8 April 2016

US moves scupper Pfizer-Allergan deal 2Sun will close Irish site by end of 2016 2GSK to drop patents in 3poorest countriesFTC sues firms over 3Lidoderm and OpanaLupin’s Mandideep plant receives 483s 4

MARKET NEWS 5

Sandoz slams AbbVie on 5biosimilar petitionUS biosimilar labels can omit trials data 5Competition has cut prices 6in US by halfSwiss reforms aim to bolster exclusivity 6GPhA brief defends inter partes reviews 7India allows global biosimilar reference 7

PRODUCT NEWS 8

Samsung gets EMA backing 8on infliximabBiocad supplies in Sri Lanka 8US politicians push Xtandi patent bar 9EU biosimilars group urges mAbs revision 9Australia pauses in 10perindopril salt caseApobiologix unveils Grastofil in Canada 10Actavis’ Lialda rival infringes a US patent 11Commission explains 12decision on infliximab

FEATURES 14

Global market is poised to 14reap benefit of biosimilars

REGULARS

Price Watch UK – UK pricing trends 10Events – Our regular listing 12People – Matsumori heads up 16Teva Japan business

COMPANY NEWS 2

US-based player Epic Pharma is to be taken over by China’s Humanwell Healthcare groupand fellow US generics firm PuraCap Pharmaceutical in a US$550 million agreement.

Scheduled to close by the end of June, subject to certain conditions, the agreement follows swiftlyon from PuraCap expanding its capabilities beyond soft-gelatine capsules by acquiring US solid-dose player Blu Pharmaceuticals and its Puerto Rican affiliate Blu Caribe at the end of March.

The Epic deal would “further establish Humanwell and PuraCap in the US generics market”,the firms commented, providing a “balanced and diversified” portfolio of 15-marketed products,composed of tablet, two-piece capsule and powder dosage formulations. Epic also currentlyboasts a 37-strong pipeline that includes “a series of controlled drug substances”.

Moreover, through the deal, Humanwell and PuraCap will also pick up Epic’s 10,200 sq mUS Food and Drug Administration (FDA) and US Drug Enforcement Administration (DEA)compliant facility in Laurelton, New York, which will “result in the addition of 215 employeesto the Humanwell and PuraCap US operations team”. Epic began operations around eight yearsago when it acquired the facility from Sandoz.

Describing the acquisition as a “major step in the growth of our company”, Dahai Guo,PuraCap’s chief executive officer and president of Humanwell’s US affiliate, said the firmslooked forward to Epic “being a platform for the development of our generic pharmaceuticalbusiness, both in the US as well as internationally”. G

Epic snapped up for US$550mn

PPUUBBLLIISSHHEEDD WWEEEEKKLLYYNext issue – 15 April 2016

Celltrion’s Inflectra (infliximab-dyyb) has become the first monoclonal antibody (mAb)biosimilar to be approved by the US Food and Drug Administration (FDA). Through

its takeover of Hospira in September last year, Pfizer acquired exclusive US marketingrights to the alternative to Janssen’s Remicade tumour necrosis factor (TNF) blocker.

“While launch timing for Inflectra will ultimately depend on a number of factors such asmarketplace dynamics and intellectual-property considerations,” Pfizer stated, “we are continuingwith the preparation of our launch plans for 2016.” As part of its litigation against Janssen in aMassachusetts district court, Celltrion and Hospira recently agreed not to launch a biosimilarrival to Remicade before Janssen’s US patent 7,223,396 expires on 29 June this year.

The FDA’s decision on 5 April to approve its second biosimilar after Sandoz’ Zarxio(filgrastim-sndz) came two months after the agency’s Arthritis Advisory Committee voted by21 to three in favour of approving Inflectra – previously known as CT-P13 – with the sameunprotected indications as Remicade (Generics bulletin, 12 February 2016, page 1).

Presented as 100mg of lyophilised infliximab in a single-use 20ml vial for intravenousinfusion, Inflectra is indicated for rheumatoid arthritis, psoriatic arthritis, plaque psoriasis,ankylosing spondylitis, ulcerative colitis and adult and paediatric Crohn’s disease.

In line with a draft labelling guideline that the FDA has just released for comment (seepage 5), highlights of prescribing information for Inflectra state that the drug is “biosimilarto Remicade”. The clinical trials section of Inflectra’s label covers studies conducted for thereference brand, rather than details of Celltrion’s comparability exercise.

The ‘dyyb’ suffix added to the international non-proprietary name (INN) reflects the FDA’scurrent thinking that biosimilars not designated as interchangeable – such as Inflectra – shouldcarry unique four-letter suffixes to “minimise inadvertent substitution” and to “facilitatepharmacovigilance” (Generics bulletin, 11 September 2015, page 1). G

Celltrion claims a firstwith infliximab in US

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Sun Pharma intends to cease operations at a former Ranbaxymanufacturing facility in Cashel, Ireland, “by the end of the

current calendar year”. Last year, the Indian firm identified the Casheltablets site in County Tipperary for potential divestment, as part of abroader strategy to better “optimise manufacturing capacity, costsand efficiencies” after completing its takeover of Ranbaxy in March2015 (Generics bulletin, 2 October 2015, page 4).

“We continuously analyse our manufacturing capacity requirementto keep in-line with customer demand and avoid overcapacity,” a Sunspokesperson told Generics bulletin. “The Cashel facility closure isbeing implemented as part of this plan to right the size of the company’sglobal manufacturing activities.”

The spokesperson added that the firm, as part of closure process,would “move some laboratory roles to other facilities within Sun’sglobal operations network”. Sun would, he said, also engage withtrade unions and employee representatives “during the next few months”and, “if necessary, proceed with redundancies”.

Local business group the County Tipperary Chamber said theclosure would lead to around 100-110 redundancies. The chamber’schief executive officer, Brian Cleary, observed that “there may be someopportunities” for staff affected by the closure at the nearby formerJohnson & Johnson facility that Amneal acquired last year (Genericsbulletin, 1 September 2015, page 5). G

COMPANY NEWS

2 GENERICS bulletin 8 April 2016

MANUFACTURING

Sun will close Irishsite by end of 2016

Pfizer and Allergan have terminated “by mutual agreement” theirplanned US$160 billion merger in the wake of measures announced

by the US Treasury and Internal Revenue Service (IRS) to limittax-inversion transactions. The deal had been scheduled to close duringthe second half of this year. Pfizer will pay Allergan US$150 millionfor reimbursement of expenses associated with the transaction.

Allergan still expects to sell its Actavis generics unit to Tevafor US$40.5 billion by June.

On 4 April, the US Treasury announced that it was taking actionto “limit inversions by disregarding foreign parent stock attributableto recent inversions or acquisitions of US companies”. This move, itsaid, would prevent foreign companies from acquiring US firms inshare-based transactions and then using their increased size to avoidcurrent inversion thresholds for subsequent US acquisitions.

The Treasury aims to “address earnings stripping” through measuresincluding new rules on debt, interest deductions and due diligence.

“Transactions should be driven by genuine business strategiesand economic efficiencies, not a desire to shift the tax residence ofa parent entity to a low-tax jurisdiction simply to avoid US taxes,”insisted the Treasury, which urged Congress “to move forward withanti-inversion legislation this year”.

Through the merger, Allergan and Pfizer had expected to reducetheir combined tax rate by adopting Allergan’s Irish tax domicile. G

MERGERS & ACQUISITIONS

US moves scupperPfizer-Allergan deal

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Actavis, Endo and Impax have been sued by the US Federal TradeCommission (FTC) for allegedly conspiring to block generic

competition to Endo’s Lidoderm (lidocaine) and Opana ER(oxymorphone) extended-release blockbuster brands via pay-for-delaysettlements worth “hundreds of millions of dollars”. The FTC hasreached a settlement agreement with Teikoku.

According to a complaint filed in a Pennsylvania district court,which also names Actavis’ parent company Allergan and Endo’sLidoderm partner, Japan’s Teikoku, Endo entered into separate “illegal”agreements with Impax over Opana ER and Actavis’ Watson overLidoderm respectively. The FTC noted that, “following more than adecade of challenges to pay-for-delay settlements”, the actionsrepresented the first FTC cases challenging agreements not to marketan authorised generic. Commissioner Maureen Ohlhausen dissented.

The Commission said it was seeking a judgment declaring thatthe firms’ conduct “violates antitrust laws, ordering the companiesto disgorge their ill-gotten gains, and permanently barring them fromengaging in similar anticompetitive behaviour in the future”.

In response, an Endo spokesperson told Generics bulletin thecompany was “disappointed by the FTC’s decision to initiate litigation”.Stressing its belief that both settlements “were supportive of acompetitive environment for a number of reasons”, the US firminsisted that “the FTC’s case is without merit”.

Concerning Opana ER, the FTC alleges that under an agreementEndo reached with Impax in June 2010, Impax agreed to drop itschallenge to US patents 5,662,933 and 5,958,456 protecting the branduntil August 2013. In return, Impax received payment in two forms:a guarantee that Endo would not market an authorised generic forcertain strengths of the analgesic during Impax’ 180 day first-filerexclusivity, and a development and co-promotion agreement coveringan under-development brand. “To date, Endo has paid Impax morethan US$112 million under the agreement,” the Commission stated.

Endo was thus able to extend its monopoly on the brand by two-and-a-half years, from the time of the settlement around six years ago(Generics bulletin, 18 June 2010, page 16) to Impax’ subsequentlaunch in January 2013 (Generics bulletin, 11 January 2013, page 13).Moreover, the agreement also gave Endo the time needed to switchpatients to a reformulated ‘crush-resistant’ version of Opana ER“that would not be subject to automatic substitution from genericversions of its original formulation”.

Turning to Lidoderm, the FTC alleges that in May 2012 Endo andTeikoku reached a patent-litigation settlement deal with Watsonwhereby Watson would “abandon its patent challenge and refrainfrom launching its generic version of Lidoderm for more than a year,until 15 September 2013” (Generics bulletin, 8 June 2012, page 21).

In return, the now Allergan affiliate received a guarantee thatEndo would not offer authorised generic Lidoderm for up to seven-and-a-half months after Watson’s entry into the market, which Endoadhered to, launching in May 2014. Moreover, the settlement includedan agreement to supply “Watson’s wholly-owned distributor with freebranded Lidoderm product worth at least US$96 million in 2013 andthe possibility of additional free product worth up to approximatelyUS$240 million through 2015”.

Without illegal deals, the FTC maintained, Impax and Watsoncould not have obtained the ‘no authorised generic payment’, or the‘side-deal’ and ‘free product’ payments respectively, “even if [they]had won their [prior] patent-infringement litigation”. G

COMPANY NEWS

3GENERICS bulletin8 April 2016

LITIGATION

FTC sues firms overLidoderm and Opana

GlaxoSmithKline (GSK) will not file for patents in least-developedand low-income countries as part of a broader scheme designed

to “make it as clear and simple as possible” for generic manufacturersto make and supply alternatives to the originator’s medicines in someof the world’s poorest countries.

Under a “series of steps” laid out by chief executive officer SirAndrew Witty, who recently announced he would step down as headof the UK’s largest pharmaceutical company next year, GSK will adoptan approach to intellectual property (IP) “reflecting a country’seconomic maturity”.

Further to its plan for least-developed and low-income countries,which is intended to give “clarity and confidence” to genericmanufacturers, GSK said it would “generally” file for patents in lowermiddle-income countries “but will seek to offer and agree licences toallow supplies of generic versions of its medicines for 10 years”.

Noting that it would “seek a small royalty on sales” in lowermiddle-income countries, GSK observed that its offer would continueto apply for countries that “move out of” such a status “due toincreased economic growth during this period”.

Finally, for remaining global markets, including high-incomecountries, upper-middle income countries and G20 member countries,GSK “will continue to seek full patent protection”.

Commenting more broadly on its strategy to increase access inthe world’s poorest countries, GSK said it had, “over the past decade,made significant changes to its business model to support increasedaccess to medicines”. This included “pioneering” tiered-pricing models,prioritising investment for “diseases of the developing world”, andforming partnerships targeting such countries.

Meanwhile, GSK intends to be “the first company” to “commitits future portfolio of cancer treatments to patent pooling”, and will“explore the concept with the Medicines Patent Pool (MPP) to helpaddress the increasing burden of cancer in developing countries”. ViivHealthcare, the venture operated by GSK, Pfizer and Shionogi, hada “number of agreements” with the MPP, GSK noted, including forits Tivicay (dolutegravir) antiretroviral in “countries with the highestHIV burden” (Generics bulletin, 18 April 2014, page 16).

Acknowledging the MPP’s efforts in facilitating access to HIV,tuberculosis and hepatitis C medicines in low-income and middle-income countries, GSK said that “expanding this approach to oncologywould enable generic versions of GSK’s next generation immuno-oncology and epigenetic therapies, currently in clinical development,to be made available [in these markets] if and when they receiveregulatory approval”.

“GSK has adopted a flexible approach with intellectual property,pooling its patents and know-how to encourage more research intoneglected diseases and agreeing voluntary licenses to enable genericmanufacturers to make HIV medicines for the countries most affectedby HIV,” observed the originator.

Separately, GSK says it will “also work towards making availableinformation about its current and future patent portfolio”, followinga similar move by Germany’s Merck KGaA. GSK hopes this initiativewill “stimulate a wider approach and provide a best practice templatefor other companies, academic institutions and generic manufacturersto share more details about their patents”.

“Being more transparent about which patents are held in whichcountries will make it clearer for generic companies looking tocommercialise products in developing countries,” GSK observed. G

BUSINESS STRATEGY

GSK to drop patentsin poorest countries

Gen 8-4-16 Pgs. 2-16_Layout 1 06/04/2016 17:11 Page 3

Lupin says its active pharmaceutical ingredient (API) and finished-dose formulation manufacturing facilities at its site in Mandideep,

Madhya Pradesh, India received ‘Form 483’ observations from theUS Food and Drug Administration (FDA) following an inspectionearlier this year. “We do not expect any disruption to productsupply…[and] there are no pending applications from the facility,”the Indian firm insisted.

Responding to an enquiry from the Bombay Stock Exchange(BSE), Lupin said that, following the FDA audit of Mandideep from2-19 February, the agency issued two separate Form 483s, eachcontaining two observations. “One of the observations was repeatedin both the forms as it is relevant to both operations,” Lupin explained,noting that this brought the total number of observations across tothe two sites to three.

Lupin said the observation covering both APIs and finished dosesrelated to the use of hand sanitisers. “The company was able todemonstrate to the FDA that the contact time – 30 seconds – requiredfor sanitisation is being followed adequately,” the firm stated.

The single observation at the API unit, Lupin revealed, was dueto an “unknown purity” that did not impact the end bulk sterile drug thatwas “a small contributor to sales”. The firm said it was in the processof filing a prior approval supplement (PAS) to reprocess an intermediateand was recalling affected batches as a “precautionary measure”.

Outlining the formulations observation, the Indian firm said acheckweigher machine was qualified for 500mg, but not for 250mg,capsules. “The company was able to qualify for the other size on thespot and demonstrated the results to the inspector,” it said.

“We believe that these observations are minor in nature and havealready addressed them,” Lupin commented. The firm anticipatesreceiving from the FDA voluntary action indicated (VAI) status,meaning “objectionable conditions were found and documented, butthe agency is not prepared to take or recommend regulatory action”.“There will be no remediation required,” Lupin predicted. G

COMPANY NEWS

4 GENERICS bulletin 8 April 2016

8 April 2016 Issue 257

Editor: Aidan FryDeputy Editor: DavidWallaceBusiness Reporter: Dean RudgeBusiness Reporter: Jake NinanProduction Controller: Debi MinalProduction Editor: Jenna MeredithDirector of Subscriptions: Val DavisGroup Sales Manager: Rob CoulsonAwards Manager: Natalie CornwellManaging Director: Mike Rice

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MANUFACTURING

Lupin’s Mandideepplant receives 483s

ANUH PHARMA has been issued a notice of non-compliancefrom France’s National Agency for Medicines and Health Productscovering its active pharmaceutical ingredient (API) processingfacility in Boisar, Maharashtra, India. The action follows aninspection in February this year that uncovered 24 deficiencies,including one critical and two major faults, the former relating toa “severe lack of transparency” of the company’s manufacturingactivities, whereby there was “no assurance as regards to theorigin of every batch”. As a result, risks identified at the site areconsidered applicable to all manufactured APIs. “The findingsreveal a critical non-compliance of the quality system of thecompany as a whole,” the agency summarised.

NOVARTIS has provided further details concerning the portfolio of19 “mature, non-promoted drugs” that it earlier this year transferredto its Sandoz generic division as part of a broader restructuringscheme that made the operation Novartis’ second-largest division(Generics bulletin, 5 February 2016, page 5). Updating its 2015full-year financial results to reflect the transfer – along with the shiftof its Alcon ophthalmic pharma business to the Pharmaceuticalsdivision – Novartis revealed the “five largest brands” in the basketas Aclasta (zoledronic acid), Foradil (formoterol), HormoneReplacement Therapy, Zofran (ondansetron) and Coartem (artemether/lumefantrine). The portfolio had sales last year of US$913 million,pushing Sandoz’ proforma sales up to US$10.1 billion. The 19products generated an operating profit of US$295 million.

IDT AUSTRALIA has reached a manufacturing and supply agreementwith WellSpring Pharma Services, under which the Canadian firmwill manufacture “an initial group of two to three” of the Australianfirm’s products. IDT, which last year engaged ANI as its USdistributor for “up to 18” of 23 previously marketed products thatit bought in 2014 (Generics bulletin, 1 September 2015, page 7),said the “IDT-WellSpring products are expected to be available” viaANI in the second half of this year. “WellSpring has been inspectedby IDT and commenced work on the products under an initial worksorder in late 2015,” the Australian firm commented, revealing the firstproduct to be manufactured under the agreement as the cardiovascularagent pindolol. G

IN BRIEF

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MARKET NEWS

5GENERICS bulletin8 April 2016

India and the European Union (EU) have “re-engaged in discussionson how to further the EU-India Broad-based Trade and Investment

Agreement (BTIA) negotiations” following a summit held in Brussels,Belgium, on 30 March.

Having started talks over a free-trade agreement in 2007, the twosides appeared in recent months to have reached an impasse. In October,the country’s commerce secretary said it was a “misapprehension” thattrade talks had broken down over the EU’s suspension of hundredsof generics authorised on the basis of trials conducted by India’sGVK Biosciences (Generics bulletin, 23 October 2015, page 10).

Pharmaceuticals is among several industry sectors identified ina joint statement as an area in which leaders on both sides “committedto further strengthen the current EU-India dialogues”. This, they said,could be achieved through “regular meetings of the EU-India jointworking group on pharmaceuticals, biotechnology and medical devices”.

They pledge to exchange “best practices in the field of intellectual-property rights and public procurement”, while the EU welcomes“India’s readiness to establish a mechanism to facilitate investmentsof all EU member states”. G

TRADE AGREEMENTS

India and EU hold trade talks

Sandoz has launched a scathing attack on AbbVie’s petition to theUS Food and Drug Administration (FDA) on standards of

biosimilar interchangeability, describing it as “baffling” and claimingthat the arguments set out by the originator reflect “a fundamentalfailure to understand the core concept of biosimilarity”.

AbbVie had called on the FDA to ensure biosimilar applicantsseeking interchangeability must prove their product can safely beswitched for every indication held by the reference drug, regardlessof labelling (Generics bulletin, 15 January 2016, page 8).

The originator’s request for studies to be carried out in indicationsfor which the biosimilar is not seeking approval was “illogical”,according to Sandoz. The petition “is clearly and unambiguously anattempt to increase the barriers to development of biosimilars andinterchangeable biologics”, Sandoz said, noting that this would limitcompetition on biologic products for which exclusivity had expired.

Clarification of the statutory standards of interchangeability anda part 15 public hearing by the agency on biosimilarity were alsorequested in AbbVie’s petition. Sandoz, in its own citizen petition tothe FDA, stated that it “supports issuance of an FDA guidancedocument on interchangeability”.

However, “AbbVie has misunderstood the FDA’s authority andthe broader regulatory role of agency guidance”, claimed Sandoz,insisting that the Biologics Price, Competition and Innovation Act(BPCIA) “does not require clinical studies per se to establishinterchangeability”. Interchangeability is a “requirement for additionaldata and does not represent a higher approval standard for the productitself”, according the generics firm.

AbbVie in its petition argued there was little evidence to supportinterchangeability from an original to a biosimilar. However Sandozresponded, “this assertion is far from the truth”. The company statedthat “every single peer-reviewed journal has, without exception,concluded that the process of interchangeability poses no concernswith respect to safety and effectiveness”.

Sandoz argued that there was “no published data to lead to aconclusion that the act of switching from one product to anotherincreases a risk of an adverse event”. The Novartis affiliate went on toinsist that completed switching studies and post-marketingpharmacovigilance “support the safety of switching between areference product and corresponding biosimilar”.

“One biological product cannot be ‘the same’ as another”, theoriginator had claimed. Sandoz however argued that “AbbVie does notappreciate that the underlying principle of biosimilarity andinterchangeable biologics”, adding, “there is no clinically meaningfuldifference between these biologics and their reference products”.

Sandoz also claimed that AbbVie’s request for a part 15 publichearing was a tactic “to delay the licensure and adoption of biosimilars,and promote hypothetical safety concerns where none exist”. Thegenerics firm suggested that public input would “be better obtainedthough the invitation to comment on the draft FDA guidance oninterchangeability when it is issued”.

Clarification was requested by Sandoz regarding interchangeability,in particular that it “does not represent a higher standard of safety orclinical effectiveness”. The firm maintained, “interchangeability isa requirement for additional data not a different standard”. Sandozalso called on the FDA to clarify that interchangeable biologics andbiosimilars “must be manufactured to the same quality levels as areapplied to originator biologics”. G

REGULATORY AFFAIRS

Sandoz slams AbbVieon biosimilar petition

Prescribing information for biosimilars in the US should generally“incorporate relevant data and information from the reference-

product labelling” rather than details from biosimilarity trials, accordingto a draft labelling guidance that the US Food and Drug Administration(FDA) has released for comment. However, the guideline does notaddress labelling for interchangeable biosimilars, which will betackled in future guidance.

The FDA says its finding of safety and efficacy that is reflectedin prescribing information for the reference biologic “may be reliedupon to provide healthcare practitioners with the essential scientificinformation needed to facilitate prescribing decisions for the proposedbiosimilar product’s labelled conditions of use”.

Information from clinical studies performed for the biosimilarshould only be detailed in labelling “when necessary to inform safeand effective use by a healthcare practitioner”. “Data from clinicalstudies designed to support a demonstration of biosimilarity are notlikely to be relevant to a healthcare practitioner’s considerationsregarding safe and effective use of the biosimilar product and potentiallymay cause confusion, resulting in an inaccurate understanding ofthe risk-benefit profile of the product,” the FDA explains.

Rather, the agency states, the highlights section of the prescribinginformation should contain a statement that the product is biosimilarto the reference drug. Biosimilar labelling may vary from that of thereference brand to reflect differences such administration, preparation,storage and safety, as well as the specific indications approved, outlinesthe agency, which is currently considering comments on its draftguide on non-proprietary names for biosimilars.

The US Generic Pharmaceutical Association (GPhA) and itsBiosimilars Council said the “proposed label contents avoid causingconfusion or raising unnecessary questions about the safety and efficacyof biosimilar products”. The non-profit US Biosimilars Forum pledgedto submit comments within the 60-day deadline. G

US biosimilar labelscan omit trials data

REGULATORY AFFAIRS

Gen 8-4-16 Pgs. 2-16_Layout 1 06/04/2016 17:11 Page 5

Generic entry in the US more than halves the cost of an activeingredient in the first year that generics are on the market,

according to an analysis conducted by market researcher IMS Healthwith funding from originators’ body the Pharmaceutical Research andManufacturers of America (PhRMA). And for a subset of oralmedicines, the first-year reduction is two-thirds.

Studying price declines for 428 drugs – “every medicine thatfirst became available as a generic between 2002 and 2014” – IMSfound that, on average, generics reduced the price of medicines by51% in the first year following loss of exclusivity in the US, and

by 57% in the second year. “Prices in this audit are best thought ofas the average invoice price of a product, prior to the negotiation ofoff-invoice discounts and rebates,” the market researcher commented.

By five years after loss of exclusivity, the prices of medicines fellto two-thirds of those of the monopoly brands, and soon after the costwas just a fifth of the original brand price (see Figure 1).

Looking solely at prices for 288 oral generics, IMS said the pricefall was around three-quarters within 24 months of the reference brandlosing exclusivity. “Oral generics cost 80% less than the brands theyreplace within five years,” the market researcher commented.

Over the 12 years covered by the audit, the price falls for oral drugsbecame steeper and deeper. “The price of [oral] generic medicinesthat entered the market between 2011 and 2013 fell by 79% within12 months, compared to 44% for generics that entered the marketbetween 2002 and 2004,” IMS noted.

“Nearly all reductions in price now occur in the first eight monthsafter generic entry,” the market researcher commented. “Generic oralmedicines now cost 90% less than the original brand within 30 months.”

“After six years,” it observed, “the price reductions for injectablemedicines are nearly equal to the price reductions for oral medicines.” G

MARKET NEWS

6 GENERICS bulletin 8 April 2016

MARKET RESEARCH

Competition has cutprices in US by half

0

-20

-40

-60

-80

-100

Pri

cere

duct

ion

(%)

0 12 24 36 48 60 72 84 96 108 120

Oral medicinesAll medicines

Months since loss of exclusivity

-51%-57%

-66% -66% -67%

-77% -78% -80% -78% -77%-66%

-74% -77% -78% -80% -80% -80% -81% -81% -81%

Figure 1: Average price reductions of a basket of 428 medicines in the monthsfollowing loss of brand exclusivity (Source – IMS)

Areform to Switzerland’s Therapeutic Products Act that willintroduce lengthy data-exclusivity periods for certain drugs has

finally been adopted the country’s National Council and Council ofStates following years of negotiations. Implementing provisions willnow be drawn up, and a public consultation period is currentlyplanned for spring next year.

Among the package that has been agreed following an initiativestarted by Switzerland’s Federal Council in November 2012 is 10years of data exclusivity for new indications that have a “significantclinical use” when compared to existing therapies and are supportedby “comprehensive clinical trials”.

For orphan drugs, Switzerland will award a 15-year data-exclusivity period upon application. New indications, delivery formsand dosages for known active ingredients will be rewarded with threeyears of exclusivity, while new molecules will continue to enjoy10-year exclusivity.

The revision to the act also includes a 10-year exclusivityperiod for drugs specifically developed for paediatric populations,while independent six-month supplementary protection certificates(SPCs) or six-month extensions to existing SPCs are also availablefor paediatric medicines.

Adoption of the revision to the law came after the parliamentarycouncils reached a compromise over rules covering financial incentivesand material benefits for prescribers and dispensers. Other provisionsof the legislation cover antibiotics usage and authorisations forcomplementary and herbal medicines. G

INTELLECTUAL PROPERTY

Swiss reforms aimto bolster exclusivity

Implementing pre- and post-grant flexibilities to challenge patents, aswell as “transparent and fair patent-administration systems”, will be

vital if developing countries are to design local intellectual-propertysystems that are favourable for local production and public health,according to a report released by the World Health Organization (WHO).

According to the study – which was supported by the EuropeanCommission, and focuses on World Trade Organization (WTO)members “that have a local generics industry with some capacity forinnovation” – local producers in developing countries and otherinterested parties need “easy access to reliable patent information” tofile pre- and post-grant oppositions, while such information helpsauthorities to decide whether to issue compulsory licences.

Amendments made by patent applicants to overcome prior artduring the patent examination process “should be publishedelectronically”, the WHO recommends.

The report stresses that the WTO’s agreement on trade-relatedaspects of intellectual-property rights (TRIPS) allows members to“decide how to protect clinical-trial data against disclosure andunfair commercial use”.

“Strict patent standards, alongside opposition procedures, canfacilitate local production,” the WHO observes, highlighting India’srefusal to grant a patent for the beta-crystalline form of imatinib mesylate(Generics bulletin, 5 April 2013, page 1). However, it notes, suchstringency can be “a double-edged sword” for generics firms seekingsecondary patents on drugs such as imatinib. G

MANUFACTURING/INTELLECTUAL PROPERTY

Flexibilities key for production

IPRF – the International Pharmaceutical Regulators Forum – has,through its biosimilars working group, proposed developing a templateto help national regulatory authorities publish summaries of theirbiosimilar application reviews in English. Public assessment reportswere often available only in local languages, the Forum noted. G

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MARKET NEWS

7GENERICS bulletin8 April 2016

Consumer access to affordable prescription drugs in the US wouldbe weakened if inter partes reviews (IPRs) of patents before the

US Patent Office (USPTO) were to be scrapped, the US GenericPharmaceutical Association (GPhA) argues in an amicus brief submittedin the Supreme Court case Cuozzo vs Lee. The brief was submittedjointly with America’s Health Insurance Plans (AHIP).

According to the Supreme Court, the IPR patent-challenge processcreated by the 2011 America Invents Act “has been both unexpectedlypopular and surprising lethal”. From over 3,400 IPR petitions filed,nearly 85% have “resulted in the cancellation of some or all claimsin the patent under review”.

In the Cuozzo case, the US Supreme Court will consider twoquestions: whether the US Court of Appeals erred in holding that,in IPR proceedings, the USPTO’s Patent Trial and Appeal Board(PTAB) may construe claims in an issued patent according to theirbroadest reasonable interpretations rather than their plain and ordinarymeaning; and whether the appeals court erred in holding that, evenif the PTAB exceeds its statutory authority in instituting an IPRproceeding, the PTAB’s decision on the matter of whether to institutea proceeding is judicially unreviewable.

On the first question, the GPhA and AHIP argue that “Congresswas not legislating on a blank slate” when creating IPRs by passingthe America Invents Act. The USPTO had for decades been usingthe broadest reasonable interpretation standard in determiningpatentability and in interference proceedings, they point out, arguingthat Congress thus intended for the same standard to apply to IPRs.

“The use of the broadest reasonable interpretation in IPRsreduces the likelihood that a patent claim will be given a broaderinterpretation in infringement litigation that under USPTO evaluation,and also encourages the elimination of ambiguous claim language,”the organisations maintain.

Turning to the second question to be considered by the SupremeCourt, the GPhA and AHIP insist that Section 314(d) of the AmericaInvents Act – which states that decisions to institute IPRs are “final andnon-appealable” – “plainly insulates that decision from judicial review”.“This is consistent with Congressional intent, which was for IPRsto be a speedy procedure for eliminating weak patents,” they add.

According to the GPhA, “the IPR process is an importantconsumer protection against abusive patent extensions”. Given the30-month stay on generic approval that originators can obtain by suingfor patent infringement, “brand-name drug-makers have a stronginterest in delaying resolution of such cases to maximise the benefitsof the 30-month stay, and thus often sue in slower jurisdictions,”the association claims.

By contrast, the America Invents Act requires IPRs to becompleted within one year of institution, making them “a valuabletool for abbreviated new drug application (ANDA) applicants toresolve certain issues involving brand-name drug patents morequickly than possible through district court litigation”.

“It is critical that any changes to current law avoid reducing ordelaying patient access to more affordable generic drugs and biosimilars,”stated the GPhA’s president and chief executive officer, Chip Davis.“Weakening the IPR process, and in turn, protecting monopoly-likepricing schemes threatens consumers’ access to more affordableprescription medicines,” commented Davis’AHIP counterpart, MarilynTavenner. “Consumers and the health system as a whole benefitfrom a more competitive prescription drug market,” she insisted. G

INTELLECTUAL PROPERTY

GPhA brief defendsinter partes reviews

Biosimilars can be registered in India using reference biologicsapproved in the European Union (EU), Japan, the US, Canada

and Switzerland, according to guidance on ‘similar biologics’ that hasjust been published by the Indian Central Drugs Standard ControlOrganization (CDSCO) and the Department of Biotechnology (DBT).If a reference biologic is not authorised in India, the guidance statesthat it “should have been approved or licensed and marketed in acountry of the International Council for Harmonisation of TechnicalRequirements for Pharmaceuticals for Human Use (ICH)”.

If the reference biologic is not marketed in India, the guidancestates, “the reference biologic product can be imported for developingthe similar biologic for quality, pre-clinical and clinical comparability”.

Currently, biosimilar applications are approved by the CDSCOand the DBT on a case-by-case basis, through an abbreviated versionof the pathway used for new drugs. The new guidance codifies theregulatory requirements necessary for biosimilar authorisation inIndia and defines the regulatory pathway. The manufacturing process,safety efficacy and quality aspects for biosimilars as well as pre-market and post-market studies are each covered by the guidelines.

Pre-clinical evaluation is outlined in the guidance and requiresboth in vitro and in vivo studies, along with toxicology studies.Applicants are also required to submit applications for the conductof clinical trials “as per CDSCO guidance for the industry”.

Phase III clinical trials may be waived if the reference biologic andthe biosimilar are structurally and functionally comparable to “a highdegree of confidence by physiochemical and in vitro techniques”, aswell as comparable in all pre-clinical evaluations conducted, includingpharmacokinetic and pharmacodynamic studies. The guidance outlinesPhase III studies in the form of “an appropriate single-arm study in atlease 100 evaluable subjects” to be carried out in the “most sensitiveindication to address any residual uncertainty”.

To obtain a marketing authorisation, the guidance requires phase IVpost-marketing study protocols to be submitted along with the marketingauthorisation application. The study should contain “more than 200evaluable patients” and be completed within two years of the marketingpermission. If immunogenicity is evaluated in clinical studies, “it isnot mandatory to carry out additional non-comparative immunogenicitystudies in post marketing studies”. The primary aim of the Phase IVstudy is safety, according to the CDSCO, while the secondaryendpoints should be efficacy and immunogenicity.

If pre-approval studies include more than 100 patients, the numberof patients in the phase IV post-marketing study can be reduced sothat “the safety data from both phase III and IV is derived from aminimum of 300 patients”. Periodic safety updates reports (PSURs)must be submitted every six months for the first two years afterapproval is granted, and annually for two years thereafter.

In the case of biosimilars targeting rare diseases, the clinical trialpopulation size can be reduced “as per the rarity and severity of thedisease as well as the limitation of access to therapeutic options”.G

REGULATORY AFFAIRS

India allows globalbiosimilar reference

EMA – the European Medicines Agency – has published a preliminarydraft reflection paper on extrapolation of clinical trial data fromadults to children. The framework sets out “when, and to what extent,and how extrapolation can be applied and validated”. G

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Samsung Bioepis has secured a positive opinion from the committeefor human medicinal products (CHMP) within the European

Medicines Agency (EMA) for the firm’s Flixabi (infliximab) biosimilarversion of Janssen’s Remicade.

The CHMP has recommended that Flixabi 100mg powder forconcentrate be approved for the indications of rheumatoid arthritis,adult and paediatric Crohn’s disease, adult and paediatric ulcerativecolitis, ankylosing spondylitis, psoriatic arthritis and psoriasis, the sameset as for Remicade. The European Commission typically decideswhether to accept such positive opinions within 67 days.

“Studies have shown Flixabi to have comparable quality, safetyand efficacy to Remicade,” the CHMP stated.

Samsung Bioepis – a joint venture between Samsung BioLogicsand Biogen through which the latter holds European marketing rights –insisted a “robust pre-clinical and clinical data package” for the drugpreviously known as SB2 included “confirmatory data from head-to-head Phase I and Phase III clinical trials” comparing Flixabi toRemicade. A 54-week Phase III study in 584 patients with moderateto severe rheumatoid arthritis showed similar response rates for Flixabiand Remicade using the American College of Rheumatology 20%(ACR20) response as the primary endpoint of the study.

Pointing out that the CHMP’s positive opinion of Flixabi had comeshortly after Samsung Bioepis had secured a marketing authorisationallowing it to roll out its Benepali (etanercept) biosimilar in Europe(Generics bulletin, 26 February 2016, page 1), the global head ofBiogen’s biosimilars business unit, Alpna Seth, said the firm would“harness this positive momentum as we prepare to bring our secondbiosimilar treatment to patients in the European Union (EU)”. G

PRODUCT NEWS

8 GENERICS bulletin 8 April 2016

BIOLOGICAL DRUGS

Samsung gets EMAbacking on infliximab

Biocad has started shipping its biosimilar alternative to Roche’sHerceptin (trastuzumab) to Sri Lanka following local approval for

the monoclonal antibody (mAb) earlier this year. The Russian firm –which recently received approval for its trastuzumab biosimilar inits domestic market (Generics bulletin, 29 January 2016, page 13) –noted that a distribution agreement had been in place with a localpartner in Sri Lanka since 2014.

The launch comes in the wake of Biocad earlier this yearcommencing a US$150 million effort to supply monoclonal antibodies to“several countries outside of Russia”, signing “more than a dozenagreements with distribution and manufacturing companies in severalcountries [in] South-East Asia, such as the Philippines, Malaysia,Indonesia and Thailand” (Generics bulletin, 22 January 2016, page 13).

Pointing out that trastuzumab was the first “biosimilar on thelist of Biocad’s drug products to be exported to Sri Lanka”, Biocadsaid its “entire contract” in the country included several of its biosimilarmAbs. “In several years ahead, the volume of sales is expected toreach US$10 million,” the Russian company commented.

“Our pharmaceutical products are considerably more affordablethan the western-made original drugs,” said Dmitry Morozov, Biocad’sfounder and chief executive officer. “This significant fact gives hopefor recovery to many more patients, and that is vitally important incountries like Sri Lanka.” G

BIOLOGICAL DRUGS

Biocad supplies in Sri Lanka

THE UK’S SUPREME COURT has agreed to hear appeals fromboth sides in Actavis’ dispute with Eli Lilly over the European vitaminregime patent EP1,313,508 protecting the originator’s Alimta(pemetrexed disodium) oncology drug. Supreme Court Lords Clarke,Hodge and Neuberger will hear the appeals. Both direct and indirectinfringement will be at play after the UK Court of Appeal last yearruled that Lilly’s ‘508 patent would be indirectly infringed by Actavismarketing alternative salt forms of pemetrexed with instructions todilute the product with saline solution (Generics bulletin, 10 July2015, page 15). More recently, the UK High Court found that Actavis’pemetrexed trometamol/diacid vials that are diluted with dextrosesolution did not infringe the ‘508 patent, which expires on 15June 2021 (Generics bulletin, 19 February 2016, page 13).

AUROBINDO PHARMA intends by June this year to introducevalganciclovir 450mg tablets and pantoprazole 40mg single-dosevials in the US following final approval from the US Food and DrugAdministration (FDA). The former is equivalent to Roche’s Valcyteantiviral agent, while the latter is a rival to Pfizer’s Protonix IVinjectable treatment for gastroesophageal reflux disease (GERD).The Indian company – which said it now held 69 final and tentativeabbreviated new drug application (ANDA) approvals from itsUnit VII non-antibiotic orals facility, and 29 ANDA approvals fromits Unit IV plant, both located in Hyderabad, India – also plans tointroduce rivastigmine tartrate 1.5mg, 3mg. 4.5mg and 6mg capsulesby June, followed later this year or early next year by vancomycin5g and 10g injectable vials.

BIOGARAN says it will soon offer France’s only generic alternativeto Novartis’ Foradil (formoterol) 12µg powder for inhalation.Launch trade-press advertising for the asthma treatment – whichcomes as 60 blister-packed, powder-filled capsules and an inhalerdevice – highlights that the generic uses the same key excipient,lactose, as Novartis’ original. Biogaran said its generic versionwas in the process of being listed on France’s répertoire list ofsubstitutable drugs.

BRECKENRIDGE plans in the near future to start distributing inthe US gabapentin 250mg/5ml oral solution that is equivalent toPfizer’s Neurontin brand. The epilepsy treatment is being madeand supplied by Breckenridge’s partner, Tris Pharma.

ANI PHARMACEUTICALS has announced US Food and DrugAdministration (FDA) approval of its oxycodone 5mg capsules.ANI cited annual sales for the product of US$7.5 million.

PANACEA BIOTEC has introduced Cabapan (cabazitaxel) inIndia as an injectable treatment for prostate cancer. The companydeveloped the oncology drug at its research centre in Mumbai, India,and is producing it at its facility in Baddi, India.

EAGLE PHARMACEUTICALS is “evaluating all options” tochallenge a decision taken by the US Food and Drug Administration(FDA) not to award seven years of orphan-drug exclusivity for thefirm’s Bendeka (bendamustine) 50ml low-volume liquid forinfusion. Eagle insists that Bendeka was “automatically entitled” toorphan exclusivity for chronic lymphocytic leukaemia and indolentB-cell non-Hodgkin lymphoma upon its approval in December 2015.But the agency wants the firm to prove Bendeka’s clinical superiorityover other bendamustine formulations with the same indicationsbefore awarding exclusivity. Eagle – which has licensed US marketingrights to Teva – says Bendeka is protected by six patents listed inthe FDA’s Orange Book with expiry dates between 2026 and 2033.G

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US presidential candidate Bernie Sanders has teamed up with 11Democrat members of Congress to call for a public meeting to

consider overriding patents protecting Astellas’ Xtandi (enzalutamide)prostate-cancer capsules. Such a move, they believe, could “makethe drug available at a lower price”.

After public-interest groups Knowledge Ecology International(KEI) and the Union for Affordable Cancer Treatment petitioned theUS National Institutes of Health (NIH) to take action, the Congressmembers wrote to the NIH and the Department of Health and HumanServices (HHS) to seek a public meeting on the issue.

Under the 1980 Bayh-Dole Act, federal agencies such as the NIHhave a ‘march-in’ authority for drugs developed using public funds tolicense patents on health and safety grounds or if the patented inventionis not available to the public “on reasonable terms”. However, thepoliticians point out in their letter, “the NIH has never used this broadand powerful authority to protect consumers from excessiveprescription drug prices”.

According to the letter, Xtandi – which is covered by three patentsexpiring in 2026 and 2027 in the Orange Book maintained by the USFood and Drug Administration (FDA), as well as new chemical entity(NCE) exclusivity running until 31 August 2017 – has a wholesaleprice of US$129,000 in the US, compared to US$30,000 in Canada.

“We do not think that charging US residents more than anyoneelse in the world meets the obligation to make the invention availableto US residents on reasonable terms,” the letter states. G

PRODUCT NEWS

9GENERICS bulletin8 April 2016

ONCOLOGY DRUGS/INTELLECTUAL PROPERTY

US politicians pushXtandi patent bar

Adraft World Health Organization (WHO) guideline on biosimilarmonoclonal antibodies (mAbs) must be revised to align it with

existing European and US guidelines, according to the BiosimilarMedicines Group of Medicines for Europe, formerly known as theEuropean Generic and Biosimilar medicines Association (EGA).

Acknowledging that the WHO draft guideline “represents a workin progress which needs further refinement and inclusion of recentlearnings in biosmilar medicine to fully leverage its potential”, theBiosimilar Medicines Group nevertheless said Medicines for Europe“applauds the WHO for this very important draft guideline”. Thedocument “has the potential to foster regulatory convergence and tofacilitate the development and approval process for biosimilarmedicines”, the group said, calling these “important aspects consideringthe urgent need for patient access to safe and effective biologicalmedicines in WHO member states”.

However, the group pointed out, “there remain major andundesirable differences between the proposed WHO draft guidelineand the corresponding guidelines in the European Union (EU) andUS”, referring to European Medicines Agency (EMA) and US Foodand Drug Administration (FDA) guidance. Some of these differences“have the potential to impede patient access to biological products,”the group warned.

“Medicines for Europe strongly encourages the WHO authors toinclude recent learnings in regulatory sciences and to align the WHOdraft with existing EMA and FDA guidelines,” the group said,“particularly on the fundamental principles of the biosimilarity/comparability concept and particularly the totality of evidence of allanalytical, non-clinical and clinical data.” WHO guidelines “play acrucial role in fostering convergence”, the group emphasised, dueto their use in “a large number of countries”.

“In order to reflect the current state of regulatory science, we askthat WHO include a description of the role of analytical, non-clinicaland clinical data and how the totality of data is considered” in evaluatingbiosimilars, the group said. This was “nicely described” in the currentEMA and FDA guidelines, which state that biosimilar evaluation isbased the ‘totality of evidence’, which the group noted was foundedon the analytical data provided by a structural and functional comparison,and complemented by confirmatory non-clinical and clinical data.

Clinical section deviates from EMA and FDAA section on non-clinical evaluation “very nicely reflects the

current state in regulatory sciences and should be retained in the finalversion”, the group stated. However, other sections, “especially thosedealing with the clinical requirements” deviate from the biosimilarconcept as established by the EMA and FDA, and “set overly restrictiveregulatory expectations” for biosimilars.

“The section on extrapolation of indications strongly deviatesfrom established regulatory sciences in biosimilar evaluation asstated in the EMA and FDA biosimilar guidelines and as written byregulators,” the group insisted. “Specifically, whereas the WHO draftrecommends additional clinical trials to justify extrapolation, the EMAand FDA guidelines emphasise to consider the totality of evidenceof all data for scientific justification.”

The WHO should also “consider introducing the globally well-established regulatory term ‘biosimilar medicine’ instead of ‘similarbiotherapeutic product’ (SBP) to further drive convergence ofregulatory guidelines”, the group urged. G

BIOLOGICAL DRUGS

EU biosimilars groupurges mAbs revision

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Apotex’Apobiologix division has introduced its Grastofil (filgrastim)subsequent entry biologic (SEB) in Canada as an alternative to

Amgen’s Neupogen reference brand.According to Apotex, the Canadian market for the neutropenia

treatment “is currently worth over C$130 million” (US$99.4 million).The independent, not-for-profit Canadian Agency for Drugs and

Technologies in Health (CADTH) believes Apotex’ SEB “shouldprovide significant cost savings” over Neupogen. The listed Grastofilprice of C$144.31 per 300µg/0.5ml pre-filled syringe represents a 25%discount over Neupogen “for all Health Canada-approved indications”.

Noting that Grastofil had been approved by Health Canada forthe same indications as Neupogen, the CADTH said the SEBdeveloper had backed up four double-blind Phase I studies to evaluatepharmacodynamics, pharmacokinetics and safety in healthy volunteerswith a Phase III trial in 120 breast-cancer patients.

In Europe, Apotex has licensed Grastofil marketing rights toStada. A filing for the biosimilar is under review in the US. G

PRODUCT NEWS

10 GENERICS bulletin 8 April 2016

PRICE WATCH ....... UK

Up to the minute live retail market pricing is available for theUK and Eire on Wavedata Live at wavedata.net.

Alternatively, contact Charles Joynson at WaveData Limited,UK.Tel: +44 (0)1702 425125. E-mail: cjoynson@wavedata.co.uk.

Price WatchIndex

PharmacyProfit Index100.0 100.0

Monthly change ±0 Monthly change ±0

Basket Price Reimbursement Price Pharmacy Profit£2,128.87 £3,812.38 £1,683.51

March 2016 March 2016

The PriceWatch Index is based on the actual average trade price according to WaveDataof a representative basket of 20 popular generic products in March 2016, when the Indexwas 100. The basket reflects recent official prescribing data for England and Wales andrepresents what an average pharmacy would pay for the products, which were selected asbeing the top cash generators within pharmacy. The Pharmacy Profit Index is calculatedon the same basis by applying Drug Tariff reimbursement prices to the basket.

Starting this issue, Generics bulletin is introducing the UK PriceWatchIndex of the actual average trade price of a representative basket of

20 popular generics. More details about how the basket was selectedare given below. The basket contains aripiprazole 10mg, aspirin 75mg,carbocisteine 375mg, co-codamol 30mg/500mg, duloxetine 60mg,eplerenone 25mg, hydrocortisone 10mg, lansoprazole 30mg, levothyroxine100µg, liothyronine 20µg, metformin 500mg, nortriptyline 10mg,omeprazole 20mg, paracetamol 500mg, phenytoin 100mg, pregabalin75mg, simvastatin 40mg, tamsulosin 400µg, tramadol 50mg andtrazodone oral solution 50mg/5ml.

On the last working day of every month, we shall be updating theIndex to indicate how the basket’s price has shifted from the perspectiveof independent pharmacists. It was 100 for March 2016, as was thePharmacy Profit Index, which is the average profit that independentpharmacies made from our basket, based on Drug Tariff reimbursementprices for the month. We shall see next month whether the two indiceshave gone up or down, and publish the results in our 6 May issue. G

March 2016

BIOLOGICAL DRUGS

Apobiologix unveilsGrastofil in Canada

Servier’s Australian patent covering the arginine salt of perindoprilis invalid and should be revoked because the originator failed to

disclose the best method of performing the claimed invention, theFederal Court of Australia has confirmed on appeal. But the court hasstayed its decision while Servier pursues special leave to appeal toAustralia’s High Court, according to local law firm Minter Ellison.

The full panel of the Federal Court upheld a previous ruling infavour of Apotex and Actavis that had held invalid Servier’s Australianpatent 2003,200,700 for failure to disclose the best method. However,it overturned a single judge’s order that the generics firms pay a largeproportion of Servier’s costs because they had unsuccessfully pursuedseveral other invalidity arguments against the patent protecting Servier’sCoversyl (perindopril arginine) antihypertensive brand.

The Federal Court panel noted that the ‘700 patent’s specificationstated only that the arginine salt – said to improve the stability ofperindopril – had been “prepared according to a classical method ofsalification of organic chemistry”. But the patent’s inventors knewthat perindopril had been prepared in 1986 and 1991 “using slightlydifferent classical salifications”, neither of which methods werereferred to in the specification.

“The disclosure of the 1986 or 1991 methods would have savedthe skilled addressee the possible dead ends and false starts that wouldotherwise have been risked in attempting to make the salt,” the FederalCourt pointed out. “It would have disclosed certainty of method ratherthan leaving the skilled addressee at risk of failure and of choosingfrom all of the parameters that may be used in classical salification.”

The court denied Servier’s appeal in its attempt to amend the‘700 patent to include methods of making perindopril arginine. G

ANTIHYPERTENSIVES

Australia pauses inperindopril salt case

Accord Healthcare’s generic alternative to Helsinn’s Aloxi(palonosetron) antiemetic should be granted a pan-European

centralised marketing authorisation, the committee for human medicinalproducts (CHMP) within the European Medicines Agency (EMA) hasrecommended. The European Commission typically decides whetherto accept the CHMP’s positive opinions within 67 days.

As the 250µg solution is administered intravenously and is 100%bioavailable, no bioequivalence study versus Aloxi was required.Palonosteron Accord is indicated for preventing nausea and vomitingin patients undergoing emetogenic cancer chemotherapy.

Hospira recently received a similar positive CHMP opinion forpalonosetron (Generics bulletin, 4 March 2016, page 10). This cameafter Aloxi lost protection from data exclusivity in March last year,followed by supplementary protection certificates (SPCs) expiring duringNovember 2015 (Generics bulletin, 9 December 2015, page 22). G

ANTIEMETICS

Accord close to Aloxi rival

ZYDUS CADILA has received US approval for acyclovir 200mgcapsules. The firm will make the antiviral agent – which is equivalentto GlaxoSmithKline’s Zovirax original – at a formulations plantin Ahmedabad, India. G

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Allergan’s Actavis has again been frustrated in its endeavour tointroduce the first US generic version of Shire’s Lialda

(mesalamine) extended-release tablets after a US district court ruledagainst the generics player in patent-litigation proceedings.

Florida District Judge Donald Middlebrooks concluded thatActavis’ abbreviated new drug application (ANDA) for a proposedrival to the treatment for inflammatory bowel disorders infringedLialda’s sole Orange Book-listed patent 6,773,720. Meanwhile,Middlebrooks rejected Actavis’ assertion that the ‘720 patent – whichexpires on 8 June 2020 – was invalid due to a lack of writtendescription or enablement.

Middlebrooks’ ruling comes almost three years since he originallyfound that Actavis’ Watson, pursuant to submitting an ANDA inMarch 2012, had infringed the ‘720 patent, which he also at that timedeemed valid. This decision was later overturned and remanded backto the Florida court for further proceedings, in March 2014, when aUS Court of Appeals found that the district court’s construction of twokey claim terms within the ‘720 patent were overly broad (Genericsbulletin, 4 April 2014, page 12).

Shire was then granted a writ of certiorari by the US SupremeCourt in January last year that vacated the appeals court’s ruling. But, inJune 2015, the appeals court affirmed its earlier ruling, and againremanded the case back for further proceedings, after finding the Floridadistrict court’s construction of the terms ‘inner lipophilic matrix’ and‘outer hydrophilic matrix’ to be “impermissibly broad” (Genericsbulletin, 26 June 2015, page 18). The Supreme Court’s order forreconsideration came in light of its own claim-construction approach inthe landmark Teva vs Sandoz case heard shortly before Shire’s petitionwas granted (Generics bulletin, 6 February 2015, page 23).

In his latest ruling, Middlebrooks said he was “not convinced”by Actavis’ argument to “adopt an entirely new construction” of thetwo claim terms. “For starters, [Actavis] did not argue on appeal thatthe 2013 constructions were incorrect due to their failure to account forthe plain meaning set forth in its new constructions,” he noted.

“Based upon…my undisturbed findings from the 2013 order,plaintiffs have established, by a preponderance of evidence that the[Actavis] ANDA meets the additional requirements established forthe claim constructions of inner lipophilic matrix and outer hydrophilicmatrix. Thus, defendants have infringed the ‘720 patent,” Middlebrooksconcluded. In addition, Middlebrooks also enjoined Actavis fromobtaining US Food and Drug Administration (FDA) approval for itsUS rival to Lialda until the ‘720 patent expires. Global sales of thebrand, which is known as Mezavant or Mezavant XL in Europeanmarkets, reached US$684 million last year.

The originator, however, faces further challenges to maintain itsmonopoly for Lialda until at least patent expiry, in light of additionalANDA submissions from five firms: Zydus Cadila, Osmotica, Mylan,Amneal and Lupin. Zydus’ trial was scheduled to begin on 28 March,while Osmotica’s has been stayed pursuant to a 2014 claim-constructionruling. Furthermore, Mylan’s litigation has been stayed until Maythis year after a previously scheduled trial date was vacated, whileno date has been set for proceedings involving Amneal and Lupin.

Moreover, in October last year, the US Patent and TrademarkOffice (USPTO) instituted an inter partes review of the ‘720 patentfollowing a challenge by hedge fund manager Kyle Bass’ Coalitionfor Affordable Drugs. “A decision from the PTAB is expected inOctober 2016,” Shire believes. G

PRODUCT NEWS

11GENERICS bulletin8 April 2016

GASTROINTESTINAL DRUGS

Actavis’ Lialda rivalinfringes a US patent

HEXAL must withdraw all quetiapine extended-release tablets ithas shipped in Denmark, the country’s Maritime and CommercialHigh Court has ordered after a preliminary injunction hearing. Inreaching its finding that Hexal had infringed the Danish part ofAstraZeneca’s European patent EP0,907,364 protecting the SeroquelProlong antidepressant, the court considered – but did not follow –invalidity decisions in Belgium, Germany, Italy, the Netherlands,Spain and the UK.

LANNETT has obtained US approval for abbreviated new drugapplications (ANDAs) for potassium chloride 8mEq and 10mEqextended-release capsules as well as for temozolomide capsules insix strengths. “The potassium chloride product represents the secondapproval received from our acquisition of Kremers Urban (KU),”commented Lannett’s chief executive officer, Arthur Bedrosian.Noting that temozolomide – equivalent to Merck & Co’s Temodar –was the only drug in the pipelines of both Lannett and KU, Bedrosiansaid the firm expected to launch the oncology drug “within the nextfew months” while it was evaluating options for introducing potassiumchloride as a hypokalaemia treatment.

HIKMA says it has obtained its first US approval through itsRoxane operation in Columbus, Ohio, having closed a transactionfor the solid-dose business on 29 February. The approval is fortemozolomide 5mg, 20mg, 100mg, 140mg, 180mg and 250mgcapsules equivalent to Merck & Co’s Temodar chemotherapy agent.Lannett has just gained a similar approval (see above).

TEVA CANADA has failed to convince the country’s Federal Courtto throw out Gilead’s case based on likely future infringement ofCanadian patent 2,261,619, which protects the Viread (tenofovirdisoproxil) antiretroviral brand until 25 July 2017.

MYLAN has launched a generic alternative to Valeant’s Ultram(tramadol) 100mg, 200mg and 300mg extended-release tabletsin the US. Citing IMS Health data, Mylan said the analgesic hadUS sales of US$52.8 million last year.

ANSM and HAS – France’s medicines agency and health technologyassessment body respectively – have delisted olmesartan-basedantihypertensives from reimbursement. The move, which is basedon both relatively weak evidence of efficacy and on pharmacovigilancereports, will come into effect three months after its announcementon 3 April. Single-molecule olmesartan medicines such as DaiichiSankyo’s Olmetec are set to be affected, as are combinationsincluding CoOlmetec and Menarini’s Alteisduo.

LUPIN has launched donepezil hydrochloride 23mg tablets in theUS as an equivalent to Eisai’s Aricept Alzheimer’s disease treatment.Aricept had US sales of US$47.1 million last year, noted Lupin,which faces generic competition from generics approved for Actavis,Dexcel, Dr Reddy’s, Macleods, Mylan, Osmotica, Par, Sun and TWi.

ACTAVIS UK has introduced gliclazide 40mg tablets to complementits existing 80mg tablets. “There are no other generic versions inthe UK,” stated the firm, which has launched the diabetes drug ata list price of £3.36 (US$4.75) for 28 tablets.

SARTORIUS STEDIM is offering assays to aid the development ofbiosimilar versions of Actemra (tocilizumab), Lucentis(ranibizumab) and Stelara (ustekinumab). The “off-the-shelfbinding assays and bioassays” are available through the firm’sBioOutsource affiliate. G

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Biosimilars should be considered “part of the same market” as theirreference products for the purposes of antitrust merger assessments,

the European Commission believes. But biological drugs that havethe same indications, but are based on different molecules, should notbe considered part of the market for competition purposes, theCommission said in explaining its decision to require Pfizer to divestits pipeline infliximab project as a condition for clearing the originator’stakeover of Hospira (Generics bulletin, 1 September 2015, page 21).

Noting that it had, in the Pfizer-Hospira case, “assessed biosimilardrugs in detail for the first time”, the Commission said Pfizer andHospira overlapped on three monoclonal antibodies. These wererituximab and trastuzumab for which both firms had candidates inPhase III clinical trials, as well as the Inflectra (infliximab) biosimilarthat Hospira marketed under licence from Celltrion as Pfizer’sPF-06438179 Phase III project.

“Defining the relevant market was one of the main challenges ofthe case,” the Commission commented. “Based on the marketinvestigation and observations drawn from the infliximab biosimilarentering the European market in 2013, the Commission concludedin the present case that the relevant market comprises the infliximaboriginator product – Johnson & Johnson’s Remicade – as well as thebiosimilar versions of infliximab on the market or under development.”

“By virtue of the extrapolation principle,” the Commissioncontinued, “Remicade and its registered biosimilars are approved bythe European Medicines Agency (EMA) for the same indications anddo compete for the same tenders. In practice, Remicade is often co-awarded the tender along with one infliximab biosimilar.”

Other anti-tumour necrosis factor (TNF) agents such asadalimumab and etanercept were not found to belong to the samemarket as infliximab, “notably because the majority of healthcarepractitioners confirmed that they cannot be used interchangeably”.Pointing out that tenders were typically organised by molecule, theCommission said while biosimilar infliximab had led to Remicade’sprice falling, it had “had little impact on the prices or sales volumesof other anti-TNF agents”. Furthermore, as infliximab is administeredintravenously, it is “less convenient to use” than other anti-TNF agentsthat have subcutaneous formulations.

Discussing the competitive landscape in Europe, the Commissionsaid “a number of prescribers are reluctant to use a biosimilar forindications for which it has not been tested due to the extrapolationprinciple”. With biosimilars largely limited to naive patients, “only afraction of the originator’s market is contestable by biosimilars”, it noted.

Observing that Celltrion sold the same product as Hospira’sInflectra under the Remsima brand name, the Commission stated that“Inflectra and Remsima are perfectly interchangeable, which is knownto purchasers and healthcare practitioners and which is why theycompete on price only”. Pfizer and Samsung Bioepis (see page 8) wereexpected to be the next biosimilar entrants, the Commission believed.

To avoid cannibalising Inflectra’s sales once it acquired Hospira,Pfizer was likely to have delayed or abandoned development of itsPF-06438179 infliximab biosimilar, the Commission anticipated. Orthe originator could have handed back to Celltrion rights to Inflectrato favour its own pipeline product, thereby reducing market competition.

Pfizer’s solution – divesting European infliximab to Sandoz(Generics bulletin, 19 February 2016, page 1) – ensured the drugwent to a suitable purchaser with “long-standing experience” in themarket, the Commission concluded. G

PRODUCT NEWS

12 GENERICS bulletin 8 April 2016

18-19 April

■ 4th Annual Biosimilars & Biobetters CongressLondon, UKTopics including market access and opportunities and commercialchallenges will be addressed at this two-day event.

Contact: Oxford Global Conferences. Tel: +44 1865 248455.E-mail: info@oxfordglobal.co.uk. Website: oxfordglobal.co.uk.

28-29 April

■ 14th EBG Biosimilars ConferenceLondon, UKThis conference will cover issues including market access, regulatoryissues, the evolving landscape and scientific developments.

Contact: Lucia Romagnoli. Tel: +44 7562 876 873.E-mail: events@egagenerics.com. Register online atwww.egaevents.org/bios/egabios2016reg.htm.

17-18 May

■ GPhA CMC WorkshopMaryland, USAThis interactive workshop will provide up-to-date informationregarding CMC regulatory requirements and the challenges of approval.

Contact: GPhA. Tel: +1 202 249 7100.E-mail: jnguyen@gphaonline.org. Website: gphaonline.org.

13-14 June

■ EuroPLX 61Valetta, MaltaThis meeting provides an opportunity to discuss and negotiateagreements, in-licensing and marketing and distribution.

Contact: Raucon. Tel: +49 6221 426296 0.E-mail: meetyou@europlx.com. Website: europlx.com.

13-14 June

■ 7th Annual Summit on BiosimilarsNew York, USAIssues to be discussed at this event include interchangeability andlabelling as well as litigation strategies, naming and substitution.

Contact: American Conference Institute. Tel: +1 212 352 3220.E-mail: customercare@americanconference.com.Website: americanconference.com.

26-30 June

■ 52nd DIA Annual MeetingPhiladelphia, USATopics covered at this event will include innovation, development,life cycle management and regulatory issues.

Contact: Drug Information Association. Tel: +1 215 442 6162.E-mail: dia@diahome.org. Website: www.diaglobal.org/DIA2016.

EVENTS – April, May & June

8-10 June

■ Joint EGA and IGBA Annual ConferenceDubrovnik, CroatiaFor 2016, the European Generic and Biosimilar medicines Association(EGA) and the International Generic and Biosimilar MedicinesAssociation (IGBA) will join forces for their annual conferences.Contact: Lucia Romagnoli. Tel: +44 7562 876 873.E-mail: events@egagenerics.com. Register online atwww.egagenerics.com or www.egaevents.org.

BIOLOGICAL DRUGS

Commission explainsdecision on infliximab

Gen 8-4-16 Pgs. 2-16_Layout 1 06/04/2016 17:11 Page 12

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When the European Commission approved theregion’s first biosimilar, Sandoz’ Omnitrope(somatropin), 10 years ago in 2006, the drug

led the way for a host of others to follow in its footstepsand give European patients access to rival versions ofseveral costly biologic brands. And with the first USbiosimilar approval coming just over a year ago – foranother Sandoz drug, Zarxio (filgrastim-sndz) –followed by a second, this month (see front page) thecountry is now poised to reap the benefits.

Indeed, according to a report just released by IMSHealth, a “surge in in biosimilars” is expected to “drivesignificant change in health system costs, patient accessand competition” over the next five years. “An activepipeline of 56 new products in clinical developmentare expected to deliver total savings of as much asUS$110 billion to health systems across Europe andthe US through 2020,” the market researcher claims.

However, IMS warns, the extent to whichbiosimilars can provide savings opportunities willdepend on policy and implementation approaches thathave to date varied widely across the European Union(EU), and which are yet to become clear in the US.“Biosimilars in the EU and US may yield total savingsof US$56-US$110 billion over the next five years,” thereport states, but “the extent of actual savings will dependon policy decisions made and actions taken aroundincentives, education and pricing”.

Nevertheless, the report acknowledges, a “robustpipeline” – comprising around 30 companies that areactively developing biosimilar versions of 16 distinctmolecules, in particular infliximab, etanercept, rituximaband adalimumab – sets the stage for significantsavings to be realised and greater access afforded tothese treatments.

Examining imminent opportunities for biosimilarcompetition, IMS pointed out that the combined valuein the year to September 2015 of the eight top-sellingbiologic medicines losing exclusivity protection frompatents or other measures between 2015 and 2020 acrossthe ‘EU5’ – France, Germany, Italy, Spain and the UK –and the US together was C42.3 billion (US$48.2 billion).

As Figure 1 shows, Humira (adalimumab) – whichIMS said it expects to lose exclusivity in the US andEU in 2018 – led the pack with sales of C10.8 billionacross the EU5 and US. This was followed by Lantus(insulin glargine) – which lost EU exclusivity in 2015 –with C8.7 billion and Enbrel (etanercept) – which isexpected to lose exclusivity in the US in 2028 followingloss of EU exclusivity this year – with C6.9 billion.

“Further biosimilar versions of RoActemra(tocilizumab), Simponi (golimumab) and Orencia(abatacept) are also in development,” IMS pointed out.

Not all markets are prepared“The prospect of more affordable biologic options

that are safe and effective opens up opportunities forhealth systems to expand access to more patients, andfrees up resources for investment in new areas,”observed Murray Aitken, executive director of theIMS Institute for Healthcare Informatics. “This alsocan yield significant cost savings – but not all marketsare ready to fully benefit from the imminent surge ofbiosimilar molecules.”

“Realising this potential is neither easy norassured,” Aitken cautioned. “The lack of uniformityacross EU nations that have had access to biosimilarmedicines for almost a decade suggests that theunderlying elements of achieving the full potential frombiosimilar medicines are not well understood at a policylevel nor implemented effectively at a practical level.”

In part, IMS said, a “lack of clarity” frommanufacturers had contributed to the current landscape,observing that “industry’s message around biosimilarmedicines has not always been helpful to policymakers”.

While this was to some extent “inevitable” giventhe natural conflict between originators and biosimilarsfirms, the report states, “even among originatormanufacturers who have a significant stake in thebiosimilars market, fundamental differences in coremessages can be observed”.

These included differences over how substitutionshould be implemented as well as the question ofwhether or not medicines should be prescribed byinternational non-proprietary name (INN). “As a resultof this diffusion,” IMS stated, “there has been nomovement toward an agreed set of principles that couldbe shared with payers, physicians and patients.”

The report identifies several desirable conditionsthat should underpin a healthy biosimilars market,emphasising that “competition lies at the heart of thebiosimilar value proposition, driving the virtuous circleof pharmaceutical innovation and healthcare system

MARKET RESEARCH

14 GENERICS bulletin 8 April 2016

An IMS report

suggests that

biosimilars have the

potential to deliver

savings of as much as

US$110 billion in

Europe and the US by

2020. But much will

depend on healthcare

policy decisions in

individual markets.

David Wallace reports.

Global market is poised toreap benefit of biosimilars

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Figure 1: US and EU5 sales in the year ended September 2015 for the eight top-selling biologicsdue to lose patent protection by 2020 (Source – IMS)

Gen 8-4-16 Pgs. 2-16_Layout 1 06/04/2016 17:11 Page 14

sustainability”. “Capturing the benefits of biosimilarmedicines requires a balance between controlling priceand ensuring a sustainable, competitive marketplace,”the report states.

“The markets best-placed to capitalise on thebenefits of biosimilars are those with a functioningcompetitive market, where manufacturers are motivatedto participate over the longer term, and where physiciansare at the heart of the decision-making process”.

“In this respect,” the repost insists, “educationof stakeholders including physicians is critical – butthere remains significant variation between countriesin terms of how physicians are educated andincentivised, and in terms of how manufacturers aremotivated to participate in the marketplace.”

A narrow focus by payers on price alone “risksconstraining the longer-term opportunities for savings”,the report states. “This would make the biosimilarsmarket less attractive for manufacturers, reducingincentives to invest in the development of subsequentwaves of biosimilars.” By driving out competition, thereport warns, “payers may lose out on the price-basedsavings they are seeking”.

Indeed, “in some countries, the actions of payersand policymakers may be hampering competition inthe marketplace”, IMS indicates. This, the marketresearcher believes, is because “not all stakeholdershave understood how to use competition to maximisethe benefits offered by biosimilar medicines”.

Currently, the report notes, “the situation acrossthe EU is very heterogeneous, with varying levels ofeducation and incentivisation among stakeholders”.“Considerable variations across the EU in payer policyapproaches are limiting the biosimilar opportunity,” while“not all stakeholders are using competition to maximisein a sustainable way the benefits offered by biosimilars”.

Germany – which has an addressable biosimilarsmarket worth C17 billion between 2016 and 2020,according to IMS (see Figure 2) – is identified as“among the most successful countries on this front,educating physicians and implementing measuresdesigned to stimulate biosimilar prescribing.”

“By contrast, Austria’s approach – where somebiosimilar medicines are subject to mandatory pricereductions that may force manufacturers out of themarket – has had the opposite effect, resulting inreduced access to some biosimilar products.”

Empowering doctors is key“It is noteworthy that in Norway and Denmark,

where physicians have been at the heart of the decision-making process in relation to biosimilar medicines,uptake of biosimilar infliximab was rapid and sustained,”IMS noted. “These markets demonstrate that trustingand empowering physicians to make the right decisionsis a key component of ensuring the longer-termsustainability of the market.”

However, the variety of policy approaches adoptedby payers across the EU on biosimilars was “reflectedin the patchwork provision of evidence to doctors toencourage them to prescribe these products”, IMS said.

“Overall, there is recognition that, across thecontinent, physicians are not fully aware of theregulatory pathways underlying biosimilar medicineapproval, nor are they given the necessary clinicalevidence to support the prescribing of biosimilar

medicines – either at the localor national level.” Inparticular, the report states,inconsistent rules oninterchangeability in Europehad caused confusion and madedoctors unsure when it isappropriate to switch certainpatients to a biosimilar.

The potential savingsoffered by biosimilars came ata time of “ongoing budgetarypressures” in Europe, IMSobserved, noting that “theconstrained payer environmentis triggering a range ofinitiatives designed to limitgrowth in healthcare budgets,and in many cases targetpharmaceutical budgets”.

“While payers cannotexpect to realise all of the netsavings resulting from theavailability of lower costbiosimilars, the extent to whichthey are able to redirectspending toward greater patientaccess, new generations ofinnovative treatment, andbudgetary relief, depends ontheir policy approaches to thebiosimilar marketplace.”

Modelling potentialsavings based on different levelsof price reduction across theeight key originator biologics,driven by biosimilarcompetition, IMS found thatthe cumulative savings over thenext five years in the EU5 andUS could range from C49 billion– based on a price reduction of 20% – to C98 billion,based on a 40% reduction.

“As these medicines also become available in theUS,” IMS said, “stakeholder education and incentiveswill play a vital role in ensuring biosimilars delivertheir full potential.” As shown by Figure 3, the scaleof the opportunity in the US dwarfs that of the EU5,with an addressable market between 2016 and 2020of C199 billion, compared to the EU5’s C47 billionaddressable market.

“A balanced approach that incorporates educationof physicians, patients and payers, and includesappropriate incentives for physicians and manufacturers,will help ensure that the benefits of biosimilars arefully realised,” the report concludes. “Above all,” itemphasises, “payers need to understand that a focuson acquisition cost rather than volume may appearattractive, but in the longer term will prove to be self-limiting, if not self-defeating.”

“Payers in some markets have begun to movetowards an acceptance that facilitating competition, andproviding appropriate education and incentives, is thebest way to realise the full potential of biosimilarmedicines.” However, IMS believes, “in othercountries, much remains to be done”. G

MARKET RESEARCH

15GENERICS bulletin8 April 2016

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Figure 2: Breakdown by country of the EU5’s addressablebiosimilar medicines market between 2016 and 2020(Source – IMS)

Gen 8-4-16 Pgs. 2-16_Layout 1 06/04/2016 17:11 Page 15

Teva has named Hiroshi Matsumori as chief executive officer(CEO) and president of Teva Pharma Japan. He will also be CEO

and president of the Israeli firm’s joint venture with Takeda in Japan,Teva Takeda Pharma. The joint venture, in which Teva will hold a 51%stake with Takeda holding the remaining 49%, will offer “the portfolioof Teva’s high-quality generic medicines and Takeda’s long-listed[branded] products” (Generics bulletin, 9 December 2015, page 1).

Matsumori – who has 34 years “of rich and diverse experience”in pharmaceuticals – will take up the role at Teva Pharma Japan from25 April, and will be based in Nagoya, Japan. Siggi Olafsson, presidentand CEO of Teva’s Global Generics Medicines unit, said Matsumori’s“extensive knowledge in the generics and the long-listed productbusinesses will help position the company for future success”.

Olafsson also noted that “Japan is one of the fastest growinggenerics markets in the world, and we expect its high growth to continuedriven by social requirements”. Japan’s government has pledged toachieve 80% generic penetration of the off-patent market by the endof the 2020 fiscal year (Generics bulletin, 5 June 2015, page 1).

Masato Iwasaki, president of Takeda’s Japan Pharma businessunit, said Takeda’s “leading brand reputation and strong distributionpresence in Japan combined with Teva’s global supply chain andproduction network, expertise in commercial deployment and researchand development” would bring forward a “new, collaborative businessmodel in line with government objectives”. G

PEOPLE

16 GENERICS bulletin 8 April 2016

APPOINTMENTS

Matsumori heads upTeva Japan business

Former head of Impax’ Global Pharmaceuticals generics business,Carole Ben-Maimon, has been appointed to US player Teligent’s

board of directors and to serve on the company’s compensation andnominating committees.

Having joined Impax in that role in September 2011, Ben-Maimonresigned three years later “for personal and family reasons” (Genericsbulletin, 3 November 2014, page 27). Prior to that, she had servedas senior vice-president of corporate strategy for now-Endo affiliateQualitest, having previously worked in a variety of senior roles withBarr and Teva in the US. From 2000 to 2003 she served as chairpersonof the US Generic Pharmaceutical Association (GPhA).

Ben-Maimon, who currently serves as consultant to the pharmaindustry, adds to a six-strong board at Teligent that includes presidentand chief executive officer Jason Grenfell-Gardner, former AurobindoUS head Narendra Borkar, and chairman James Gale. BhaskarChaudhuri, Steven Koehler and John Celentano complete thefirm’s board.

Describing Ben-Maimon as a “valuable asset” to Teligent andits board of directors, Grenfell-Gardner said the firm looked forwardto working with her as Teligent continued to accelerate its topicals,injectables, ‘complex’ generics and ophthalmics strategy. G

APPOINTMENTS

Ben-Maimon broughtin on Teligent board

Concordia has appointed former Mylan, Sandoz and Cubistexecutive Patrick Vink to its board of directors. Vink, the firm

noted, was expected to be appointed to the audit committee and humanresources and compensation committee of the board of directors,replacing Doug Deeth and Rochelle Fuhrmann respectively “whowere appointed to such committees on an interim basis”.

“Given Concordia’s recent global expansion, Patrick’s globalpharmaceutical experience will be invaluable to the board,” commentedchairman and chief executive officer Mark Thompson. G

APPOINTMENTS

Vink joins Concordia’s board Perrigo has announced that Neil Lister will head a single leadershipteam overseeing the US store-brand specialist’s legacy UK consumer

healthcare and prescription units, primarily engaged in making generics,as well as Perrigo’s Branded Consumer Healthcare business in theUK and Ireland, formerly known as Omega Pharma UK.

Commenting on his new role, Lister – who was already head ofthe UK and Ireland Branded Consumer Healthcare business – said thathe had “big ambitions to combine the agile way of working thatmade Omega’s UK business so successful with the might of Perrigo”.The combined business would employ more than 1,000 people acrosssix sites, Perrigo said, and would be the “second-largest consumerhealthcare company in the UK and an OTC powerhouse”. G

APPOINTMENTS

Lister leads Perrigo UK team

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