to per-form advanced animal effi-cacy testing of Restanza against various Plasmodium specides that cause malaria

The CRADA is built on the positive in vitro and in vivo e f f i c a c y r e s u l t s t h a t Restanza demonstrated in initial studies (11/3)


National Cancer Institute’s Vaccine Section

CRADA To develop live attenuated Listeria vaccines against cancer

Advaxis will provide the vaccines, and NCI will use different in vitro and in vivo models to elucidate the effect of the vaccines on many different types of immune cells (11/1)

AesRx LLC* National Institutes of Health

Collaboration To take the firm’s Aes-103, an orphan drug treatment of sickle cell disease, through preclinical development and initial clinical trials

Contributing to the program will be the Therapeutics for R a r e a n d N e g l e c t e d Diseases unit , the NIH Clinical Center and the National Heart, Lung, and Blood Institute (11/18)

Aileron Therapeutics Inc.*

Scripps Research Institute

Agreement To add Scripps’ “Click” chemistry to Aileron’s stabi-lized peptide and protein technology platforms

Aileron gets exclusive, worldwide rights to use Click for therapeutics and nonexclusive, worldwide rights for diagnostics (12/1)

Amylin Pharmaceuticals Inc. (AMLN)

Juvenile Diabetes Research Foundation

Research collab-oration

To provide financial support for a clinical proof-of-con-cept study to investigate the effects of metreleptin in patients with Type I diabetes

Leptin is a hormone secret-ed by fat cells that plays a fundamental role in the reg-ulation of glucose metabo-lism (11/17)





Type of Agreement


Anacor Pharmaceuticals Inc. (ANAC)

University of California San Francisco Sandler Center and the Lindsley F. Kimball Research Institute

Research and development collaboration

To discover new drug thera-pies for the treatment of river blindness

The collaboration will com-bine Anacor’s boron-based chemistry platform and drug discovery and devel-opment capabilities with the Sandler Center’s expertise in neglected disease biology and drug discovery and the LFKRI’s expertise in oncho-cerciasis (12/2)

Arrowhead Research Corp. (ARWR)

MD Anderson Cancer Center

Exclusive world-wide agreement

For technology developed by Wadih Arap and Renata Pasqualini for use in weight loss and obesity-related metabolic conditions

Arrowhead launched a new c o m p a n y , A b l a r i s Therapeutics Inc., to com-mercialize the platform (12/21)


Leukemia and Lymphoma Society

Agreement To support clinical develop-ment of AT-406, a small-mol-ecule IAP inhibitor for acute myeloid leukemia

A Phase I trial is slated to begin in 2011 (12/7)

AtheroNova Inc. (OTC BB:AHRO)

Cedars-Sinai Heart Institute’s Division of Cardiology

Research agree-ment

For the second phase of a preclinical laboratory study

The study is aimed at vali-dating results from initial preclinical testing that showed 95% less occurrence of arterial plaque compared to the control group (11/10)

AtheroNova Inc. (OTC BB:AHRO)

David Geffen School of Medicine at the University of California, Los Angeles

Research agree-ment

For the second round of pre-c l in ical studies , as an adjunct to a preclinical trial a t C e d a r s - S i n a i H e a r t Institute

The company is developing natura l compounds to regress atherosclerotic plaque deposits (11/12)

Banyan Biomarkers Inc.*


Contract To develop a diagnostic test for traumatic brain injury


BioCryst Pharmaceuticals Inc. (BCRX)

Southern Research Institute

Agreement To sell BioCryst's bioanalyti-cal laboratory assets


BioTheryX Inc.* Leukemia & Lymphoma Society

Partnership To accelerate the develop-ment of new therapies for hematological malignancies with an initial focus on acute myelogenous leukemia

LLS has provided $4.5M to support preclinical studies needed for an investigation-al new drug application and a clinical trial of BTX-10504 (12/1)


California Institute for Regenerative Medicine

Agreement To provide the institute with five research-grade human embryonic cell lines

BioTime also will provide GMP-grade cell lines with DNA sequence information; BioTime will receive a royal-ty on net sales (11/30)


University of California

Agreement To provide five research-grade human embryonic stem cell lines to university researchers

Within one year, if request-ed, BioTime also will provide GMP-grade cell lines, which would be used to develop therapies and could lead to royalties for BioTime (12/23)





Type of Agreement


Bluebird Bio* Genethon Partnership For process development and scale-up efforts for manufacturing lentiviral vectors



iPS Academia Japan

Nonexclusive rights agree-ment

To develop and commercial-ize two stem cell-related assets

Cellectis has the right to develop and commercialize research tools, human ther-apeutics and prophylaxis derived from iPS's induced pluripotent stem cells (10/19)

ContraFect Corp.* The Rockefeller University


For eight patents for anti-bacterial lysin enzymes

The company will develop the lysin enzymes in combi-nation with monoclonal antibodies as possible drug products for methicillin-resistant Staphylococcus aureus, group B streptococ-cus, pneumococcus, entero-coccus and anthrax (11/19)

Cortex Pharmaceuticals Inc. (OTC BB:CORX)

University of California


For exclusive worldwide rights for the combination of Ampakine and mGluR5 compounds for the treat-ment of Fragile X syndrome



Singapore’s Agency for Science, Technology and Research

Extended col-laboration

For the development of a virus-like particle-based influenza vaccine

A*STAR will engage Cytos to develop, manufacture and supply it with an investiga-tional vaccine candidate for a proof-of-concept study in Singapore (12/17)


National Research Council Canada

Collaborative research pro-gram

To evaluate the efficacy of a carbohydrate-based vaccine formulated in its vaccine delivery and enhancement platform, DepoVax

Immunovaccine's technolo-gy can formulate the carbo-h y d r a t e a n t i g e n i n t o liposomes and then in oil (10/19)

Insight Genetics Inc.

St. Jude Children’s Research Hospital

Exclusive, worldwide licensing agree-ment

To help create a diagnostic test to assist physicians in monitoring cancer patients and make treatment selec-tion decisions

Insight has gained rights for mutations in the anaplastic lymphoma kinase gene that confer resistance to ALK inhibitors (12/15)

Inviragen Inc.* and PharmaJet Inc.*


Contract To advance the develop-ment of a needle-free den-gue fever vaccine

The award will fund preclini-cal studies, regulatory fil-ings, manufacturing and c l i n i c a l t e s t i n g o f Inviragen's tetravalent den-gue vaccine DENVax deliv-e r e d w i t h P h a r m a J e t ' s needle-free injection device (10/11)

Kineta Inc.* National Institutes of Health

Contract Focused on mining vast, existing, basic research databases with the goal of identifying new drug targets and candidates

The project is directed at infectious, cardiovascular, neurological, metabolic and autoimmune diseases (10/15)





Type of Agreement


Lonza Group Ltd. (PK:LZAGY)


Contract For the development and c o m m e r c i a l i z a t i o n o f PermaDerm, a regenerative medicine skin substitute for severe burns

Lonza received $18M in funding for the program (11/23)

Medicago Inc. (Canada; TSX:MDG)

PATH Collaboration To work together on a broad-coverage influenza v a c c i n e b a s e d o n Medicago's plant-based virus-like particle technolo-gies for the developing world

M e d i c a g o r e c e i v e d $946,000 in funding as part of the agreement (10/14)

MolecularMD Corp.*

New York University and New York's Memorial Sloan-Kettering Cancer Center


For U.S. commercial rights to the detection of the BRAF V600E mutation

MolecularMD is working on commercializing assay tech-nology in the area of mela-noma therapy (10/19)

Morphotek Inc. (subsidiary of Eisai Inc.; FSE:EII)


Contract For development of mono-clonal antibody therapies against staphylococcal-derived toxins and patho-genic staphylococcal strains


Morphotek Inc. (subsidiary of Eisai Inc.; FSE:EII)

Hokkaido University

Sponsored research agree-ment

To evaluate the antitumor effect of amatuximab for advanced pancreatic cancer

Funding will support a pre-clinical study to test ama-tuximab a long and in combination with gem-citabine in an adjuvant set-ting (11/18)

PharmaGap Inc. (Canada; CDNX:GAP)

Queen’s University (Canada)

Collaboration To investigate the potential f o r d e v e l o p m e n t o f PharmaGap’s lead cancer drug GAP-107B8 in bladder cancer



Regents of the University of California, Los Angeles

Exclusive research agree-ment

To focus on the identifica-tion of biological markers of mucosal healing in patients with inflammatory bowel disease

Researchers will determine the correlation of genotoxic-ity markers to mucosal heal-ing and disease activity, and Prometheus will evaluate a d d i t i o n a l m a r k e r s o f inflammation and other markers associated with IBD (12/13)

Pro-Pharmaceuticals Inc. (AMEX:PRW)

Mount Sinai School of Medicine

Research alli-ance

To evaluate in preclinical models the anti-fibrotic effects of several of the c o m p a n y ’ s G a l e c t i n -targeting compounds

A team at the school will t e s t s e v e r a l o f P r o -Pharmaceuticals’ galacto-m a n n a n s a n d rhamnogalacturonans as Galectin blockers in liver a n t i - f i b r o t i c t h e r a p i e s (12/22)





Type of Agreement


Proteostasis Therapeutics Inc.*

Harvard School of Public Health and Harvard Medical School

Research collab-oration

To evaluate new signaling pathways important for the treatment of neurodegener-ative disorders such as Parkinson’s disease and Huntington’s disease


Provid Pharmaceuticals Inc.*

Fast Forward LLC (a National Multiple Sclerosis Society’s subsid-iary)

Expanded part-nership

To support Provid’s preclini-cal studies of its candidate multiple sclerosis drug, PV-267

The partnership will enable Provid to enhance knowl-edge of the immune mecha-nisms involved in the activity of PV-267 (11/18)

Resolve Therapeutics LLC*

University of Washington

Exclusive license

For certain biologic com-pounds and technology developed to treat autoim-mune diseases, including systemic lupus erythemato-sus

The compounds are target-ed biologic therapies engi-n e e r e d t o i n h i b i t t h e proximal steps in the inter-feron-alpha cascade (11/11)

Sangart Inc.* U.S. Navy CRADA To develop MP4 in traumatic brain injury

MP4 is a pegylated hemo-globin molecule designed to enhance oxygen delivery to the capillaries and target tis-sues (12/7)

Sanofi-Aventis Group SA (France; NYSE:SNY)

Harvard University Partnership To advance translational biomedical research in areas such as cancer, diabetes and inflammation

Harvard researchers will compete for grants and Sanofi-Aventis will be able to develop the discoveries (10/19)

Sequella Inc.* Ludwig-Maximilians-University (Germany)

Agreement To coordinate a European Union grant for Phase II tri-als of SQ109 in adult pulmo-nary tuberculosis at seven sites in Africa

The studies are funded by a $16.8M grant and a $4. 19M commitment from Sequella (10/19)

SIGA Technologies Inc. (SIGA)

Department of Health and Human Services

Contract For SIGA to deliver 1 .7M courses of its smallpox anti-v ira l for the Strategic National Stockpile

The HHS award includes base revenues of about $500M and the potential for up to $2.8B if all options are exercised (10/14)

Sirius Genomics Inc.* (Canada)

National Research Council of Canada Industrial Research Assistance Program

Agreement For the discovery of genom-ic biomarkers that are pre-dictive of patient response to therapeutics used in criti-cal care medicine leading to improved disease outcomes


Stromedix Inc.* University of California

Exclusive licens-ing agreement

For rights to a monoclonal antibody to integrin v-β 5 from the university

Preclinical results sggested that v-β 5 plays a role in a variety of acute and chronic organ failure settings (11/19)

Takeda Pharmaceutical Company Ltd. (Japan)

Sanford-Burnham Medical Research Institute

Agreement To identify metabolic path-ways and signatures to develop new, more personal-ized treatments for obesity and its associated condi-tions

Terms were not disclosed; it is a two-year partnership, with an option to extend (12/29)





Type of Agreement


Tivorsan Pharmaceuticals*

Brown University Licensing agree-ment

For intellectual property for the biglycan molecule for Duchenne's muscular dys-trophy

Brown University spun out Tivorsan to take the mole-cule through preclinical development and to enter the clinic (10/7)

Tolerx Inc.* Cancer Vaccine Acceleration Fund

Collaborative research agree-ment

To advance TRX518, a GITR-targeted antibody

Tolerx will receive $1 .5M in funding and access to clini-cal resources, while the non-p r o f i t i s e l i g i b l e f o r milestone payments upon FDA approval (12/2)

Vical Inc. (VICL) IPPOX Foundation Manufacturing agreement

For plasmid DNA vaccines against HIV



Kitasato Institute Research license agreement

To evaluate the replication of an undisclosed virus in Vivalis' EB66 cell line for the manufacturing of human vaccines


Notes:

This chart does not include grants or contract awards, or agreements between biotech companies and clinical trial centers.

* Denotes privately held company; ** Denotes the date the item ran in BioWorld International.


@ Some institutions listed have for-profit components. They are located in the U.S. unless otherwise noted.

CRADA = Cooperative Research and Development Agreement.

Unless otherwise noted, shares are traded on the Nasdaq exchange.

AMEX = American Stock Exchange; ASX = Australian Stock Exchange; BR = Brussels Stock Exchange; CDNX = Canadian Venture Stock Exchange; FSE = Frankfurt Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; PK = Pink Sheets; SSE = Stockholm Stock Exchange; SWX = Swiss Stock Exchange; TSX = Toronto Stock Exchange.

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D E V E L O P M E N T


Biotechnology Products Approved by the FDA in 2010Company Product Description Indication Action

AcordaTherapeuticsInc.

Ampyra Extended-release tab-lets; dalfampridine

Multiple sclerosis

FDA approved it to improve walking in MS patients (1/25)

Acrux Ltd. and Eli Lilly and Co.

Axiron Testosterone topical solution CIII

Testosterone deficiency

FDA approved Axiron (11/29)

Actelion Ltd. Veletri Improved formulation of epoprostenol

Pulmonary arterial hypertension

FDA approved addi-tional in-use condi-t i o n s , a l l o w i n g patients who do not respond to conven-tional therapy to pre-pare their medication up to seven days in advance (10/6)

Alkermes Inc. Vivitrol Antagonist to the opi-oid receptors

Opioid dependence

FDA approved it to prevent relapse to opi-oid dependence (10/14)

Allergan Inc. Botox Onaboltulinumtoxin A Upper limbspasticity

FDA approved Botox to treat increased muscle stiffness in theelbow, wrist and fin-gers in adults with upper limb spasticity (3/11)

Amgen Inc. Prolia Denosumab Osteoporosis Gained FDA approval in post-menopausal women who are at high risk for fractures (6/2)

Amgen Inc. Xgeva A RANK ligand inhibi-tor; denosumab

To prevent skeletal-related events in patients with bone metastases from solid tumors

The FDA approved denosumab 120 mg as a therapy to prevent skeletal-related events (11/22)

AstraZeneca plc Faslodex Fulvestrant injection Hormone receptor-positive metastatic breast cancer

FDA approved the 500-mg dose, replac-ing the previously approved monthly dose of 250 mg (9/15)

AuxiliumPharmaceuticalsInc.

Xiaflex Collagenase Clostridium histolyti-cum

Dupuytren’scontracture

FDA approved Xiaflex (2/4)

Avanir Pharmaceuticals Inc.

Nuedexta Dextromethorphan hydrobromide and quinidine sulfate

Pseudobulbar affect FDA granted approval (11/2)

BioAlliancePharma SA

Oravig Miconazole Lauriad,branded Loramyc inEurope

Oropharyngealcandidiasis

FDA approved Oravig (4/19)

Boehringer Ingelheim GmbH

Pradaxa Dabigatran etexilate Nonvalvular atrial fibrillation

Received FDA approv-al (10/21)



Company Product Description Indication Action


Baraclude Entecavir Chronic hepatitis B virus

FDA approved the sNDA for use in adult patients with decom-pensated liver disease (10/19)

Cadence Pharmaceuticals Inc.

Ofirmev Formerly Acetavance; an intravenous formu-lation of acetamino-phen

Pain and fever FDA approved it to manage mild to mod-erate pain, moderate to severe pain with a d j u n c t i v e o p i o i d analgesics and reduc-tion of fever (11/4)

CanyonPharmaceuticalsGroup

Iprivask Desirudin injection Deep-veinthrombosis

FDA approved it (3/2)

Cepheid Inc. Xpert vanA A rapid test for vanA Vancomycin-resistantenterococci

Received FDA clear-ance to market it (1/7)

Cerexa Inc. and par-ent company Forest Laboratories Inc.

Teflaro Ceftaroline fosamil; a broad-spectrum bac-tericidal cephalospo-rin

Community-acquired bacterial pneumonia

FDA approved Teflaro (11/2)

CipherPharmaceuticalsInc.

CIP-Tramadol An extended-releasetramadol product

Severe chronicpain

FDA approved it to t r e a t m o d e r a t e l y severe chronic pain inadults (5/11)

CNS Therapeutics Inc.

Gablofen Baclofen injection Severe spasticity

F D A a p p r o v e d Gablofen (11/24)

CombinatoRxInc. and Covidienplc

Exalgo A once-daily, extend-ed-release formulation of hydromorphone

Pain inopioid-tolerantpatients


CSL Behring Hizentra Immune globulin sub-cutaneous (human) 20% liquid

Primaryimmuno-deficiency

FDA granted approval (3/8)

Cubist Pharmaceuticals Inc.

Cubicin An antibiotic Methicillin-resistant Staphylococcus aure-us

Approved by the FDA for once-a-day intrave-nous injection (12/3)

CytoriTherapeuticsInc.

PureGraftSystem

Aesthetic body con-touring using autolo-gous fat

Aestheticbody contouring

FDA granted market-ing clearance (1/11)

Dendreon Corp. Provenge Sipuleucel-T vaccine Prostate cancer FDA approved the product (4/30)

Eisai Inc.(subsidiary ofEisai Co. Ltd.)

Dacogen Decitabine injection Myelodysplasticsyndromes

FDA approved a five-day dosing regimen (3/15)

Eisai Inc. (part of Eisai Co. Ltd.)

Halaven Eribulin mesylate Metastatic breast can-cer

FDA approved it for patients who have received at least two prior chemotherapy regimens for late-stage disease (11/16)

Endo Pharmaceuticals Inc.

Fortesta Testosterone 2% gel Low testosterone Received FDA approv-al of Fortesta (12/30)

BiotechnologyProductsApprovedbytheFDAin2010



Forest Labora-tories and MerzPharmaceuticals

Namenda XR Memantine hydro-chloride; 28 mg

Alzheimer’sdisease

FDA approved once-daily Namenda XR to treat moderate to s e v e r e d e m e n t i a (6/23)

Genentech Inc. Actemra Tocilizumab Rheumatoidarthritis

FDA approved it in adults who have had a n i n a d e q u a t e response to tumor necrosis factor antag-onist therapies (1/12)

Genentech Inc. Herceptin Trastuzumab HER2-positive meta-static stomach cancer

FDA approved its use with chemotherapy (10/22)

Genentech Inc.and Biogen IdecInc.

Rituxan Rituximab Chroniclymphocyticleukemia

FDA approved Rituxan in combination with fludarabine and cyclo-phosphamide for pre-viously untreated and previously treated CD20-positive chroniclymphocytic leukemia (2/22)

Genentech Inc.(unit of theRoche Group)

Lucentis Ranibizumab Macular edema F D A a p p r o v e d Lucentis for macular edema following reti-nal vein occlusion (6/24)

Genentech Inc. (a unit of Roche Group)

Valcyte Valganciclovir hydro-chloride

For use in adult kidney transplant at high risk for cytomegalovirus disease

FDA approved longer use of Valcyte (8/12)

Genzyme Corp. Lumizyme 4,000L version of Myozyme; alglucosi-dase alfa; a lysosomal glycogen-specific enzyme

Pompe disease FDA granted approval (5/26)

Gilead SciencesInc.

Cayston Inhaled aztreonam lysine drug

Cystic fibrosispatients infectedwith Pseudo-monas aeruginosa

FDA approved it to improve respiratory symptoms and pul-m o n a r y f u n c t i o n s (2/24)

GlaxoSmithKlineplc

Lamictal XR Extended-release tab-lets

Epilepsy F D A a p p r o v e d Lamictal XR extended-release tablets as once-a-day add-on therapy (2/8)

GlaxoSmithKlineplc

Tykerb Lapatinib First-linemetastaticbreast cancer

Received FDA acceler-a t e d a p p r o v a l o f Tykerb plus hormone therapy letrozole (2/2)

HRA Pharma SA Ulipristal Emergency contracep-tive pill ella

For use as a five-day emergency contracep-tive

FDA approved the pill (8/17)




ISTA Pharmaceuticals Inc.

Bromday Topical ophthalmic solution bromfenac 0.09 percent

Postoperative inflam-mation and reduction of ocular pain in cata-ract extraction patients

FDA approved the product (10/19)

Johnson &Johnson

Pancreaze Pancrelipase; a por-cine-derived, delayed-release enzyme replacement

Exocrinepancreaticinsufficiency

Gained FDA approval (4/14)

Kamada Ltd. Glassia An alpha-1 proteinase inhibitor

Alpha-1 antitrypsin deficiency

Gained FDA approval (7/7)

Labopharm Inc. Oleptro Trazodone hydrochlo-ride

Major depres-sive disorder

FDA approved Oleptro (2/4)

Merz Pharmaceuticals LLC

Xeomin Incobotulinum toxin A

Cervical dystonia or blepharo-spasm


MillenniumPharmaceuticalsInc. (unit ofTakeda Pharma-ceutical Co. Ltd.)

Velcade Bortezomib Multiplemyeloma(untreated)

F DA a p p r o v e d a n sNDA, expanding the label to include long-term overall survival data (1/5)

Momenta Pharmaceuticals Inc. and Sandoz (unit of Novartis AG)

Generic Lovenox Enoxaparin; a complex protein-based antico-agulant derived from the blood thinner hep-arin

Deep vein thrombosis and cardiovascular indications

FDA approved the generic version of L o v e n o x ( S a n o f i -Aventis Group) (7/26)

MonoSol Rx and Reckitt Benckiser Pharmaceuticals Inc.

Suboxone Buprenoprhine HCl/naloxone HCl dihy-drate sublingual film

Opioid dependence Received approval from the FDA to mar-ket Suboxone (9/1)

Novartis AG Afinitor Everolimus tablets Subependymal giant cell astrocytoma

Received FDA approv-al (11/2)

Novartis AG Gilenya Fingolimod Multiple sclerosis

FDA approved the first oral disease-modify-ing agent for MS (9/23)

Novartis AG Tasigna Nilotinib; 150-mgcapsules; a selectiveBcr-Abl inhibitor

Philadelphiachromosome-positive chronicmyeloid leukemia

FDA approved it in adults with newly diagnosed disease (6/21)

Novartis AG Zortress Everolimus oral tab-lets

To preventrejection of kidneytransplants

F D A a p p r o v e d Zortress (4/23)

Novo Nordisk Victoza Liraglutide; once-dailyinjectable glucagon-like peptide-1 receptor agonist

Type II diabetes FDA approved the drug (1/27)

OSI Pharma-ceuticals Inc. and GenentechInc./Roche AG

Tarceva Erlotinib Non-small-celllung cancer

FDA granted approval for Tarceva as a main-t e n a n c e t h e r a p y (4/20)




Pfizer Inc. and Eisai Co. Ltd.

Aricept Donepezil tablet Alzheimer's disease

Received FDA approv-al for a once-daily, higher dose (7/27)

Pozen Inc.and AstraZenecaplc

Vimovo Nonsteroidal inflam-matory drug

Arthritis pain Received FDA approv-al (5/3)

Progenics Pharmaceuticals Inc.

Relistor Methylnaltrexone bro-mide subcutaneous injection

Opioid-induced con-stipation

FDA, EMEA and Health Canada approved sin-g l e - u s e , p r e f i l l e d syringes of Relistor subcutaneous injec-tion in palliative care p a t i e n t s w i t h a d v a n c e d i l l n e s s (9/30)

PurduePharma LP

OxyContin Oxycodone drug coat-ed in a tamper-resis-tant plastic-like polymer

Pain FDA approved the reformulated version (4/7)

Questcor Pharmaceuticals Inc.

H.P. Acthar Gel Repository corticotro-pin injection

Infantile spasms Won FDA approval for the product (10/18)

Roxro PharmaInc.

Sprix Intranasal formulation of generic NSAID ketorolac

Moderate tomoderatelysevere pain


SagentPharmaceuticalsInc.

Bacitracin For injection USP(bacitracin); an anti-infective product

Pneumoniaand empyema

The FDA approved it (5/13)

Sagent Pharmaceuticals Inc.

Sumatriptan and Rocuronium

Sumatriptan succinate injection and rocuronium bromide injection

Migraine and for use in routine tracheal intubation and mechanical ventilation

FDA approved the injectable products (8/3)

SalixPharmaceuticalsLtd.

Xifaxan Rifaximin Overt hepaticencephalopathy;irritable bowelsyndrome

FDA approved it in a 5 5 0 m g s t r e n g t h (3/26); FDA approved it for a third indication (4/5)

Sanofi-AventisGroup SA

Jevtana Cabazitaxel Prostate cancer FDA approved Jevtana as a chemotherapy drug used with pred-nisone (6/18)

Sanofi Pasteur Fluzone High-dose influenzavirus vaccine

Influenza FDA approved the firm’s sBLA (1/6)

Savient Pharmaceuticals Inc.

Krystexxa Pegloticase; a pegylat-ed uric acid specific enzyme

Chronic refractory gout


Shire plc Daytrana Methylphenidate transdermal system

Attention deficit hyperactivity disorder

Received FDA approv-al expanding the age range into teenagers (7/8)

Shire plc Vpriv Enzyme replacementtherapy

Gaucher disease

Cleared official FDA approval (3/1)




Shire plc Vyvanse Lisdexamfetamine dimesylate

Attention deficit hyperactivity disorder

F D A a p p r o v e d Vyvanse for attention deficit hyperactivity disorder in adoles-cents ages 13 to 17 (11/16)

SomaxonPharmaceuticalsInc.

Silenor Doxepin Insomnia FDA approved i ts insomnia drug (3/19)

Strativa Pharmaceuticals and MonoSol Rx

Zuplenz Ondansetron oral sol-uble film

To prevent cancer therapy-induced nausea and vomiting

F D A a p p r o v e d Zuplenz (7/7)

Sunuvion Pharmaceuticals Inc. (formerly Sepracor Inc. and a unit of Dainippon Sumitomo Pharma Co. Ltd.)

Latuda Lurasidone HCl tablets Schizophrenia FDA approved the product (10/29)

Talecris Biotherapies Inc.

Gamunex-C Immune globulin injection

Primary immunodefi-ciency

FDA has approved it f o r s u b c u t a n e o u s administration (10/15)

Theratechnologies Inc.

Egrifta Tesamorelin HIV-associated lipo-dystrophy

FDA approved Egrifta (11/12)

Three Rivers Pharmaceuticals LLC

Infergen Consensus inferferon; a bio-optimized, selec-tive and highly potent Type I interferon alpha

Chronic hepatitis C virus

F D A a p p r o v e d expanding the label-ing for daily use with ribavirin as a retreat-ment for chronic hep-atitis C virus (7/7)

WatsonPharmaceuticalsInc. (DebiopharmSA was developer)

Trelstar Triptorelin pamoate for injectable suspen-sion

Advancedprostate cancer

FDA approved the 22.5-mg dose (3/15)

WyethPharmaceuticalsInc. (subsidiaryof Pfizer Inc.)

Prevnar 13 A pneumococcal 13-valent conjugate vaccine

To preventinvasive pneumo-coccal disease andotitis media

FDA approved Prevnar 13, the successor to Prevnar (2/25)

Notes:

# The date indicated refers to the BioWorld Today issue in which the news item can be found.


Biotech Products: 1982-2010, A-Z Company Product Marketer Indication (U.S. Approval Date; Month/Year)

Abbott HIVAG-1 monoclo-nal antibody

Abbott Diagnostic for use in blood banks and plasma cen-ters, and for prognostic use in HIV patients (4/96)

Abbott Humira Abbott Laboratories Rheumatoid arthritis (12/02); expanded label to include reducing symptoms and inhibiting structural damage (1/03); improvement in physical function in RA patients (8/04); ankylosing spondylitis (7/06); psoriatic arthritis (11/06); moderately to severely active Crohn's disease unresponsive to conventional therapy (2/07); moderately to severely active polyar-ticular juvenile idiopathic arthritis in patients four years or older (2/08)

Abbott Simcor Abbott Complex lipid disease (2/08)

Acambis plc ACAM2000 Acambis plc Smallpox (9/07)

Access Pharmaceuticals Inc.

MuGard Access Pharmaceuticals Inc.

Oral mucositis in cancer patients (12/06)

Acorda Therapeutics Inc.

Ampyra Acorda Therapeutics

To improve walking in multiple sclerosis patients (1/10)

Acrux Ltd. Axiron Eli Lilly and Co. Testosterone deficiency (11/10)

Actelion Ltd. Tracleer Actelion Ltd. and Genentech Inc.

Pulmonary arterial hypertension (11/01)

Actelion Ltd. Veletri Actelion Additional in-use condition for pulmonary arterial hypertension (10/10)

Actelion Ltd. Ventavis Actelion Pulmonary arterial hypertension (8/09)

Adolor Corp. Entereg Adolor Corp. Postoperative ileus (5/08)

Advanced Tissue Sciences Inc.

Dermagraft Smith & Nephew plc Chronic foot ulcers in diabetic patients (10/01)

Agouron Pharmaceuticals Inc.

Viracept Glaxo Wellcome plc; Hoffmann-La Roche Ltd.

A 625-mg formulation for HIV (5/03); HIV protease inhibitor (3/97); twice-daily dosing for HIV(12/99)

Alexion Pharmaceuticals Inc.

Soliris Alexion Pharmaceuticals Inc.

For treating paroxysmal nocturnal hemoglobinuria patients to reduce hemolysis (3/07)

Alkermes Inc. Risperdal Consta Johnson & Johnson Schizophrenia (10/03); new injection site, the deltoid muscle in the arm (10/08)

Alkermes Inc. Vivitrol Cephalon Inc. Alcohol dependence (4/06); to prevent relapse to opioid dependence (10/10)

Allergan Inc. Acuvail Allergan Inc. Pain and inflammation following cataract surgery (7/09)

Allergan Inc. Botox Allergan Inc. Upper limb spasticity (3/10)

Alliance Pharmaceutical Corp.

Imagent Alliance Pharmaceutical Corp., Cardinal Health Inc. and inChord Communications Inc.

To provide anatomical information about the heart not obtainable using echocardiography alone (6/02)

Allos Therapeutics Inc.

Folotyn Allos Peripheral T-cell lymphoma (9/09)


BiotechProductApprovals,1982-2010


Company Product Marketer Indication (U.S. Approval Date; Month/Year)

Alpha Therapeutic Corp.

Aralast Baxter Healthcare Corp.

For patients with congenital deficiency of alpha-1 proteinase inhibitor and clinically evident emphyse-ma (1/03)


AlphaNine SD Alpha Therapeutic Corp.

To prevent and control bleeding due to Factor IX deficiency associated with hemophilia B (7/96)


Venoglobulin-S Alpha Therapeutic Corp.

Treatment of primary immunodeficiencies (11/91); idiopathic thrombocytopenia purpura; kawasaki dis-ease (1/95)

Alza Corp. Amphotec Alza Corp. Invasive aspergillosis infections (2nd-line therapy) (11/96)

Alza Corp. Doxil Alza Corp. Second-line therapy for Kaposi's sarcoma in AIDS patients (11/95); refractory ovarian cancer (6/99)

AMAG Pharmaceuticals Inc.

Feraheme AMAG Iron deficiency (6/09)

American Pharmaceutical Partners Inc.

Abraxane APPI FDA approved the drug for use after failure of che-motherapy in metastatic breast cancer (1/05)

Amgen Inc. Kepivance Amgen Inc. The FDA approved the drug for severe oral mucositis in patients with blood cancers who are undergoing high-dose chemotherapy followed by a bone marrow transplant (12/04)

Amgen Inc. Aranesp Amgen Inc. Anemia associated with chronic renal failure (9/01); for chemotherapy-induced anemia in patients with non-myeloid malignancies (7/02)

Amgen Inc. Enbrel Wyeth Once-weekly dosing approved (10/03); to improve physical function in patients with moderately to severely active rheumatoid arthritis (8/03); ankylos-ing spondylitis (7/03); rheumatoid arthritis (10/98); severely active polyarticular-course juvenile rheuma-toid arthritis (5/99); psoriatic arthritis (1/02); plaque psoriasis (4/04); improving physical function in pso-riatic arthritis (6/05); chronic severe plaque psoriasis in children 8 years and older (1/09)

Amgen Inc. Epogen Amgen Inc. Treatment of anemia associated with chronic renal failure and anemia in Retrovir-treated HIV-infected patients (6/89); anemia caused by chemotherapy in patients with nonmyeloid malignancies (4/93)

Amgen Inc. Etoposide Injection

SuperGen Inc. Treatment of refractory testicular tumors and small-cell lung cancer (3/96)

Amgen Inc. and Three Rivers Pharmaceuticals LLC

Infergen Amgen Inc.; Yamanouchi Pharmaceutical Co. Ltd.

Consensus alpha interferon for hepatitis C (10/97); expanded label for daily use with ribavirin as a retreatment for chronic hepatitis C virus (7/10)

Amgen Inc. Kineret Amgen Inc. Rheumatoid arthritis (11/01)

Amgen Inc. Leukine Amgen Inc. Treatment of autologous bone marrow transplanta-tion (3/91); neutropenia resulting from chemothera-py in acute myelogenous leukemia (9/95); bone marrow transplant engraftment or failure (11/95); peripheral blood stem cell mobilization (12/95); to stimulate production of white blood cells in patients undergoing bone marrow and peripheral blood pro-genitor cell transplants, and for treating chemothera-py-induced neutropenia (11/96)




Amgen Inc. Neulasta Amgen Inc. Cancer (2/02)

Amgen Inc. Neupogen Hoffmann-La Roche Ltd.; Amgen; Kirin Brewery Co. Ltd. (Japan)

Chemotherapy-induced neutropenia (2/91); bone marrow transplant (6/94); severe chronic neutrope-nia (12/94); support peripheral blood progenitor cell transplantation(12/95); acute myelogenous leukemia (4/98)

Amgen Inc. Novantrone Amgen Inc. Treatment of hormone-refractory prostate cancer (in combination with steroids) (11/96); secondary pro-gressive, progressive relapsing-remitting multiple sclerosis (10/00)

Amgen Inc. Nplate Amgen Inc. Chronic immune thrombocytopenic purpura (8/08)

Amgen Inc. Procrit (EPO) Ortho Biotech Treatment of anemia in AZT-treated HIV-infected patients (12/90); anemia in cancer patients on che-motherapy (4/93); for use in anemic patients sched-uled to undergo elective noncardiac, nonvascular surgery (12/96); anemia in children with chronic renal failure who are undergoing dialysis (11/99)

Amgen Inc. Prolia Amgen Inc. Osteoporosis (6/10)

Amgen Inc. Vectibix Amgen Inc. The FDA approved the monoclonal antibody for treating EGFr-expressing metastatic colorectal can-cer (9/06)

Amgen Inc. Xgeva Amgen Inc. To prevent skeletal-related events in patients with bone metastases from solid tumors (11/10)

Amylin Pharmaceuticals Inc.

Byetta (exenatide) Amylin Pharmaceuticals Inc. and Eli Lilly and Co.

For use as an adjunctive therapy to improve blood sugar control in Type II diabetes (4/05); For Type II diabetics who have not achieved adequate control on a thiazolidinedione (12/06); for use as a mono-therapy in diabetes (11/09)


Symlin Amylin Pharmaceuticals Inc.

For use with insulin to treat Types I and II diabetics who are not achieving desired glucose control with insulin therapy (3/05)

Anesiva Inc. Zingo Anesiva Inc. Pain in children ages 3-18 (8/07); expanded to adults in treating pain associated with blood draws (1/09)

Anika Therapeutics Inc.

Orthovisc Ortho Biotech Products LP

Pain from osteoarthritis of the knee (2/04)

Anika Therapeutics Inc.

Shellgel Anika Therapeutics Inc.

For protecting eye tissue and maintaining eye shape during ophthalmic surgery (7/01)

AnorMED Inc. Fosrenol Shire Pharmaceuticals Group plc

The FDA approved the phosphate binder to reduce elevated blood levels of phosphate in patients with end-stage renal disease (10/04)

Antisoma plc Tablet formulation of fludarabine phosphate

Antisoma Chronic lymphocytic leukemia (12/08)

Astellas Pharma US Inc.

Vaprisol Astellas New formulation premixed with 5% dextrose for low blood sodium (10/08)

AstraZeneca plc Faslodex AstraZeneca For the 500-mg dose to treat hormone receptor-posi-tive metastatic breast cancer (9/10)

AstraZeneca plc Seroquel XR AstraZeneca Major depressive disorder (12/09)

Auxilium Pharmaceuticals Inc.

Xiaflex Auxilium Pharmaceuticals Inc.

Dupuytren's contracture (2/10)




Atrix Laboratories Inc.

Atridox Block Drug Co. Periodontal disease (9/98)


Atrisorb Barrier Block Drug Co. Periodontal disease (3/96); periodontal surgery (9/00)


Eligard Sanofi-Synthelabo Inc.

7.5 mg for advanced prostate cancer (1/02); 22.5 mg for advanced prostate cancer (7/02); 30 mg for the palliative treatment of advanced prostate cancer (2/03)


Abreva GlaxoSmithKline plc Cold sores and fever blisters (7/00)


FazaClo Avanir Pharmaceuticals Inc.

A 12.5-mg dosage strength for schizophrenia (5/07)


Nuedexta Avanir Pharmaceuticals Inc.

For pseudobulbar affect (11/10)

Avant Immunother-apeutics

Rotarix GlaxoSmithKline plc Rotavirus (4/08)

Berlex Laboratories Inc.

BLU-U Berlex Laboratories Inc.

Non-hyperkeratonic actinic keratoses of the face or scalp (9/00)

Berlex Laboratories Inc.

Refludan Bayer Healthcare Pharmaceuticals

For anticoagulation in patients with heparin-induced thrombocytopenia and associated thromboembolic disease in order to prevent further complications (3/98)

BioAlliance Pharma SA

Oravig BioAlliance Pharma Oropharyngeal candidiasis (4/10)

BioDelivery Sciences International

Onsolis BioDelivery Sciences

Breakthrough cancer pain (7/09)

Biogen Idec Inc. Amevive Biogen Idec Inc. Moderate to severe chronic plaque psoriasis (1/03)

Biogen Idec Inc. Avonex Biogen Idec Inc. Multiple sclerosis (5/96); for retreatment after the first MS attack, if a brain scan shows abnormalities typical of the disease (2/03)

Biogen Idec Inc. Engerix-B GlaxoSmithKline plc Hepatitis B vaccine (9/89); adults with chronic hepa-titis C infection (8/98)

Biogen Idec Inc. Intron-A Schering-Plough Corp.

Hairy cell leukemia (6/86); genital warts (6/88); AIDS-related Kaposi's sarcoma (11/88); hepatitis C (2/91); hepatitis B (7/92); adjuvant with surgery in those with high risk of malignant melanoma recur-rence (12/95); low-grade non-Hodgkin's lymphoma (11/97); hepatitis B in pediatric patients (8/98)

Biogen Idec Inc. Recombivax HB Merck & Co. Inc. Hepatitis B vaccine (7/86)




Biogen Idec Inc. Rituxan Genentech Inc. Low-grade non-Hodgkin's lymphoma recurrences (11/97); for retreatment after a prior course of Rituxan therapy, doubling of infusions and treatment of bulky disease, or tumors greater than 10 centimeters, for patients with relapsed or refractory, low-grade or follicular, CD20-positive B-cell non-Hodgkin's lym-phoma (5/01); for first-line treatment of diffuse large B-cell, CD20-positive, non-Hodgkin's lymphoma in combination with chemotherapy (2/06); for use with methotrexate in moderately to severely active rheu-matoid arthritis (2/06); for treating low-grade NHL in those with stable disease who responded to chemo-therapy (9/06); in combination with fludarabine and cyclophosphamide for previously untreated and pre-viously treated CD20-positive chronic lymphocytic leukemia (2/10)

Biogen Idec Inc. and Elan Corp. plc

Tysabri Biogen Idec Inc. and Elan Corp. plc

The FDA granted accelerated approval to the drug for treating relapsing forms of multiple sclerosis (11/04); Crohn's disease (1/08)

BioMarin Pharmaceutical Inc.

Kuvan BioMarin Pharmaceutical Inc.

Phenylketonuria (12/07)


Naglazyme BioMarin Pharmaceutical Inc.

The FDA approved the orphan product for treating mucopolysaccharidosis VI (6/05)


Orapred ODT Alliant Pharmaceuticals Inc.

Inflammation and asthma (6/06)

Biomatrix Inc. Synvisc Wyeth Viscosupplementation treatment for arthritis of the knee (8/97)

BioSante Pharmaceuticals Inc.

Bio-E-Gel (Elestrin) Bradley Pharmaceuticals Inc.

The FDA approved the product for treating moderate to severe vasomotor symptoms (hot flashes) associ-ated with menopause (12/06)

Biosonix Ltd. (sub-sidiary of Neoprobe Corp.)

FlowGuard Neoprobe Corp. Diagnostic product to determine blood flow in non-invasive diagnostic and intraoperative applications (2/02)

Biota Holdings Ltd. Relenza Glaxo Wellcome plc Zanamivir for inhalation for treatment of influenza A and B (7/99)

Bio-Technology General Corp.

BioTropin Cannot sell in U.S. due to court injunc-tion

Human growth hormone deficiency in children (5/95)

BioTime Inc. Hextend N/A Hypovolemia (3/99)

Biovail Corp. Aplenzin Biovail Corp. Depression (4/08)


Micardis Boehringer Ingelheim

To reduce the risk of myocardial infarction, stroke or death from cardiovascular causes (10/09)


Pradaxa Boehringer Ingelheim

Nonvalvular atrial fibrillation (10/10)

Boehringer Ingelheim Pharmaceuticals Inc.

Viramune Boehringer Ingelheim Pharmaceuticals Inc.

For use in combination with nucleoside analogues for treating HIV-infected adults (6/96)

Bone Care International Inc.

Hectorol Bone Care International Inc.

FDA approved added indication of secondary hyper-parathyroidism that develops in earlier stages of chronic kidney disease prior to dialysis (4/04)





Baraclude Bristol-Myers For use in adult hepatitis B patients with decompen-sated liver disease (10/10)

Bristol-Myers Squibb Co. and AstraZeneca plc

Onglyza Bristol-Myers and AstraZeneca

Type II diabetes (7/09)

Cadence Pharmaceuticals Inc.

Ofirmev Cadence Pharmaceuticals Inc.

To manage mild to moderate pain, moderate to severe pain with adjunctive opioid analgesics and reduction of fever (11/10)

Cangene Corp. Accretropin Apotex Group Growth failure or short stature associated with Turner syndrome (1/08)

Cangene Corp. HepaGam B Apotex Corp. For treatment following acute exposure to hepatitis B virus (1/06); to prevent hepatitis B recurrence fol-lowing liver transplantation in hepatitis B surface antigen-positive liver transplant patients (4/07)

Cangene Corp. Vaccinia immune globulin (VIG)

Cangene Corp. The FDA approved the product for use in counteract-ing certain adverse reactions to smallpox vaccina-tion (5/05)

Cangene Corp. VariZIG FFF Enterprises Varicella zoster exposure (1/06)

Canyon Pharmaceuticals Group

Iprivask Canyon Pharmaceuticals Group

Deep vein thrombosis (3/10)

Celgene Corp. Revlimid Celgene Corp. FDA approved the product for treating transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with a dele-tion 5q cytogenetic abnormality (12/05); for use with dexamethasone to treat multiple myeloma in newly diagnosed patients (5/06) and in patients who received at least one prior therapy (6/06)

Celgene Corp. Focalin Novartis Pharmaceuticals Corp.

Attention deficit/hyperactivity disorder (11/01)

Celgene Corp. Thalomid Celgene Corp. Multiple myeloma (5/06)

CellPro Inc. Ceprate SC System CellPro Inc. Separated cells returned to patient after chemothera-py or marrow-destroying procedures to restore bone marrow (12/96)

Celltech Pharmaceuticals Inc.

Metadate CD Celltech Pharmaceuticals Inc.

Attention deficit hyperactivity disorder (4/01)

Celltech Group plc Zavesca Actelion Ltd. To treat Type I Gaucher's disease (8/03)

Cell Therapeutics Inc.

Trisenox Cell Therapeutics Inc.

Acute promyelocytic leukemia (9/00)


Zevalin Cell Therapeutics Inc.

Non-Hodgkin's lymphoma (2/02)




Centocor Inc. (unit of Johnson & Johnson)

Remicade Centocor Inc. Crohn's disease (8/98); rheumatoid arthritis (11/99); for use with methotrexate to inhibit the progression of damage in patients with moderately to severely active rheumatoid arthritis; to be used, in combina-tion with methotrexate, to improve physical function in patients with moderately to severely active rheu-matoid arthritis who have had an inadequate response to methotrexate alone (2/02); for long-term remission-level control of symptoms associat-ed with Crohn's disease (7/02); ankylosing spondylitis (12/04); ulcerative colitis (5/05); reducing arthritis signs and symptoms in patients with psori-atic arthritis (5/05); ulcerative colitis in those who have inadequately responded to other therapies (10/06)

Centocor Inc. (unit of Johnson & Johnson)

ReoPro Eli Lilly & Co. To inhibit platelet aggregation in high-risk angio-plasty (12/94); prevention of blood flow stoppages to the heart in patients undergoing percutaneous coro-nary intervention and refractory unstable angina (11/97)

Centocor Ortho Biotech Inc. (unit of Johnson & Johnson)

Simponi Centocor Rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis (4/09)

Centocor Ortho Biotech Inc. (unit of Johnson & Johnson)

Stelara Centocor Moderate to severe plaque psoriasis (9/09)

Cephalon Inc. Fentora Cephalon Inc. The FDA approved the fentanyl-based tablet treating breakthrough pain in cancer patients (9/06)

Cephalon Inc. Nuvigil Cephalon Inc. Sleepiness related to sleep apnea, shift work and nar-colepsy (6/07)

Cephalon Inc. Provigil Cephalon Inc. Treatment for excessive daytime sleepiness associ-ated with narcolepsy (12/98); excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome and shift-work sleep disorder (1/04)

Cephalon Inc. Treanda Cephalon Inc. Chronic lymphocytic leukemia (3/08); non-Hodgkin's lymphoma (10/08)

Cepheid Inc. Xpert MRSA test Cepheid Inc. To detect Methicillin-resistant Staphylococcus aure-us (4/07)

Cerexa Inc. Teflaro Forest Laboratories Inc.

Community-acquired bacterial pneumonia (11/10)

Cipher Pharmaceuticals Inc.

CIP-Tramadol Cipher Pharmaceuticals Inc.

Severe chronic pain (5/10)

CNS Therapeutics Inc.

Gablofen CNS Therapeutics Severe spasticity (11/10)

CollaGenex Pharmaceuticals Inc.

Periostat ND For the treatment of adult periodontitis in a new tab-let formulation (2/01)

Connaught Laboratories Inc.

Tripedia Connaught Laboratories Inc.

Vaccination of infants 2, 4 and 6 months of age and first booster at 15-20 months; primarily for whooping cough (7/96)

Connetics Corp. Luxiq Connetics Corp. Relief of inflammatory and pruritic manifestations of corticoid-responsive dermatoses of the scalp (3/99)




Connetics Corp. Olux Connetics Short-term topical treatment of the inflammatory and pruritic manifestations of moderate to severe corticoid-responsive dermatoses of the scalp (5/00); for mild to moderate plaque-type psoriasis of n on-scalp regions (12/02)

Corixa Corp. Bexxar GlaxoSmithKline plc To treat patients with CD20-positive, follicular, non-Hodgkin's lymphoma, with and without transforma-tion, whose disease is refractory to Rituxan and has relapsed following chemotherapy (6/03)

CollaGenex Pharmaceuticals Inc.

Oracea CollaGenex Pharmaceuticals Inc.

The FDA approved the drug for treating rosacea (5/06)

Collegium Pharmaceutical

AllerNaze Collegium Allergic rhinitis (1/09)

CombinatoRx Inc. Exalgo Covidien plc Pain in opioid-tolerant patients (3/10)

CoTherix Inc. Ventavis CoTherix Inc. The FDA approved the product for treating pulmo-nary arterial hypertension in patients with NYHA Class III or IV symptoms (12/04)

Critical Therapeutics Inc.

Zyflo CR Critical Therapeutics and Dey LP

Extended-release version for asthma (5/07)

CSL Behring Afluria CSL Behring For use in pediatric patients, 6 months of age and older, with influenza (11/09)

CSL Behring Berinert CSL Behring Hereditary angioedema, acute abdominal or facial attacks (10/09)

CSL Behring Helixate FS CSL Behring Hemophilia A for children 16 or younger who do not have pre-existing joint damage (8/09)

CSL Behring Hizentra CSL Behring Primary immunodeficiency (3/10)

CSL Behring Rhophylac RhO CSL Behring To raise platelet counts in RhO(D)-positive, non-sple-nectomized adult patients with immune thrombocy-topenic purpura (4/07)

CSL Behring Riastap CSL Behring Rare congenital fibrinogen deficiencies (1/09)


Cubicin Cubist Pharmaceuticals Inc.

To treat skin infections (9/03); for S. aureus blood-stream infections (5/06); for use as a once-a-day intravenous injection to treat Methicillin-resistant S. aureus (12/10)

Curis Inc. OP-1 Stryker Corp. To repair and regenerate tissue (10/01)

CV Therapeutics Inc.

Lexiscan Astellas Pharma Inc. For use with MPI to detect coronary artery disease (4/08)

CV Therapeutics Inc.

Ranexa CV Therapeutics Inc.

Chronic angina (1/06); 1 ,000-mg tablet for chronic angina (8/07); first-line indication with new labeling showing it reduces arrhythmias in chronic angina patients with coronary artery disease (11/08)

Cypress Bioscience Inc. and Fresenius Hematology Inc.

Prosorba Column Cypress Bioscience Inc.

Moderate to severe rheumatoid arthritis (3/99)

Cypress Bioscience Inc.

Savella Forest Laboratories Inc.

Fibromyalgia (1/09)

Cytogen Corp. OncoScint CR/OV CIB bio-International Detection, staging and follow-up of colorectal and ovarian cancers (12/92)




Cytogen Corp. ProstaScint Cytogen Corp. Diagnostic imaging of prostate cancer in newly diag-nosed patients; also for use in post-prostatectomy patients suspected of having occult metastatic dis-ease (10/96)

Cytogen Corp. Quadramet Cytogen Corp. Radiopharmaceutical for pain associated with bone cancer (3/97)

Cytori Therapeutics Inc.

PureGraft System Cytori Therapeutics Aesthetic body contouring (1/10)

Debiopharm SA Trelstar LA Debiopharm SA Advanced-stage prostate cancer (7/01)

Dendreon Corp. DACS SC Dendreon Corp. Used to isolate cells for transplantation in cancer patients following chemotherapy or radiation (8/99)

Depomed Inc. Glumetza Biovail Corp. The FDA approved the product for treating Type II diabetes (6/05); 1 ,000-mg tablet for Type II diabetes (1/08)

Dendreon Corp. Provenge Dendreon Corp. Prostate cancer (4/10)

Depomed Inc. Proquin XR Partner was being finalized

The FDA approved the product for treating uncom-plicated urinary tract infections (5/05)

DVC LLC (unit of Computer Sciences Corp.)

VIGIV DVC LLC FDA approved the drug for treating adverse reac-tions to smallpox vaccination (2/05)

Dyax Corp. Kalbitor Dyax Acute attacks of hereditary angioedema (12/09)

Eisai Co. Ltd. Dacogen Eisai Co. Ltd. Five-day dosing regimen for myelodysplastic syn-dromes (3/10)

Eisai Co. Ltd. Gliadel Eisai Co. Ltd. For use as adjunct to surgery to prolong survival of patients with recurrent glioblastoma multiforme (2nd-line therapy) (9/96); Gliadel Wafer for first-line therapy for patients with high-grade malignant glio-ma (2/03)

Eisai Inc. Halaven Eisai Inc. Following two prior chemotherapy regimens for met-astatic breast cancer (11/10)

Eisai Corp. of North America

Lusedra Eisai Co. Ltd. For use as a sedative-hypnotic (12/08)

Elan Corp. plc Abelcet The Liposome Co. Aspergillosis in those unable to take conventional drug (11/95); treatment of all types of confirmed or suspected invasive fungal infections (especially can-didiasis) as 2nd-line therapy (10/96); severe systemic fungal infections (9/99)

Elan Corp. plc Avinza Ligand Pharmaceuticals Inc.

For chronic, moderate to severe pain (3/02)

Eli Lilly & Co. Alimta Eli Lilly & Co. Non-small-cell lung cancer (7/09)

Eli Lilly & Co. Effient Eli Lilly & Co. To reduce the risk of blood clots in patients undergo-ing angioplasty (7/09)

Eli Lilly & Co. Humalog Eli Lilly & Co. Diabetes (6/96)

Eli Lilly & Co. Humatrope Eli Lilly & Co. Human growth hormone deficiency in children (3/87); somatotropin deficiency syndrome in adults (8/96)

Eli Lilly & Co. Xigris Eli Lilly & Co. Sepsis (11/01)

Eli Lilly & Co. Zyprexa Relprevv Eli Lilly & Co. Injectable formulation for schizophrenia (12/09)

Emergent BioSolutions Inc.

BioThrax Emergent Anthrax (12/08)




Encysive Pharmaceuticals Inc.

Argatroban GlaxoSmithKline plc Anticoagulant for prevention or treatment of throm-bosis associated with heparin-induced thrombocyto-penia (6/00); patients with heparin-induced thrombocytopenia undergoing percutanous coro-nary interventions (4/02)


Fortesta Endo Pharmaceuticals Inc.

Low testosterone (12/10)


Opana ER and Opana tablets


The FDA approved the products for treating moder-ate to severe pain (6/06)

Enzon Inc. Adagen Enzon Inc. Treatment of infants and children with severe com-bined immunodeficiency (3/90)

Enzon Inc. Oncaspar Rhone-Poulenc Rorer Inc.

Acute lymphoblastic leukemia (2/94); for use in first-line ALL treatment (7/06)

Enzon Inc. Peg-Intron Schering-Plough Corp.

Chronic hepatitis C (1/01); powder version (8/01)

Enzon Inc. Rebetol Schering-Plough Corp.

Pediatric hepatitis C (7/03); to be used in combina-tion with Intron A injection for chronic hepatitis C (7/01)

EPIX Pharmaceuticals Inc.

Vasovist EPIX To evaluate aortoiliac occlusive disease (12/08)

Eurand NV Lamictal GlaxoSmithKline plc Bipolar disorder (5/09)

Eurand NV Zenpep Eurand Exocrine pancreatic insufficiency in patients with cystic fibrosis and other conditions (8/09)

Forest Laboratories Inc.

Namedna XR Merz Pharmaceuticals GmbH

Moderate to severe dementia in Alzheimer's disease (6/10)

GelTex Pharmaceuticals Inc.

Welchol Sankyo Parke Davis Adjunctive therapy to diet and exercise for the reduction of low-density lipoprotein (LDL) cholester-ol in patients with primary hypercholesterolemia (5/00)

GelTex Pharmaceuticals Inc.

Welchol Sankyo Parke Davis Adjunctive therapy to diet and exercise for the reduction of low-density lipoprotein (LDL) cholester-ol in patients with primary hypercholesterolemia (5/00)

Genentech Inc. Actemra Genentech Inc. Rheumatoid arthritis patients who have had an inad-equate response to tumor necrosis factor antagonist (1/10)

Genentech Inc. and InterMune Pharmaceuticals Inc.

Actimmune InterMune Pharmaceuticals Inc.

Chronic granulomatous disease (12/90); treatment for severe malignant osteopetrosis (2/00)

Genentech Inc. Activase Genentech Inc. Acute myocardial infarction (11/87); acute pulmonary embolism (6/90); accelerated infusion (4/95); acute ischemic stroke within 3 hours of symptom onset (subset of adults whose strokes are caused by bleed-ing are not included in treatment group) (6/96)




Genentech Inc. Avastin (bevaci-zumab)

Roche First-line treatment, in combination with 5-FU, in metastatic colorectal cancer (2/04); for use with other drugs in second-line metastatic colorectal can-cer (6/06); for use with paclitaxel chemotherapy in first-line treatment of metastatic HER2-negative breast cancer (2/08); refractory glioblastoma multi-forme (5/09); untreated metastatic renal-cell carcino-ma (8/09)

Genentech Inc. Cathflo Activase Genentech Inc. For use in breaking down clots in central venous catheters (9/01)

Genentech Inc. Herceptin Genentech Inc. Metastatic breast cancer in combination with pacli-taxel as a first-line agent and as single agent in women who have failed other therapies (9/98); for the adjuvant treatment of HER2-positive node-posi-tive breast cancer (11/06); breast cancer therapy in combination with docetaxel and carboplatin, or in combination with anthracycline, cyclophosphamide and doce-taxel (5/08); for use with chemotherapy to treat HER2-positive metastatic stomach cancer (10/10)

Genentech Inc. Humulin Eli Lilly & Co. Diabetes (10/82)

Genentech Inc. Kogenate Bayer Corp. Hemophilia A (2/93); Kogenate FS (6/00)

Genentech Inc. Lucentis Genentech Inc. Wet age-related macular degeneration (6/06); macu-lar edema following retinal vein occlusion (6/10)

Genentech Inc. Nutropin and Nutropin AQ

Genentech Inc. Growth failure associated with chronic renal insuffi-ciency (11/93); growth hormone inadequacy (1/94); for treating children whose short stature is caused by growth hormone inadequacy or by chronic renal insufficiency (1/96); expanded label to include treat-ment of short stature in females with Turner's syn-drome (12/96); growth hormone replacement therapy on spine bone mineral density in young adults with childhood-onset growth hormone defi-ciency (12/99); long-term treatment of idiopathic short stature (7/05)

Genentech Inc. and Alkermes Inc.

Nutropin Depot Genentech Inc. and Alkermes Inc.

Human growth hormone for pediatric deficiencies (12/99)

Genentech Inc. Protropin Genentech Inc. Growth hormone inadequacy; growth failure associ-ated with chronic renal insufficiency in children (10/85)

Genentech Inc. Pulmozyme Genentech Inc. Cystic fibrosis (12/93); treatment of cystic fibrosis in severely ill patients (less than 40% lung function) (12/96); treatment of cystic fibrosis in infants and young children (3/98)

Genentech Inc. and XOMA Ltd.

Raptiva Genentech and XOMA

Moderate to severe plaque psoriasis (10/03)

Genentech Inc. Roferon-A F. Hoffmann-La Roche Ltd. (Switzerland)

Hairy cell leukemia (6/86); AIDS-related Kaposi's sar-coma, Philadelphia chromosome positive chronic myelogenous leukemia (11/88); chronic myelogenous leukemia and hepatitis C (10/95)

Genentech Inc. TNKase (tenecteplase)

Genentech Inc. Single-bolus thrombolytic for the treatment of acute myocardial infarction; can be administered over five seconds in a single dose (6/00)

Genentech Inc. Valcyte Roche Group For longer use in adult kidney transplant at high risk for cytomegalovirus disease (8/10)




Genentech Inc. Xolair Novartis Pharma AG For moderate to severe persistent asthma in adults and adolescents (6/03)

GeneSoft Pharmaceuticals Inc.

Factive GeneSoft Pharmaceuticals Inc.

To treat mild to moderate, community-acquired pneumonia due to multidrug-resistant Streptococcus pneumoniae (7/03)

Genetics Institute Inc.

BeneFix Genetics Institute Inc.

Treatment of hemophilia B (6/97)


Recombinate Baxter International Inc.

Blood clotting Factor VIII for hemophilia A (12/92)


Neumega Genetics Institute Inc.

Blood platelet booster (11/97)


ReFacto Wyeth To control and prevent bleeding; surgical prophylax-is with hemophilia A patients (3/00)

Genmab A/S Arzerra GlaxoSmithKline plc Chronic lymphocytic leukemia (10/09)

Gen-Probe Inc. Procleix HIV-1/HCV Assay and the Procleix Semi-Automated System

Novartis AG Test to be used to detect human immunodeficiency virus type 1 and hepatitis C virus (2/02)

Genta Inc. Ganite Genta Inc. Cancer-related hypercalcemia (9/03)

Genzyme Corp. and BioMarin Pharmaceutical Inc.

Aldurazyme Genzyme Corp. For mucopolysaccharidosis-1 (4/03)

Genzyme Corp. Campath Bayer HealthCare Pharmaceuticals Inc.

Leukemia (5/01); B-cell chronic lymphocytic leukemia (9/07)

Genzyme Corp. Carticel Genzyme Corp. Autologous cultured chonddrocytes to repair knee cartilage damage (8/97)

Genzyme Corp. Ceredase Genzyme Corp. Type I Gaucher's disease (4/91)

Genzyme Corp. Cerezyme Genzyme Corp. Type I Gaucher's disease (5/94)

Genzyme Corp. Clolar (clofarabi-ne)

Genzyme Corp. For treating children with refractory or relapsed acute lymphoblastic leukemia (12/04)

Genzyme Corp. Fabrazyme Genzyme Corp. For Fabry's disease (4/03)

Genzyme Corp. Lumizyme Genzyme Pompe disease (5/10)

Genzyme Corp. Mozobil Genzyme For multiple myeloma and non-Hodgkin's lymphoma (12/08)

Genzyme Corp. Myozyme Genzyme Corp. The FDA approved the drug for treating Pompe dis-ease (4/06)

Genzyme Corp. Renagel Genzyme Corp. Reduction of serum phosphorus in patients with end-stage renal disease (11/98); reduction of serum phosphorus in hemodialysis patients with end-stage renal disease (7/00)

Genzyme Corp. Renvela Genzyme Corp. To control serum phosphorus in patients with chron-ic kidney disease on dialysis (10/07)

Genzyme Corp. Seprafilm Genzyme Corp. To reduce postsurgical adhesions following open abdominal or pelvic surgery (8/96)

Genzyme Corp. Synvisc-One Genzyme Corp. For pain associated with osteoarthritis of the knee (2/09)

Genzyme Corp. Thymoglobulin Genzyme Corp. Prevention of kidney transplant rejection (12/98)

Genzyme Corp. Thyrogen Knoll Pharmaceutical Co.

Follow-up diagnostic for patients who have been treated for thyroid cancer (12/98)




Gilead Sciences Inc. AmBisome Fujisawa Healthcare Inc. (Japan)

Fungal infections (8/97); label expansion for inject-able liposomal formulation of aphotericin B for cryp-tococcal meningitis in HIV-infected patients (7/00)

Gilead Sciences Inc. Atripla Bristol Myers Squibb Co.

The FDA approved the combination product for treating HIV (7/06)

Gilead Sciences Inc. Cayston Gilead Sciences Inc. To improve respiratory symptoms and pulmonary functions in cyst ic f ibrosis patients with Pseudomonas aeruginosa (2/10)

Gilead Sciences Inc. DaunoXome Swedish Orphan AB 1st-line therapy for Kaposi's sarcoma in AIDS patients (4/96)

Gilead Sciences Inc. Emtriva Gilead Sciences Inc. To treat HIV (7/03)

Gilead Sciences Inc. Hepsera Gilead Sciences Inc. Chronic hepatitis B (9/02)

Gilead Sciences Inc. Letairis Gilead Sciences Inc. Pulmonary arterial hypertension (6/07)

Gilead Sciences Inc. Tamiflu F. Hoffmann-La Roche Ltd. (Switzerland)

Influenza A and B (10/99); flu prevention (11/00); influ-enza for children ages 1 to 12 (12/00)

Gilead Sciences Inc. Truvada Gilead Sciences Inc. Accelerated approval for the Emtriva-Viread combi-nation product for use in HIV regimens (8/04); tradi-tional approval (3/06)

Gilead Sciences Inc. Viread Gilead Sciences Inc. Accelerated approval for HIV (10/01); traditional approval (3/06); chronic hepatitis B virus (8/08)

Gilead Sciences Inc. Vistide Pharmacia To delay progression of cytomegalovirus retinitis in AIDS patients (6/96)

GlaxoSmithKline plc Lamictal XR GlaxoSmithKline plc Extended-release tablets for epilepsy (2/10)

GlaxoSmithKline plc Lymerix GlaxoSmithKline plc Lyme disease (12/98)

GlaxoSmithKline plc Tykerb GlaxoSmithKline plc First-line metastatic breast cancer (2/10)

GlaxoSmithKline plc Votrient GlaxoSmithKline plc Advanced renal cell carcinoma (10/09)


Istodax Gloucester Cutaneous T-cell lymphoma (11/09)

GTC Biotherapeutics Inc.

ATryn Ovation Pharmaceuticals Inc.

To prevent perioperative and peripartum thrombo-embolic events in patients with hereditary anti-thrombin deficiency (2/09)

Halozyme Therapeutics Inc.

Hylenex Baxter Healthcare Corp.

The FDA approved the product for for use as an adju-vant agent to increase the absorption and dispersion of other injected drugs (12/05)

Halozyme Therapeutics Inc.

Cumulase Cook Ob/Gyn Inc., MediCult A/S and MidAtlantic Diagnostics Inc.

The product received 510(k) clearance from the FDA for treatment of oocytes to facilitate certain in vitro fertilization procedures (4/05)

ICN Pharmaceutical Inc. and Schering-Plough Corp.

Rebetron ICN Pharmaceutical Inc. and Schering-Plough Corp.

Treatment of chronic hepatitis C in patients with compensated liver disease who have relapsed fol-lowing alpha interferon therapy (6/98); treatment of chronic hepatitis C in patients with compensated liver disease previously untreated with alpha inter-feron therapy (12/98)

ICOS Corp. and Eli Lilly and Co.

Cialis Lilly ICOS LLC Erectile dysfunction (11/21)

Idenix Pharmaceuticals Inc.

Tyzeka Idenix Pharmaceuticals Inc. and Novartis Pharma AG

The FDA approved the product for treating chronic hepatitis B (10/06)




ImClone Systems Inc.

Erbitux (cetux-imab)


FDA approved the drug for patients with metastatic colorectal cancer who are refractory to or intolerant of irinotecan (2/04); for use with radiation therapy for treating advanced head and neck cancer (3/06)

Immunomedics Inc. CEA-Scan Mallinckrodt Inc. In vivo diagnostic imaging agent to determine site and extent of colorectal cancer (for use in conjunc-tion with standard diagnostic tests) (7/96)

Indevus Pharmaceuticals Inc.

Sanctura (trospi-um chloride)

Indevus Pharmaceuticals Inc. and Pliva d.d.

Overactive bladder (5/04); approved Sanctura XR for overactive bladder (8/07)


Sarafem Eli Lilly and Co. Fluoxetine hydrochloride (the same active ingredient found in Prozac) for the treatment of premenstrual dysphoric disorder (7/00)


Supprelin-LA Indevus Pharmaceuticals Inc.

Central precocious puberty (5/07)

Insmed Inc. iPlex Insmed Inc. Growth failure in children with severe primary IGF-1 deficiency or with growth hormone gene deletion who have developed neutralizing antibodies to GH (12/05)

Inspire Pharmaceuticals Inc.

AzaSite Inspire Pharmaceuticals Inc.

Bacterial conjunctivitis (4/07)

Inspire Pharmaceuticals Inc.

Elestat Allergan Inc. Persistent itching associated with allergic conjuncti-vitis (10/03)

Integra LifeSciences Corp.

Artificial Skin Dermal Regeneration Template


Treatment of full-thickness or deep partial-thickness burns where conventional autograft is not available or desirable (to regenerate body's own dermis) (3/96)


DuraGen DuralGraft Matrix


Dural closure in neurological procedures (7/99)

Intercell AG Ixiaro Intercell Japanese encephalitis virus (3/09)

Interferon Sciences Inc.

Alferon N Injection The Purdue Frederick Co.

Genital warts (10/89)

Isis Pharmaceuticals Inc.

Vitravene CIBA Vision Corp. Treatment of cytomegalovirus retinitis in AIDS patients (8/98)


Bepreve ISTA Pharmaceuticals

For use as a twice-daily eye drop treatment of ocular itching associated with allergic conjunctivitis (9/09)


Bromday ISTA Pharmaceuticals

For postoperative inflammation and reduction of ocular pain in cataract extraction patients (10/10)


Istalol ISTA Pharmaceuticals Inc.

The FDA approved the product for treating glaucoma (6/04)


Vitrase ISTA Pharmaceuticals Inc.

FDA approved the product for use as a spreading agent to facilitate the dispersion and absorption of other drugs (5/04)


Xibrom ISTA Pharmaceuticals Inc.

The FDA approved the product for treating ocular inflammation following cataract surgery (3/05)




Janssen Pharmaceutica NV

Sustenna Janssen Schizophrenia (8/09)

Jazz Pharmaceuticals Inc.

Luvox CR Jazz Pharmaceuticals Inc.

Social anxiety disorder and obsessive-compulsive disorder (2/08)

Johnson & Johnson Pancreaze J&J Exocrine pancreatic insufficiency (4/10)

Kamada Glassia Kamada Apha-1 antitrypsin deficiency (7/10)

King Pharmaceuticals Inc.

Embeda King Moderate to severe pain with extended-release cap-sules (8/09)

Kowa Pharmaceuticals America Inc.

Livalo Kowa Hypercholesterolemia and combined dyslipidemia (8/09)

Labopharm Inc. Olepto Labopharm Major depressive disorder (2/10)

Labopharm Inc. Ryzolt Labopharm Chronic pain (12/08)

Lev Pharmaceuticals Inc.

Cinryze Lev Pharmaceuticals

Prophylactic treatment for hereditary angioedema (11/08)

LifeCycle Pharma A/S

Fenofibrate Sciele Pharma Inc. Hyperlipidemia and hypertriglyceridemia (8/07)

Ligand Pharmaceuticals Inc.

Ontak Ligand Persistent or recurrent cutaneous T-cell lymphoma whose cells express the CD25 component of the IL-2 receptor (2/99)


Panretin Gel Integrated Commercialization Solutions

Dermal lesions in AIDS-related Kaposi's sarcoma (2/99)


Promacta GlaxoSmithKline plc Idiopathic thrombocytopenic purpura (11/08)


Simulect Novartis AG Acute rejection episodes in renal transplants (5/98)


Targretin Ligand Refractory cutaneous T-cell lymphoma (12/99); cuta-neous lesions in patients with early-stage cutaneous T cell lymphoma who have refractory or persistent disease after other therapies or who have not toler-ated other therapies (6/00)

MDRNA Inc. Calcitonin-salmon nasal spray

MDRNA Osteoporosis (6/09)

Medicis Pharmaceutical Corp.

Dysport Ipsen SA Cervical dystonia and glabellar lines (4/09)

MedImmune Inc. CytoGam Connaught Laboratories Inc.

Prevention of cytomegalovirus in kidney transplant patients (11/91); prophylaxis against CMV disease associated with kidney, lung, liver, pancreas and heart transplants (12/98)

MedImmune Inc. Ethyol MedImmune Inc. To reduce kidney toxicity after chemotherapy for advanced ovarian cancer (12/95); to reduce the cumulative kidney toxicity of cisplatin in patients undergoing chemotherapy for non-small-cell lung cancer (3/96); moderate to severe post-operative, radiation-induced xerostomia in patients undergoing radiation treatment for head and neck cancer (6/99)




MedImmune Inc. FluMist MedImmune Inc. Vaccine approved for influenza (6/03)

MedImmune Inc. NeuTrexin MedImmune Inc. For Pneumocystis carinii pneumonia in immunocom-promised patients (12/93)

MedImmune Inc. RespiGam American Home Products Corp.

Prevention of respiratory syncytial virus in children under 24 months of age with bronchopulmonary dysplasia or a history of premature birth (1/96)

MedImmune Inc. Synagis MedImmune/Abbott Laboratories

Prevention of respiratory syncytial virus in children and infants (6/98); new labeling supports use in young children with hemodynamically significant congenital heart disease (9/03); new liquid formula-tion (7/04)

Medivir AB Lipsovir Medivir Cold sores (8/09)

Merck Serono Fertinex Merck Serono Infertility treatment (8/96); hormone deficiency (10/96)

Merck Serono Geref Merck Serono Treatment of growth hormone deficiency in children (10/97)

Merck Serono Gonal-F Merck Serono Treatment of functional infertility not due to primary ovarian failure (9/97); recombinant follicle-stimulat-ing hormone for treatment of infertility in men and women (6/00); multi-dose for infertility (3/01)

Merck Serono Luveris Merck Serono The FDA approved the product for use with Gonal-f to stimulate follicular development in infertile hypo-gonadotropic hypogonadal women (10/04)

Merck Serono Ovidrel Merck Serono Infertility due to anovulation and promote final egg maturation in ovaries of women undergoing assisted reproductive technologies (10/00)

Merck Serono Rebif Merck Serono For relapsing forms of multiple sclerosis (3/02)

Merck Serono Saizen Merck Serono Growth hormone deficiency in children (10/96); adult growth hormone deficiency (8/04)

Merck Serono Serostim Merck Serono Treatment for AIDS wasting (8/96); short bowel syn-drome (12/03)

Merz Pharmaceuticals LLC

Xeomin Merz Pharmaceuticals

Cervical dystonia or blepharospasm (8/10)

MGI Pharma Inc. (acquired by Eisai Corp.)

Aloxi Helsinn Healthcare SA

For acute and delayed nausea and vomiting associat-ed with chemotherapy (7/03); to prevent nausea and vomiting for up to 24 hours following surgery (3/08); to prevent chemotherapy-induced nausea and vomiting (8/08)

MGI Pharma Inc. and SuperGen Inc.

Dacogen MGI Pharma Inc. The FDA approved the drug for treating myelodys-plastic syndromes (5/06)

MiddleBrook Pharmaceuticals Inc.

Moxatarg MiddleBrook Pharmaceuticals Inc.

Pharyngitis or tonsillitis secondary to Streptococcus pyogenes (1/08)

Millennium Pharmaceuticals Inc.

Campath Berlex Laboratories Inc.

Leukemia (5/01)


Integrilin Schering-Plough Corp.

Acute coronary syndrome and angioplasty (5/98)





Velcade Millennium Pharmaceuticals Inc.

For multiple myeloma (5/03); mantle cell lymphoma in those who have received at least one prior therapy (12/06); first-line treatment of multiple myeloma (6/08); untreated multiple myeloma, label includes long-term overall survival data (1/10)

Momenta Pharmaceuticals Inc.

Generic Lovenox Sandoz (unit of Novartis AG)

Deep vein thrombosis and cardiovascular indica-tions (7/10)

MonoSol Rx and Strativa Pharmaceuticals

Zuplenz Strativa Pharmaceuticals

To prevent cancer therapy-induced nausea and vom-iting (7/10)

Mylan Inc. Efavirenz, lamivu-dine and tenofovir disoproxil fuma-rate tablets

Mylan Fixed-dose combination for AIDS (9/09)

Nabi WinRho SDF Nabi Prevention of Rh isoimmunization in pregnant women and the treatment of thrombocytopenic pur-pura (3/95)

Nabi and Cangene Corp.

Nabi-HB N/A Hepatitis B (3/99)

NaPro Biotherapeutics Inc., Abbott Laboratories and Bristol-Myers Squibb Co.

Paclitaxel injec-tion

NaPro Biotherapeutics Inc. and Abbott Laboratories

For metastatic cancer of the ovary after the failure of first-line or subsequent chemotherapy, and for meta-static breast cancer after the failure of combination chemotherapy for metastatic disease (5/02)

Nastech Pharmaceutical Co. Inc.

Nascobal Questcor Pharmaceuticals Inc.

To treat vitamin B-12 deficiency (2/05)

Nektar Therapeutics Inc. and Pfizer Inc.

Exubera Pfizer Inc. (dropped it in October 2007)

The FDA approved the drug for treating types I and II diabetes (1/06)

Nektar Therapeutics Inc.

Somavert Pharmacia Corp. Acromegaly (3/04)

NeoRx Corp. Verluma Merck & Co. Inc. Diagnostic imaging agent used to determine extent of disease in patients diagnosed with small-cell lung cancer (8/96)

Neurobiological Technologies Inc.

Namenda Forest Laboratories Inc.

Moderate to severe Alzheimer's disease (10/03)

NeurogesX Inc. Qutenza NeurogesX Postherpetic neuralgia (11/09)

Nexell Therapeutics Inc.

Isolex 300 Isolex 300i

Nexell Therapeutics Inc.

Ex vivo stem cell selection for patients undergoing high-dose chemotherapy and bone marrow trans-plants (7/99)

New River Pharmaceuticals Inc.

Vyvanse Shire plc Attention deficit hyperactivity disorder (2/07); for adolescents ages 13 to 17 with ADHD (11/10)

NitroMed Inc. BiDil NitroMed Inc. The FDA approved the product for treating heart fail-ure in African-Americans (6/05)

North American Vaccine

Certiva Abbott Laboratories Inc.

Combined diphtheria, tetanus and acellular pertussis vaccine (8/98)

NovaDel Pharma Inc.

NitroMist Par Pharmaceutical Cos. Inc.

The FDA approved the product for acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease (11/06)




NovaDel Pharma Inc.

Zolpimist NovaDel Insomnia (12/08)

Novalar Pharmaceuticals Inc.

OraVerse Novalar Pharmaceuticals Inc.

To reverse soft tissue anesthesia from a local dental anesthetic (5/08)

Novartis AG Afinitor Novartis Subependymal giant cell astrocytoma (11/10)

Novartis AG Agriflu Novartis For patients 18 and older with influenza virus sub-types A and B (11/09)

Novartis AG Aredia Novartis AG Treatment of metastatic bone disease in patients with breast cancer (8/96)

Novartis AG Betaseron Berlex Laboratories Inc.

Relapsing, remitting multiple sclerosis (7/93); new labeling includes studies in secondary progressive MS, and to reflect indication for treating relapsing forms of disease to reduce the frequency of clinical exacerbation (3/03)

Novartis AG Gilenya Novartis AG Multiple sclerosis (9/10)

Novartis AG Ilaris Novartis AG Cryopyrin-associated periodic syndrome (6/09)

Novartis AG Proleukin Novartis AG Renal cell carcinoma (5/92); metastatic melanoma (1/98)

Novartis AG Regranex Gel Novartis AG Treatment of diabetic foot ulcers (12/97)

Novartis AG RIBA HCV 3.0 Strip Immuno-blot Assay

OrthoClinical Diagnostics Inc.

Confirmatory test for hepatitis C (2/99)

Novartis AG Tasigna Novartis For adults with newly diagnosed Philadelphia chro-mosome-positive chronic myeloid leukemia (6/10)

Novartis AG Valturna Novartis High blood pressure patients not adequately con-trolled on aliskiren or angiotensin receptor blocker monotherapy and as initial therapy in patients likely to need multiple drugs to achieve their blood pres-sure goals (9/09)

Novartis AG Zortress Novartis AG To prevent rejection of kidney transplants (4/10)

Noven Pharmaceuticals Inc.

Daytrana Shire plc Attention deficit hyperactivity disorder (4/06); expanded use in teenagers with ADHD (7/10)

Novo Nordisk A/S Norditropin Novo Nordisk A/S Human growth hormone deficiency in children (5/95); recombinant somatropin (human growth hor-mone) for long-term treatment of children who have growth failure due to inadequate secretion of endog-enous growth hormone (6/00); short stature in chil-dren with Noonan syndrome (6/07); short stature in children born small for gestational age with no catch-up growth by ages 2 to 4 years (11/08)

Novo Nordisk A/S Victoza Novo Nordisk A/S Type II diabetes (1/10)

NPS Pharmaceuticals Inc.

Sensipar (cinacal-cet)

Amgen Inc. FDA approved the drug to treat secondary hyper-parathyroidism in kidney disease patients on dialy-sis, and to treat elevated calcium levels in patients with parathyroid carcinoma (3/04)

Nuvo Research Inc. Pennsaid Covidien Inc. Osteoarthritis of the knee (11/09)

Nycomed Amersham plc

EchoSeed Nycomed Amersham plc

Prostate cancer (6/01)

Octapharma AG Octagam Octapharma AG Primary immunodeficiency diseases (5/04)




Oculus Innovative Sciences Inc.

Microcyn Skin and Wound Gel

Oculus To exude wounds (5/09)

Omrix Biopharmaceutical Inc.

Evicel Ethicol Inc. For hemostasis in vascular surgery (5/07); for use during general srugery (1/08)

Omrix Biopharmaceutical Inc.

Evithrom Johnson & Johnson Wound Management

For use in general surgery procedures to control minor bleeding (8/07)

Onyx Pharmaceuticals Inc.

Nexavar (sorafenib)

Onyx Pharmaceuticals Inc. and Bayer Pharmaceuticals Corp.

Advanced renal cell carcinoma, or kidney cancer (12/05); liver cancer (11/07)

OraPharma Inc. Arestin ND Adjunct treatment for periodontitis following scaling and root planing (2/01)

Orexo AB Edluar Orexo Insomnia (3/09)

Organogenesis Inc. Apligraf Novartis AG Venous leg ulcers (5/98); living, bi-layered skin sub-stitute for use in the treatment of diabetic foot ulcers (6/00)

Organon Inc. Puregon / Follistim

Organon Inc. Recombinant follicle-stimulating hormone to treat infertility (9/97)

Orphan Medical Inc. (unit of Jazz Pharmaceuticals)

Xyrem Orphan Medical Inc. For cataplexy associated with narcolepsy (7/02); excessive daytime sleepiness associated with narco-lepsy (11/05)

Ortec International Inc.

Composite cul-tured skin (Orcel)

ND For use in patients with recessive dystrophic epider-molysis bullosa undergoing hand reconstruction sur-gery; also for covering donor sites (2/01); for healing donor site wounds in burn victims (9/01)

Ortho Biotech Inc. Orthoclone OKT3 Ortho Biotech Inc. Reversal of acute kidney rejection (6/86); reversal of heart and liver transplant rejection (6/93)

OSI Pharmaceuticals Inc.

Macugen Pfizer Inc. The FDA approved the drug for treating wet age-related macular degeneration (12/04)

OSI Pharmaceuticals Inc. and Genentech Inc.

Tarceva Genentech Inc. and Roche AG

The FDA approved supplemental filing for use with gemcitabine for treating advanced pancreatic cancer (11/03); advanced or metastatic non-small-cell lung cancer (11/05); non-small-cell lung cancer mainte-nance therapy (4/10)

Ovation Pharmaceuticals Inc. (part of H. Lundbeck A/S)

Sabril Ovation Epileptic seizures in adults and infantile spasms (8/09)

Pacira Pharmaceuticals Inc.

DepoCyt Enzon Pharmaceuticals

Accelerated approval for lymphomatous meningitis (4/99); final approval granted (4/07)


DepoDur EKR Therapeutics The FDA approved the drug for treating pain follow-ing major surgery; launch is expected by the end of the year (5/04)

PDL BioPharma (sell-ing to EKR Therapeutics Inc.)

Retavase PDL BioPharma Thrombolytic agent for acute myocardial infarction (10/96)

PDL BioPharma Zenapax PDL BioPharma For the prevention of kidney transplant rejection (12/97)




Pfizer Inc. Aricept Eisai Co. Ltd. A once-daily higher dose version for Alzheimer's dis-eases (7/10)

Pfizer Inc. Revatio Pfizer An intravenous formulation for pulmonary arterial hypertension (11/09)

Pharmacia Corp. (unit of Pfizer Inc.)

Fragmin Pharmacia Prevention of deep-vein thrombosis following hip replacement surgery (3/99); unstable angina and non-Q-wave myocardial infarction (5/99)

Pharmacia Corp. (unit of Pfizer Inc.)

Genotropin Pharmacia Growth hormone deficiency in children (8/95); growth hormone deficiency in adults (11/97)

Pharmion Corp. Vidaza Pharmion Corp. The FDA approved the drug for treating all five sub-types of myelodysplastic syndrome (5/04); added intravenous use as a new route of administration (1/07)

PhotoCure ASA Metvix PDT PhotoCure ASA For premalignant skin changes or actinic keratosis (9/02)

Pozen Inc. Treximet GlaxoSmithKline plc Migraine attacks with or without aura (4/08)

Pozen Inc. Vimovo AstraZeneca plc Arthritis pain (5/10)

Praecis Pharmaceuticals Inc.

Plenaxis Praecis Pain relief in advanced prostate cancer (11/25)

Prestwick Pharmaceutical Inc.

Xenazine Prestwick Chorea associated with Huntington's disease (8/08)


Relistor Progenics Pharmaceuticals Inc.

Constipation due to painkillers in patients with incurable cancer and other advanced-stage diseases (4/08); single-use, prefilled syringes of Relistor sub-cutaneous injection for use in opioid-induced consti-pation patients (9/10)

Protherics plc DigiFab Protherics plc Digoxin toxicity (9/01)

ProCyte Corp. Iamin Gel Kissei Pharmaceutical Co.

Wound dressing and management (2/96)

ProCyte Corp. OsmoCyte Ultra Pillow Wound Dressing

ProCyte Corp. Dressing for a variety of exudating chronic and acute wounds (both infected and noninfected) (12/96)

Protherics plc CroFab Protherics plc Rattlesnake bites (12/00)

pSivida Ltd. Vitrasert Bausch & Lomb Cytomegalovirus retinitis infection in AIDS patients (3/96)

Purdue Pharma LP OxyContin Purdue Pharma LP Reformulated, tamper-resistant version for pain (4/10)

QLT Phototherapeutics Inc.

Photofrin Axcan Pharma Inc. Advanced throat cancer (12/95); high-grade dyspla-sia in patients with Barrett's esophagus (8/03)

QLT Phototherapeutics Inc.

Visudyne CIBA Vision Corp.; Novartis Ophthalmics

Wet age-related macular degeneration (4/00); the form of subfoveal choroidal neovascularization that occurs in people 30 and older (8/01)

Questcor Pharmaceuticals Inc.

H.P. Acthar Gel Questcor Pharmaceuticals

Infantile spasms (10/10)

Regeneron Pharmaceuticals Inc.

Arcalyst Regeneron Pharmaceuticals Inc.

Familial cold auto-inflammatory syndrome and Muckle-Wells syndrome (2/08)




Repligen Corp. SecreFlo Repligen Corp. To stimulate pancreatic secretions to aid in the diag-nosis of pancreatic exocrine dysfunction, or chronic pancreatitis, and stimulation of gastrin secretion to aid in the diagnosis of gastrinoma (4/02); to aid in the location and cannulation of the pancreatic ducts in patients undergoing ERCP (11/02)

Roxro Pharma Inc. Sprix Roxro Pharma Inc. Moderate to moderately severe pain (5/10)


Bacitracin Sagent Pharmaceuticals Inc.

Pneumonia and empyema (5/10)


Sumatriptan and Rocuronium


Migraine and for use in routine tracheal intubation and mechanical ventilation (8/10)

Salix Pharmaceuticals Inc.

Visicol InKine Pharmaceuticals

For cleansing the bowel prior to colonoscopy (9/00); new, smaller Visicol tablet formulation that contains less microcrystalline cellulose for bowel cleansing prior to colonoscopy (3/02)

Salix Pharmaceuticals Ltd.

Xifaxan Salix Pharmaceuticals Ltd.

A 550-mg strength for overt hepatic encephalopathy (3/10); irritable bowel syndrome (4/10)

Sanofi-Aventis Bioclate Sanofi-Aventis Treatment of hemophilia A for the prevention and control of hemorrhagic episodes; perioperative man-agement of patients with hemophilia A (12/93)

Sanofi-Aventis Helixate Sanofi-Aventis Treatment of hemophilia in which there is a deficien-cy of activity of Factor VIII (2/94); second-generation Factor VIII for hemophilia A (6/00)

Sanofi-Aventis Humate-P Sanofi-Aventis Treatment of bleeding due to von Willebrand disease and treatment and prevention of bleeding episodes in hemophilia A patients (4/99)

Sanofi-Aventis Jevtana Sanofi-Aventis For use with prednisone for prostate cancer (6/10)

Sanofi-Aventis Lantus Sanofi-Aventis Long-acting, once-daily form of insulin glargine (rDNA origin) injection for adults with Type II diabe-tes and children with Type I (4/00)

Sanofi-Aventis Multaq Sanofi-Aventis To reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibril-lation or atrial flutter (7/09)

Sanofi-Aventis Taxotere Sanofi-Aventis For non-small-cell lung cancer (12/02)

Sanofi Pasteur Fluzone Sanofi Pasteur Influenza (1/10)

Santarus Inc. Zegerid Santarus Inc. The FDA approved the drug for treating gastrointes-tinal bleeding in critically ill patients for short-term treatment of active benign gastric ulcers (12/04); heartburn and other symptoms associated with gas-troesophageal reflux disease, as well as esophagitis and ulcer indications (2/06); frequent heartburn (12/09)

Santarus Inc. Rapinex Santarus Inc. The FDA approved the drug for treating heartburn and related symptoms (6/04)


Krystexxa Savient Pharmaceuticals Inc.

Chronic refractory gout (9/10)


Soltamox Partner being sought

The FDA approved the drug for treatment of breast cancer in adjuvant and metastatic settings, and to reduce risks under certain conditions (10/05)




Scios Inc. Natrecor Scios Inc. Acute congestive heart failure (8/01)

Shire plc 3TC (Epivir) Shire plc In combination with AZT for HIV infection and AIDS (11/95)

Shire plc Combivir GlaxoSmithKline plc Single-tablet formulation of 3TC and AZT for HIV (9/97)

Shire plc Trizivir Shire plc HIV (11/00)

Shire plc Vpriv Shire plc Gaucher's disease (3/10)

Sirion Therapeutics Inc.

Durezol Sirion Postoperative ocular inflammation and pain (6/08)

Sirion Therapeutics Inc.

Zirgan Sirion Acute herpetic keratitis (9/09)

SkyePharma plc Solaraze SkyePharma plc, seeking partner

Actinic keratosis (10/00)

Somaxon Pharmaceuticals Inc.

Silenor Somaxon Pharmaceuticals Inc.

Insomnia (3/10)

Spectrum Pharmaceuticals Inc.

Levoleucovorin Spectrum Pharmaceuticals Inc.

For use after high-dose methotrexate therapy in osteosarcoma (3/08)

Spectrum Pharmaceuticals Inc.

Zevalin Spectrum Pharmaceuticals Inc.

For follicular non-Hodgkin's lymphoma patients with untreated disease who achieve a partial or complete response to first-line chemotherapy (9/09)

Speedel Group Tekturna Novartis AG (Switzerland)

High blood pressure (3/07); HCT version for hyper-tension (1/08)

SRI International Pralatrexate SRI International Peripheral T-cell lymphoma (9/09)

Sucampo Pharmaceuticals Inc.

Amitiza Sucampo Pharmaceuticals Inc. and Takeda Pharmaceuticals America Inc.

Chronic idiopathic constipation in adults (1/06); con-stipation-predominant irritable bowel syndrome (4/08)

Sunuvion Pharmaceuticals Inc. (formerly Sepracor Inc.)

Latuda Sunuvion Pharmaceuticals Inc.

Schizophrenia (10/10)


Lunesta (formerly Estorra)

Sunuvion Pharmaceuticals Inc.

The FDA approval the drug for treating insomnia (12/04)


Xopenex brand levalbuterol HCl inhalation solu-tion

Sunuvion Pharmaceuticals Inc.

For treatment or prevention of bronchospasm in chil-dren ages 6 to 11 years old with reversible obstructive airway disease, such as asthma (1/02)

SuperGen Inc. Dacogen MGI Pharma Inc. Myelodysplastic syndromes (5/06)

SuperGen Inc. Daunorubicin SuperGen Inc. Acute leukemia (11/01)

SuperGen Inc. Mitozytrex SuperGen Inc. For disseminated adenocarcinoma of the stomach or pancreas in proven combination with other approved chemotherapeutic agents (11/02)

Talecris Biotherapeutics Inc.

Gamunex Talecris Chronic inflammatory demyelinating polyneuropa-thy (9/08); subcutaneous administration for primary immunodeficiency (10/10)

Talecris Biotherapeutics Inc.

Prolastin-C Talecris Alpha1-antitrypsin deficiency (10/09)




Tercica Inc. Increlex Tercica Inc. The FDA approved the drug for the long-term treat-ment of growth failure in children with severe prima-ry IGF-1 deficiency (8/05)

Tercica Inc. Somatuline Depot Ipsen SA Acromegaly (8/07)

Teva Pharmaceutical Industries Ltd.

Copaxone Teva Pharmaceutical Industries Ltd.

To reduce flare-ups in relapsing multiple sclerosis (12/96)

The Medicines Co. Angiomax Innovex Inc. Unstable angina (12/00); expanded label includes patients undergoing percutaneous coronary inter-vention (6/05)

The Medicines Co. Cleviprex The Medicines Co. Hypertension (8/08)

Theratechnologies Inc.

Egrifta Theratechnologies Inc.

For HIV-associated lipodystrophy (11/10)

Theravance Inc. Telavancin Astellas Pharma US Inc.

Complicated skin and skin structure infections caused by Gram-positive bacteria (9/09)

Tibotec Therapeutics

Intelence Johnson & Johnson HIV infection (1/08); traditional approval for HIV (11/09)

Tibotec Therapeutics

Prezista Johnson & Johnson Expanded indication for once-daily dosing in HIV combination therapy in treatment-naive adults (10/08)

Trimeris Inc. Fuzeon F. Hoffmann-La Roche Ltd.

For HIV-1 infection in treatment-experienced patients (3/03)

UCB SA Cimzia UCB SA Crohn's disease (4/08); rheumatoid arthritis (5/09)

UCB SA Keppra UCB SA Extended-release version for partial onset seizures in epileptic patients 16 years or older (9/08)

UCB SA Vimpat UCB SA For use as an add-on therapy to treat partial onset seizures in people with epilepsy who are 17 years and older (10/08)

UCB SA Xyzal Sanofi-Aventis Allergic rhinitis and uncomplicated skin manifesta-tions of chronic idiopathic urticaria in adults (5/07)

Unigene Laboratories Inc.

Fortical Nasal Spray

Upsher-Smith Laboratories Inc.

The FDA approved the product for treating post-menopausal osteoporosis (8/05)

United Therapeutics Corp.

Adcirca United Therapeutics Corp.


United Therapeutics Corp.

Remodulin United Therapeutics Corp.


United Therapeutics Inc.

Tyvaso United Therapeutics Corp.


Vanda Pharmaceuticals Inc.

Fanapt Titan Pharmaceuticals Inc.

Schizophrenia (5/09)

Vernalis Group plc Frovatriptan Elan Corp. plc For the acute treatment of migraine (11/01)

VeroScience LLC Cycloset VeroScience Type II diabetes (5/09)

Vertex Pharmaceuticals Inc.

Lexiva GlaxoSmithKline plc HIV infection (10/03)


Agenerase GlaxoSmithKline plc HIV infection in children ages 4 and older, and in twice-daily dosage with other antiretrovirals for HIV infection (4/99)




Visible Genetics Inc. TruGene HIV-1 Genotyping Kit and OpenGene DNA Sequencing System

Visible Genetics Inc. To analyze genetic information of AIDS patients so doctors can prescribe individual drug therapies (9/01)

Vivus Inc. Evamist KV Pharmaceutical Co.

Moderate to severe vasomotor symptoms due to menopause (7/07)

Vysis Inc. UroVysion Vysis Inc. Monitoring recurrence of bladder cancer (8/01)

Watson Pharmaceuticals Inc.

Trelstar Watson Pharmaceuticals Inc.

22.5-mg dose for advanced prostate cancer (3/10)

Wyeth Mylotarg Wyeth Targeted chemotherapy agent to treat patients 60 years and older in first relapse with CD33-positive acute myeloid leukemia who are not considered can-didates for cytotoxic chemotherapy (5/00)

Wyeth Prevnar 13 Wyeth To prevent invasive pneumococcal disease and otitis media (2/10)

Wyeth Rapamune Wyeth Prevention of organ rejection following renal trans-plantation (9/99)

Xanodyne Pharmaceuticals Inc.

Lysteda Xanodyne Menorrhagia (11/09)

Xanodyne Pharmaceuticals Inc.

Zipsor Xanodyne Acute pain (6/09)

Zogenix Inc. Sumavel DosePro Zogenix Inc. Acute migraine (7/09)

ZymoGenetics Inc. Glucagen Novo Nordisk A/S Treatment of hypoglycemia and for use as a diagnos-tic (6/98)

ZymoGenetics Inc. Novolin Novo Nordisk A/S Insulin-dependent diabetes mellitus (7/91)

ZymoGenetics Inc. NovoSeven Novo Nordisk A/S Bleeding episodes in hemophiliacs (3/99)

ZymoGenetics Inc. Recothrom Thrombin

ZymoGenetics For use during surgery to control minor bleeding (1/08)

Notes:

This chart is a broad overview of biotech and biotech-related products on the market in the U.S. and covers products approved through 2010. Not all of the companies represented are biotechnology firms. Large pharmaceutical companies are included when the products they developed represented breakthroughs in the area and/or where biotech companies were developing competing products.

*In most cases, companies are the firms that now own the products, not necessarily the original developers or those that obtained approval.

FDA Actions on Pending Applications in 2010Company Product Description Indication Action

Actelion Ltd. Zavesca Miglustat Niemann-PickType C disease

FDA issued a complete response letter asking for more preclinical and clinical informa-tion (3/10)

Alexza Pharmaceuticals Inc.

AZ-004 Inhalable form of generic antipsychotic drug loxapine

Agitation FDA issued a complete response letter raising unexpected pulmo-nar y safety issues (10/12)

Alimera Sciences Inc. and pSivida Corp.

Iluvien Fluocinolone aceton-ide intravitreal insert

Diabetic macular edema

FDA issued a complete response letter (12/28)

AmylinPharmaceuticalsInc.

Bydureon Byetta LAR; once-weekly version of Byetta; glucagon-like peptide-1 inhibitor

Type II diabetes FDA issued a complete response letter show-ing concern over the risk evaluation and mitigation strategy (3/16); company sub-mitted its reply (4/26); Received a complete response letter, indi-cating there may be a two-year delay for the once-weekly version (10/21)

A.P. PharmaInc.

APF530 A long-acting formula-tion of granisetron

To preventchemotherapy-inducednausea andvomiting

Received a complete response letter from the FDA for the NDA; it raises concerns about the drug’s two-syringe administration system (3/22)

Arena Pharmaceuticals Inc.

Lorqess Lorcaserin hydrochlo-ride

Obesity FDA issued a complete response letter over concerns of tumors in rodents treated with the drug (10/26); com-pleted an end-of -review meeting with the FDA and plans to resubmit an NDA by the end of 2011 (12/23)

AstraZeneca plc Brilinta Ticagrelor; an oral antiplatelet treatment

Acute coronary syn-dromes

FDA has issued a com-plete response letter (12/20)

AstraZeneca plc Rezield Motavizumab Respiratory syncytial virus

Dropped development as a prevention to RSV and withdrew the BLA, following two com-plete response letters; i t is remaining in development for RSV treatment (12/22)



FDAActionsonPendingApplications


AvanirPharmaceuticalsInc.

Zenvia Dextromethorphan/quinidine

Pseudobulbaraffect

Submitted its com-plete response to the FDA’s October 2006 a p p r o v a b l e l e t t e r (5/3)

CadencePharmaceuticalsInc.

Acetavance Intravenous acetamin-ophen

Pain and fever Received a complete response letter from the FDA, citing manu-facturing deficiencies (2/12); re-submitted the NDA (5/6)

CellTherapeuticsInc.

Pixuvri Pixantrone Relapsed orrefractoryaggressivenon-Hodgkin’slymphoma

F DA r e j e c t e d t h e application for Pixuvri due to insufficient data (4/12); Company intends to appeal the FDA’s decision on its NDA that the company should conduct an additional trial prior to approval (12/6)

Cephalon Inc. Nuvigil Armodafinil Excessivesleepinessassociated withjet lag disorder

FDA issued a complete response letter ques-tioning the robustnessof the efficacy data ( 3 / 3 1 ) ; c o m p a n y dropped development after a second com-plete response letter from the FDA (12/28)

ChemGenexPharmaceuticalsLtd.

Omapro Omacetaxinemepesuccinate

Chronicmyeloidleukemia

FDA issued a complete response letter and is waiting for a compan-ion diagnostic test (4/13)

ForestLaboratoriesInc.

Bystolic Nebivolol Stable chronicheart failure

FDA did not approve an sNDA (2/24)

ForestLaboratoriesInc. andNycomed GmbH

Daxas Roflumilast Chronicobstructivepulmonarydisease

Received a complete response letter from t h e F D A ( 5 / 1 9 ) ; C o m p a n y f i l e d a response to the FDA’s complete response letter (9/14)

Genentech Inc. Avastin Bevacizumab HER2-negative meta-static breast cancer

FDA is trying to get the indication stricken from labeling because four follow-up studies failed to demonstrat-ed that the drug pro-l o n g e d o v e r a l l survival (12/17)




GlaxoSmithKline plc Avandia Rosiglitazone Type II diabetes FDA decided to keep the drug on the U.S. market, but under a restricted access pro-gram due to cardio-vascular safety risks (9/24)

Human Genome Sciences Inc. and Novartis AG

Zalbin Albinterferon alfa-2b Hepatitis C FDA issued a complete response letter (10/6)

IntelGenx Corp. CPI-300 Antidepressant; high-strength version ofbupropion hydro-chloride

Depression Received a complete response letter from the FDA (2/9)

InterMune Inc. Esbriet Pirfenidone Idiopathicpulmonaryfibrosis

Failed to win FDA approval of Esbriet; the company needs anadditional clinical trial (5/5)


JZP-6 Sodium oxybate Fibromyalgia FDA rejected it, requir-ing additional studies for approval (10/12)

Lux Biosciences Inc. Luveniq Oral voclosporin Noninfectious uveitis FDA issued a complete response letter and the company is start-i n g a n a d d i t i o n a l Phase III before the end of the year (8/5)

MannKind Corp. Afrezza Insulin human rDNA origin; inhaled

Diabetes FDA issued a complete response letter asking for more information about its clinical utilityand comparison data about the newer ver-sion of the drug’s inhaler device (3/16)

MedImmune Inc. Rezield Motavizumab Respiratory syncytial virus

FDA issued a complete response letter, saying an additional trial w o u l d b e n e e d e d (8/31)

NicOx SA Naproxcinod A cycloxygenase inhibiting nitric oxide donator

Osteoarthritis FDA rejected the drug, refusing to approve it until more studies are completed (7/23)

Protalix Bio-Therapeutics Inc.

– Taliglucerase alfa Gaucher’sdisease

FDA requested addi-tional data regarding the chemistry, manu-facturing and controls section of the NDA (2/3)

Sepracor Inc. Stedesa Eslicarbazepine ace-tate

Epilepsy FDA issued a complete response letter (5/5)




SkyePharmaplc

Flutiform An inhaled, fixed-dosecombination of the corticosteroid flutica-sone and formoterol

Persistentasthma

FDA issued a complete r e s p o n s e l e t t e r , requesting additional c l i n i c a l w o r k f o r approval (1/22)

Theravance Inc. Vibativ Antibiotic telavancin Hospital-acquiredpneumonia

FDA said the compa-ny’s reply to a com-plete response letter was not adequate (2/1)

UCB SA Neupro Rotigotine transder-mal system

Parkinson’sdisease andrestless legssyndrome

FDA issued a complete response letter recom-mending reformu-l a t i o n o f N e u p r o (4/26)

Valeant Pharmaceuticals International Inc. and GlaxoSmith-Kline plc

Ezogabine Formerly retigabine Epilepsy FDA issued a complete response for ezogabi-ne as an adjunctive treatment for adults with parial onset sei-zures; the FDA cited nonclinical reasons for its action (12/3)

Vivus Inc. Qnexa Phentermine/topira-mate

Obesity FDA issued a complete r e s p o n s e l e t t e r , requesting a detailed assessment of the ter-atogenic potential and evidence that it does not increase risk for major adverse cardio-vascular events (11/1); Submitted a briefing document to the FDA to address items in t h e c o m p l e t e response letter (12/15)

XenoPort Inc.and GlaxoSmith-Kline plc

Horizant Gabapentin enacarbil Moderate tosevere primaryrestless legssyndrome

Received a complete response letter raising concerns about pan-creatic acinar cel l tumors in rats in pre-clinical data (2/19); F DA a c c e p t e d f o r review GSK’s response to the February com-plete response letter (11/9)

Notes:


Licensing Applications Filed and Pending at FDA in 2010Company Product Description Indication Action

Acura Pharmaceuticals Inc. and King Pharmaceuticals Inc.

Acurox Oxycodone HCl tab-lets

Moderate to severe pain

King submitted an NDA (12/21)

AdventrxPharmaceuticalsInc.

ANX-530; Exelbine An emulsion version of vinorelbine

Non-small-celllung cancer

Submitted an NDA (1/5); FDA issued a refuse-to-file letter (3/2); Submitted an NDA (11/4)

AlexzaPharmaceuticalsInc.

AZ-004 Staccato loxapine Agitationassociated withschizophrenia

FDA accepted and filed its NDA (2/12)

Alimera Sciences Inc.



The company’s NDA has been accepted for filing and granted pri-ority review status by the FDA (9/1)

Alkermes Inc. Vivitrol Naltrexone for extended-release injectable suspension

Opioiddependence

Submitted an sNDA (4/14)

Amgen Inc. Denosumab Subcutaneous RANKligand inhibitor

Advanced cancer Filed a BLA for its use in preventing skeletal-r e l a t e d e v e n t s i n a d v a n c e d c a n c e r patients (5/17)

Amylin Pharmaceuticals Inc. and Eli Lilly and Co.

Byetta Exenatide Type II diabetes Submitted an sNDA seeking approval as an add-on therapy to basal insulin (12/27)


Metreleptin Recombinant methio-nyl human leptin

Diabetes and hyper-tryglyceridemia

Began submission of a rolling BLA (12/21)

ArenaPharmaceuticalsInc.

Lorcaserin Lorcaserin hydrochlo-ride

For weightmanagement

FDA accepted the NDA for filing (2/25)

AstraZeneca plc Vandetanib VEGF, EGFR and RET inhibitor

Advancedmedullary thyroid cancer

The NDA and MAA were accepted for review (9/24)

Biodel Inc. VIAject A formulation of recombinant human insulin

Diabetes FDA accepted the NDA (3/2)


Ipilimumab Immunotherapy Advanced melanoma FDA has accepted for filing and review the BLA (8/19)

Centocor Ortho Biotech Inc.

Simponi Golimumab Moderately to severe active rheumatoid arthritis

Submitted an sBLA seeking to expand the label to include inhib-iting the progression of structural damage (9/28)


LicensingApplicationsFiledandPendingatFDA



Clinical Data Inc. Vilazodone A dual-acting selectiveserotonin reuptakeinhibitor and a 5-HTIAreceptor partial ago-nist

Major depressivedisorder

Submitted an NDA (3/24); FDA accepted it for filing (5/25)

CumberlandPharmaceuticalsInc.

Acetadote Acetylcysteine injec-tion

Non-aceta-minophen acuteliver failure

Submitted an sNDA (3/31)

Depomed Inc.and Abbott

DM-1796 An extended-release, once-daily tablet for-mulation of gabapen-tin

Postherpeticneuralgia

F i l e d a n N DA f o r DM-1796 (4/1)

Eisai Inc. Aricept Patch (donepezil) transdermal system

Alzheimer’s disease F DA a c c e p t e d f o r review the NDA (9/20)


Foresta Testosterone gel Hypogonadism Submitted a complete response to the FDA's complete response let ter received in October 2009 (7/2)

EpiCept Corp. Ceplene Histamine dihydro-chloride

Acute myeloidleukemia

Submitted an NDA (6/30); FDA refused to accept its NDA and r e c o m m e n d e d a n additional pivotal trial (8/24)

EUSA Pharma Inc. Erwinase L-asparaginase derived from Erwinia chrysanthem

Acute lymphoblastic leukemia

Submitted a BLA for use in ALL patients with hypersensitivity t o E . c o l i - d e r i v e d asparaginase (11/10)

Fibrocell Science Inc.

Azficel-T An autologous cell therapy

For nasolabial folds and wrinkles

Submitted a complete response to the FDA for azficel-T (12/21)

Genentech Inc. Actemra Tocilizumab Rheumatoidarthritis

Submitted an sBLA (3/17)

Genentech Inc. Herceptin Trastuzumab AdvancedHER2-positiveadenocarcinomaof the stomach

Submitted an sBLA for Herceptin plus chemo-therapy (4/26)

Genentech Inc. T-DM1 Trastuzumab-DM1; an antibody-drug conju-gate

Advanced HER2-positive breast cancer

Submitted an NDA (7/8); FDA rejected the company’s application f o r a c c e l e r a t e d approval, indicating the trial should have included patients who had tried other avail-a b l e t r e a t m e n t options as well (8/30)




Gilead Sciences Inc. Truvada Emtricitabine and tenofovir disoproxil fumarate

HIV Submitted an NDA to market a single com-b i n a t i o n p i l l o f Truvada plus Tibotec Pharmaceuticals Ltd.’s TMC278, after Phase III data showed it cut the risk of infection by 44% (11/24)

Human GenomeSciences Inc.

Benlysta Belimumab Systemiclupuserythematosus

Submitted its BLA to the FDA for Benlysta (6/11)

InterMune Inc. Pirfenidone Small-molecule P38-gamma inhibitor

Idiopathicpulmonaryfibrosis

F DA a c c e p t e d f o r review the NDA (1/5)

JavelinPharmaceuticalsInc.

Dyloject Diclofenac sodium Pain FDA accepted the NDA (2/3)

JazzPharmaceuticalsInc.

JZP-6 Sodium oxybate Fibromyalgia FDA has accepted for filing the NDA (2/22)

Johnson & Johnson Abiraterone acetate Oral androgen biosys-nthesis inhibitor

Metastatic prostate cancer

Submitted marketing applications in the U.S. and Europe (12/22)

Lux BiosciencesInc.

LX211 Luveniq; voclosporin Uveitis Filed for approval in the U.S. and Europe (2/5)

MannKind Corp. Afrezza Insulin human (rDNA origin)

Type I diabetes Submitted, and the FDA has accepted, an NDA (7/21)

Merck SeronoAG

Cladribine Tablets Relapsing multi-ple sclerosis

Submitted an NDA (6/9)

NuPathe Inc. Zelrix A single-use, transder-mal sumatriptan patch

Migraine Submitted an NDA for Zelrix (11/2)

Optimer Pharmaceuticals Inc.

Fidaxomicin A twice-daily oral medication

Clostridium difficile infection

Submitted a rolling N D A t o t h e F D A (9/22); completed the submission of its NDA (12/1)

OrexigenTherapeuticsInc.

Contrave Naltrexone SR/bupro-pion SR

Obesity Submitted an NDA to the FDA (4/2)


Exparel A bupivacaine Postsurgical pain F DA a c c e p t e d f o r review the NDA (12/15)

Pain Therapeutics Inc. and King Pharmaceuticals Inc.

Remoxy A twice-daily formula-tion of oxycodone

Pain Resubmitted its NDA (12/28)




PoniardPharmaceuticalsInc.

Picoplatin A new generationplatinum-based chemo-therapy agent


Company decided to suspend efforts to o b t a i n r e g u l a t o r y a p p r o v a l a f t e r a detailed analysis of Phase III data and an evaluat ion of the ongoing NDA process with the FDA (3/25)

Protalix BioTherapeutics Inc.

Taliglucerase alfa A plant cell-expressed recombinant form of human glucocerebro-sidase

Gaucher's disease

FDA accepted the NDA for review (7/13)

PSivida Corp. &Alimera Sciences

Iluvien A sustained-releasedrug delivery system

Diabeticmacular edema


Sanofi Pasteur Fluzone Intradermal influenza virus vaccine

Influenza Filed a supplemental BL A with the FDA (9/14)

Santarus Inc. and Pharming Group NV

Rhucin Recombinant human C1 inhibitor

Acute angioedema

S u b m i t t e d a B L A (12/29)

SavientPharmaceuticalsInc.

Krystexxa Pegloticase Chronic gout Resubmitted its BLA (3/16); FDA accepted it for review (3/31)

Shire plc Replagal Agalsidase alfa Fabry disease W i t h d r e w i t s December BLA, but received fast-track designation to start a rolling BLA process (2/25)

Sigma-TauPharmaceuticalsInc.

– Cysteamine hydro-chloride ophthalmicsolution

Corneal cystinecrystals inpatients withlysosomal storagedisorder cystinosis

FDA accepted its NDA (5/18)

SomaxonPharmaceuticalsInc.

Silenor Doxepin Insomnia Resubmitted its NDA after receiving a sec-o n d c o m p l e t e response letter (1/25)

Spectrum Pharmaceuticals

Fusilev Levolucovorin for injection

Advanced metastatic colorectal cancer

Submitted a complete response to the FDA’s complete response l e t t e r i s s u e d i n October 2009 (11/2); FDA accepted it for fil-ing and review (11/30)

Tibotec Pharmaceuticals Ltd.

TMC278 Rilpivirine; a once-dai-ly, non-nucleoside reverse transcriptase inhibitor

HIV Submitted an NDA (7/27)


Telaprevir Protease inhibitor Hepatitis C virus Vertex completed its rolling NDA submis-sion (11/24)




Vivus Inc. Qnexa An oral, controlled-release formation of low-dose phentermine and topiramate

Obesity FDA accepted the NDA (3/2)

Winston Pharmaceuticals Inc.

Civanex Civamide cream Osteoarthritis of the knee


Notes:


Recommendations by FDA Advisory Panels in 2010Company Product Description Indication Action

ActelionPharmaceuticalsLtd.

Zavesca Miglustat Niemann-Picktype C disease

FDA panel backed approval of Zavesca (1/13)

AcuraPharmaceuticalsInc.

Acurox Oxycodone HCl andniacin

Pain FDA advisory panel r e f u s e d t o b a c k approval saying data were insufficient in showing its niacine additive and mixture of functional excipi-ents could effectively deter potential abuse of the oxycodone drug (4/26)

Alkermes Inc. Vivitrol Naltrexone for extended-release injectable suspension

Opioid dependence

FDA panel voted in favor of approval (9/17)

Amgen Inc. Aranesp Darbepoetin alfa; erythropoiesis-stimu-lating agent

Chronic kidney dis-ease

An FDA panel voted 15 to 1 , with one absten-tion, that Aranesp should continue to be used to treat anemia in patients not on dial-ysis (10/19)


Lorquess Lorcaserin Obesity F D A p a n e l v o t e d against the drug, say-ing the benefits failed to outweigh potential risks of tumors, psy-chiatric effects and heart problems (9/17)

CellTherapeuticsInc.

Pixuvri Pixantrone Non-Hodgkin’slymphoma

FDA advisory panel voted unanimously that data were insuffi-cient for accelerated approval (3/23)

Cerexa Inc. and Forest Laboratories Inc.

Ceftaroline Injectable antibiotic Community-acquired bacterial pneumonia and complicated skin and skin structure infections

FDA panel voted unan-imously that it was safe and effective (9/8)

ForestLaboratoriesInc.

Bystolic Nebivolol Chronicheart failure

FDA advisors recom-m e n d e d a g a i n s t approval, saying the pivotal trial lacked robustness (1/8)

ForestLaboratoriesInc. andNycomed GmbH

Daxas Roflumilast Chronicobstructivepulmonarydisease

F D A p a n e l v o t e d against the drug’s approval, saying it lacked substantial effi-cacy and safety data (4/8)


RecommendationsbyFDAAdvisoryPanels



Genentech Inc. and Roche AG

Avastin Bevacizumab HER2-negative meta-static breast cancer

An FDA panel voted to remove the metastatic breast cancer indica-tion from Avastin's labeling because fol-low-up studies failed to confirm the magni-tude of improvement in progression-free survival (7/21)

HRA Pharma Ulipristal Emergency contracep-tive pill

To preventpregnancy

F D A c o m m i t t e e backed the approval of the drug (6/21)

Human Genome Sciences Inc.

Benlysta Belimumab Systemic lupus ery-thematosus

FDA panel voted in favor of approval (11/17)

InterMune Inc. Pirfenidone Small-molecule P38-gamma inhibitor


FDA review said the Phase I I I package failed to provide sub-stantial evidence of efficacy (3/8); an FDA p a n e l b a c k e d i t s approval (3/10)


Rekinla Oral liquid sodium oxybate drug JZP-6; Xyrem at a different concentration

Fibromyalgia FDA advisory panel voted 20-to-2 that the drug’s risk-benefit bal-ance did not favor its approval (8/23)

MedImmuneInc.

Rezield Motavizumab Respiratorysyncytial virus

FDA drug reviewers said the drug had three times as many n o n - f a t a l a d v e r s e h y p e r s e n s i t i v i t y events, including urti-caria, as Synagis (6/1); FDA panel recom-m e n d e d a g a i n s t approval (6/3)

NicOx SA Naproxcinod A cycloxygenase inhibiting nitric oxidedonator

Osteoarthritis P h a s e I I / I I I d a t a showed it was safe and effective, but drug r e v i e w e r s r e c o m -mended that labeling that implied a benefi-cial blood pressure effect be removed (5/11); the FDA panel rejected it (5/13)

Novartis AG Gilenia Fingolimod; sphingo-sine-1 phosphate receptor modulator

Multiplesclerosis

FDA panel unanimous-ly backed approval (6/14)

Orexigen Therapeutics Inc.

Contrave Naltrexone/bupropion Obesity FDA committee voted 13 to 7 in favor of the drug (12/8)

RecommendationsbyFDAAdvisoryPanels



SalixPharmaceuticalsInc.

Xifaxan Rifaximin Hepaticencephalopathy

FDA advisory commit-tee voted 15-to-3 to recommend approval (2/24)

Theratechnol-ogies Inc.

Egrifta Tesamorelin acetate HIV FDA panel backed Egrifta in reducing excess abdominal fat i n H I V - i n f e c t e d patients with lipodys-trophy (5/28)

Valeant Pharmaceuticals International Inc.

Potiga Ezogabine/ retigabine

Epilepsy FDA panel backed approval of Potiga (8/12)

Vivus Inc. Qnexa Phentermine/topira-mate

Obesity F D A r e g u l a t o r s showed concerns over teratogenicity, along with metabolic acido-sis and adverse psy-chiatric, cognitive and cardiovascular events ( 7 / 14 ) ; F DA p a n e l voted against approv-al due to risks of fetal exposure, increased heart rate, depression and other problems (7/16)

Notes:


Overseas Approvals and Other Regulatory Actions in 2010Company Product Description Indication Action

Abraxis BioScience Inc. , Taiho Pharmaceutical Co. Ltd. and Specialised Therapeutics Ltd.

Abraxane Intravenous infusion 100 mg, paclitaxel injection

Breast cancer Approved in Japan (7/26); approved in New Zealand (7/30)

Actelion Ltd. Zavesca Miglustat Niemann-PickType C disease

Approved in Canada (3/24)

AlexionPharmaceuticalsInc.

Soliris Eculizumab Paroxysmalnocturnalhemoglob-inuria

Received Japanese regulatory approval (4/19)

Alimera Sciences Inc. and PSivida Corp.



Submitted an MAA in the UK (7/9)


Folotyn Pralatrexate injection Peripheral T-cell lym-phoma

EMA accepted the MAA for review (12/22)

AMAGPharmaceuticalsInc. and TakedaPharmaceuticalCo. Ltd.

Feraheme Ferumoxytol Iron deficiencyanemia inchronic kidneydisease

E M E A v a l i d a t e d AMAG’s submission of its MAA (6/30)

Amgen Inc. Prolia Denosumab; a RANKligand inhibitor

Osteoporosis Approved in Europe (6/1)

AmsterdamMolecularTherapeutics

Glybera A gene therapy prod-uct that targets lipo-protein lipase deficiency

Lipoproteinlipase-deficiency

Submitted an MAA (1/12)

Apricus Biosciences Inc.

Vitaro Topically applied treatment that incor-porates alprostadil

Erectile dysfunction Health Canada grant-ed marketing approv-al for Vitara as a first-line therapy (11/16)

ArchimedesPharma Ltd.

PecFent A fentanyl nasal spray Pain Received a positive o p i n i o n f r o m t h e CMPH 6/28); Received marketing authoriza-t i o n f r o m t h e European Commission (9/2)

ArkTherapeuticsGroup plc

Cerepro Gene therapy Glioma Pulled the MAA after European officials said another Phase III is needed to prove clini-cal benefit (3/10)

BasileaPharmaceuticaAG

Zevtera Cephalosporin antibi-otic

Complicatedskin and skinstructureinfections

CHMP issued a nega-tive opinion on the MAA (2/22)


OverseasApprovalsandOtherRegulatoryActions



BioAlliancePharma SA

Setofilm An anti-emetic drugdelivered via a thin film strip

To prevent andtreat chemo-therapy-, radio-therapy- andpostoperative-induced nauseaand vomiting

Received European approval of Setofilm (3/24)

BioCrystPharmaceuticalsInc.

Peramivir Intravenous Influenza Filed an NDA in South Korea through partner Green Cross Corp. (1/11); received approv-al in Japan ( 1/ 14) ; approved for use in Mexico (1/13); Received marketing and manu-facturing approval from Korean authori-ties (8/17)

BioDelivery Sciences International Inc.

BEMA Fentanyl Fentanyl buccal solu-ble film

Breakthrough cancer pain

Wa s a p p r o v e d i n Europe via the decen-tralized procedure, with Germany acting as reference member state (10/21)

Biogen Idec Inc. Fampridine Prolonged-release tab-lets

Multiple sclerosis Submitted a European MAA (1/13)

BioMarinPharmaceuticalInc.

3,4-diamino-pyridine

Amifampridine phos-phate

Lambert EatonMyasthenic Syndrome

European Commission granted marketing approval (1/7)

Biota Holdings Ltd. and Daiichi Sankyo Co. Ltd.

Inavir Laninamivir octano-ate; a long-acting neuraminidase inhibi-tor

Influenza Received approval to manufacture and mar-ket Inavir in Japan (9/14)


Orencia Abatacept Active rheumatoid arthritis

European Commission approved Orencia in c o m b i n a t i o n w i t h methotrexate (7/8)

Cangene Corp. ImmunoGam Human hepatitis Bimmunoglobulin

Hepatitis Bvirus

Received European approval (3/18)

Cardiome PharmaCorp. &Merck & Co. Inc.

Brinavess Vernakalant Atrial fibrillation CHMP recommended approval (6/28); Was granted marketing a p p r o v a l i n t h e E u r o p e a n U n i o n , Iceland and Norway (9/2)

Celgene Internat-ional

Revlimid Lenalidomide Multiplemyeloma

Was granted full mar-keting authorization in Japan (6/28)





Pixuvri Pixantrone dimaleate Non-Hodgkin’s lym-phoma

Submitted a market-i n g a u t h o r i z a t i o n application to the EMA for Pixuvri (11/2); MAA was validated and accepted for review by the EMA (11/19)

Cel-Sci Corp. Multikine An immunotherapy Head and neck cancer Received approval from Hungarian regu-lators for a Phase III trial (10/6)

CipherPharmaceuticalsInc.

CIP-TramadolER

Extended-release for-mulation of tramadol

Moderatelysevere pain

The new drug submis-sion to Health Canada w a s a c c e p t e d f o r review (3/29)

CSL BehringCanada

Berinert Human C1 esterase inhibitor

Acute abdominalor facial attacksof hereditaryangioedema


Daiichi SankyoCo. Ltd.

Edoxaban Anticoagulant To preventvenous thrombo-embolism aftermajor ortho-pedic surgery

Submitted an NDA in Japan (4/7)

Eisai EuropeLtd.

E7389 Eribulin mesylate Locally advancedor metastaticbreast cancer

Submitted an MAA to the EMEA (4/1)

EpiCept Corp. Ceplene Histamine dihydro-chloride

Acute myeloid leuke-mia

The Israeli Ministry of Health has approved the marketing applica-t i o n f o r C e p l e n e (12/22)

Genzyme Corp. Synvisc Hylan G-F 20 Osteoarthritis of the knee

G a i n e d J a p a n e s e approval of Synvisc (9/21)

GracewayPharmaceuticalsLLC

Zyclara Imiquinomod cream3.75%

Multipleactinic kera-tosis of the faceor balding scalp

H e a l t h C a n a d a approved Zyclara (1/6)

GW Pharmaceuticals plc and Bayer Inc.

Sativex Cannabis-based thera-py

Multiple sclerosis

H e a l t h C a n a d a approved Sativex and an ajunctive treatment for symptomatic relief of spasticity in adult patients with MS (9/1)

Helsinn Groupand Taiho Pharma-ceutical Co. Ltd.

Palonosetron Second-generation 5-HT(3) receptor antagonist

To preventchemo-inducednausea and vomiting

Received approval in Japan (1/21); approved in Europe (5/11)

Hospira Inc. Retacrit Epoetin zeta Anemiaassociatedwith chronicrenal failure

CHMP recommended approval of Retacrit for use subcutaneous-ly in the nephrology setting (2/23)




Hospira Inc. Nivestim A filgrastim biosimilar Prevent febrileneutropenia

European Commission granted marketing a p p r o v a l ( 6 / 1 1 ) ; Approved in Australia (9/28)

Human GenomeSciences Inc. andGlaxoSmithKline

Benlysta Belimumab erythema-tosus

Systemiclupus

Submitted an MAA to the EMEA (6/8)

Human GenomeSciences Inc.

Joulferon Albinterferon alfa-2b;Zalbin in the U.S.

Hepatitis Cvirus

Withdrew its European marketing application a f t e r t h e E M E A requested new data (4/20)

InspirePharmaceuticalsInc. andSantenPharmaceuticalCo. Ltd.

Diquas Diquafosol tetrasodi-um ophthalmic solu-tion 3%

Dry eyesyndrome

Was granted approval in Japan (4/19)

InterMune Inc. Esbriet Pirfenidone Idiopathic pulmonaryfibrosis

Submitted an MAA in Europe(3/3) ; EMEA validated the MAA (3/24); CHMP issued a positive opinion, posi-tioning the company f o r a E u r o p e a n approval in early 2011 (12/20)

Johnson & Johnson (which acquired devel-oper Cougar Biotechnology Inc.)

Abiraterone acetate An oral androgen bio-synthesis inhibitor

Metastatic, advanced prostate cancer

Submitted a market-ing application in C a n a d a ( 1 2 / 2 7 ) ; Submitted marketing applications in the U.S. and Europe (12/22)

LigandPharmaceuticalsInc. and Glaxo-SmithKline plc

Revolade Eltrombopag Chronic immunethrombocytopenicpurpura

Granted marketing a u t h o r i z a t i o n i n Europe (3/15); Granted approval in Japan (11/3)

LuxBiosciencesInc.

Luveniq Oral voclosporin Noninfectiousuveitis

EMEA accepted for fil-ing the MAA (3/3)

Merck KGaA Cladribine Tablets Relapsing-remitting multiple sclerosis

E M E A c o m m i t t e e issued a negative opinion, stating the drug’s benefits do not outweigh the risks (9/27)

Merck Serono AS Movectro Cladribine tablets Relapsing-remitting multiple sclerosis

Australian authorities approved the tablets (9/7)

Movetis NV Resolor Prucalopride Idiopathic chronic constipation

A p p r o v e d i n Switzerland (8/5)




MundipharmaInternationalCorp. Ltd.

Bendamustine Marketed in the U.S. asTreanda

Indolent non-Hodgkin’slymphoma,chronic lympho-cytic leukemiaand multiplemyeloma

The CHMP issued a positive opinion rec-ommending that mar-keting authorizations b e g r a n t e d i n Germany and other EU member states (3/22)

Neurim Pharmaceuticals Ltd.

Circadin A prolonged-release melatonin

Primary insomnia

European Commission approved a change in treatment duration from three weeks to 13 weeks (7/7)

Novalar Pharmaceuticals Inc. and Sanofi-Aventis Deutschland GmbH

OraVerse Local anesthesia reversal agent

For use with routine dental procedures

Regulatory agencies in the UK, Germany, Italy, France and Sapin accepted for review the MAA for OraVerse (7/15)

Novo NordiskAS

Victoza Liraglutide, a gluca-gon-like peptide-1 , GLP-1 , analogue

Type II diabetes Received approval in Japan (1/21); Health Canada approved it (5/27)

Optimer Pharmaceuticals Inc.

Fidaxomicin A macrocycle that inhibits the bacterial enzyme RNA poly-merase

Clostridium difficile infection

Submitted an MAA (7/30); EMEA accepted for review its MAA (8/20)

Orexo AB andKyowa HakkoKirin Co. Ltd.

Abstral KW-2246; a sublingualfentanyl product

Cancer Submitted an NDA in Japan (2/26)

OSI Pharma-ceuticals Inc.and Roche AG

Tarceva Erlotinib; monothera-py


CHMP issued a posi-tive opinion recom-mending approval formaintenance treat-ment in patients with stable disease (3/22); received approval in Europe (4/30)

Paladin LabsInc.

Abstral Sublingual fentanyl Breakthroughcancer pain

Filed a new drug sub-mission in Canada; Health Canada accept-ed i t for pr ior i ty review (2/5)

Paladin Labs Inc. and Isotechnika Pharma Inc.

Voclera Voclosporin Psoriasis Submitted a dossier for approval for the C a n a d i a n m a r k e t (12/21)

Pfizer Inc. Sutent Sunitinib malate Pancreatic neuroendo-crine tumors

European Commission has approved Sutent (12/3)

Pharming Group NV and Swedish Orphan Biovitrum AB

Ruconest A recombinant C1 inhibitor

Hereditary angioede-ma

European Commission granted approval (11/3)




PharmaMar SA (sub-sidiary of Grupo Zeltia SA) and Centocor Ortho Biotech Products LP (Johnson & Johnson company)

Yondelis Trabectedin; a tris tet-rahydroisoquinoline alkaloid

Platinum-sensitive ovarian cancer

Approved in combina-tion with pegylated liposomal doxorubicin h y d r o c h l o r i d e i n B r a z i l , I n d i a a n d Argentina (10/4)

Pfizer Inc. Revatio Sildenafil solution forinjection; phosphodi-esterase 5 inhibitor

Peripheralarterialhypertension

European Commission approved Revatio for those who cannot take oral medication (1/5)

PPD Inc. Nesina Alogliptin; a highly selective DPP-4 inhibi-tor

Type II diabetes Approved in Japan (4/28)


Relistor Methylnaltrexone bro-mide subcutaneous injection in prefilled syringes

Opioid-induced con-stipation

CHMP issued a posi-tive opinion (8/6); FDA, EMEA and Health Canada approved sin-g l e - u s e , p r e f i l l e d syringes of Relistor subcutaneous injec-tion in palliative care p a t i e n t s w i t h a d v a n c e d i l l n e s s (9/30)

Protalix BioTherapeutics Inc.

Taliglucerase alfa A plant cell-expressed recombinant form of glucocerebrosidase

Gaucher's disease

French regulator y a u t h o r i t i e s h a v e granted temporary authorization (7/14); Submitted an MAA to the EMA (11/30)

Roche HoldingsAG

Herceptin Trastuzumab HER2-positivemetastaticstomach cancer

European Commission approved Herceptin in combination with che-motherapy (1/29)

Roche AG MabThera Rituximab Follicular lymphoma European Commission approved its use as a maintenance treat-ment for people who have responded to ini-tial induction therapy (11/1)

Shire plc Vpriv Velaglucerase alfa Gaucher’sdisease

Received a positive o p i n i o n f r o m t h e C H M P ( 6 / 2 8 ) ; European Commission granted marketing a p p r o v a l ( 8 / 2 7 ) ; H e a l t h C a n a d a approved Vpriv for long-term use in pedi-atric and adult Type I Gaucher ’s d isease (12/2)




Sinovac Biotech Ltd.

Anflu Seasonal influenza vaccine

Influenza Received the certifi-cate of drug registra-tion in Hong Kong (10/26)

SymBioPharmaceuticalsLtd.

SyB L-0501 Bendamustine hydro-chloride

Indolent non-Hodgkin’slymphoma

Submitted an NDA in Taiwan (3/19)

Takeda Canada Inc. Dexilant Dexlansoprazole; pro-ton pump inhibitor with a dual delayed-release technology

Heartburn associated with noner-osive gastroesopha-geal reflux disease

H e a l t h C a n a d a approved Dexilant (9/23)

Talecris Bio-therapeuticsHoldings Corp.

Prolastin-C Alpha1-proteinaseinhibitor

Panacinaremphysemain patientswith alpha1-antitrypsindeficiency

Received approval from Health Canada for a more purified and concentrated ver-sion of Prolastin (2/19)

UnitedTherapeuticsCorp.

Tyvaso An inhalable version of treprostinil

Pulmonaryarterial hypertension

Company withdrew t h e M A A a f t e r European regulators expressed concerns over good clinical practice at two clinicalsites; United will con-duct an additional piv-otal trial (2/22)

ValeantPharmaceuticalsInternational

Onsolis Fentanyl buccal solu-ble film

Breakthroughcancer pain


ViroPharma Inc. Cinryze C-1 esterase inhibitor Hereditaryangioedema

EMEA accepted for fil-ing the MAA (3/25)

Vivus Inc. Qnexa Phentermine/topira-mate controlled-release capsules

Obesity Filed an MAA with the EMA (12/21)

Zogenix Inc. and Desitin Pharmaceuticals GmbH

Sumavel DosePro Sumatriptan injection needle-free delivery system

Migraine attacks and cluster headache

The Danish Medicines Agency has approved the MAA for Sumavel DosePro (12/3)

Notes:


Orphan Designations Granted in 2010Company Product Description Indication Action

Acceleron Pharma Inc.

ACE-031 A fusion protein that inhibits signaling through the activin receptor type IIB

Duchenne’s muscular dystrophy

FDA granted orphan d r u g d e s i g n a t i o n (8/20)

ACT BiotechInc.

Telatinib Oral kinase inhibitor Gastric cancer Received orphan drug designation from the FDA (6/3)

Advanced CellTechnology Inc.

MA09-hRPE Based on the compa-ny’s retinal pigment epithelium cells

Stargardt’smaculardystrophy

FDA granted orphan designation (3/3)

Aeterna ZentarisInc.

– Perifosine Multiplemyeloma

EMEA issued a posi-t i v e o p i n i o n f o r o r p h a n m e d i c i n a l product designation (3/2)

AeternaZentaris Inc.

AEZS-108 A doxorubicin-target-ed conjugate com-pound

Ovariancancer

Received a positive opinion for orphan medicinal product designation in Europe (5/18) ; FDA issued orphan drug designa-tion (5/7)

Aeterna Zentaris Inc. and Keryx Biopharm-aceuticals Inc.

Perifosine An oral Akt inhibitor Neuroblastoma FDA granted orphan d r u g d e s i g n a t i o n (7/16)

AllonTherapeuticsInc.

Davunetide Neuroprotective can-didate

Progressivesupranuclearpalsy

FDA granted orphan d r u g d e s i g n a t i o n (1/13); granted orphan drug status in Europe (3/18)

AllosTherapeuticsInc.

Folotyn Pralatrexate Advanced ormetastatictransitionalcell carcinomaof the urinarybladder


AllosTherapeutics

Folotyn Pralatrexate CutaneousT-cell lymphoma

European Commission granted orphan desig-nation (6/18)


Folotyn Pralatrexate Hodgkin’slymphoma

Received orphan drug s t a t u s f r o m t h e European Commission (10/18)

Amsterdam Molecular Therapeutics Inc.

AMT-080 Gene therapy Duchenne muscular dystrophy


Aprea AB APR-246 Tumor specific agentthat targets p53


European Medicines Agency adopted a positive opinion rec-ommending orphan designation (2/19)


OrphanDesignations



AriadPharmaceuticalsInc.

AP24534 Pan-BCR-ABL inhibitor Chronic myeloidleukemia

Granted orphan drug designation by the FDA and the EMEA (3/2)

Athersys Inc. MultiStem Multipotent adult pro-genitor stem cell ther-apy

To prevent graft-vs.-host disease

Was granted orphan drug designation by the FDA (9/22)

AVEOPharmaceuticals

Tivozanib An inhibitor of VEGFreceptors 1 , 2 and 3

Renal-cellcarcinoma

Received European orphan designation (6/25)

AVI BioPharmaInc.

AVI-5038 Drug candidate Duchenne’smusculardystrophy

Received an orphan drug designation from the EMEA (2/8)

BioDiem Ltd. BDM-E Prevents photorecep-tor apoptosis and reduces retinal dam-age

Retinitis pigmentosa

Received orphan drug designation (9/10)


BMN-701 A fusion of insulin-like growth factor 2 and alpha glucosidase

Pompe disease Received orphan drug status from the FDA (8/31)

Biomimetic Therapeutics Inc.

rhPDGF-BB (active ingredient of Regranex and GEM21S)

Recombinant human platelet-derived growth factor biologic therapy

Osteochondritis disse-cans (OCD)

Received orphan drug designation from the FDA (8/13)

BioSantePharmaceuticalsInc.

GVAX Vaccine Pancreaticcancer; acutemyeloid leukemia;chronic myeloidleukemia

Received orphan des-ignation for its GVAX v a c c i n e ( 3 / 1 6 ) ; received orphan des-i g n a t i o n i n A M L (3/24); FDA granted orphan drug designa-tion in CML (6/8)

BiovestInternationalInc.

BiovaxID Personalized lympho-ma vaccine

Lymphoma FDA granted orphan drug designation (1/8)

Biovest International Inc.

BiovaxID Personalized anti-idio-type vaccine

Mantle cell lymphoma


Catalyst Pharmaceutical Partners Inc.

CPP-115 Its GABA aminotrans-ferase inhibitor

Infantile spasms Was granted orphan d r u g d e s i g n a t i o n (9/22)

Chiasma Inc. Octreolin An oral form of octreo-tide acetate

Acromegaly FDA granted orphan d r u g d e s i g n a t i o n (6/29)

Clavis PharmaASA

CP-4126 Intravenous drug based on Lipid Vector Technology

Pancreaticcancer

FDA granted orphan status (1/11)

Cleveland BioLabs Inc.

CBLB502 Targets a mutation in the TLR5 gene

To prevent death fol-lowing total body irra-diation

Received orphan drug status to treat expo-sure to radiation (12/1)

Clinical Data Inc. PRX-8066 Selective serotonin 2B receptor antagonist

Pulmonary arterial hypertension

FDA granted orphan drug designation (11/2)

OrphanDesignations



Cyclacel Pharmaceuticals Inc.

CYC682 Nuceloside analogue sapacitabine

Acute myeloid leuke-mia and myelodys-plastic syndromes

FDA granted orphan drug designation (7/2)

CytokineticsInc.

CK-2017357 Fast skeletal muscletroponin activator

Amyotrophiclateral sclerosis

Granted orphan drug designation by the FDA (3/11)

Diamyd MedicalAB

Diamyd Diabetes vaccine Type I diabetes FDA granted orphan d r u g d e s i g n a t i o n (3/24)

Discovery Laboratories Inc.

KL4 KL4 surfactant Cystic fibrosis FDA granted orphan drug designation (11/2)

Elorac Inc. Naloxone Lotion; opiate antago-nist also available via injection

Pruritus accompany-ing cutaneous T-cell lymphoma


Emergent BioSolutions Inc.

AVP-21D9 Monoclonal antibody

Anthrax Was granted orphan drug designation by the FDA (11/5)

EntreMed Inc. ENMD-2076 An Aurora A/angio-genic kinase inhibitor


FDA granted orphan drug status for ENMD-2076 (2/17)

EpiCept Corp. NP-1 Prescription topicalanalgesic cream

Post-herpeticneuralgia

FDA granted orphan drug designation to NP-1 (1/28)

ERYtech Pharma Graspa A new enzyme formu-lation of L-asparaginase

Acute lympho-blastic leukemia

F D A g r a n t e d a n orphan drug designa-tion for Graspa (1/27)

Genta Inc. Tesetaxel An oral, small-mole-cule taxane

Gastric cancer Granted orphan drug status by the EMEA (10/12)

iCo Therapeutics Inc.

iCo-009 An oral formulation of amphotericin B; an antifungal

Visceral leishmaniasis


ImmunoCellularTherapeutics

ICT-107 A dendritic cell-basedcancer vaccine

Glioblastomamultiforme


ImmunoGen Inc. IMGN901 Consists of the cancer cell killing agent, DM1 , attached to a CD56-targeting antibody, huN901

Merkel cellcarcinoma


Immunogen Inc. IMGN901 Lorvotuzumab mer-tansine

Small-cell lung cancer FDA granted orphan drug status (8/19)

Inspiration Bio-pharmaceuticals Inc.

OBI-1 Designed to treat sub-jects who have devel-oped inhibitors against human Factor VIII

Hemophilia European Commission granted orphan drug status (10/20)

Ipsen SA and InspirationBiopharmaceuticalsInc.

OBI-1 A recombinant B-domain deleted FVIII bioengineered for low cross reactivity to antihuman FVIII inhibi-tors

Hemophilia CHMP issued a posi-tive opinion on the granting of orphan drug status (6/18)

OrphanDesignations



Kiadis PharmaBV

Atir Donor lymphocyte depleted of alloreac-tive T cells

To reducetransplant-related mortalitydue to graft-vs.-host disease orinfections follow-ing allogeneicbone marrowtransplantation

FDA granted orphan drug status (4/28)

LFB Biotechnologies SA

LFB-R603 A chimeric monoclo-nal antibody directed at CD20

Chronic lymphocytic leukemia

Received orphan drug status from the FDA (8/27)

Marina Biotech Inc. CEQ508 Therapeutic agent that uses the transk-ingdom RNA interfer-ence platform; orally administered RNAi-based therapeutic

Familial adenomatous polyposis


Neogenix Oncology Inc.

NPC-1C Ensituximab Pancreatic cancer FDA granted orphan drug status (11/2)

NeoPharm Inc. IL13-PE38QQR Cintredekin besudo-tox; agent designed to deliver bacterial cyto-toxic PE38



NephRx Corp. NX001 A kidney growth fac-tor peptide

Renal transplant Received orphan drug designation from the FDA (8/19)

NeuroVive Pharmaceutical AB

NeuroSTAT Cyclosporine Traumatic brain injury Granted orphan drug status (12/7)

Octapharma AG Wilate High-purity, double virus inactivated von Willebrand Factor/Coagulation Factor VIII Concentrate (Human)

von Willebranddisease

Received orphan drug status (1/14)

OsirisTherapeuticsInc.

Prochymal Stem cell product Type I diabetesmellitus

Was granted orphan drug designation by the FDA (5/6)

Pharmalink AB Nefecon PL-56 IgA nephropathy, or Berger’s disease

Received FDA orphan d r u g d e s i g n a t i o n (10/14)

Prolor Biotech Inc. hGH-CTP Longer-acting version of human growth hor-mone

Growth hormone defi-ciency


ProtalixBioTherapeuticsInc.

Taliglucerasealfa

A plant cell-expressedrecombinant form ofglucocerebrosidase

Gaucher’s disease

Recommended for orphan drug designa-tion in Europe (1/14)

QLT Inc. QLT091001 Oral, synthetic reti-noid

Retinitis pigmentosa and Leber congenital amaurosis

FDA granted orphan designation for both indications (12/8)

QuarkPharmaceuticalsInc.

QPI-1002 A synthetic siRNAtar-geting p53 mRNA

For the prophy-laxis of delayedgraft function inkidney transplant

CHMP granted orphan drug status (6/16)

OrphanDesignations



RaptorPharmaceutical

DR Cystea-mine

A delayed-release, oralformulation of cystea-mine bitartrate

Cystinosis CHMP issued a posi-tive opinion recom-m e n d i n g o r p h a n status (6/16)

Repligen Corp. RG2833 A selective histone deacetylase 3 inhibi-tor

Freidreich’sataxia


Sangart Inc. MP4CO Therapy based on the MP4 molecule designed to enhance the perfusion of oxy-gen-deprived tissues and provide targeted oxygen delivery in the capillaries

Sickle cell disease Was granted orphan drug designation by the FDA in treating acute painful sickling crises (11/16)

S*BIO Pte Ltd. SB1518 JAK2 inhibitor Primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelo-fibrosis

European Commission granted orphan drug status (10/19)

Semafore Pharmaceuticals Inc.

SF1126 A peptidic prodrug of the P13K and mTOR inhibitor LY294002

B-cell chronic lympho-cytic leukemia


Stromedix Inc. STX-100 Humanized monoclo-nal antibody

Idiopathic pulmonary fibrosis


SuppreMolGmbH

SM101 A recombinant humansoluble Fc-gammareceptor IIb

Idiopathicthrombocyto-penic purpura

FDA granted orphan designation for SM101 (4/20)

Synageva BioPharma Corp.

SBC-102 A preclinical enzyme replacement therapy

Lysosomal acid lipase deficiency

FDA granted orphan d r u g d e s i g n a t i o n ( 7 / 8 ) ; R e c e i v e d orphan product desig-nation from the EMA (11/10)

T2Cure GmbH t2c001 An autologous cellulartherapeutic aimed at improving neovascu-larization

Buerger’sdisease

FDA granted orphan designation (6/25)

TalecrisBiotherapeuticsInc.

– Aerosol formulation ofalpha1-antitrypsin deficiency

Congenitalalpha1-antitrypsindeficiency

Granted orphan drug designation in the U.S. (2/8)

TarixPharmaceuticalsLtd.

TXA127 Tarix’s lead drugengraftment in patients receiving a stem cell transplant

To enhancenation (6/29)

FDA granted orphan drug designation

To-BBBtechnologies BV

2B3-101 Uses glutathione to enhance the delivery of doxorubicin

Brain cancer Received a positive o p i n i o n f r o m t h e Committee for OrphanMedicinal Products (6/15); FDA granted orphan drug status (8/24)

OrphanDesignations



ToleraTherapeutics

TOL101 Anti-TCR murine monoclonal antibody, type IgM

Type I diabetes

FDA granted orphan status (6/23)

XOMA Ltd. XOMA 052 An antibody to inter-leukin-1 beta

Behcet's disease A committee at the EMEA adopted a posi-tive opinion and rec-o m m e n d e d i t b e g r a n t e d o r p h a n medicinal product designation (7/30); FDA designated it an orphan drug (8/5)

YM BioSciences Inc. CYT387 JAK1/2 inhibitor Myelofibrosis Received orphan sta-tus (8/11)

Ziopharm Oncology Inc.

Zinapar Darinaparsin, ZIO-101 Peripheral T-cell lym-phoma


Notes:


OrphanDesignations



BioWorld®

R E P O R T

C A R D F O R

WA L L S T R E E T


U.S. Public Offering Performance By Underwriter: Jan. 1 - Dec. 31, 2010

RANKED BY GROSS PROCEEDS*Rank Underwriter Offerings As

LeadOfferings as

Lead or Co-Manager

Gross Proceeds

(M)

1 J.P. Morgan Securities 8 9 $1 , 127.89

2 Morgan Stanley 7 7 $917.93

3 Leerink Swann 6 12 $903.54

4 Jefferies & Co. 17 17 $869. 15

5 Wedbush PacGrow 1 12 $850.51

6 Piper Jaffray 4 10 $745.69

7 Canaccord Adams 2 8 $617.58

8 Canaccord Genuity 0 8 $534.45

9 Oppenheimer & Co. 3 8 $519. 15

10 Lazard Capital Markets 9 11 $518.04

11 Deutsche Bank Securities 6 7 $496.31

12 Cowen & Co. LLC 2 9 $480.39

13 Citigroup Global Markets 5 5 $470.81

14 Credit Suisse 3 4 $464.95

15 Robert W. Baird & Co. 3 6 $434.32

16 Needham & Co. 1 9 $431 . 18

17 Goldman, Sachs & Co. 3 3 $352.9

18 Roth Capital Partners 4 9 $350.6

19 JMP Securities 0 5 $329.7

20 Stifel Nicolaus Weisel 5 7 $316.35

21 Rodman & Renshaw 1 5 $312.0

22 RBC Capital Markets 0 5 $298.84

23 Bank of America Merrill Lynch 0 1 $216.00

24 UBS Investment Bank 3 3 $180.67

25 Merriman Curhan Ford 0 2 $134.23

26 William Blair & Co. 0 2 $124.7

27 Barclays Capital 2 2 $120.7

28 Maxim Group LLC 3 6 $120.61

29 WBB Securities 0 1 $100.0

30 McAdams Wright Ragen 0 1 $96.6

31 National Securities 1 3 $89.7

32 Summer Street Research 0 1 $88

33 Ladenburg, Thalmann & Co. 1 2 $85.73

34 Cantor Fitzgerald & Co. 0 1 $82.8

35 Morgan Joseph 0 1 $82.8

36 Pacific Crest Securities 0 1 $78.0

37 Wells Fargo 1 1 $56.0

38 Collins Stewart 0 1 $47.5

39 BMO Capital Markets 1 1 $32.0

40 Noble Financial Capital 0 1 $24.5


41 Dundee Capital Markets 0 1 $22.95

42 Versant Partners 0 1 $22.95

43 ThinkEquity LLC 0 1 $15.5

44 Boenning & Scattergood 0 2 $15.38

45 Gilford Securities 0 1 $7.8

46 Paulson Investment Co. 1 1 $6.5

* The offerings in this chart include only those that were completed on U.S. stock exchanges (NASDAQ, NYSE or AMEX) from Jan. 1 - Dec. 31, 2010.

Note: Rankings in each chart are made for the purpose of listing underwriters starting with the highest amount raised or highest average percent change. All figures are rounded for the chart. In many cases, multiple underwriters performed exactly the same and are, therefore, ranked alphabetically.


U.S. Public Offering Performance By Underwriter:Jan. 1 - Dec. 31, 2010

RANKED BY AFTER-MARKET PERFORMANCE*#Rank Underwriter Offerings As

LeadOfferings as

Lead or Co-Manager

After-Market Performance

(Average)

1 Noble Financial Capital 0 1 +100%

2 Barclays Capital 2 2 +71%

3 McAdams Wright Ragen 0 1 +63%

4 Collins Stewart 0 1 +49%

5 ThinkEquity LLC 0 1 +49%

6 Wells Fargo 1 1 +42%

7 Roth Capital Partners 4 9 +41%

8 William Blair & Co. 0 2 +40%

9 Canaccord Adams 2 8 +38%

10 Goldman, Sachs & Co. 3 3 +37%

11 Leerink Swann 6 12 +36%

12 National Securities 1 3 +35%

13 Needham & Co. 1 9 +33%

14 JMP Securities 0 5 +33%

15 Oppenheimer & Co. 3 8 +30%

16 WedBush PacGrow 1 12 +30%

17 Jefferies & Co. 17 17 +23%

18 Credit Suisse 3 4 +22%

19 Morgan Stanley 7 7 +22%

20 Deutsche Bank Securities 6 7 +19%

21 Stifel Nicolaus Weisel 5 7 +18%

22 Cantor Fitzgerald & Co. 0 1 +16%

23 Morgan Joseph 0 1 +16%

24 J.P. Morgan Securities 8 9 +15%

25 RBC Capital Markets 0 5 +14%

26 Canaccord Genuity 0 8 +13%

27 Cowen & Co. LLC 2 9 +13%

28 Rodman & Renshaw 1 5 +13%

29 BMO Capital Markets 1 1 +11%

30 Citigroup Global Markets 5 5 +9%

31 WBB Securities 0 1 +4%

32 Gilford Securities 0 1 +4%

33 Lazard Capital Markets 9 11 +3%

34 Ladenburg, Thalmann & Co. 1 2 +3%

35 Paulson Investment Co. 1 1 0%

36 Robert W. Baird & Co. 3 6 -2%

37 Summer Street Research 0 1 -7%

38 Bank of America Merrill Lynch 0 1 -8%

39 Piper Jaffray 4 10 -8%


40 UBS Investment Bank 3 3 -11%

41 Pacific Crest Securities 0 1 -18%

42 Merriman Curhan Ford 0 2 -19%

43 Maxim Group LLC 3 6 -25%

44 Dundee Capital Markets 0 1 -43%

45 Versant Partners 0 1 -43%

46 Boenning & Scattergood 0 2 -47%


# After-market performance is expressed as the percent change in stock price between the offering price and the closing price on 12/31/10. For underwriters with multiple offerings, the after-market performance (as a percent change) was calculated for each stock in that underwriter’s “group,” the percentage summed, and then averaged.



Lead Underwriter Performance on All U.S. Offerings:Jan. 1 - Dec. 31, 2010

RANKED BY GROSS PROCEEDS*Rank Underwriter Offerings As

LeadOfferings as

Lead or Co-Manager

Gross Proceeds

(M)

1 J.P. Morgan Securities 8 9 $1 ,021 . 17


3 Jefferies & Co. 17 17 $869. 15



6 Lazard Capital Markets 9 11 $361 .44

7 Goldman, Sachs & Co. 3 3 $352.9


9 Deutsche Bank Securities 6 7 $296.31



12 Oppenheimer & Co. 3 8 $152.7


14 Barclays Capital 2 2 $120.7


16 Robert W. Baird & Co. 3 6 $99.9

17 Roth Capital Partners 4 9 $95.6

18 Needham & Co. 1 9 $63.55




22 Wedbush PacGrow Life Sciences 1 12 $44.0

23 BMO Capital Markets 1 1 $32.0

24 Cowen & Co. LLC 2 9 $24.7

25 Maxim Group LLC 3 6 $23. 1 1

26 Paulson Investment Co. 1 1 $6.5

27 Ladenburg, Thalmann & Co. 1 2 $5.23




Lead Underwriter Performance on All U.S. Offerings:Jan. 1 - Dec. 31, 2010

RANKED BY AFTER-MARKET PERFORMANCE*#

Rank Underwriter Offerings As Lead

Offerings as Lead or

Co-Manager


(Average)

1 Wedbush PacGrow Life Sciences 1 12 +121%

2 Barclays Capital 2 2 +71%

3 Roth Capital Partners 4 9 +43%



6 Goldman, Sachs & Co. 3 3 +37%



9 Jefferies & Co. 17 17 +23%

10 Deutsche Bank Securities 6 7 +23%

11 Cowen & Co. LLC 2 9 +23%




15 BMO Capital Markets 1 1 +11%



18 Citigroup Global Markets 5 5 +9%

19 Robert W. Baird & Co. 3 6 +6%

20 Lazard Capital Markets 9 11 0%

21 Paulson Investment Co. 1 1 0%

22 Credit Suisse 3 4 -11%

23 Ladenburg, Thalmann & Co. 1 2 -11%



26 Needham & Co. 1 9 -34%






Underwriters’ Performance on IPOs: Jan. 1 - Dec. 31, 2010FULL CREDIT TO LEAD UNDERWRITER, RANKED BY GROSS PROCEEDS*

Rank Underwriter IPOs As Lead IPOs as Lead or

Co-Manager

Gross Proceeds (M)

1 J.P. Morgan Securities 3 3 $505.73





6 Deutsche Bank Securities 2 3 $113. 13





11 Jefferies & Co. 1 1 $54.0




FULL CREDIT TO LEAD UNDERWRITER, RANKED BY AFTER-MARKET PERFORMANCE*#

Rank Underwriter IPOs As Lead IPOs as Lead or

Co-Manager


(Average)








8 Citigroup Global Markets 3 3 -8%


10 Deutsche Bank Securities 2 3 -12%

11 Jefferies & Co. 1 1 -17%




* The IPOs in this chart include only those that were completed on U.S. stock exchanges (NASDAQ, NYSE or AMEX) from Jan. 1 - Dec. 31, 2010.



Underwriters’ Performance on IPOs: Jan. 1 - Dec. 31, 2010 FULL CREDIT TO ALL UNDERWRITERS, RANKED BY GROSS PROCEEDS*

Rank Underwriter IPOs As Lead IPOs as Co-Manager

Gross Proceeds (M)

1 J.P. Morgan Securities 3 3 $505.73




5 Deutsche Bank Securities 2 3 $313. 13

6 Wedbush PacGrow Life Sciences 0 2 $282.9


8 Cowen & Co. LLC 0 4 $239. 18

9 Bank of America Merrill Lynch 0 1 $216.0


11 Oppenheimer & Co. 0 2 $128.05

12 Canaccord Genuity 0 2 $97.5


14 Needham & Co. 0 2 $97.5


16 Pacific Crest Securities 0 1 $78.0

17 RBC Capital Markets 0 1 $78.0





22 Jefferies & Co. 1 1 $54.0

23 Robert W. Baird & Co. 0 1 $54.0


25 JMP Securities 0 1 $50.0

26 Collins Stewart 0 1 $47.5

27 Merriman Curhan Ford 0 1 $46.23






Underwriters’ Performance on IPOs: Jan. 1 - Dec. 31, 2010 FULL CREDIT TO ALL UNDERWRITERS, RANKED BY AFTER-MARKET PERFORMANCE*#

Rank Underwriter IPOs As Lead IPOs as Co-Manager



2 Collins Stewart 0 1 +49%




6 Needham & Co. 0 2 +20%





11 Canaccord Genuity 0 2 +12%



14 Wedbush Pacgrow Life Sciences 0 2 -1%

15 Deutsche Bank Securities 2 3 -8%

16 Bank of America Merrill Lynch 0 1 -8%

17 Citigroup Global Markets 3 3 -8%


19 Cowen & Co. LLC 0 4 -12%

20 Jefferies & Co. 1 1 -17%

21 Robert W. Baird & Co. 0 1 -17%


23 Pacific Crest Securities 0 1 -18%

24 RBC Capital Markets 0 1 -18%


26 JMP Securities 0 1 -26%

27 Merriman Curhan Ford 0 1 -30%






BioWorld®

S T O C K

P E R F O R M A N C E


2010 U.S. Biotechnology Stock Report

3S Bio SSRX 14.98 9.42%Aastrom Biosci ASTM 2.56 732.52%Acadia Pharma ACAD 1.23 -6.82%Accentia Biopharma ABPI 0.75 150.00%Access Pharma ACCP 2.45 -25.53%Achillion ACHN 4.06 30.55%Acorda Therap ACOR 27.51 9.17%Acusphere ACUS 0.062 -17.33%Adamis ADMP 0.205 -35.94%Adolor ADLR 1.24 -15.07%Advanced Life Sci ADLS 0.0159 -90.65%AEterna Zentaris AEZS 1.75 116.88%Affymax AFFY 6.65 -73.12%Affymetrix AFFX 5.11 -12.50%Albany Molecular AMRI 5.88 -35.24%Alexion Pharma ALXN 80.65 65.20%Alexza Pharma ALXA 1.26 -47.50%Alimera Sciences ALIM 10.21 -7.18%Alkermes ALKS 12.3 30.71%Allos Therapeutics ALTH 4.62 -29.79%Alnylam Pharma ALNY 9.88 -43.93%Alseres ALSE 0.13 -35.00%AMAG Pharma AMAG 18.17 -52.22%Amarin AMRN 8.29 479.72%Amgen AMGN 55.53 -1.84%Amicus FOLD 4.79 20.65%Amylin Pharma AMLN 14.89 4.93%Anthera Pharma ANTH 4.87 -30.53%Antigenics AGEN 1.01 57.81%Ardea Biosciences RDEA 26.28 87.71%Arena Pharma ARNA 1.71 -51.83%Ariad Pharma ARIA 5.18 127.19%ArQule ARQL 5.79 56.91%Array BioPharma ARRY 2.98 6.05%Aryx ARYX 0.27 -91.59%Auxilium Pharma AUXL 21.21 -29.25%Avanir AVNR 4.01 111.05%Avax Tech AVXT 0.045 -73.53%AVEO Pharma AVEO 14.7 63.52%AVI BioPharma AVII 2.16 47.95%Bellus Health BLUS 0.155 -3.13%BioCryst Pharma BCRX 5.13 -20.59%Biodel BIOD 1.92 -55.76%Biodelivery Sci BDSI 3.7 -5.85%Biogen Idec BIIB 66.8 24.86%BioMarin Pharma BMRN 27.17 44.44%Biomimetic Therap BMTI 12.9 8.13%Bio-path Holdings BPTH 0.36 -16.28%BioSante Pharma BPAX 1.66 14.48%Cadence Pharma CADX 7.54 -22.03%Cardiome CRME 6.55 47.19%Cardiovascular Bio CVBT 0.34 70.00%Catalyst Pharma CPRX 0.96 52.38%Celera Genomics CRA 6.19 -10.29%Celgene CELG 59.43 6.73%Cell Therapeutics CTIC 0.372 -67.37%Celldex Therap CLDX 4.17 -10.71%CEL-SCI CVM 0.8323 -7.52%Cephalon CEPH 62.16 -0.42%Cerus CERS 2.48 24.62%Chelsea Therap CHTP 7.59 181.11%Cleveland Biolabs CBLI 7.19 117.22%Columbia Labs CBRX 2.19 102.78%CombiMatrix CBMX 2.23 -65.16%

Compugen CGEN 4.98 2.68%Corcept CORT 3.92 41.01%CorMedix CRMD 1.76 -41.33%Cornerstone Therap CRTX 5.65 -7.38%Cortex Pharma CORX 0.18 80.00%Crucell CRXL 31.26 54.91%Cubist Pharma CBST 21.58 13.76%Curis CRIS 2.02 -37.85%Cypress Biosci CYPB 6.49 12.48%Cytokinetics CYTK 2.09 -28.18%CytRx CYTR 1 -10.71%Dara Biosciences DARA 3.37 -52.27%Dendreon DNDN 35.41 34.74%DepoMed DEPO 6.48 93.43%DiaDexus DDXS 0.29 -40.82%DURECT DRRX 3.55 43.72%Dusa Pharma DUSA 2.46 58.71%Dyax DYAX 2.09 -38.35%Dynavax DVAX 3.1 118.31%Emergent BioSol EBS 23.68 74.25%Emisphere Tech EMIS 2.37 123.58%Entremed ENMD 5.08 -42.27%Enzo Biochem ENZ 5.43 0.93%Enzon Pharma ENZN 12.2 15.86%Epicept EPCT 0.85 -51.15%Exelixis EXEL 8.59 16.55%Flamel Tech FLML 6.96 -5.95%Forest Labs FRX 31.97 -0.44%Generex Biotech GNBT 0.2949 -44.36%Genomic Health GHDX 21.88 11.86%Genoptix GXDX 18.8 -47.09%Gen-Probe GPRO 58.91 37.26%GenVec GNVC 0.57 -52.50%Genzyme GENZ 71.4 45.68%Geron GERN 5.21 -6.13%Gilead Sciences GILD 36.26 -16.20%GTC Biotherap GTCB 0.35 -53.33%GTx GTXI 2.76 -34.29%Harbor Biosci HRBR 0.13 -74.51%Harvard Bio HBIO 4.06 13.73%Human Genome HGSI 24.2 -20.86%Idenix Pharma IDIX 4.99 132.09%Idera Pharma IDRA 2.9 -43.91%Immucor BLUD 20.04 -0.99%ImmunoGen IMGN 9.42 19.85%Immunomedics IMMU 3.6 12.15%Incyte INCY 16.77 84.08%Infinity Pharma INFI 6.05 -2.10%Inhibitex INHX 2.69 192.39%Insmed INSM 0.6316 -17.97%Inspire Pharma ISPH 8.41 52.36%InterMune ITMN 36.91 183.05%Ironwood Pharma IRWD 10.35 -11.16%ISIS Pharma ISIS 10.15 -8.64%ISTA Pharma ISTA 4.98 9.21%Keryx Biopharma KERX 4.67 86.80%La Jolla Pharma LJPC 0.026 -84.43%Labopharm DDSS 0.95 -54.33%Lexicon LXRX 1.49 -12.35%Ligand Pharma LGND 8.91 310.60%MannKind MNKD 8.13 -7.19%Map Pharma MAPP 16.66 74.82%MDRNA MRNA 1.529 88.77%Maxygen MAXY 3.94 -35.30%

Company Symbol Close %Change 12/31YTD



Metabolix Inc. MBLX 11.9 7.69%Micromet MITI 8.27 24.17%Momenta Pharma MNTA 15.02 19.21%Myrexis MYRX 4.25 -15.51%Myriad Genetics MYGN 22.93 -12.11%Nabi Biopharma NABI 5.85 19.39%Nanogen NGEN 0.0085 -63.83%Nektar Therap NKTR 12.96 39.06%NeoPharma NEOL 0.29 0.00%Neurocrine Biosci NBIX 7.69 182.72%NeurogesX NGSX 6.32 -18.03%Northwest Biothera NWBO 0.75 -5.06%NovaBay NBY 1.67 -18.93%Novavax NVAX 2.55 -4.14%NPS Pharma NPSP 8.02 135.88%Omeros OMER 8.36 19.09%OncoGenex Pharma OGXI 16.45 -26.17%Oncothyreon ONTY 3.27 -39.33%Onyx Pharma ONXX 36.95 25.94%Opko Health OPK 3.71 102.73%Optimer Pharma OPTR 11.5 2.04%OraSure Tech OSUR 5.97 17.52%Ore Pharma ORXE 0.246 -38.50%Orexigen OREX 8.16 9.68%Osiris Thera OSIR 7.94 11.20%Osteotech OSTE 6.5 103.13%OXiGENE OXGN 0.24 -78.95%Oxis International OXIS 0.135 -32.50%Pain Therapeutics PTIE 6.69 24.81%Palatin Tech PTN 1.29 249.12%Panacos Pharma PANC 0.006 -70.00%Protein Design PDLI 6.22 -9.33%Peregrine Pharma PPHM 2.2 -25.68%Pharma Prdt Dev PPDI 27.51 17.36%Pharmacyclics PCYC 6.24 98.73%Pharmasset VRUS 43.94 112.27%Pharmos PARS 0.1 53.85%Poniard Pharma PARD 0.58 -68.31%Pozen POZN 6.57 9.87%Progenics Pharma PGNX 5.41 21.85%Qiagen QGEN 19.45 -12.90%QLT Inc. QLTI 7.16 44.35%Regeneron Pharma REGN 33.38 38.05%



Repligen RGEN 4.727 15.01%Response Genetics RGDX 2.32 84.13%Rexahn Pharma RNN 1.15 69.12%Rigel Pharma RIGL 7.6 -20.08%Rosetta Genomics ROSG 0.95 -45.71%Rxi Pharma RXII 2.64 -42.36%Sangamo Biosci SGMO 6.86 15.88%Santarus SNTS 3.29 -28.79%Savient Pharma SVNT 11.23 -17.49%SciClone Pharma SCLN 4.24 81.97%Seattle Genetics SGEN 15.34 50.98%Sequenom SQNM 8.14 96.62%SIGA Tech SIGA 13.96 140.69%Somaxon Pharma SOMX 3.21 197.22%Spectrum Pharma SPPI 7.08 59.46%StemCells STEM 1.11 -11.90%Sucampo Pharma SCMP 3.83 -5.20%Sunesis Pharma SNSS 0.508 -52.52%SuperGen SUPG 2.64 0.76%Synta Pharma SNTA 6.12 20.95%Targacept TRGT 26.69 27.70%Targeted Genetics TGEN 0.37 131.25%Telik TELK 0.805 2.64%Tengion TNGN 2.74 -87.70%Theravance THRX 25.55 95.49%Titan Pharma TTNP 1.22 -47.19%Transcept Pharma TSPT 7.55 11.03%Transgenomic TBIO 0.71 2.90%Trimeris TRMS 2.44 -6.87%Trinity Biotech TRIB 8.84 118.81%Trius Therap TSRX 3.615 -23.57%Trubion Pharma TRBN 4.3303 12.48%Unigene UGNE 0.67 -6.94%United Therap UTHR 63.33 20.28%Vanda Pharma VNDA 9.38 -16.62%Vermillion VRML 7.42 -32.36%Vertex Pharma VRTX 35.34 -17.53%Vical VICL 2.05 -37.69%ViroPharma VPHM 17.6 109.77%Vivus VVUS 9.53 3.59%XenoPort XNPT 8.66 -53.32%Zalicus Inc ZLCS 1.63 21.64%ZymoGenetics ZGEN 9.76 52.74%


2010 British Biotechnology Stock ReportCompany Symbol Close %Change 12/31YTD

Antisoma ASM 6.05 -81.67%Ark Therapeutics AKT 4.96 -64.70%Asterand ATD 16.21 -12.85%Oxford Biomedica OXB 5.5 -51.11%Phytopharm PYM 7.28 -32.84%Puricore PURI 47.85 257.09%Renovo Group RNVO 70 142.21%SkyePharma SKP 31.5 -63.36%Vernalis plc VER 40.85 -53.05%


2010 Canadian Biotechnology Stock Report

Adherex Tech AHX 0.05 11.11%Allon Therap NPC 0.375 17.19%BELLUS Health BLU 0.17 -5.56%Bioniche Life Sci BNC 1.46 160.71%Cangene Corp CNJ 3.05 -40.20%Isotechnika Inc ISA 0.245 48.48%Lorus Therapeutics LOR 1.04 1500.00%Medicago Inc MDG 0.59 -11.94%MethylGene Inc MYG 0.14 -50.00%Oncolytics Biotech ONC 6.8 147.27%Protox Therap PRX 0.7 -17.65%Resverlogix RVX 2.32 -4.13%SemBioSys Gen SBS 0.07 -65.00%Tekmira Pharma TKM 4.61 395.70%Thallion Pharma TLN 0.125 13.64%Theratechnologies TH 5.54 25.06%Wex Pharma WXI 0.095 -42.42%YM BioSciences YM 2.35 62.07%



BioWorld®

R E S T R U C T U R I N G S

Biotech Restructurings, Scale-Backs, Bankruptcies: January 1 - December 31, 2010

Biotech Company (Country; Symbol)

Action Taken Details (Date)#

Accentia Biopharmaceuticals Inc. (PK:ABPIQ)

Company filed a proposed reorgani-zation plan with the U.S. Bankruptcy Court for the Middle District of Florida, Tampa Division; successful-ly completed its reorganization

Accentia expects to emerge from Chapter 11 bankruptcy this summer as a fully restructured company (6/2); Accentia and its subsidiary, Biovest (See Biovest below), said the plan of reorganization was confirmed, and the companies expect to emerge from bankruptcy by mid-November (10/29); emerged from Chapter 11 with a $7M financing and structural changes to certain agreements, including the reduction of the outstanding royalty on Biovax ID sales from 35% to 6.3% (11/18)

Alnylam Pharmaceuticals Inc. (ALNY)

Company is restructuring its work force, reducing staff levels by 25% to 30% in order to save $25M next year

The layoffs affect 45 to 55 employees, based on the company's work force of 182 employees as of June 30; the restructuring is in response to Novartis AG's deci-sion not to take a $100M option to extend its partnership with Alnylam for RNAi therapeutics (9/27)

AmpliMed Corp.* Company trimmed its work force from 12 to four full-time and two part-time employees

The decision to downsize came after the failure of a midstage trial of pancreatic cancer drug Amplimexon (7/13)

Anesiva Inc. (PK:ANSV) Company is on the verge of filing for bankruptcy after its merger agreement with Arcion was nixed

The merger was not completed because Anesiva was unable to meet multiple closing conditions by Dec. 31 (1/5)

ARYx Therapeutics Inc. (ARYX)

Terminated all of its employees, effective Dec. 15, as part of a board-approved restructuring plan to reduce operational expenses

All employees entered consulting agreements to contin-ue to provide services needed to allow the company to function; the decision followed the FDA's delay until the first quarter of 2011 for responding to the company's special protocol assessment submission for Phase III testing of gastrointestinal drug naronapride; the compa-ny had $3M as of Sept. 30, which was expected to last until the end of 2010 (12/17)

AutoImmune Inc.(PK:AIMM)

Stockholders voted in favor of the company’s voluntary dissolution, with the proposal receiving an affir-mative vote from about 99% of votes cast at the May 11 meeting

AutoImmune’s business activities will be limited to those necessary to preserve the value of its assets, wind up its business affairs and distribute assets in accor-dance with its plan of liquidation and dissolution (5/17)

Avexa Ltd. (Australia;ASX:AVX)

Company is reducing its staff and the CEO has resigned now that part-nering talks have ceased

The company had about A$26.6M in cash as of March 31 (5/11)

Biogen Idec Inc. (BIIB) Company is reducing its work force by about 650 full-time positions, or 13% of total full-time employees

The move, along with a focus on neurological diseases and selecting high-impact biological therapies, will save the company $300M annually; the company is closing its San Diego site and consolidating sites in eastern Massachusetts into facilities in Cambridge and Weston; the headcount reduction leaves the company with 4,275 employees worldwide (11/4)

Biotie Therapies Corp.* (Finland)

Company is cutting personnel and costs in a restructuring move to focus on clinical development

It will transfer all operations to its Finland headquarters, spinning off Biocrea GmbH at its site in Radebeul, Germany; it is reducing its employee headcount by 15 people, and transferring 43 to Biocrea, leaving Biotie with 22 employees (11/1)


BiotechRestructurings,Scale-Backs,Bankruptcies




Biovest InternationalInc. (PK:BVTI)

Reached a settlement to restructure the company’s debt with Laurus Master Fund Ltd.; filed a proposed reorganization plan with the U.S. Bankruptcy Court; successfully completed its reorganization

About $30.2M of pre-petition indebtedness will be restructured, consisting primarily of short-term obliga-tions (4/20); the plan includes establishing a two-year deferral of all scheduled interest and principal on senior secured debt, converting intercompany debt owed to subsidiary Accentia Biotherapeutics Inc. to equity, and making nondisruptive arrangements for payment to trade creditors (5/17); expects to emerge from bankrupt-cy by mid-November (see Accentia above) (10/29); emerged from Chapter 11 (11/18)

CDEX Inc. (OTC BB:CEXI)

Restructuring plan converting cer-tain existing debt into two-year notes

Creditor’s response has been strong with more than 90% of the outstanding notes and more than 50% of the accounts payable being converted to long-term two-year notes or written off (4/19)

Cell Therapeutics Inc. (CTIC)

Company is cutting 36 employees and reducing expenses by 21% in a move that is expected to save $16M in 2010

The company’s monthly net operating burn is expected to be $4.4M starting this quarter (4/16)

CombiMatrix Corp.(CBMX)

Implemented a restructuring plan to reduce operating costs 40% to 60%

The company said its diagnostic laboratory in Irvine, Calif., will not be affected (4/20)

ConjuChemBiotechnologies Inc.(Canada; TSX:CJB)

Filed for restructuring and said the Superior Court of Quebec granted an initial order to the firm under the Canadian Companies’ Creditors Arrangement Act

As of Oct. 31 , 2009, ConjuChem had about C$7.5M ($7. 1M) in cash, with another C$1 .6M in accounts receiv-able (3/1); a plan for arrangement approved by its credi-tors calls for the cancellation of common shares for no consideration (6/15); filed a voluntary assignment in bankruptcy to effect an orderly liquidation of its assets, property and operations; directors and officers have resigned (7/22)

DeCode Genetics ehf(Iceland; PK:DCGNQ;former subsidiary ofDeCode Genetics Inc.)

The subsidiary emerged as a new company, DGI Resolution Inc., after being purchased by an investment consortium, Saga Investments LLC

DeCode filed for bankruptcy in November 2009 (1/22)

Enzo Biochem Inc. (NYSE:ENZ)

Company streamlined its opera-tions in an attempt to reduce its annualized operating expenses of more than $4M beginning in the fis-cal 2011 first quarter

The action will generate a positive cash flow from oper-ations next year and result in increased gross margins (9/22)

Exelixis Inc. (EXEL) Company is narrowing its pipeline and cutting its work force by 65%

About 40% of those cuts – about 160 jobs – are expected by year-end; that comes on top of a 40% cut of 270 jobs earlier this year (12/6)

Febit Holding GmbH (Germany)

Company cut about 60% of its work force in a restructuring move to shift its strategic focus to blood-based microRNA biomarker discovery and on partnerships and intellectual property commercialization

The exact number of jobs lost was not available (6/24)

Genaera Corp. (GENR) Argyce LLC is liquidating the assets of Genaera and will divest the remaining assets on an “as-is” basis with bids due by Feb. 12

The assets include an interest in IL-9 antibody MEDI-528, and pexiganan acetate, a small peptide anti-infec-tive (1/11)

Genmab AS (Denmark; CSE:GEN)

Company is reducing its work force by 15%, or 33 people

This will translate into an operational cost savings of $5.6M in 2011 (10/27**)





Gentium SpA (Italy; GENT)

Restructuring that involves the clos-ing of the company’s New York office and the consolidation of cor-porate activties and the executive management team at the Italy head-quarters

The restructuring includes the appointment of Khalid Islam as full-time CEO (3/2)


The firm planned to reduce head-count by about 1 ,000 employees, roughly 10% of its global work force

The cuts come after a bid to acquire Genzyme from Sanofi-Aventis SA; Genzyme also is divesting its fran-chises, selling Genzyme Genetics to Laboratory Corp. of America for $925M in cash (9/14); the company revealed in an 8-K filing that it is cutting 392 jobs in the first phase of its work force reduction that will eliminate 1 ,000 jobs by the end of 2011 (11/8)

GTC Biotherapeutics Inc. (OTC BB:GTCB)

Company is downsizing approxi-mately 30 full-time positions at its headquarters and an additional 20 positions at its farm facility

In addition, Geoffrey Cox and several other members of the senior management team are leaving; the company closed a new $7M secured convertible debt financing by LFB Biotechnologies SAS in connection with the restruc-turing (6/17)

Haemacure Corp.(Canada; TSX:HAE)

Filed for bankruptcy in both Canada and the U.S.

Angiotech Pharmaceuticals Inc. agreed to provide financing to fund the insolvency proceedings and Haemacure’s day-to-day operations, up to a maximum of $1M; it was delisted from the Toronto Stock Exchange (1/12)

Halozyme Therapeutics Inc. (HALO)

Company is decreasing its research relating to the discovery and pre-clinical assessment of new com-pounds; this results in a reduction in the work force of about 25%

The company had 108 employees as of June 30, 2010, meaning the work force reduction affects about 27 peo-ple; Halozyme will incur a one-time charge in the fourth quarter that will be offset by reduced payroll expenses (10/13)

Helicos BioSciencesCorp. (HLCS)

Company is cutting about 40 posi-tions this quarter as part of a restructuring plan

The firm will have 40 employees remaining, half of who are supported by National Institutes of Health funding (5/19)

Intercell AG (Austria; FSE:IJE)

Company plans to cut R&D spend-ing by about 40% in 2011 , and it also will reduce headcount

The company has not discussed specific plans yet, but the decision is the result of the company's patch-based vaccine for traveler's diarrhea failing to demonstrate efficacy in Phase II and Phase III studies (12/14)

Medicure Inc. (Canada;AMEX:MCU)

Retained Bloom Burton & Co. to assist in the evaluation of financial alternatives and fundraising options

It also retained Beal Advisors LLC to assist in the part-nership, license or sale of cardiovascular drug Aggrastat; as of Aug. 31, 2009, the company had $908,896 in cash (1/14)

MediGene AG (Germany; PK:MDGEF)

Restructured its business by cutting its work force from 107 employees to 55 and reducing costs

The estimated one-off restructuring cost will incur in full in 2010 and is estimated to be about $1 .36M, with cost savings of at least $6.8M per year (9/30)

Medivation Inc.(MDVN)

Company is reducing its work force by 20%, or 23 employees, and also is cutting operating costs to focus its resources on dimebon trials and the development of MDV3100

The company’s shares plunged in March after its Phase III trials of dimebon in Alzheimer’s disease missed all of the study’s stated goals (4/1)





MiddleBrookPharmaceuticals Inc.(MBRK)

Company is filing for Chapter 11 bankruptcy

MiddleBrook had engaged Broadpoint Gleacher Securities Group Inc. as its financial advisor to help iden-tify and evaluate alternatives, including a possible merger or sale, but was unable to do so; in March, it eliminated its field sales force and significantly reduced its corporate staff (5/4); entered an asset purchase agreement with Victory Pharma Inc. for about $17. 1M, which is subject to bankruptcy court approval (5/18)

Molecular InsightPharmaceuticals Inc. (MIPI)

Molecular is eliminating nine posi-tions as part of a plan to support the development of its oncology prod-uct candidates and to reduce oper-ating costs

A one-time charge of $200,000 is expected to be taken in the first quarter; afterward, it expects to achieve about $1M in annualized savings in its operating expenses (1/11); company received a 30-day extension of its waiver agreement with its bond holders so that restructuring of debt efforts can continue without default (4/19); company received a third extension of its waiver agreement with its bond holders (6/23); it received a fourth extension (7/6); company filed for Chapter 11 bankruptcy in order to receive a $45M financ-ing commitment from Savitr Capital LLC (12/13)

Myriad Pharmaceuticals Inc.

Company suspended development of its HIV compounds and is cutting 21 employees and conserving cash to extend its runway beyond 2013

Myriad had about $148M in cash as of March 31; the com-pany plans to seek partners for its HIV viral maturation inhibitors (6/9)

Neuropharm Groupplc (UK; LSE:NPH)

Company’s shares jumped 33% after it informed investors that the board resolved to explore a return of cash to shareholders

Neuropharm said the cash return could be achieved by way of a proposal to shareholders for a members’ volun-tary liquidation within the next two months (3/11); the company moved into a voluntary liquidation and has more than 34% shareholder approval, with a final vote set for May 18 (4/28**)

NicOx SA (France; Paris:COX)

Company decided to close U.S. headquarters, effective Aug. 31

The decision comes after the FDA said it would not approve naproxcinod (8/5)

Osteotech Inc. (OSTE) Company incurred costs and expenses of $391 ,000 and $539,000 from its ongoing evaluation by its financial adviser, Deutche Bank Securities Inc., for strategic alterna-tives focused on enhancing share-holder value

The firm said the costs were significant, but the evalua-tion was a needed investment to make a well-informed decision about its future (8/10)

Oxigene Inc. (OXGN) Company is restructuring, reducing its work force by 20 positions, or 49%, and stopping further enroll-ment in the Phase II/III FACT trial in anaplastic thyroid cancer

The reduction should generate annual expense savings of about $2.6M (2/12)

Palatin Technologies Inc. (AMEX:PTN)

Company is cutting in half its 40-person staff and discontinuing its discovery research to conserve capital

The company has struggled after the clinical delay with sexual dysfunction drug bremelanotide and the prema-ture exit by partner King Pharmaceuticals Inc. in 2007 (9/28)

Phenomix Corp.* Phenomix ceased operations and closed its doors; it is searching for a buyer for dutogliptin

The decision was made following Forest Laboratories Inc.'s exit from a $340M development and commercial-ization deal for dutogliptin, despite positive Phase III results in Type II diabetes; the company's European part-ner, Chiesi Farmaceutici SpA, also backed out of a $191M deal (10/28)





Poniard PharmaceuticalsInc. (PARD)

Plans to reduce its work force by 57% to 21 employees and cut its operating costs to focus resources on picoplatin development in solid tumors

The cut of about 29 jobs is expected to result in $4M in reduced annualized operating expenses in 2010 (2/4); company eliminated about 45% of its work force, to a total of 12, effective April 30, and it has engaged Leerink Swann LLC to look at strategic alternatives (3/25)

Roche AG (Switzerland)

Company is discontinuing its pre-clinical research in the area of RNA interference at sites in Kulmbach, Germany; Madison, Wis.; and Nutley, N.J.; it also is reducing its worldwide work force by 4,800, or about 6%

The company will now focus on Phase II studies of new molecular entities; it will transfer 800 jobs to other Roche sites, and outsource another 700; restructuring costs are estimated at $2.72B, with total annual cost savings of $2.42B (11/18)


Company is cutting about 14 posi-tions, or nearly 20%, of its work force, primarily in R&D and general and administrative positions as part of a corporate restructuring

This is expected to result in a 32% reduction in monthly burn rate; all company employees will move to a four-day work week with an attendant 20% reduction in sala-ry (10/6)

Santarus Inc. (SNTS) Company is cutting about 120 employees, a 37% reduction in work force, and is ceasing promotion of Zegerid due to the launch of an authorized generic

The company expects restructuring-related charges in the third quarter to total between $7.4M and $8.5M, and said selling and marketing expenses should be reduced by about $40M annually beginning in the fourth quarter; Santarus expects to regain about 110 sales reps to pro-mote Glumetza in Type II diabetes (7/6)

SemBioSys Genetics Inc. (Canada; TSX:SBS)

Company is working on a potential corporate sale or merger, an accel-erated partnering transaction for either insulin or Apo, an asset sale, a significant restructuring and recapi-talization or a wind-down of its business

The company is unable to continue operations at cur-rent levels and has provided working notice of termina-tion to all affected employees (at one time, there were 45 employees at the company); as of June 30, it had $1 .6M on its balance sheet (9/27); it retained Deloitte & Touche Corporate Finance Canada Inc. to advise it on potential strategic alternatives (10/4)

Silence Therapeuticsplc (UK; LSE:SLN)

Eliminated about 20 jobs, mostly in research and development, from its Palo Alto, Calif., and Berlin locations

The cuts were related to the integration of siRNA deliv-ery firm Intradigm Corp., with which Silence merged late last year (4/14)

The Medicines Co. (MDCO)

Company is cutting its field-based work force by 26%, or 43 employ-ees, by the end of February

The firm expects a one-time charge of $3.5M and an estimated annualized cost savings in the range of $8M to $9M starting this quarter (2/17)

Upstream Biosciences Inc. (Canada; PK:UPBS)

Company is reviewing various financing and restructuring options and is exploring new strategic opportunities to supplement its cur-rent holdings

The company is working on genetic diagnostics for can-cer susceptibility and drug response, as well as develop-ing compounds for tropical parasite diseases (11/16)

Vermillion Inc. (PK:VRMLQ)

Its first amended Chapter 11 plan of reorganization was accepted by creditors

The firm filed for Chapter 11 last year but is working to emerge from bankruptcy with a recent private place-ment of $43M (1/7); it successfully emerged from bank-ruptcy protection less than 10 months after its Chapter 11 financing (1/25); the U.S. Bankruptcy Court for the District of Delaware issued an order approving the dis-tribution of $5M in cash and 302,541 shares of restricted stock to three directors who successfully restructured the company (4/19); the U.S. Bankruptcy Court approved the final fee application associated with the company’s bankruptcy proceedings (4/21)





VIA Pharmaceuticals Inc.(PK:VIAP)

Company is reducing its work force by 63% to a core R&D team of six employees to focus resources on pipeline development

About 10 people are losing their jobs; the company also drew down $1 .25M from a $3M secured note and war-rant purchase agreement with its principal stockholder (4/1)

Vion Pharmaceuticals Inc. (OTC BB:VIONQ)

Company, which has filed for bank-ruptcy, told investors that it does not believe there will be any value for the company’s common stock “even under the most optimistic of scenari-os” despite recent high trading

The firm said it doesn’t believe all claims against the company will be settled; Vion filed for bankruptcy Dec. 17, 2009, listing assets at $14.6M and liabilities of $62.8M (1/26)

XenoPort Inc. (XNPT) Company is cutting about half its work force and eliminating discov-ery efforts in the wake of a regula-tory setback with restless legs drug Horizant

The company is eliminating about 110 jobs, which will reduce its annual cash expenses by about $15.6M (3/8)

Notes:

This chart contains publicly announced restructurings, scale-backs and bankruptcy filings of biotech companies that occurred in 2010 and that were published in BioWorld Today.



Unless otherwise indicated, shares are traded on the Nasdaq exchange.

ASX = Australian Stock Exchange; CSE = Copenhagen Stock Exchange; FSE = Frankfurt Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; PK = Pink Sheets; TSX = Toronto Stock Exchange.


BioWorld®

L AW S U I T S

Biotech Lawsuits: Jan. 1 - Dec. 31, 2010Defendant Plaintiff Details/Decisions (Date)#

Ablynx NV reMYND NV Companies have reached a settlement concerning a dispute from a 2003 collaboration to discover and commercialize new Nanobodies in which Ablynx was obligated to pay a portion of income received if certain Nanobodies were licensed to a third party; reMYND could receive up to $2.45M based on milestones, plus a 1% royalty on sales; the collabo-ration was terminated as a result of the settlement (6/3)

Allergan Inc. Department of Justice Allergan agreed to plead guilty and pay $600M to settle charges it had marketed Botox for off-label uses, including headache, pain, spasticity and juvenile cerebral palsy (9/7)

Alpharma Inc. Federal government and various states

Alpharma agreed to pay $42.5M to resolve false claims act allegations in connection with the marketing of the mor-phine-based Kadian (3/18)

AMAG PharmaceuticalsInc.

Shareholders AMAG faces a class-action lawsuit alleging that it withheld information about adverse reactions in some patients taking Feraheme; the company said the claimers were “without merit,” and that it will “vigorously” defend itself (4/2)

Angiotech Pharmaceuticals Inc.

Rex Medical LP Rex started court proceedings against Angiotech after it decided to terminate a March 2008 license, supply, market-ing and distribution agreement between the two companies; Rex is seeking more than $3M in damages; it also received a restraining order from the U.S. District Court for the Southern District of New York requiring Angiotech to contin-ue to honor the agreement (11/30)


Izard Nobel LLP on behalf of shareholders

The law firm filed a class-action lawsuit against Arena in the U.S. District Court for the Southern District of California charging that Arena violated securities laws by making materially false statements about its weight loss drug lorca-serin by hyping its efficacy, safety and tolerability without disclosing certain health risks (an increase in tumors in rats) (9/27)

Ark Therapeutics Group plc and its subsidiary Lymphatix Ltd.

Circadian Technologies Ltd.

Circadian settled its arbitration proceedings against Ark regarding Trinam, Ark's Phase II VEGF-D gene therapy prod-uct for dialysis patients; Circadian granted Lymphatix an exclusive license and will receive a license payment and roy-alties (11/12)

AstraZeneca plc U.S. government AstraZeneca agreed to pay $520M to resolve allegations that it illegally marketed its schizophrenia and biopolar dis-order drug Seroquel; the company signed a civil settlement that it had caused false claims for payment to be submitted to federal insurance programs, including Medicaid and Medicare (5/3)

Barr Laboratories Inc. Endo PharmaceuticalsHoldings Inc. and PenwestPharmaceuticals Co.

Settled their litigation allowing Barr to sell generic Opana ER on or after Sept. 15, 2012 (4/14)


BiotechLawsuits


Defendant Plaintiff Details/Decisions (Date)#

Barr Laboratories Inc., Cobalt Laboratories Inc., Lupin Ltd., Orchid Chemicals & Pharmaceuticals Ltd., Teva Pharmaceuticals USA Inc., Upsher-Smith Laboratories Inc., Wockhardt Ltd., Dr. Reddy's Laboratories Ltd., Genpharm Inc., Interpharm Inc., Mylan Pharmaceuticals Inc., Ranbaxy Laboratories Ltd. and Sun India Pharmaceutical Industries Ltd.

Forest Laboratories Inc. and Merz Pharma GmbH & Co.

Forest and Merz entered settlement agreements with all remaining defendants in patent infringement litigation relat-ed to Namenda immediate-release tablets for Alzheimer's disease; the first generic versions of memantine will be available to enter the market on Jan. 11 , 2014, under licenses from Forest and Merz to specific companies (7/23)

Biovail Corp. SAC Capital Advisors LLC and Gradient Analytics Inc.

Separate complaints were filed, alleging malicious prosecu-tion related to Biovail’s 2006 filing of a lawsuit against them and others (2/23)

Cell Therapeutics Inc. Shareholders The class action complaint filed in the U.S. District Court for the Western District of Washington on behalf of purchasers of CTI common stock between May 5, 2009, and Feb. 8, 2010, alleges that CTI’s pixantrone drug candidate is cardiotoxic despite CTI’s claims to the contrary; the complaint also charges that CTI failed to disclose that the special protocol assessment was invalidated in March 2008; an FDA advisory panel voted against pixantrone in March 2010 (3/25)

Cipher PharmaceuticalsInc.

Purdue Pharma Products LPand Napp PharmaceuticalGroup Ltd.

A final judgment has been entered in favor of Cipher pend-ing patent litigation in the U.S. District Court for the Eastern District of Virginia, involving Cipher’s new drug application for CIP-Tramadol ER, terminating any further stay of FDA approval (1/5)

Cyclacel PharmaceuticalsInc.

Celgene Corp. Celgene issued a complaint seeking a declaration from the court that four Cyclacel-owned patents, which claim the use of romidepsin injection in T-cell lymphomas, are not infringed by Celgene’s products and are invalid (5/4)

Elan Corp. plc Health and Human Services Office of Inspector General

Elan agreed to establish a reserve of $206.3M for settlement and related costs tied to a Department of Justice investiga-tion into illegal sales and marketing practices for the antiepi-leptic medicine Zonegran; as part of the settlement, Elan Pharmaceutical Inc. will plead guilty to a misdemeanor viola-tion (7/19)

FDA Actavis Elizabeth LLC U.S. District Court for the District of Columbia upheld the FDA’s decision to grant five-year new chemical entity exclu-sivity to Shire plc’s Vyvanse, approved in attention deficit hyperactivity disorder; Actavis sued the agency in February 2009 following its refusal to file an abbreviated new drug application for a generic version (3/8); Shire said the U.S. Court of Appeals for the District of Columbia Circuit affirmed the ruling (11/11)

Forest Laboratories Inc. FDA / U.S. Attorney's Office for the District of Massachusetts

Forest decided to plead guilty and pay $313M to settle charg-es it obstructed justice, illegally distriubted its thryoid hor-m o n e L e v o t h r o i d a n d u n l a w f u l l y p e d d l e d i t s antidepressants Celexa and Lexapro for use in children (9/17)

BiotechLawsuits



Gen-Probe Inc. Genetic Technologies Ltd.

Companies signed a settlement and license agreement relat-ed to Genetic Technologies’ patent infringement suit, filed in the U.S. District Court, Western District of Wisconsin (5/4)

GPC Biotech AG (mergedin 2009 with Agennix AG)

Shareholders A class action lawsuit brought against GPC in early 2009 was dismissed and closed (2/11)

Johnson & Johnson U.S. Attorney’s Office for the District of Massachusetts

The office accused J&J of paying millions of dollars in kick-backs to Omnicare Inc. under a scheme in which the nursing home pharmacy firm purchased or recommended J&J drugs, such as the antipsychotic drug Risperdal; the Justice Department’s complaint is filed under the False Claim Act, and prosecutors say the payments were disguised as grants or educational funding (1/25)

Eli Lilly and Co. Ariad Pharmaceuticals Inc.

The U.S. Court of Appeals for the Federal Circuit ruled in favor of Lilly concerning a 2007 judgment that held Lilly lia-ble for infringement of four claims on an Ariad patent; the court held that the claims are invalid due to an inadequate written description; the patents cover methods of treating human disease by regulating NF-kB cell-signaling activity (3/24)

Eli Lilly and Co. Teva PharmaceuticalsIndustries Ltd.

A U.S. District judge rejected Teva’s claim that Lilly’s com-pound patent for the cancer drug Gemzar was invalid and unenforceable; Lilly also sought an injunction on the meth-od-of-use patent, but was denied, due to a ruling earlier by the U.S. District court for the Eastern district of Michigan, which invalidated the patent; Lilly has appealed the Michigan court’s ruling (4/5); the U.S. Court of Appeals for the Federal Circuit affirmed a prior ruling by the U.S. District Court for the Southern District of Indiana that the company's method-of-use patents for Evista are valid (9/2)

Genentech Inc. (part of Roche AG; Switzerland)

PDL BioPharma Inc. Genentech sent PDL a letter saying its monoclonal antibod-ies Avastin, Herceptin, Lucentis and Xolair do not infringe on patents held by PDL in Europe; royalties received for Genentech drugs sold outside the U.S. accounted for about 30% of PDL's revenue in the first half of 2010 (8/16); PDL filed a complaint in the Second Judicial District of Nevada, Washoe County, seeking royalty payments from Genentech on inter-national sales of Genentech products, after rejecting an argument by Genentech claiming that Avastin, Herceptin, Lucentis and Xolair do not infringe supplementary protec-tion certificates in Europe (9/2)

Genentech Inc. (part of Roche AG; Switzerland)

Regeneron Pharmaceuticals Inc.

Regeneron filed a complaint in U.S. District Court in White Plains, N.Y., seeking a declaratory judgment that activities relating to its VEGF Trap do not infringe any valid claim of Genentech patents (11/23)

Genzyme Corp. Pomerantz Haudek Grossman & Gross LLP on behalf of Genzyme shareholders

The law firm filed a class action lawsuit against the compa-ny, certain of its top officials and members of the board, claiming a breach of fiduciary duties in connection with a tender offer by Sanofi-Aventis to buy the company for $18.5B; the suit states that the offer was twice rejected with-out a “credible explanation” as to why (10/20)

Geron Corp. Hagens Berman law firm

Hagens Berman is investigating Geron pursuant to a lawsuit claiming the company violated the SEC Act of 1934; The law-suit alleges that deceiving statements were made concern-ing Geron's funding (12/28)

BiotechLawsuits



Hemispherx Biopharma Inc.

Shareholders Hemispherx agreed to settle all of the pending securities class actions, upon formal court approval; the settlement will paid from insurance coverage, and it is not an admission of culpability by the firm or its officers; the class action suit was filed in 2009 following a 41% share drop on news that the FDA rejected the new drug application for Ampligen in chronic fatigue syndrome (8/25)

JCI Ltd. Hemispherx Biopharma Inc.

Hemispherx was awarded a $188M judgment in its six-year litigation with JCI, under which it alleged that JCI's chariman, later indicted by the South African government on charges of securities fraud, had targeted the company for an illegal takeover attempt (8/19)

Johnson & Johnson Basilea Pharmaceutica AG

Basilea was awarded $130M under an arbitration process that found partner J&J to be in breach of its license agree-ment on the cephalosporin antibiotic ceftobiprole (11/30)

Life TechnologiesCorp. (formerly AppleraCorp.)

Enzo Biochem Inc. The Court of Appeals for the Federal Circuit reversed a dis-trict court’s summary judgment that will enable the compa-ny to pursue a claim for substantial damages against Life; the asserted patents cover technologies relating to com-pounds used in DNA sequencing systems to read the genetic code (3/30)

Lupin Ltd. Gilead Sciences Inc. Gilead filed a lawsuit in the U.S. District Court in New Jersey for infringement against its patents for Ranexa; Lupin filed an abbreviated NDA for approval for a generic version of Ranexa before the expiration of Gilead's patents (7/16)

MannKind Corp. John Arditi (MannKind's former vice president of worldwide regulatory affairs)

Arditi filed suit in the Superior Court of New Jersey that he was wrongfully fired in May for reporting problems with clinical data involving the inhaled diabetes drug Afrezza; he claims that internal audits he conducted in 2009 revealed potential fraud and scientific misconduct involving trials in Bulgaria and other sites, but the company has said its own investigations have shown no basis for the claims (11/8)

Mayo Collaborative Services

Prometheus Laboratories Inc.

In light of its ruling in Bilski v. Krappos, the Supreme Court wanted the Federal Circuit to look again at its decision in Mayo v. Prometheus, in which it ruled in September 2009 that the machine-or-transformation test had been met; the Mayo Clinic had challenged the patentability of Prometheus' PRO-PredictRx test and planned to sell its own similar test, but was sued by Prometheus, who won the case (7/6)

Medivation Inc. Shareholders Medivation faces several class-action lawsuits in the wake of the Phase III failure with its Alzheimer’s disease therapy Dimebon (3/11)

Momenta Pharmaceuticals Inc.

Sanofi-Aventis SA Sanofi's request for a preliminary injunction directing the FDA to suspend and withdraw approval of the abbreviated new drug application for enoxaparin sodium injection, a generic version of Sanofi's Lovenox, was denied in U.S. District Court (8/27)

BiotechLawsuits



Novartis AG and Chiron Corp. (acquiredby Novartis in 2006)

Federal government(through former Chironemployees Robert Lalley,Courtney Davis and William Manos)

Novartis agreed to pay $72.5M to settle civil False Claims Act allegations that the company has been promoting its cystic fibrosis drug TOBI off label; the federal government will get $43.5M, and another $29M will go to various states to settle their respective claims (5/10) ; Novartis Pharmaceuticals Corp. agreed to plead guilty and pay a crim-inal fine and forfeiture of $185M and also pay $237.5M to resolve civil liabilities for its off-label marketing of the anti-seizure medicine Trileptal and payment of kickbacks to health care providers (10/4)

Novel Laboratories Inc. Salix Pharmaceuticals Ltd. and Norgine BV

Settlement agreement concerning patent litigation involving Novel's proposed generic version of Moviprep; the settle-ment includes a sublicense agreement to patents covering Moviprep effective no later than Sept. 24, 2018 (8/31)

Ortho-McNeil PharmaceuticalLLC and Ortho-McNeil-Janssen PharmaceuticalsInc.

U.S. government Companies agreed to pay more than $81M to resolve crimi-nal and civil liability arising from the illegal off-label promo-tion of epilepsy drug Topamax, approved for a variety of psychiatric uses (5/3)

OSI Pharmaceuticals Inc. Astellas Pharma Inc. Astellas filed a lawsuit against OSI and its directors, seeking declaratory and injunctive relief enjoining OSI and directors from engaging in any action or inaction, including applying a “poison pill” rights plan; Astellas is trying to acquire OSI for $52 per share in cash (3/3)

Pacific Biosciences, Life Technologies Corp. and Illumina Inc.

Helicos Biosciences Corp.

Helicos filed suit in the U.S. District Court for the District of Delaware, alleging that Pacific is infringing two patents allegedly licensed by Helicos and two patents allegedly owned by Helicos, by making, using and selling its SMRT technology for single-molecule sequencing of DNA and teaching customers how to use the SMRT technology and PacBio RS sequencing platform (9/2); Helicos filed a lawsuit in the same court claiming Pacific infringed four patents (10/18); it amended the lawsuit to include additional defen-dants Life Technologies and Illumina (10/26)

Par Pharmaceutical Inc. Santarus Inc. The U.S. District Court for the District of Delaware has ruled that five patents covering the firm’s Zegerid are invalid due to obviousness; Par had submitted an abbreviated new drug application to the FDA in 2007 seeking marketing approval for generic versions of Zegerid (4/16)

Pfizer Inc., AstraZeneca plc and Merck & Co. Inc.

California's Santa Clara County

The Supreme Court agreed to hear an appeal from the drug-makers involving a federal drug discount program for hospi-tals and clinics; the county claimed its hospitals and health clinics had been overcharged for prescription medications and a federal judge had dismissed the suit, but a U.S. appeals court said the county had standing in the case, known as Astra USA v. County of Santa Clara (10/4)

Precision BioSciences Inc. Cellectis SA The U.S. Patent and Trademark Office rejected every patent claim asserted against Precision in litigation filed in March 2008 by Cellectis regarding U.S. Pat. Nos. 6,833,252; 7,214,536; 6,610,546; and 7,309,605, which are owned by the Institut Pasteur and the Universite Pierre et Marie Curie, and licensed to Cellectis SA (10/29)

Protein Sciences Corp. Emergent BioSolutions Inc.

Companies reached an agreement resolving all remaining issues from the failed attempt by Emergent to purchase PSC's assets in June 2008; all litigation is dismissed and all entanglements are ended (11/4)

BiotechLawsuits



Regenerative Sciences LLC*

FDA The FDA sought an injunction against Regenerative Sciences aimed at stopping it from making and using cultured stem cell products without a license, claiming the company is pro-ducing misbranded, adulterated and unapproved products (8/16)

Rosetta Genomics Ltd. Prometheus Laboratories Inc.

Rosetta settled arbitration with Prometheus regaining U.S. commercial rights to three microRNA-based cancer tests; Rosetta will pay $1 .2M on Dec. 2, and $3. 1M over the next 18 months (11/24)

Sandoz Inc. (part of Novartis AG)

Endo Pharmaceuticals Inc. and Penwest Pharmaceuticals Co.

Settled litigation regarding the production and sale of gener-ic formulations of Opana ER; Endo and Penwest will grant Sandoz a license; further terms were not disclosed (6/9)

Sanofi-Aventis Deutschland GmbH

Proteome Sciences plc Proteome Sciences will receive an $11M settlement under a breach claim involving contractual and statutory obligations arising from or in connection with an agreement of sale and transfer for a share in Xzillion Proteomics Vewaltungs GmbH and concerning a limited partnership interest in Xzillion (10/1)

Schwarz Pharma Inc. U.S. Justice Department

Schwarz will pay $22M to resolve False Claims Act allega-tions that it failed to advise the Centers for Medicare & Medicaid Services that two unapproved products did not qualify for coverage under federal health care programs (5/4)

SciClone Pharmaceuticals Inc.

Barroway Topax Kessler Meltzer & Check LLP, on behalf of shareholders

The law firm filed a shareholder class action lawsuit in the U.S. District Court for the Northern District of California against SciClone for allegedly engaging in illegal and improper sales and marketing activities in China, which led to an SEC and Justic Department investigation (8/23)

Sequenom Inc. Shareholders Sequenom entered a settlement agreement to resolve the consolidated securities class action lawsuits stemming from the commercial delay of the SEQureDx Down syndrome test following the discovery of data mishandling; defendants agreed to pay $14M, funded by insurance proceeds, and agreed to issue the plaintiff’s class a number of shares of common stock, constituting 9.95% of total shares outstand-ing; the settlement contains no admission of liability (1/19); the U.S. District Court for the Southern District of California entered an order approving the stipulation of settlement reached in the class-action securities lawsuits (5/6)

SIGA Therapeutics Inc. PharmAthene Inc. Breach of contract suit filed against SIGA in December 2006 regarding the licensing of ST-246, following the termination of a merger agreement; a trial date is set for Jan. 3, 2011 , and if the decision is favorable for PharmAthene, it will get a share of a $2.8B contract SIGA just signed with the govern-ment for the smallpox vaccine (10/20); the Delaware Court of Chancery issued a ruling denying in full a motion for partial summary judgment by SIGA (11/29)

Takeda PharmaceuticalsCo. Ltd.

Sucampo PharmaceuticalsInc. and R-Tech Ueno Ltd.

Sucampo submitted a demand for arbitration to the International Court of Arbitration, International Chamber of Commerce, regarding an alleged material breach of a 2004 collaboration; it claims that Takeda’s conduct injured Sucampo, the Amitiza brand and consumers (3/17); R-Tech is seeking similar relief in a an amended and supplemental request for arbitration (8/17)

BiotechLawsuits



Teva ParenteralMedicines Inc. andPliva Hrvataska doo

The Medicines Co. Lawsuit filed in the U.S. District Court for the District of Delaware alleging patent infringement based on abbreviat-ed new drug applications seeking FDA approval to market generic versions of The Medicines Co.’s Angiomax prior to expiration of the U.S. patent (1/6); a judge determined the PTO incorrectly determined that the firm had missed its 60-day deadline for filing its patent term extension for Angiomax (8/9); the government declined to appeal the August decision of the U.S. District Court for the Eastern District of Virginia (10/6)

Teva Pharmaceutical Co. Ltd.

Celgene Corp. The U.S. District Court for the District of New Jersey granted the requested dismissal of all claims and counterclaims in the thalidomide patent case following the withdrawal by Barr Laboratories, a subsidiary of Teva, of an abbreviated new drug application for generic thalidomide (5/28)

Teva Pharmaceutical Industries Ltd.


The U.S. District Court for the District of Delaware issued a claim construction order in the litigation between Cubist and Teva; Cubist filed a patent infringement suit related to antibiotic Cubicin (6/9); Cubist said it will oppose a motion filed by Teva that alleges that certain Cubist patents are unenforceable due to inequitable conduct (6/14)

Teva PharmaceuticalIndustries Ltd.

Sanofi-Aventis SA and Debiopharm SA

Patent infringement litigation pertaining to Teva’s generic version Eloxatin has been dismissed by the U.S. District Court for the District of New Jersey pursuant to a settlement that prohibits Teva from selling its product and a license to re-enter the market later (4/2)

Teva PharmaceuticalsUSA Inc.

Pozen Inc. Entered a settlement to resolve a U.S. patent infringement suit related to Teva’s filing of an abbreviated new drug appli-cation to market generic Treximet marketed by Pozen’s exclusive licensee, GlaxoSmithKline plc (4/15)

Theratechnologies Inc. Former shareholder 121851 Canada Inc.

Filed for a class action lawsuit on behalf of shareholders who sold common shares on May 25 or May 26; the suit alleges that Theratechnologies failed to disclose a material change involving Egrifta for HIV-associated lipodystrophy; the stock had plunged 52% on FDA concerns outlined in briefing documents, although the advisory panel voted in favor of the drug on May 27 (7/28)

Trimeris Inc. and F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc.

Novartis Vaccines and Diagnostics Inc.

Reached an agreement between Roche and Trimeris reliev-ing Trimeris of any obligation to repay certain deferred mar-keting expenses, and settling the U.S. patent infringement suit related to their product Fuzeon with the paintiff, Novartis Vaccines (9/28)

BiotechLawsuits



U.S. Government and Department of Health and Human Services Secretary Kathleen Sebelius

Two scientists work-ing on adult stem cell projects (James Sherley of the Boston Biomedical Research Institute, and Theresa Deisher of AVM Biotechnology Co.)

A federal district judge blocked expanded federal funding for human embyronic stem cell research after deciding it violates a 1996 law that prohibits taxpayer funds to be used in any research that involves the destruction of a human embryo; the Department of Justice filed an appeal to the Aug. 23 ruling, asking the court to stay its preliminary injunction to avoid terminating research projects mid-stream; the plaintiffs filed the suit alleging President Obama's expansion of taxpayer-funded research from 21 embryonic stem cell lines (under the Bush administration) to up to 75 lines would jeopardize their ability to get funding for research on adult stem cell projects (9/7); the National Institutes of Health can continue to fund hESC research tem-porarily, after a three-judge panel from the U.S. Circuit Court of Appeals for the District of Columbia issued a temporary stay on the injunction (9/13); the court issued a permanent stay (9/30); a government lawyer argued that the decision should be reversed before a three-judge panel from the U.S. Circuit Court of Appeals for the District of Columbia (12/13)

FDA and the U.S. Patentand Trademark Officeand Health and Human Services

The Medicines Co. The U.S. District Court for the Eastern District of Virginia said the PTO had relied too heavily on the FDA’s interpretation of several key issues regarding its denial of Medicines’ patent extension application for anticoagulant Angiomax, which was filed a day late; it was sent back to the PTO for reconsid-eration (3/18); the patent office completed its reconsidera-tion and issued another denial (3/23); filed a complaint seeking to set aside the PTO’s denial last week of the firm’s Feb. 14, 2001 , Hatch-Waxman application to extend the princi-pal U.S. patent covering Angiomax (3/29); the U.S. District Court for the Eastern District of Virginia ordered the PTO to take the actions necessary to ensure the company’s patent does not expire until at least 10 days after the court issues an order deciding the case (5/24); PTO issued a one-year inter-im patent extension for Angiomax until Aug. 13, 2011 , after a district judge was convinced that the PTO incorrectly deter-mined the firm had missed its 60-day deadline for filing its patent-term extension (8/9); the U.S. Solicitor Geneeral has elected against appeal (9/13)

U.S. Patent and TrademarkOffice (PTO)

The American Civil Liberties Union and a coalition of patients, pathologists, genetic researchers and other sci-entists

The lawsuit was filed in the U.S. District Court for the Southern District of New York in Manhattan, challenging PTO’s decisions to grant patents for the BRCA gene, which is associated with breast and ovarian cancers, to Myriad Genetics and the University of Utah Research Foundation; a U.S. federal judge ruled PTO had improperly granted seven BRCA gene patents to Myriad because they involved a law of nature (3/31); Myriad and the university filed a notice of appeal (6/21)

Vermillion Inc. Health Discovery Corp.

Health Discovery received the final payment due under an agreement that settled its patent infringement lawsuit against Vermillion, formerly Ciphergen Biosystems Inc.; the suit claimed infirngement of patents covering the use of support vector machines for the discovery of biomarkers (2/4)

BiotechLawsuits



Whitehead Institute forBiomedical Research andUniversity of Massachusetts

Alnylam PharmaceuticalsInc.

Alnylam and Max Planck asked the court to dismiss the Massachusetts Institute of Technology from any claims for monetary damages in the ongoing litigation related to the Tuschl I patent series; Whitehead and UMass remain as defendants in the suit filed in June 2009 (3/3)

Wisconsin Alumni Research Foundation and Geron Corp.

Consumer Watchdog The U.S. Patent & Trademark Office Board of Patent Appeals and Interferences reversed an earlier decision that upheld the claims of a patent assigned to the WARF and licensed to Geron covering human embryonic stem cells (5/4)

Wyeth Russell and Robalee Bruesewitz

The Supreme Court heard oral arguments in a lawsuit filed by parents of a girl who suffered seizures after receiving the company's diphtheria-tetanus-pertussis vaccine in 1992 when she was 6 months old; the family filed suit against Wyeth after being denied compensation from the federal vaccine court (10/18)

Notes:

This chart contains information on lawsuits involving biotech companies or the industry as a whole., and is based on news items published in BioWorld Today in 2010.


BiotechLawsuits


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BioWorld's Biotechnology State of the Industry Report 2011

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