Sandoz closes in on US filgrastim biosimilar nod · Sun Pharma and Ranbaxy have cleared ah urdle in...

16 January 2015

Abdi Ibrahim teams with Algerian player 2Kremers deal falters 3after US FDA actionTianyin teams up to tackle its troubles 4Apotex and Panacea ally over two drugs 5US business booms to aid Zydus Cadila 6Strides starts work on Malaysian facility 7Walgreens completes 8Alliance Boots deal

MARKET NEWS 9

Suspensions in EU follow GVK review 9Four firms share in South African tender 11Teva takes top spot amongAOK awards 12GPhA voices concern 13over TPP provisionsRussia may consider compulsory licensing 14

PRODUCT NEWS 15

FDA accepts Apotex’ filing 15of pegfilgrastimZydus Cadila debuts adalimumab in India 17Torrent and Reliance 18strike biologics dealSandoz’ filgrastim is introduced in Japan 19US firms introduce their Celebrex rivals 20NZ awards Remicade 21sole supply to 2020Sandoz appeal fails over US etanercept 22Teva eyes EU launch 23for Copaxone 40mg

FEATURES 26

Eastern expansion and OTC 26feature for Mylan in Europe

Teva is to make more from 28less sales in fewer markets

REGULARS

Events – Our regular listing 24PriceWatch UK – Our in-depth 25look at pricing trends in the UKPeople – Endo seeks a leader for 30its Qualitest unit

COMPANY NEWS 2

Sandoz has taken a major step towards securing the first approval through the USbiosimilar pathway after an advisory panel to the US Food and Drug Administration

(FDA) recommended the agency should approve the company’s EP2006 filgrastimcandidate with all the same indications as its reference product, Amgen’s Neupogen.

“We are pleased with the Oncologic Drugs Advisory Committee’s (ODAC’s) recommendationto approve our biosimilar filgrastim and we look forward to continuing to work with FDA asit completes its review of our filing,” said Sandoz’ Mark McCamish. If the agency followsthe committee’s non-binding advice, Sandoz proposes to market biosimilar filgrastim pre-filled syringes in the US under the brand name Zarxio.

A briefing document for the ODAC meeting on 7 January stated that “considering thetotality of the evidence, the data submitted by the applicant show that EP2006 is highly similarto US-licensed Neupogen. The clinical data have shown that there are no clinically meaningfuldifferences between EP2006 and US-licensed Neupogen, suggesting that EP2006 should receivelicensure for each of the five indications for which Neupogen is currently licensed”.

The proposed commercial product was “analytically highly similar” albeit with a “slightlylower” protein content than Neupogen, an issue that “may be resolved by manufacturing andcontrol strategies”. In response, Sandoz submitted additional data analysing the protein-concentration levels of clinical and commercial EP2006 batches against Neupogen licensedin the US and European Union (EU). The FDA declared its satisfaction that commercial andclinical batches of EP2006 had “the same strength” as US-licensed Neupogen. Furthermore, areanalysis of immunogenicity data confirmed that EP2006 and Neupogen had “similarly lowrates of anti-drug antibody (ADA) in treated subjects”.

To support its application, Sandoz submitted five clinical studies for subcutaneous dosesbetween 1µg/kg and 10µg/kg. Two trials used US-licensed Neupogen as the reference productto demonstrate safety and efficacy using endpoints including pharmacokinetics and absoluteneutrophil count. The other three trials used EU-approved Neupogen. G

Doctors in France must use the international non-proprietary names (INNs) of medicines onall prescriptions from 1 January, under legislation issued by the country’s health ministry.

The requirement – first outlined in a package of measures introduced in 2011 – was confirmedin a decree published in France’s Official Journal towards the end of last year. Brand namesmay still be used alongside INNs.

Catherine Bourrienne-Bautista of France’s generics industry association, Gemme, toldGenerics bulletin that strict INN prescribing would help to develop the use of off-patentmedicines that are not included in the country’s répertoire of substitutable generic equivalents,such as paracetamol. It could also aid patients’ understanding of the medicines being prescribed,Bourrienne-Bautista suggested. However, the impact of the change would be limited, sheacknowledged. France’s generics industry already benefits from a mechanism of pharmacysubstitution for all eligible prescriptions.

While the requirement to use INNs entered into force at the start of this year, Bourrienne-Bautista predicted that electronic prescribing software used by doctors would not be ready toincorporate the change for around six months. She also acknowledged the reticence on the partof certain doctors to accept the new requirement. Local medical union CSMF has describedthe measure as “an extra complication for doctors”. G

INNs become mandatory in France

Sandoz closes in on USfilgrastim biosimilar nod

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Dr Reddy’s Laboratories and Ipca Laboratories have agreed toHealth Canada’s request that they quarantine certain products

manufactured in India due to “data-integrity concerns”.“In keeping with the current regulations of Health Canada,”

Reddy’s stated, “the company has voluntarily placed under quarantineall active pharmaceutical ingredients (APIs), and formulations basedon APIs, produced at our API facility in the Srikakulam district ofAndhra Pradesh.”

Stressing that it was working with the agency towards reachinga “satisfactory resolution”, Reddy’s said it believed its products met“intended quality standards” and posed no risk to health.

The move to quarantine drugs had, the Indian company added, “noimplication on any activity at the plant” at present, so would not affectthe group’s operations or financial results.

Similarly, Ipca – which is already subject to an import ban on APIsmade at its plant in Ratlam, India (Generics bulletin, 17 October 2014,page 8) – said it did not “generate any material business” in Canadafrom its affected formulations facility in Indore, Pithampur.

Describing the voluntary quarantine as a “precautionary step inview of US Food and Drug Administration (FDA) audit observationsmade regarding good manufacturing practice (GMP) deficiencies atthe said manufacturing unit”, Ipca stressed it was “fully committed”to resolving the issue at the earliest opportunity. G

COMPANY NEWS

2 GENERICS bulletin 16 January 2015

MANUFACTURING

Reddy’s and Ipca tohalt Canada exports

Turkey’s Abdi Ibrahim has formed a partnership with leadingAlgerian pharmaceutical player RemedePharma. As part of the

deal, the Turkish company has undertaken to open by the beginningof 2016 a local facility that complies with good manufacturingpractice (GMP) standards.

Operating under the name Abdi Ibrahim RemedePharma, theventure will “unite the power of the two companies to produce andmarket a variety of products addressing a wide range of treatments”.

As part of the agreement, Abdi Ibrahim – which has operated inAlgeria since 1999 – has acquired shares in RemedePharma.

“The synergy created by the combination of RemedePharma’sknowledge of the Algerian market dynamics and our company’s focuson international targets will make important achievements,” statedAbdi Ibrahim’s chairman, Nezih Barut. The group, he pointed out,now boasted production facilities in Algeria, Kazakhstan and Turkey.

RemedePharma’s owner, Lamine Bousteila, said the Turkish group’sexpertise would be “invaluable” in constructing the GMP-compliantfacility and expanding the Algerian firm’s product portfolio.

Just over US$50 million of Abdi Ibrahim’s 2013 turnover ofTL813 million (US$349 million) came from international markets.Having established its own operations in Algeria, Azerbaijan, Georgiaand Kazakhstan, the group towards the end of last year struck alicensing deal with Saudi Arabia’s Deef. G

STRATEGIC ALLIANCES

Abdi Ibrahim teamswith Algerian player

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AUS$1.53 billion transaction through which Kremers UrbanPharmaceuticals (KU) – the US generics arm of Belgian biopharma

firm UCB – was due to be acquired by private-equity firms AdventInternational and Avista Capital Partners has been terminated by thefirms, following action taken by the US Food and Drug Administration(FDA) over the generics firm’s local rival to Janssen’s Concerta(methylphenidate) extended-release tablets.

The FDA recently stripped KU of its ‘AB’ bioequivalence ratingfor its generic version of Concerta following concerns over whethergeneric rivals to the brand – also including a version marketed byMallinckrodt – were equivalent (Generics bulletin, 5 December 2014,page 23). UCB said it had “mutually agreed” with Advent and Avistato terminate the acquisition agreement, which was announced inNovember and had been expected to close in the first quarter of nextyear (Generics bulletin, 14 November 2014, page 1).

“We are disappointed that we could not complete the transactionas planned at this time, but believe that the mutual termination isthe right step to allow time for the needed evaluation of the best wayforward,” said UCB’s chief financial officer, Detlef Thielgen.

Noting that the firm was “working on clarifying the situationaround extended-release methylphenidate”, including performingadditional bioequivalence studies requested by the FDA, Thielgen saidUCB would “continue the divestiture process for Kremers Urban”.

George Stevenson would continue to serve as president and chiefexecutive officer of KU, the firm said. G

COMPANY NEWS

3GENERICS bulletin16 January 2015

MERGERS & ACQUISITIONS

Kremers deal faltersafter US FDA action

Sun Pharma and Ranbaxy have cleared a hurdle in their bid toclose on their proposed US$4 billion merger by agreeing to divest

seven finished-dose formulations on the orders of the CompetitionCommission of India (CCI). The deal – which was first announcedin April (Generics bulletin, 18 April 2014, page 1) – now requiresapproval from the US Federal Trade Commission (FTC).

According to the prospective partners, the products to be divested“constitute less than 1% of the combined entity’s revenues in India”.

To gain the CCI’s approval, Sun has agreed to divest its Tamlet(tamsulosin/tolterodine) brand, which holds around a third of theIndian market, with Ranbaxy’s Roliflo holding nearly two-thirds andIntas a minor share.

Ranbaxy will divest its distribution rights to Eligard (leuprorelin) asthe combined entity would control up to 90% of the market.Furthermore, Ranbaxy must sell its Rosuvas EZ (rosuvastatin/ezetimibe),Terlibax (terlipressin) and Olanex F (olanzapine/fluoxetine) brands,along with its Raciper L (levosulpiride/esomeprazole) and Triolvance(olmesartan/amlodipine/hydrochlorothiazide) combinations, due tocombined market shares of up to 95%.

No significant overlap in API portfoliosPotential competition to Sun’s in-licensed sitagliptin-based Istavel

and Istamet brands was sufficient to outweigh the danger of Ranbaxydiscontinuing development of rivals in its pipeline, the CCI decided.Moreover, the watchdog said, “horizontal overlap in activepharmaceutical ingredients (APIs) is insignificant to raise anycompetition concern”, with Sun and Ranbaxy deriving only 5% and6% respectively of their turnover from selling APIs to third parties.

“[This approval] revalidates our view that the Sun Pharma andRanbaxy businesses complement each other with limited productoverlap,” commented Sun’s managing director, Dilip Shanghvi, “andwill offer a comprehensive product basket to enable future growth.”

Last year, the Indian firms quashed speculation that they had beendirected by the CCI to divest certain businesses within their operationsto receive final approval (Generics bulletin, 3 November 2014,page 3). This followed the CCI reaching a prima facie opinion inSeptember that the combination “was likely to have an appreciableadverse effect on competition”, after Sun and Ranbaxy had publisheddetails of the merger pursuant to the CCI’s request. G


Sun and Ranbaxy todivest seven in India

Privately-owned Dannex has taken a controlling 71.3% stake in itsfellow Ghanaian pharmaceuticals player Starwin Products, making

it “the leader in the pharmaceutical sector” in Ghana.Stressing that the deal would give Dannex “a bigger balance

sheet”, thereby helping the firm to cope with “uncertainties in themarketplace”, managing directorYaw Opare-Asamoah hailed Starwin’sstrong brand, staff and board. Joining forces would, he said, give thefirms “a stronger presence in West Africa”.

Through a share issue, Dannex paid GHS5.57 million (US$1.74million) to add just over 68.6% to its existing 2.69% stake in Starwin.In 2013, Accra-based Starwin achieved a turnover of around GHS6.7million through brands such as Paraking (paracetamol) syrup. G


Ghana’s Dannex gets Starwin

Two substitutable rivals to Teva’s Copaxone (glatiramer acetate)20mg/ml are expected by the Israeli firm to be launched in the US

in September 2015. An earlier entry could reduce Teva’s operatingincome by US$30 million to US$50 million per month, the firm noted.

As a result, Teva anticipates its global Copaxone sales falling byUS$400-US$500 million to US$3.5-US$3.7 billion from an estimatedUS$4.1 billion in 2014.

In 2015, Teva anticipates generics sales of between US$9.1 billionand US$9.5 billion, comprising around US$4.4 billion in the US,US$2.8 billion in Europe, and US$2.2 billion in the rest of the world.This represents a decline of around 5% from an estimated US$9.8billion in 2014 (see page 28).

Following a 1% dip to US$20.0-US$20.3 billion last year, Teva’sgroup turnover is set to fall by around another US$1.0 billion this yearto US$19.0-US$19.4 billion. Specialty brands other than Copaxoneare set to contribute around US$4.5 billion – up from US$4.3 billionin 2014 – as the firm rolls out DuoResp Spiromax (budesonide/formoterol) and Lonquex (lipegfilgrastim), in Europe. OTC and otherproducts should add about US$1.6 billion.

The 2015 mid-point turnover forecast of US$19.2 billion assumesUS$700 million of negative currency shifts as well as a US$400-US$500 million hit from new generic entrants with generic Pulmicort(budesonide) in the US during the first half of this year.

But Teva expects better margins from its generics business to liftits group operating profit by a tenth to around US$5.70 billion in 2014,with a slight improvement to US$5.7-US$5.9 billion this year. G

RESULTS FORECAST

Teva awaits Copaxone rivals

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Breckenridge Pharmaceutical has entered into a multi-productagreement with India’s MSN Laboratories. The Hyderabad-based

company will develop, manufacture and supply abbreviated new drugapplication (ANDA) drugs for Breckenridge to market in the USunder its own label.

Under the deal – which is aimed at developing “multiple first-to-file paragraph IV ANDAs” – the two firms have agreed to developan oral antibiotic with US brand sales of US$644 million and acardiovascular drug with US generics sales of US$35 million. Thepartners said they had already collaborated on two first first-to-fileparagraph IV submissions which were pending approval.

During 2014, privately-held Breckenridge – part of Spain’s Estevegroup – filed 23 paragraph IV patent challenges in the US. Privately-owned MSN holds more than 130 drug master files (DMFs) tosupply bulk drugs in the US. G

COMPANY NEWS


16 January 2015 Issue 224

Editor: Aidan FryDeputy Editor: DavidWallaceAssistant Editor: Liudmila KotkoBusiness Reporter: Dean RudgeProduction Controller: Debi MinalProduction Editor: Jenna MeredithDirector of Subscriptions: Val DavisGroup Sales Manager: Anisa ShanAwards Manager: Natalie CornwellManaging Director: Mike Rice

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STRATEGIC ALLIANCES

Breckenridge workswith MSN for the US

Tianyin Pharmaceutical (TPI) is exploring an alliance withundisclosed private and state-owned companies in China as it seeks

to meet the challenges of “intensified market competition and policychanges amid ongoing healthcare reforms in China”.

TPI plans to hold a majority stake in the alliance, which will focuson the Chinese branded generics and active pharmaceutical ingredients(APIs) producer’s “core product portfolio”, such as antiviral andimmunology drugs, as well as modernised traditional Chinese medicinesincluding cardiovascular agent Ginkgo Mihuan liquid.

By combining its salesforce with that of its partners, TPI expectsto drive up sales. The alliance will be based on the firm’s facility inQionglai, China, for which it anticipates obtaining a certificate fromChina’s Food and Drug Administration (SFDA) imminently. Anydeal will exclude TPI’s Jiangchuan macrolide APIs plant.

“Continuous pricing pressure and restrictive sales practices”caused TPI to reporting a turnover slide of a third to US$9.73 millionin the first quarter of its financial year ending 30 June 2015. The firmblamed increased research and development spending on Gingko Mihuanfor its operating profit experiencing a similar fall to US$1.42 million. G

STRATEGIC ALLIANCES

Tianyin teams up totackle its troubles

Lannett has been served with a grand jury subpoena seekingcorporate documents “relating to corporate, financial and employee

information, communications or correspondence with competitorsregarding the sale of generic prescription medications, and themarketing, sale or pricing of certain products”.

A month earlier, the US generics specialist’s senior vice-presidentof sales and marketing had received a similar subpoena as part of afederal investigation into possible antitrust violations within the USgenerics industry (Generics bulletin, 5 December 2014, page 12).

“The company maintains that it has acted in compliance withall applicable laws and regulations, and intends to cooperate withthe federal investigation,” Lannett commented. G

ANTITRUST INVESTIGATIONS

Lannett gets second subpoena

Russian biopharmaceutical company Nanolek has opened itsmanufacturing site in Kirov Oblast, Russia, as part of a strategy

to produce alternatives to around 55 imported brands in Russia.Having invested RUB4.0 billion (US$64 million) in the factory –

which will have annual capacity of around 35 million bottles and 42million pre-filled syringes – the firm intends initially to makeantihistamines, antihypertensives and statins. In the longer term, itwill offer central nervous system, HIV and oncology drugs. G

BUSINESS STRATEGY/MANUFACTURING

Nanolek opens Russian site

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Good manufacturing practice (GMP) deficiencies including “thedesign and operation of the cleanrooms” and “controls for

preparation of components and equipment” at the cephalosporin-producing unit of Ranbaxy’s Dewas manufacturing facility in MadhyaPradesh, India, have led German authorities to state the plant does notcomply with GMP requirements. The same facility is also subject toterms of a US Food and Drug Administration (FDA) consent decree.

However, the Indian firm described as “misleading” suggestionsthat it had been banned from exporting all cephalosporin formulations.

“The development pertains only to the company’s cephalosporininjectables unit at Dewas,” Ranbaxy said of the inspection from Germanregulators – as well as those from Australia, Canada and other parts ofEurope – in June last year. “Well before that time, the firm had decidedto stop producing cephalosporin injectables at Dewas,” Ranbaxy stated.

“Since then, the agencies have approved all our facilities formanufacturing dosage forms and active pharmaceutical ingredients(APIs) at Dewas, including for oral cephalosporins, with only theexception of the cephalosporin injectable unit,” the Indian firm added.

Noting that its decision to discontinue injectable cephalosporin“would not have a significant impact on business”, Ranbaxy stressedthat “the current approvals cover all other dosage forms and API unitsat Dewas, including those producing penem API and injectables, andoral cephalosporins”.

Meanwhile, French authorities have declared in the EudraGMDPdatabase that Medreich’s Unit V facility in Bollaram, India, does notcomply with GMP requirements for sterile and non-sterile betalactamantibiotics. An inspection conducted in May 2014 found 58 deficiencies,one of which – related to “data falsification” – was categorised as“critical”, while 29 were viewed as “major”.

“The statement of non-compliance previously issued is maintained,and the site should not be named on any marketing authorisationswhilst this statement remains in place,” the French authorities said,adding that Medreich had not distributed batches of finished productsin the European Union (EU) since an inspection carried out in early2013 had uncovered several deficiencies.

Discovery of “10 major deviations from EU GMP” – includingoverwriting undesirable sample results – have led Italy’s medicinesagency to declare that Sri Krishna Pharmaceuticals’ Unit II bulkgranules facility in Nacharam near Hyderabad, India, does not complywith GMP standards. The Italian agency said it had no concern overthe quality of finished drugs because the facility made only intermediategranules for formulation into drugs that were subject to further testing.

Due to “data-integrity concerns”, Health Canada has askedimporters to quarantine products made using bulk drugs made at theSri Krishna site near Hyderabad. “This action comes in light of recentinformation from trusted regulatory partners that raised concerns aboutthe reliability of the laboratory data generated at this site,” the Canadianagency explained.

A list of affected products – which the Canadian agency intends toupdate – identifies Teva’s Ratio-Oxycocet (oxycodone/acetaminophen)tablets as “medically necessary”, and thus subject to “appropriatetesting to address any potential safety concerns”.

Among the affected products not deemed medically necessaryare several Teva drugs that contain acetaminophen – known asparacetamol in other countries – either alone or in combination. Alsoaffected are acetaminophen-based brands marketed by Jamp, Novartis,Pro Doc, Riva and Trianon. G

COMPANY NEWS


MANUFACTURING

Ranbaxy’s Dewas ispulled up over GMP

Apotex has struck an agreement with Indian firm Panacea Biotecto develop, manufacture and market two “high-barrier-to-entry”

oncology generics in the US, Canada, Australia and New Zealand.Both drugs would be developed using Panacea’s proprietary nano-particle, liposomal and micro-particle drug delivery systems, theIndian firm said. The generics’ reference products combined hadcurrent sales of around US$1 billion, it added.

“The strategic alliance was initially established for a drug-delivery-based drug for which Panacea had received research fees,” Panaceaexplained, noting that that development was “progressing on priority”.“Panacea and Apotex have now further expanded the scope of thecollaboration,” the Indian firm said, adding that the partners intendedto broaden the collaboration in the future “by adding new drug-delivery-based complex generics”.

Under the terms of the agreement, Panacea will develop,manufacture and supply the generics to the Canadian firm, which willin turn be responsible for regulatory affairs, managing patent litigationand marketing the products. The Indian firm said it would receiveupfront and milestone payments from Apotex, along with a share ofthe development costs. “Profit post-commercialisation of the productsshall be shared at a pre-agreed ratio between both firms,” Panacea said.

Apotex’ chief business officer, Steven Lydeamore, said suchstrategic partnerships enabled the Canadian company to compete indifficult-to-make generics “where Apotex does not have its ownmanufacturing capabilities”.

Describing the alliance with Apotex as “one of the cardinalmilestones in our global generics strategy”, Panacea’s joint managingdirector, Rajesh Jain, said the Indian firm planned to use its nano-particle, liposome and micro-particle drug-delivery technologies tostrengthen its presence in the oncology arena.

“This collaboration reflects the shared belief that the developmentand commercialisation of drug-delivery-based, high-barrier-to-entryproducts will not follow a typecast brand or generic model, and willrequire significant innovation, technical expertise, infrastructure andinvestment to achieve the desired ends,” Panacea stated. G

STRATEGIC ALLIANCES

Apotex and Panaceaally over two drugs

Canada’s Vanc Pharmaceuticals says it has reached a “key step”towards rolling out its generic and OTC drugs portfolio after being

issued with a Drug Establishment License (DEL) by local regulatoryagency Health Canada. This, the Vancouver-based company said,would allow it to import drugs from its facilities in China and India,and then to distribute them in Canada.

“We have partnered with leading global generics manufacturers,”stated Vanc’s chief executive officer, Arun Nayyar. Having just receivedNotices of Compliance (NOCs), or marketing authorisations, for 22ingredients or combinations from Health Canada (Generics bulletin,5 December 2014, page 24), Vanc – which used to operate underthe name Nova – reiterated that it intended to launch its genericportfolio in the second quarter of 2015.

The Canadian firm – which subsequently claimed to have boostedits portfolio to 30 molecules – has named Aman Parmar as chieffinancial officer. He takes over from Jamie Lewin, who has resigned. G

BUSINESS STRATEGY

Vanc can import into Canada

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Launching four products helped Zydus Cadila to increase its USsales by 67.6% to Rs8.02 billion (US$131 million) in the Indian

firm’s financial second quarter ended 30 September 2014. The US – inwhich the firm secured six approvals during the three-month period –accounted for 38% of the Indian group’s turnover, which advancedby 21.2% to Rs21.1 billion.

The Indian company introduced 16 new products, including lineextensions, in its domestic market, where Formulations sales aheadby 8.7% to Rs6.81 billion made up the bulk of total local turnoverthat rose by 10.5% to Rs8.84 billion.

Two launches in Mexico took the firm’s local marketed portfolioto 12 out of 17 drugs it has approved in the country to date. ButLatin American sales nevertheless slipped by 1.1% to Rs647 million.

European sales fell by 17.5% to Rs777 million, while turnoverin Japan was negligible following the firm’s decision to discontinuelocal operations (Generics bulletin, 3 February 2014, page 3). Thecompany’s sales in emerging markets declined by 4.3% to Rs885million, while its turnover from active pharmaceutical ingredients(APIs) and animal health products also decreased (see Figure 1).

Lower finance costs helped Zydus Cadila to post a 71.2%increase in pre-tax profit to Rs3.45 billion. G

COMPANY NEWS


SECOND-QUARTER RESULTS

US business boomsto aid Zydus Cadila

Second-quarter sales Change Proportion(Rs millions) (%) of total (%)

India 8,835 +10.5 42

US 8,020 +67.6 38Europe 777 -17.5 4Latin America 647 -1.1 3Japan 2 -98.3 –Emerging Markets 885 -4.3 4APIs 630 -14.6 3Animal Health/others 132 -1.6 1Exports 11,093 +33.5 53

Joint ventures 1,136 +6.4 5

Zydus Cadila 21,064 +21.2 100

Figure 1: Breakdown by business and region of Zydus Cadila’s gross sales in itsfinancial second quarter ended 30 September 2014 (Source – Zydus Cadila)

ABBOTT has completed its RUB16.7 billion (US$305 million)acquisition of Russian branded generics supplier Veropharm. Bytaking over Garden Hills, a holding company that owned 98% ofVeropharm, Abbott has established a local manufacturing base inRussia, including a facility that is currently under construction. Abbottsaid the cash deal would give it “an offering in the field of oncology”in Russia and would complement its existing portfolio in therapeuticareas such as cardiovascular, central nervous system, gastroenterologyand women’s health drugs (Generics bulletin, 11 July 2014, page 1).

IGI LABORATORIES has closed a US$125 million bond offeringto institutional buyers. The US specialty generics specialist expectsto raise net proceeds of around US$120 million from the convertiblesenior notes, which bear a fixed interest rate of 3.75% and willmature in December 2019. It will use the proceeds for “generalcorporate purposes”, including for “strategic transactions”.

AUROBINDO PHARMA has completed a US$132.5 million dealfor the brands, manufacturing, personnel and commercialinfrastructure assets of bankrupt US food supplements maker Natrol(Generics bulletin, 5 December 2014, page 5). The Indian firm –which already operates in the US OTC market through its Aurohealthsubsidiary – intends to improve the acquired business’ profitabilityby “combining the strength of both enterprises in creating a fullyintegrated nutraceuticals platform in the US and other internationalmarkets”. “Natrol comes with certain well-established brands andan extensive distribution network, consisting of retail pharmacy chainsand specialty health-food stores, to help us tactically positionourselves in the US nutraceuticals space,” commented Aurobindo’smanaging director, N Govindarajan. The US supplements maker isalso set to open a manufacturing site near its headquarters inChatsworth, California.

DR DATSONS has secured board approval to negotiate Hong Kong-based investor Leaders Group Asia taking a majority stake in theIndian bulk drugs and formulations provider. Noting that due diligenceand antitrust approval would “take about six months”, Datsons saidthe proposed deal aligned with Leaders Group Asia’s “interests andsupplies of products to many countries in Africa and South America”.

LUPIN has appealed against the European Commission’s decision tofine the Indian firm C40.0 million (US$47.6 million) over a patent-litigation settlement involving Servier’s (perindopril). Lupin contendsthat the Commission applied “a wholly novel and incorrect legaltest” in basing its case around payment of a ‘significant inducement’.Furthermore, the Indian firm argues, “the Commission breachedthe principle of equal treatment in comparison with the fine imposedon Krka”. Krka was fined C10.0 million (Generics bulletin, 8August 2014, page 14).

ANI PHARMACEUTICALS has closed a US$144 million bondoffering. The US specialty drugs developer expects net proceedsfrom the 3.00% convertible senior notes to be around US$138million, which it will use largely to fund development and marketingof its pipeline as well as to “acquire complementary businesses,products and technologies”.

HOVIONE said a pre-approval inspection of its active pharmaceuticalingredients (APIs) plant in Loures, Portugal, led to the US Foodand Drug Administration (FDA) issuing a Form 483 containing threeobservations. The Portuguese firm – which has pledged to improveits quality systems at Loures and other sites – said the inspectioncovered two new drug application (NDA) filings. G

IN BRIEF

McKesson and Celesio say they can now “operate as an integratedcompany” after a court in Stuttgart, Germany, approved the

registration of a domination and profit and loss transfer agreement.Once the agreement is registered, a newly-formed global procurementteam will deal with manufacturing suppliers to both companies.

The two firms aim to create “a global leader in pharmaceuticalpurchasing and distribution”, with a turnover of over US$170 billionthrough operations in more than 20 countries. The combined entitywill serve around 120,000 pharmacy and hospital locations in the US,Canada, Brazil and Europe. That total includes more than 12,000outlets that the group either owns or covers as part of a banner orfranchise network of community pharmacies. G


McKesson and Celesio merge

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Nippon Chemiphar expects to “increase group-wide productioncapacity and reduce manufacturing costs” by establishing a joint

venture with Vietnamese company MST Pharm from March 2015.Initially, the venture – to be formed through the Japanese firm’s

wholly-owned subsidiary, Nihon Pharmaceutical – will focus onmanufacturing drugs for the Japanese market. But Chemiphar intendsto “expand sales channels to Vietnam and other Asian companies”.

The Japanese generics supplier will hold a 60% stake in the newentity, which will be located in Vietnam’s Binh Duong province. G

COMPANY NEWS


STRATEGIC ALLIANCES

Chemiphar lines upventure in Vietnam

Cipla has entered into a definitive agreement through its Meditabsubsidiary to sell the Indian group’s entire 48.22% shareholding

in China’s Jiangsu Cdymax Pharmaceuticals. The purchaser in theUS$18.5 million deal is an affiliate of one of Jiangsu’s othershareholders. The transaction is subject to regulatory approvals in China.

The Indian company offered no explanation for its decision tosell its minority holding. Cipla first acquired its stake in the Chinesebulk-drugs producer in February 2012. G

BUSINESS STRATEGY

Cipla sells its Chinese stake

Strides Arcolab’s Stelis Biopharma subsidiary has broken groundon building a 13,000 sq m biologics facility in Johor, Malaysia.

The Indian company – which is investing RM201 million (US$60million) in the facility – expects to complete construction and installationwithin 24 months, allowing commercial operations to begin in mid-2017.

Stelis’ site on the Bio-XCell biotechnology park will incorporate“single-use bioprocessing technology with both mammalian andmicrobial manufacturing suites”. The company plans to manufactureand market its “pipeline of biosimilars and biobetters”, using a varietyof delivery forms including cartridges, pre-filled syringes and vials.

After acquiring a controlling stake in Bangalore-based InbioproSolutions at the end of 2010, Strides boosted its pipeline through a 2013deal with Pfenex (Generics bulletin, 3 May 2013, page 7). The companyhas identified emerging markets such as in Asia, the Middle East and theCommonwealth of Independent States (CIS) as “initial target markets”.

The Malaysian plant – which will house a research and developmentunit for conducting scale-up and process-development work – will alsoprovide contract manufacturing and clinical supplies.

When Strides signed a US$34.4 million “build-and-lease”agreement with the Bio-XCell park almost two years ago (Genericsbulletin, 5 April 2013, page 7), the partners said they aimed to haveboth the research and manufacturing facilities “operational by theend of 2014”. G

MANUFACTURING

Strides starts workon Malaysian facility

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Walgreens Alliance Boots is now operating as a combined companyafter the US drugstore chain’s shareholders approved a share swap

that saw Walgreens become a wholly-owned subsidiary of the retailingand distribution giant. The combined entity will be based in the USand will trade on the Nasdaq stock exchange under the symbol WBA.

Having taken a 45% stake in Alliance Boots more than two yearsago (Generics bulletin, 29 June 2012, page 3), Walgreens has nowacquired the remaining 55% for around US$5.3 billion in cash and144.3 million shares.

Spanning more than 25 countries, Walgreens Boots Alliance willoperate over 12,800 retail stores in 11 countries and serve more than180,000 pharmacies and other healthcare centres through a networkof over 340 distribution centres.

The combined entity will be led by Stefano Pessina as acting chiefexecutive officer after Walgreens boss Greg Wasson announced plans toretire once the merger was completed. Having joined the US companyas an intern in 1980, Wasson took various positions of increasingseniority before being appointed president and chief operating officerin 2007. Two years later, he was named chief executive officer, andalso that year took a seat on the firm’s board of directors. G

COMPANY NEWS


DISTRIBUTION/RETAILING

Walgreens completesAlliance Boots deal

Fostering the development and approval of biosimilars “such asvaccines and insulin”, improving and accelerating generic approval

mechanisms, and improving access to paediatric medicines and drugsfor rare diseases are among the European Commission’s key goals as itnegotiates a Transatlantic Trade and Investment Partnership (TTIP)free-trade agreement with the US.

Unveiling a series of factsheets on the TTIP’s 24 chapters coveringmarket access, regulatory cooperation and rules – as well as certainproposed legal texts – European Union (EU) Trade CommissionerCecilia Malmström insisted the disclosures made on 7 January marked“a first in EU trade policy” by publishing specific legal proposalswhilst negotiating a bilateral trade agreement.

TTIP will not disturb IP balanceA two-page pharmaceuticals factsheet states that the EU and US

each have a “solid and comprehensive intellectual-property (IP) rightssystem” that enables originators to thrive. “We will not negotiate anyIP rules that change this delicate balance or put more strain on alreadystretched national health budgets,” it pledges.

EU member states will retain control over pricing andreimbursement decisions, the Commission promises, while TTIPwill not influence EU rules on publishing data from clinical trials.

Rather, the EU’s pharmaceutical goals for TTIP include to “worktogether on our requirements for approving biosimilars” and to“streamline systems for authorising generic drugs”. Other goals include:recognising each other’s good manufacturing practice (GMP)inspections; exchanging information between regulators; andstrengthening collaboration under the International Conference onHarmonisation (ICH).

The International Generic Pharmaceutical Alliance (IGPA) iscurrently pushing for full participation as a member of the ICH steeringcommittee (Generics bulletin, 5 December 2014, page 21). G

TRADE AGREEMENTS

EU says TTIP wouldaid biosimilar moves

Details of “considerations in demonstrating interchangeability toa reference product” and of labelling are among four biosimilarity

draft guidances that the Center for Drug Evaluation and Research(CDER) within the US Food and Drug Administration (FDA) intendsto publish during 2015. The other two will address statistical approachesto evaluating analytical similarity data for supporting biosimilaritydemonstrations and additional questions and answers on implementingthe 2009 Biologics Price Competition and Innovation Act.

For generics, the CDER intends to guide industry on draft packageinsert labelling to support abbreviated new drug application (ANDA)approvals and on refusals to receive ANDAs due to typographicalerrors and misplaced files. Furthermore, it will issue guidelines oncomplete assessments and checklists for type II drug master files(DMFs) under the Generic Drug User Fee Amendments (GDUFA).

Several other proposed CDER guidances relate to risk evaluationand mitigation strategies (REMS). Topics to be covered includemodifying and revising REMS, using DMFs for shared-system REMSand submitting study protocols for drugs for REMS for review bythe CDER’s Office of Generic Drugs (OGD). G

REGULATORY AFFAIRS

CDER plans switching guide

US injectables specialist Eagle Pharmaceuticals believes it hasmoved closer to offering an alternative to Teva’s Treanda

(bendamustine) brand after a clinical trial found Eagle’s EP-3102ready-to-dilute version was bioequivalent to the original, but couldbe administered more quickly.

Since July, Eagle has held tentative US approval for its EP-3101bendamustine formulation, but orphan drug exclusivity for Treandablocks final approval until September this year. But having securedits own orphan drug designation for chronic lymphocytic leukaemiaand non-Hodgkin’s lymphoma, Eagle believes it may be able tocircumvent Teva’s exclusivity by proving that its version of thechemotherapy agent is superior and deserves a different label.

At the end of October 2014, Teva’s lawsuit against Eagle overUS Treanda patent 8,791,270 was consolidated in a Delaware districtcourt with 25 other suits that the originator had brought against 16generic challengers. A trial is scheduled for 30 November this year,following a claim-construction hearing in March.

Eagle – which focuses on the hybrid 505(b)(2) new drugapplication (NDA) regulatory pathway – is preparing to submit an NDAfor ready-to-use bivalirudin, the active ingredient in The MedicinesCompany’s Angiomax anticoagulant.

Sales of, and royalties from, argatroban sold by partners TheMedicines Company and Sandoz accounted for about US$15 millionof Eagle’s turnover that rose by 40% to US$19.1 million in its financialyear ended 30 September 2014. The August 2014 launch of Ryanodex(dantrolene) added US$0.2 million, while most of the remainder camefrom a deal with Hikma over diclofenac/misoprostol tablets.

Eagle – which raised around US$46.1 million through an initialpublic offering (IPO) in February last year – more than doubled itsoperating loss to US$18.8 million, largely as a result of higher researchand development spending. G

BUSINESS STRATEGY/ANNUAL RESULTS

Eagle chases after Treanda

Gen 16-1-15 Pgs. 2-8_Layout 1 13/01/2015 16:19

MARKET NEWS


Draft guidance issued by the US Food and Drug Administration(FDA) aimed at helping generics applicants to obtain samples of

reference products that are governed by a risk evaluation andmitigation strategy (REMS) has been welcomed by the US GenericPharmaceutical Association (GPhA). The document describes “howto obtain a letter from the FDA stating that bioequivalence studyprotocols contain safety protections comparable to applicableREMS for a reference listed drug (RLD)”.

“FDA is aware of instances in which a RLD sponsor has refusedto sell a drug product to a prospective abbreviated new drug application(ANDA) applicant seeking to conduct the testing needed to obtainapproval, and the RLD sponsor has cited the REMS ‘elements to assuresafe use’ (ETASU) as justification,” the agency states in the draftguidance document.

The FDA said it had, on request, reviewed bioequivalence studyprotocols proposed by ANDA applicants to assess whether theyprovided the necessary safety protections “in the interest of facilitatingprospective generic applicants’ access to RLD supplies”.

“When the agency has determined that comparable protectionsexisted, FDA has issued letters to the RLD sponsors stating so, andindicating that the FDA would not consider it to be a violation of theREMS for the RLD sponsor to provide the drug product to theprospective ANDA applicant,” the FDA noted. While this was not alegal requirement, the agency emphasised, the guidance was intendedto clarify the process “if a prospective ANDA applicant chooses torequest such a letter”.

Letter issued after study reviewAccording to the guidance, the prospective ANDA applicant

should submit draft bioequivalence study protocols to the FDA bye-mail, based on the provisions of the reference drug’s labelling andETASU as detailed on the agency’s online REMS listing.

The FDA’s Office of Generic Drugs (OGD) will review theseprotocols, and either recommend revisions or confirm that the protocolsare comparable to the ETASU. The ANDA applicant will then bedirected to notify the agency if they wish to have the FDA issue aletter to the RLD sponsor.

Welcoming the guidance, the GPhA’s president and chiefexecutive officer, Ralph Neas, said the agency had taken “helpfulsteps to address, and hopefully limit, scenarios in which some branddrug companies misuse REMS programmes to thwart competitionfrom more affordable generic drugs”.

Last year, a study commissioned by the GPhA found thatabuse by brand companies of REMS and ‘restricted access drug’programmes to deny generics firms access to product samples wascosting the US healthcare system US$5.4 billion annually (Genericsbulletin, 8 August 2014, page 15).

The report by Matrix Global Advisors also warned that, afterbiosimilars enter the US market, similar abuse could lead to aroundUS$140 million in lost savings for every US$1 billion in biologics sales.

“The FDA guidance comes at a time when this issue is alsoreceiving elevated attention in Congress,” Neas noted. RepresentativesSteve Stivers and Peter Welch had introduced a bill for the Fair Accessfor Safe and Timely (FAST) Generics Act, Neas observed, “whicheffectively prohibits companies from adopting restricted-access practicesto avoid generic competition”. This, Neas said, was “a manoeuvre thatcomes at the expense of patient access to affordable medicines”. G

REGULATORY AFFAIRS

GPhA lauds FDA forlimiting REMS abuse

Marketing authorisations based on data from studies conducted byGVK Biosciences have been suspended by certain European

Union (EU) member states as a “precautionary measure” pending areview by the European Medicines Agency (EMA) of the Indiancontract research organisation’s site in Hyderabad, India.

In mid-December, Germany’s BfArM agency issued a list of 80drugs such as candesartan, clopidogrel, escitalopram and irbesartanfor which it had suspended marketing authorisations. Among the 15marketing-authorisation holders affected were Dr Reddy’s and itsBetapharm subsidiary, Mylan Dura, Ranbaxy’s Basics and Stadapharm,as well as Lupin’s Hormosan and Torrent’s Heumann.

But as of 8 January, BfArM had been forced to scale down thatlist to 53 products. And of those 53, 21 had not had their marketingauthorisations suspended due to legal challenges filed by firms includingAlfred Tiefenbacher, Fair-Med, Hormosan, Mylan Dura, PanaceaBiotec and Stadapharm. A further 17 were Betapharm products whichwere not currently marketed and for which authorisations weresuspended as of 19 December.

No appeals had been launched against suspensions for 15 productsfrom Ranbaxy’s Basics, Micro Labs, Unichem Laboratories andWelding, the German agency said.

France’s ANSM agency has suspended 25 marketing authorisations.Belgium’s AFMPS confirmed that it had suspended four marketingauthorisations, while Luxembourg has also taken action.

Marketing authorisations suspended in France cover escitalopramsold by Abbott and Zydus, Biogaran’s and Mylan’s ebastine, anddesloratadine marketed by Arrow, Cristers, Medipha, Teva and Zydus.Cristers and Zydus have also had marketing authorisations for ibuprofensuspended, while Mylan has also seen suspensions for candesartan,donepezil, rizatriptan and trimetazidine. Zydus has also had a marketingauthorisation for tramadol/paracetamol suspended in France.

Suspensions in Belgium include Mylan’s candesartan andesomeprazole, along with desloratadine marketed by Apotex and Teva.

Several months ago, firms with marketing authorisations that hadbeen approved in Europe on the basis of clinical work carried out byGVK were asked to contact local European regulators, following“serious concerns” raised by France’s ANSM after an inspectionthat bioequivalence trials at the Hyderabad facility had not beenconducted according to good clinical practice since 2008 (Genericsbulletin, 8 August 2014, page 15). Shortly afterwards, the EMA’scommittee for human medicinal products (CHMP) began a reviewof GVK to determine which medicines were affected by ANSM’sinspection findings (Generics bulletin, 3 October 2014, page 8).

GVK said it believed that the studies conducted were “in accordancewith good clinical practice guidelines”. “We are working with ourclinical development customers to provide new data that meets allregulatory requirements,” the firm added. Given that the authoritieshad concluded that the bioequivalence studies conducted at theHyderabad plant were not sufficient to support marketing authorisations,GVK said it expected that the marketing-authorisation holders wouldhave to repeat studies “in the next 12-15 months”.

Commenting on the suspensions, the European Generic medicinesAssociation (EGA) said it was “very concerned about the allegationsof data falsification”, adding that “to date, there is no evidence of anyrisk posed to human health by the medicines concerned”. EGA membersare “actively cooperating with EU and national competent authorities toensure that patient safety and access to treatment will be ensured”. G

REGULATORY AFFAIRS

Suspensions in EUfollow GVK review

Gen 16-1-15 Pgs. 9-14_Layout 1 13/01/2015 16:40 Page 3

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The European Generic medicines Association (EGA) will join theEuropean Stakeholders Model (ESM) established to implement

anti-counterfeiting elements of the European falsified medicinesdirective, the association has announced in conjunction with brandindustry organisation the European Federation of PharmaceuticalIndustries and Associations (Efpia). The two bodies called the EGA’sparticipation in the ESM “another positive step in the pharmaceuticalindustry’s united effort to combat counterfeiting”.

EGA director general Adrian van den Hoven said the associationwas “proud to join forces with Efpia”, as well as with the EuropeanAssociation of Pharmaceutical Full-line Wholesalers (GIRP), theEuropean Association of Euro-Pharmaceutical Companies (EAEPC)and the Pharmaceutical Group of the European Union (PGEU). “Nowit is time for us to work with the support of European Union (EU) andnational authorities to get the system up and running effectively,” headded, “while maintaining access to safe medicines.”

ESM membership is EGA ‘milestone’Welcoming the EGA’s membership of the ESM as a “milestone”

for the group, Efpia director general Richard Bergström emphasisedthat “by joining together, we can best protect patients and their security”.The cost of a repository for unique identifiers on packaging hadpreviously proved a stumbling block on an alliance (Genericsbulletin, 20 June 2014, page 28).

Meanwhile, the two groups have also called for measures to“stimulate healthy and sustainable generic and biosimilar medicinescompetition” to be included in an “integrated life sciences strategy”by the European Union (EU). Van den Hoven said the pharmaceuticalsector was “a partner for better health and for growth and jobs” inEurope. “We need a decisive pharmaceutical industry strategy toboost our manufacturing capacities to serve Europe,” he added. G

MARKET NEWS


REGULATORY AFFAIRS

EGA and Efpia ally oncounterfeiting battle

Deals struck on AndroGel (testosterone) and TriCor (fenofibrate)between Teva and AbbVie in the US amounted to a payment not

to compete, the US Federal Trade Commission (FTC) has contendedin a filing made as part of an antitrust case brought by the stateregulator in a Pennsylvania district court.

Opposing a motion tabled by defendants Teva, AbbVie and Besins,to dismiss a charge of engaging in an illegal restraint of trade (Genericsbulletin, 19 September 2014, page 12), the FTC insisted a disputeover an AndroGel formulation patent expiring in 2020 amounted to“a sham patent-infringement suit”. “The defendants’ failure to accountfor these allegations is fatal to their motion,” the Commission maintained.

The FTC argued that its restraint of trade allegations were similarto those considered by the US Supreme Court in its ruling on theCommission’s dispute with Actavis over AndroGel. Insisting that thedefendants had effectively agreed a payment for Teva not to competewith AndroGel, the FTC said: “Their primary argument – that thecomplaint fails to allege a ‘payment’ – rests on the defendants’ insistencethat the simultaneously executed contracts on TriCor and AndroGelwere entirely independent, pro-competitive deals and that AbbVie wasunaware of Teva’s difficulties with its generic TriCor product.” G

ANTITRUST LITIGATION

FTC persists over AndroGel

Four generics firms – Aspen Pharma, Cipla Medpro, Mylan andSonke Pharmaceuticals – will share a three-year tender for

antiretrovirals in South Africa worth over ZAR10 billion (US$855million) in total, the country’s Department of Health has announced.The deals cover a period running from 1 April 2015 to 31 March 2018.

Sonke won the largest share of the tender with ZAR3 billion, whileMylan was awarded a ZAR2.8 billion share. Aspen followed with anaward worth ZAR2.5 billion while Cipla will enjoy a ZAR2 billionshare of the antiretrovirals tender.

As part of the award, Mylan noted that it would supply SouthAfrica with triple-therapy fixed-dose combination (FDC) drugs, havingpreviously been selected as a “leading supplier” of a tenofovir/emtricitabine/efavirenz FDC tablet for the previous tender covering2013 and 2014 (Generics bulletin, 14 December 2012, page 9).

Aspen noted that it had been awarded a quarter of the tenofovir/emtricitabine/efavirenz FDC, “which will be used to treat upwards of80% of first-line adult treatment”. The South African firm also securedshares of awards for abacavir solution, and atazanavir, nevirapine andtenofovir tablets, as well as capturing all of the tender awards fordarunavir 600mg tablets, etravirine 100mg tablets, and stavudinecapsules in 15mg, 20mg and 30mg strengths.

Also among the 41 presentations covered by the tender wereefavirenz tablets, lamivudine tablets and oral solution, zidovudinetablets and a zidovudine/lamivudine combination.

Cipla noted that its ZAR2 billion share was its “third tender winin the last year”, following two previous awards in South Africantenders in 2014, including a respiratory contract.

During the antiretrovirals tender process, the Department ofHealth also received bids from AbbVie, Adcock Ingram, Aurobindo,Emcure and Macleods, as well as from Merck, Sharp & Dohme,Sanofi and its Zentiva subsidiary, and Specpharm. G

PRICING & REIMBURSEMENT

Four firms share inSouth African tender

Health Canada plans to amend the country’s Patented Medicines(Notice of Compliance), or PM (NOC), patent-linkage regulations

in light of recent court rulings. A “strict interpretation” of recentdecisions on patents claiming single active ingredients found incombination drugs could, the agency fears, force it to change its practiceon listing certain patents on its patents register.

The planned amendments – to be published for comment in thecountry’s official gazette on an as-yet undecided date – are intended to“confirm established Health Canada practices in relation to the policyintent of the NOC regulations and clarify the listing requirements as theyrelate to single medicinal ingredients found in combination drugs”. G

INTELLECTUAL PROPERTY/REGULATORY AFFAIRS

Canada plans linkage changes

FDA – the US Food and Drug Administration – has issued a seriesof product-specific bioequivalence guidelines for generics. Morethan 30 new recommendations were added to the agency’s list ofbioequivalence guidances at the end of December, while a further 22existing documents were revised. G

IN BRIEF


Teva’s bidding group with its affiliate, Ratiopharm, led the field insecuring supply contracts in the 14th tender round run by leading

German statutory health insurance fund, the AOK. Sanofi’s Zentivaand Stada’s Aliud were also among the most successful participants.

“For 103 of the 116 active ingredients or combinations for whichwe had sought bids, we were able to reach supply deals with 29pharma companies,” noted the AOK’s chief negotiator, ChristopherHermann. No deals could be struck for molecules including cefixime,entacapone, hydrocortisone and octreotide.

Of the 103 active ingredients covered by supply contracts, 88 wereawarded on an exclusive basis across eight regions. Teva captured 20of those, including deals to provide the AOK across Germany withcaptopril, diclofenac, efavirenz, gabapentin and meloxicam.

When the two-year contracts under the AOK’s 14th round comeinto effect on 1 June this year, Zentiva will become the fund’s exclusivesupplier of 10 molecules, such as alfuzosin, fexofenadine, glimepirideand ibuprofen.

Aliud picked up nine exclusive contracts for drugs includingibandronate, lormetazepam, metoclopramide and nifedipine. Citalopram,lamotrigine and sertraline are among the six molecules for which Mylanwill be the AOK’s exclusive supplier, while Torrent’s Heunet/Heumannlabel secured four exclusive deals for azathioprine, escitalopram,finasteride and indapamide.

Aurobindo picked up three nationwide exclusive deals, whileAristo, Sandoz’ Hexal, Glenmark and Neuraxpharm each secured two.

For 15 active ingredients or combinations, the AOK chose to awardsupply contracts to up to three companies (Generics bulletin, 17October 2014, page 10). Among such drugs were: the antihypertensivesamlodipine and losartan; the antibiotics cefaclor, ceftriaxone, cefuroximeand ciprofloxacin; the proton-pump inhibitor omeprazole; thecholesterol-lowering agent simvastatin; and neuroleptic risperidone.

Combined sales of C2 billionIdentifying bisoprolol, escitalopram, ibuprofen, omeprazole

sertraline and simvastatin as the best-selling molecules covered bythe latest deals, the AOK said the 103 active ingredients included in thesupply contracts had a combined annual turnover through the fundof around C2 billion (US$2.4 billion).

The AOK’s 14th tender round will largely replace its 10th and11th rounds for which contracts expire this year. At present, the fundhas under contract 259 off-patent molecules or combinations withcombined annual sales of more than C5 billion. Since 2007, the AOKclaims, tenders have saved it more than C3.6 billion.

Hermann insisted there was “no alternative” to tenders, especiallyas funds’ medicines outlay had risen by almost a tenth in the first ninemonths of 2014.

Noting that draft legislation passed by Germany’s federal cabineton 17 December last year would relax certain penalties for doctors whoprescribed a disproportionate level of expensive medicines, Hermannfeared that doctors would prescribe fewer substitutable medicines.

Quoting IMS Health data, German generics industry associationPro Generika said generics had saved the country’s health insurancefunds more than C11 billion in the first 10 months of 2014, and hadaccounted for 68% of all prescriptions dispensed. Over the sameperiod, Pro Generika observed, a total of 69 companies had launched992 new products ranging across 12 single substances and twocombination drugs. G

MARKET NEWS



Teva takes top spotamong AOK awards

FRANCE has modified reference prices for just under 400 genericgroups in the country’s répertoire of equivalents from 1 January 2015,following a decision by the economic committee for healthcareproducts (CEPS). Reference prices – or tarifs forfaitaires deresponsabilité (TFRs) – are applied by CEPS to product groupslisted in France’s répertoire of generic equivalents in which genericsare failing to achieve target penetration rates.

FDA – the US Food and Drug Administration – has confirmedthat its Office of Pharmaceutical Quality (OPQ) within the Centerfor Drug Evaluation and Research (CDER) will officially startoperations this month, led by acting director Janet Woodcock. TheOPQ will aim to “enhance the review process” for abbreviated newdrug applications (ANDAs) by offering “real-time communication”between the applicant and the FDA in advance of formal action.

EBG – the European Biosimilars Group – has told a Drug InformationAssociation (DIA) conference in Berlin, Germany, that no scientificevidence exists to suggest switching to and from comparablebiopharmaceuticals creates safety concerns. EBG coordinatorSuzette Kox advised doctors to review scientific data contained inEuropean Public Assessment Reports (EPARs) to guide decisionson interchangeability.

GERMAN exceptions to automatic pharmacy substitution havecome into effect following publication of a list of products in thecountry’s federal gazette, the Bundesanzeiger. Excluded fromsubstitution are beta-acetyldigoxin, digitoxin and digoxin tablets,as well as tablet forms of phenytoin and levothyroxine sodium.The latter includes combinations with potassium iodide. Tacrolimushard capsules are excluded, as are ciclosporin soft-gel capsulesand oral solution (Generics bulletin, 3 October 2014, page 10).

ROMANIA’s generics industry association, APMGR, has launcheda national campaign aimed at providing information and educationon the safety, quality and efficacy of generics, in partnership withthe country’s medicines agency ANMDM. Meanwhile, APMGRhas urged Romania’s government to consider modifying the country’spharmaceutical clawback as part of health budget debates.

MHRA – the UK’s Medicines and Healthcare products RegulatoryAgency – has issued a new ‘orange guide’ and ‘green guide’containing information and legislation relating to the manufactureand distribution of medicines. The guides include revised EuropeanUnion (EU) guidelines on good distribution practice.

EMA – the European Medicines Agency – has published its workprogramme and budget for 2015. Among the agency’s goals are“enhancing cooperation within the European medicines regulatorynetwork, as well as with European and international partners” andincreasing transparency and access to data.

GPhA – the US Generic Pharmaceutical Association – has welcomedthe findings of a US Senate committee on ageing that has highlightedthe role of generics in slowing healthcare spending growth, particularlywithin the Medicare Part D insurance programme. A reportrecommends “finding innovative ways to expand generic drug usageamong low-income subsidy beneficiaries”.

CANADA’s Patented Medicine Prices Review Board (PMPRB)has concluded that “prices of generic drugs in Canada have declinedsignificantly since 2010”. This was mainly due to ‘more rigorous’provincial generic reimbursement policies, the PMPRB concluded. G

IN BRIEF


Biosimilar labelling must be consistent with that of the referenceproduct, the European Generic medicines Association (EGA) has

insisted as part of a ‘position statement’ presented by the association’sEuropean Biosimilars Group (EBG).

Addressing the DIA biosimilars conference in Berlin, Germany,in December on behalf of the EBG, Sandoz’ Elke Grooten expressed“full support for the European Medicines Agency (EMA) approach onbiosimilar labelling”, which requires consistent labelling.

Having earlier this year refuted suggestions by originatorassociation EuropaBio that the current approach to labelling wasinsufficient and that biosimilar labels should reflect extra data relatingto the extent of ‘biosimilarity’ demonstrated for each claimed indication(Generics bulletin, 3 October 2014, page 6), the EGA insisted thatthe current system was “adequate, reliable, safe and transparent”.

Prescribers and patients were already able to safely and effectivelyuse biosimilars, Grooten pointed out, while the public was able toretrieve data on how individual biosimilars had been evaluated by theEMA, as well as post-authorisation information.

Deviations in product information could in fact create“unnecessary confusion and deepen the misinterpretation of thebiosimilarity concept”, Grooten argued, concluding that “continuationof labels consistent between the reference product and biosimilarmedicines is a must”. G

MARKET NEWS


LABELLING

EGA backs EMA onbiosimilar labelling

ATrans-Pacific Partnership (TPP) trade deal being negotiated betweenthe US and several other countries “fails to strike the right balance

between fostering innovation and ensuring expedited access to moreaffordable medicines” in its current form, according to the US GenericPharmaceutical Association (GPhA).

Insisting that the TPP “does too much to extend already generousmonopolies enjoyed by brand-name drugs, and too little to ensurethat safe, low-cost generic versions are available to patients as soon aslegally possible”, GPhA president and chief executive officer RalphNeas said that “every intellectual-property provision affectingpharmaceuticals proposed in the TPP – including patent linkage,patent-term extensions, and exclusivity provisions – would delay thelaunch of generic drugs to the detriment of patients, healthcarebudgets and the generics industry”.

Moreover, Neas said, the TPP would delay the entry of biosimilarsby ‘locking in’ 12-year data exclusivity for biological brands despiterecent domestic US proposals to reduce this term to seven years.“Trade agreements are supposed to open markets,” Neas observed,adding: “The current TPP opens markets for big pharma but closesthem for generics.”

The GPhA has signed a letter to US President Barack Obamaexpressing these “deep concerns” over the TPP alongside groupssuch as Médecins Sans Frontières (MSF) and Oxfam. G

TRADE AGREEMENTS

GPhA voices concernover TPP provisions


Only 8% of patent settlements concluded between generics firms andoriginators in the European Union (EU) in 2013 contained a limit

on generic market entry as well as a “value transfer” from the originatorto the generics firm, according to the latest monitoring report publishedby the European Commission. The figure was almost unchanged from7% in 2012 (Generics bulletin, 10 January 2014, page 15).

Following its fifth round of monitoring, the Commission concludedthat the 8% figure – representing just 11 of the 146 patent settlementsagreed during 2013 – indicated that such settlements, which mightattract competition law scrutiny, “have stabilised at a low level”.

Of the 146 settlements concluded, 45% – or 66 – did not includeany limitation on generic market entry, while 47% – 69 – limitedgeneric market entry but did not include a “value transfer”.

Meanwhile, the Commission noted, statements made by certainindustry stakeholders during the Commission’s earlier pharmaceuticalsector inquiry – indicating that the Commission would be “forcingcompanies to litigate each patent dispute until the end” – had provedto be “unfounded”, given the increase in the number of settlementsoverall. The figure of 146 in 2013 compared to 24 per year betweenJanuary 2000 and June 2008, the Commission observed.

However, brand industry body the European Federation ofPharmaceutical Industries and Associations (Efpia) said that patentsettlements were “a symptom of a fragmented and partly inefficientenforcement regime in Europe as far as pharmaceutical patent disputesat the point of generic entry are concerned”.

Urging the Commission to “tackle the root cause rather than thesymptoms”, Efpia said it should consider an early-resolution mechanismthat would address patent disputes “sufficiently in advance of genericlaunch to increase legal certainty for all stakeholders”. G

MARKET NEWS


INTELLECTUAL PROPERTY

Problem settlementsremain low in the EU

Legislation that would allow interchangeable biologics in the US tobe automatically substituted by pharmacists has been proposed by

the US Generic Pharmaceutical Association (GPhA). The “compromiseautomatic substitution legislation” – which GPhA president and chiefexecutive officer Ralph Neas noted had been introduced as statelegislatures prepared for their 2015 sessions – includes provisionsdirecting pharmacists to communicate to doctors details of thedispensed drug “within a reasonable time”.

Calling the compromise language “a vast improvement over 2012language that we strongly opposed, and which originally erectednumerous barriers to the automatic substitution of interchangeablebiologics”, Neas insisted that state legislation “must be in place to allowautomatic substitution when the US Food and Drug Administration(FDA) approves the first interchangeable biologics in this country”.

Meanwhile, proposals by the FDA to amend labelling regulationsto require electronic distribution of prescribing information to healthprofessionals have also been welcomed by the GPhA. “This informationcould include critical details necessary for effective use of the productor timely updates to safety information,” the association pointedout. “This means that manufacturers can provide electronic updatesto labels in weeks, rather than the months or even years now requiredfor paper labels.” G

REGULATORY AFFAIRS

GPhA backs biosimilar rules

Russia should consider issuing compulsory licences for domesticfirms to produce generic versions of certain patented medicines,

according to local member of parliament Sergey Kalashnikov.In a letter to the country’s Prime Minister, Dmitry Medvedev,

Kalashnikov urged Russia’s national authorities to follow theexample that had been set by countries including Brazil, India,Indonesia, and Thailand, and adopt a compulsory licensingmechanism for vital AIDS, cancer and hepatitis medicines.

Furthermore, Kalashnikov said, introducing compulsory licensingwould bolster domestic production of pharmaceutical substances, forwhich production had currently been suspended due to currencydevaluation of the Russian rouble.

Meanwhile, Russia’s Ministry of Health has outlined plans tocreate an online portal to inform doctors and patients about equivalentsto brands. It will list brands and their international non-proprietarynames (INNs), along with available alternatives.

The listing – which is due to be launched in the first half of thisyear as part of a wider healthcare information system – will also providedetailed information on each drug’s composition, dosage form, storageconditions, expiry date and instructions for use. Doctors and pharmacistswill have expanded access to the system, allowing them to detectwhether products contain narcotic and psychotropic substances orother additional characteristics.

Health authorities insisted that the scheme would “facilitate thework of doctors in terms of implementing mandatory prescribingby INN rather than by brand name”, as well as serving as a referenceresource to support prescribing decisions. Meanwhile, patients whoknew a product’s brand name would be able to identify cheaperalternatives, the authorities added. G

REGULATORY AFFAIRS

Russia may considercompulsory licensing

Marketing authorisations granted in Australia, Canada, the EuropeanUnion, Japan or the US should be automatically recognised in

Ukraine through a mutual-recognition procedure, according to thecountry’s Prime Minister, Arseniy Yatsenyuk. He stressed that thegovernment intended to take this “unprecedented step” to “stopbureaucratic and corrupt registrations [in Ukraine] of drugs which hadalready been appropriately authorised in other countries”.

However, the Ukrainian Association of Pharmaceutical Producersinsisted that such a reform should not cover generics. G

REGULATORY AFFAIRS

Ukraine plans for recognition

Astatutory 16% price reduction for drugs facing competition fromtheir first generic equivalents has been applied from December to

several products listed on Australia’s Pharmaceutical Benefits Scheme(PBS). Treatments affected include oral adefovir, celecoxib, clindamycinand dipyridamole/aspirin, as well as oxycodone, raloxifene and thehydrochlorothiazide component of valsartan/hydrochlorothiazide.The 16% cut has also been applied to dorzolamide/timolol eye drops. G


More cuts hit Australia’s PBS


Sandoz is claiming the first launch of a Brazilian generic rival toEli Lilly’s Cialis (tadalafil) 5mg and 20mg tablets ahead of local

patent expiry in March through a licensing agreement with theoriginator. André Brázay, Sandoz’ Brazilian country head, said the dealmeant the firm was “the only company in Brazil to have both sildenafiland tadalafil molecules, key products to meet the needs of patientswith erectile dysfunction”.

“As part of the agreement, Sandoz will be responsible formarketing and the packaging of the product under the Sandoz brandin Brazil,” the firm observed. Sandoz’ range of men’s healthcareproducts in Brazil also includes doxazosin and leuprorelin. G

PRODUCT NEWS


ERECTILE DYSFUNCTION DRUGS

Sandoz rivals Cialiswith Brazilian deal

Apotex says the US Food and Drug Administration (FDA) hasaccepted for filing its application for a biosimilar rival to Amgen’s

Neulasta (pegfilgrastim) neutropenia treatment. The Canadian firm –which developed the drug through a partnership with India’s IntasPharmaceuticals – believes it is the first firm to have had a dossieraccepted for review under the FDA’s 351(k) biosimilar pathway forthe long-acting formulation of filgrastim.

Noting that it would market the biosimilar pegfilgrastim in theUS through its ApoBiologix division, the Canadian company citedIMS Health data that showed Neulasta as having US sales of aroundUS$3.6 billion in 2013.

Six years ago, Apotex extended its collaboration with Intas tocover pegfilgrastim (Generics bulletin, 13 February 2009, page 17).The two firms had almost a year earlier struck a collaboration dealin North America and Europe. This has seen Intas provide from itsplant in Moraiya, India, the biological active substance for the Grastofil(filgrastim) pre-filled syringes for which Apotex secured a pan-Europeanmarketing authorisation in October 2013 (Generics bulletin, 1November 2013, page 14).

“We are very pleased to be at the forefront of companies who willintroduce high-quality biosimilar products into the US marketplace,”commented Apotex’ president and chief executive officer, Jeremy Desai.“Our entry into this new frontier of medicine in the US,” he added,“is a watershed event in Apotex’ 40-year history of providingquality, affordable medicines.” G

BIOLOGICAL DRUGS

FDA accepts Apotex’filing of pegfilgrastim

India’s Supreme Court has upheld lower court rulings that acompulsory licence issued to Natco Pharma for a generic version

of Bayer’s Nexavar (sorafenib) cancer treatment is legal.“In the facts of the present case, we are not inclined to interfere,”

the Supreme Court judges stated in dismissing Bayer’s ‘special leave’petition to appeal against a Bombay High Court’s ruling from last year.

In that ruling (Generics bulletin, 8 August 2014, page 20), theBombay court had found that Bayer had supplied the liver- and kidney-cancer drug to only around 200 patients, meaning “the reasonablerequirement of the public” in India was not being met.

Furthermore, the court observed, Bayer was charging aroundRs284,000 (US$4,464) for a month’s course of 120 tablets, whileNatco – which pays Bayer a royalty of 7% on sales – had set a priceof just Rs8,800 per month. “The patented drug is not being offeredat a reasonably affordable price by the petitioner,” it added. G

ONCOLOGY DRUGS

India backs sorafenib licence

Aposition statement issued by the UK’s National Institute for healthand Care Excellence (NICE) has “updated the body’s methods

for providing guidance and advice on biosimilar medicines, as theiravailability and use on the UK National Health Service (NHS) grows”.Biosimilars could offer “considerable cost savings, especially as theyare often used to treat long-term conditions”, NICE acknowledged.

“Over the past 10 years there has been a rapid worldwide increasein the number of biological medicines that have received regulatoryapproval,” NICE observed. “Although biosimilars are already used tosome extent in the NHS, and NICE has previously included biosimilarsin its technology appraisal on the human growth hormone somatropin,it is likely that their availability and use will become more widespreadover the next few years.”

Biosimilars will “usually be considered in the context of a multipletechnology appraisal in parallel with their reference products in theindication under consideration”, the position statement explains. “NICEtechnology appraisals will use the name of the active drug substance,including reference products and brand-named similar biologicalmedicinal products in its documentation where appropriate, to informclinical decision-making.”

A technology appraisal remit referred by the UK’s Departmentof Health to NICE enables the regulator “to decide to apply the sameremit, and the resulting guidance, to relevant licensed biosimilarproducts which subsequently appear on the market”, according to theposition statement. Evidence summaries will use brand names“because substitutability and interchangeability cannot be assumed”.

Evidence summaries, NICE emphasised, “do not makerecommendations, hence the decision regarding the choice of biosimilaror originator biologic for an individual patient rests with the clinician”.G

FARMAK has extended its range of prescription drugs in Ukraine bylaunching its tranexamic acid as well as dexketoprofen solutionsfor injection under the brand names Gemotran and Keywer. The firmis offering its anti-fibrinolytic agent Gemotran in 50mg/5ml and100mg/5ml doses, while anti-inflammatory drug Keywer comes in50mg/2ml vials as well as in 25mg tablets. The company has alsointroduced its Vial Tear (tetryzoline) 10ml ophthalmic eye drops. G

IN BRIEF

BIOLOGICAL DRUGS

UK alters biosimilars position

HOSPIRA’s 50mg/10ml and 100mg/20ml presentations of oxaliplatinand its 30mg/5ml and 100mg/16.7ml strengths of paclitaxel have beenadded to Japan’s National Health Insurance (NHI) price list. Bothdrugs were approved by the country’s Ministry of Health, Labour andWelfare (MHLW) in August (Generics bulletin, 5 September 2014,page 20). The injectables specialist has a local oncology co-promotionagreement with Mochida. G

IN BRIEF


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Zydus Cadila says it has become “the first company anywhere inthe world” to launch a biosimilar rival to AbbVie’s Humira

(adalimumab) blockbuster after introducing the autoimmune diseasestreatment in India following approval from the Drug Controller Generalof India (DCGI). Humira had global sales of around US$10.7 billionin 2013, making it the world’s best-selling drug, Zydus observed.

Developed at the Indian firm’s Zydus Research Centre, Zydussaid its adalimumab was “a ‘fingerprint match’ with [Humira] in termsof safety, purity and potency”. The Indian company has establisheda new division called Zydus Biovation to market its adalimumab –which it has given the fantasy name Exemptia – and said the launchwould be supported by “scientific symposia to highlight the gaps inthe current management of autoimmune disorders”.

Zydus said Exemptia was presented as a 40mg subcutaneousinjection, administered once a week on alternating weeks, typically overthe course of six months. Around 12 million patients in India sufferedfrom diseases treatable with adalimumab, the Indian firm stated.

24 biologics in pipeline“The biosimilar of adalimumab is part of Zydus’ robust biologics

programme, which has the largest number of monoclonal antibodiesunder development in India,” the Indian company said, noting that thisprogramme comprised 24 biologic drugs, “including biosimilars andthree novel biologics”.

Humira’s US composition patent is expected to expire in December2016, while patent protection in most European Union (EU) states isexpected to end in April 2018.

Stada recently announced that it was in talks with Swiss firmmAbxience to in-license a biosimilar version of Humira (Genericsbulletin, 5 December 2014, page 22), while Momenta recentlyrevealed that it was developing adalimumab with Baxter (Genericsbulletin, 3 November 2014, page 20). G

PRODUCT NEWS


BIOLOGICAL DRUGS

Zydus Cadila debutsadalimumab in India

Actavis has been thwarted in its plans to withdraw the immediate-release formulation of its Alzheimer’s disease treatment Namenda

(memantine) from the US market in order to more swiftly transitionpatients to the extended-release formulation, Namenda XR, after aUS district court issued a preliminary injunction requiring the companyto continue distribution. Actavis would have pulled Namenda IR fromthe US market on January 1 2015.

Having immediately appealed this ruling, Actavis has been awardedan expedited appeal by the US Court of Appeals, meaning a furtherdecision will now be made by 16 February 2015. But the appeals courtrefused to lift the preliminary injunction while Actavis’ appeal is pending.

The lawsuit had been brought against Actavis by New Yorkattorney general Eric Schneiderman, who last year described thecompany’s plan to ‘forcibly’ switch patients to the extended-releaseformulation of Namenda formed “part of an anticompetitive strategydesigned to maintain high drug prices” (Generics bulletin, 3 October2014, page 16).

Patents protecting Namenda IR – which Actavis obtained throughits multi-billion dollar deal for US originator Forest Laboratorieslast year – expire in July 2015, but generic rivals, once available,will not be automatically substitutable for Namenda XR, and willrequire a doctor’s approval.

The extended-release formulation, having been launched by Forestin June 2013, had sales of US$136 million in the US firm’s financialyear ended 31 March 2014. Namenda IR, meanwhile, enjoyed salesof US$1.54 billion.

“The present Forest sales programme is consistent with an acceptedindustry practice of a ‘soft switch’ when a new product is introduced,”said New York District Judge Robert Sweet, “a practice that maintainsconsumer choice before and after generic entry into the market.”Rejecting Actavis’ argument that “allowing them to engage in the ‘hardswitch’ will allow increased innovation in the long term, [due to]greater financial resources”, Sweet ruled that “providing financialrewards for anticompetitive conduct is not in the public interest”.

“The irreparable injury has been established, the balance ofhardships tips markedly in the favour of the State, and the public interestis best served by preliminary relief maintaining the status quo,” heconcluded. Actavis said it was “prepared to manage its business ina way that…minimises any financial impact”. G

ALZHEIMER’S DISEASE DRUGS

Actavis told to keepselling Namenda IR

Wilshire Pharmaceuticals – the US generics subsidiary of US-basedoriginator Arbor Pharmaceuticals – has been sued by Allergan

and its partner Vistakon in a US district court after filing an abbreviatednew drug application (ANDA) for a generic version of the former’sLastacaft (alcaftadine) 0.25% ophthalmic solution.

The treatment for itching associated with conjunctivitis is currentlyshielded by two US patents: US composition patent 5,468,743 thatexpires in April 2016, and US method-of-use patent 8,664,215 thatexpires in October 2029.

US market exclusivity for Lastacaft – which was one of severalproducts revealed by the US Food and Drug Administration to havereceived a paragraph IV challenge last year (Generics bulletin, 3November 2014, page 16) – runs until July 2015.

As the first to file a complete ANDA containing a paragraph IVcertification, Wilshire said that it believed it was eligible for 180-dayUS generic market exclusivity.

“We are excited about the continued development of our pipeline,and alcaftadine represents another key milestone for Wilshire,”commented company president Scott White. G

OPHTHALMIC DRUGS

Wilshire sued on alcaftadine

Three firms distributing generic Oxarol (maxacalcitol) ointment inJapan, along with the active pharmaceutical ingredient (API)

importer, must cease their respective activities after losing a patent-infringement lawsuit against originator Chugai Pharmaceutical in aTokyo district court.

Japanese distributors Iwaki, Pola Pharma and Takata, bulk-drugimporter DKSH, and API manufacturer Cerbios-Pharma, have inresponse filed a request for patent invalidation against the keratosistreatment with the Japan Patent Office following the verdict. Chugai –which is majority-owned by Swiss originator Roche – had filed thelawsuit against the Japanese companies almost two years ago(Generics bulletin, 8 March 2013, page 20). G

DERMATOLOGICAL DRUGS

Oxarol rivals barred in Japan


An attack launched by Celltrion against three method-of-use patentsprotecting Janssen’s Remicade (infliximab) in the US has been

dismissed by a New York district court because the South Koreanfirm’s preparations to introduce a US biosimilar version are “simplynot at a stage that can support a declaratory judgement action”.

Earlier this year, Celltrion filed a complaint insisting that USpatents 7,846,442, 8,298,537 and 8,383,120 – held by the KennedyTrust for Rheumatology Research and covering the use of anti-tumour necrosis factor (TNF) antibodies such as Remicade alongsidemethotrexate – were invalid. This, Celltrion argued, was because thepatents claimed “the same invention or obvious variations of theinvention Kennedy claimed in [an] earlier, now expired patent”(Generics bulletin, 18 April 2014, page 19).

While Kennedy argued that Celltrion had not established theexistence of a controversy because the South Korean firm had “notyet engaged in meaningful preparation to conduct potentiallyinfringing activity”, Celltrion insisted that it had “substantiallyprepared” to bring its Remsima product to the US market.

But District Judge Paul Crotty decided in Kennedy’s favour,concluding that Celltrion was “simply too far from receiving US Foodand Drug Administration (FDA) approval for the exercise of declaratoryjudgement jurisdiction to be proper”.

While Celltrion has initiated the filing process for its infliximabwith the FDA (Generics bulletin, 5 September 2014, page 17), Crottyobserved that the potential for patent infringement would only berealised if this application was accepted for review, approved by theFDA, and received approval for the same use as Remicade beforepatent expiry. While these steps were “not wholly speculative orunlikely”, Crotty acknowledged, they demonstrated that any currentcourt opinion would have to be based on hypothetical facts.

The potential dispute between the parties “has not yet ripened intoa controversy”, Crotty stated. And even if the threat of injury was“sufficiently demonstrable”, he added, “the court would still exerciseits discretion to decline to hear this case in light of the existence ofthe Biologics Price Competition and Innovation Act (BPCIA) statutoryframework for the resolution of patent disputes”.

There was no reason to believe, Crotty said, that the BPCIA’sdispute-resolution procedure would be “insufficient to resolve anypatent disputes here”. Labelling as “untenable” Celltrion’s contentionthat the case was both ripe for review yet also should not be subjectto BPCIA provisions because “the time has not yet arisen for the partiesto engage in the necessary information-exchange process”, Crotty stated:“Celltrion’s attempt to skirt the BPCIA’s dispute-resolution mechanismswhile reaping the benefits of its approval process is improper.”

While Celltrion had argued that the dispute was “not appropriatefor the BPCIA pathway because Kennedy is not the reference productsponsor, but the patent owner”, Crotty said the BPCIA pathway “doesprovide for a level of involvement by the patent owner”. Moreover, hesaid, for the dispute to become ‘ripe’, Celltrion would have to resolveany patent disputes with Janssen to enable it to market its infliximab.

Celltrion had previously challenged Remicade patents held byJanssen that protect the brand until 2018, but recently withdrew thelitigation (Generics bulletin, 3 November 2014, page 1).

“Should Celltrion have a ripened patent dispute against Kennedyonce it properly engages in the BPCIA dispute-resolution proceduresand once it is further along the pathway towards approval,” Crottyconcluded, “Celltrion may litigate those issues at that time.” G

PRODUCT NEWS


BIOLOGICAL DRUGS

Celltrion is too earlyon infliximab attack

Torrent Pharmaceuticals will license versions of adalimumab,cetuximab and rituximab from Reliance Life Sciences to market

in India, under an exclusive 10-year deal struck between the twocompanies. Under the terms of the deal, Reliance will develop andsupply the biologicals to Torrent after obtaining “all necessaryregulatory approvals”.

Pointing out that it would be “the only company to market thesebiosimilars in India other than Reliance Life Sciences”, Torrent alsonoted that it had gained a “strong position” in oncology anddermatology in India since creating dedicated divisions for thesesegments in 2011 and 2012. The deal with Reliance was expected to“significantly boost its presence in these segments in the comingyears”, Torrent predicted.

“Reliance Life Sciences will manufacture these products at itsfacility in Navi Mumbai and supply to Torrent Pharma for a periodof 10 years,” Torrent stated. “Torrent Pharma has in the past launchedthe biosimilar darbepoetin under the brand name of Darbatitor, whichis used during dialysis,” the Indian company noted. G

BIOLOGICAL DRUGS

Torrent and Reliancestrike biologics deal

Amneal has failed in an attempt to challenge US patents protectingSupernus Pharmaceuticals’ Oracea (doxycycline) rosacea treatment

through inter partes review. The generics firm had claimed beforethe patent trial and appeal board of the US Patent and TrademarkOffice (PTO) that US patents 8,206,740, 8,394,405, and 8,394,406 –which relate to “once-daily, sub-antimicrobial formulations ofdoxycycline” – were invalid due to obviousness.

“Amneal has failed to persuade us that the prior art it cites fordisclosure of immediate-release/delayed-release ratios actually disclosessuch ratios,” the board said. Without evidence that the claimed ratiowas known or could have been reached through routineexperimentation, the board concluded, “Amneal’s challenge fails”. G

DERMATOLOGY DRUGS

Amneal’s Oracea reviews fail

Leading generics players such as Lupin, Mylan and Teva havebegun shipping further US rivals to Novartis’ Diovan (valsartan)

40mg, 80mg, 160mg and 320mg tablets following final US Foodand Drug Administration (FDA) approval.

The firms will compete for US market share with Ranbaxy, whichlaunched the first generic version of the antihypertensive blockbusterlast year after a near two-year wait (Generics bulletin, 11 July 2014,page 19). Sandoz has an authorised generic.

Meanwhile, India’s Jubilant Life Sciences has received final FDAapproval and said it expected to launch “immediately”, while Aurobindosaid its approved valsartan tablets were “ready for launch”. Actavis,Alembic, Hetero Labs and Torrent also hold final approvals forvalsartan tablets, while Dr Reddy’s has tentative approval.

Citing IMS Health data, Mylan said the four strengths of valsartantablets had annual US sales of around US$2 billion. G

More Diovan rivals enter USANTIHYPERTENSIVES


Sandoz has launched filgrastim in Japan in 75µg, 150µg and 300µgsyringes. The biosimilar will be jointly marketed with Sawai.Early last year, Sandoz became the “first company to secure

approval for two biosimilars in Japan” when it received a local marketingauthorisation for its filgrastim (Generics bulletin, 4 April 2014, page13). At the time, Sandoz noted that its filgrastim had been approved“for the same range of indications as the reference product”, KyowaKirin’s Gran neutropenia treatment.

Sandoz had filed an application with the Japanese health authorityfor its EP2006 filgrastim candidate – sold in other markets as Zarzio –in early 2013 (Generics bulletin, 3 May 2013, page 15). Approval forSandoz’ filgrastim in Japan follows the firm’s launch of the country’sfirst biosimilar, somatropin, towards the end of 2009 (Genericsbulletin, 16 October 2009, page 1).

Meanwhile, Sandoz has announced data from a Phase III trial thathas “demonstrated similarity of its investigational biosimilar filgrastimcompared to the US-licensed reference product, Amgen’s Neupogen”.The study – which was designed to “compare the efficacy and safetyof the investigational biosimilar and the reference product with respectto mean duration of severe neutropenia following cycle-1 chemotherapy”– supports a US filing that has just been unanimously backed forapproval by a US Food and Drug Administration (FDA) advisorycommittee (see front page). G

PRODUCT NEWS


BIOLOGICAL DRUGS

Sandoz’ filgrastim isintroduced in Japan

Aruling that found a US patent protecting Par Pharmaceutical’sMegace ES (megestrol acetate) brand until April 2024 invalid due

to obviousness has been vacated by the US Court of Appeals andremanded to the Maryland district court for further consideration.

The litigation – which also involves TWi Pharmaceuticals –revolves around US patent 7,101,576, which claims a method oftreating wasting – such as from anorexia or cachexia – in humansby administering an oral suspension of megestrol acetate once daily.

Although the appeals court said it would “agree with the districtcourt’s analysis on motivation to combine, reasonable expectation ofsuccess, and objective indicia of non-obviousness”, it found that thelower court had applied the “incorrect standard for inherency in itsobviousness analysis”.

To rely on inherency to establish the existence of a claim limitationin prior art, the appeals court said, a party must meet a “high standard”.The limitation at issue “necessarily must be present, or the naturalresult of the combination of elements explicitly disclosed by theprior art”, the court insisted.

However, because the district court had not required Taiwan’sTWi Pharmaceuticals to present evidence sufficient to prove inherencyunder this standard, the appeals court said, it had to remand the casefor “further analysis”, adding that the district court should also “considerTWi’s other grounds for invalidity”. G

WEIGHT-LOSS TREATMENTS

Par megestrol rulingoverturned on appeal


PRODUCT NEWS


TEVA has received US Food and Drug Administration (FDA)approval for its Granix (tbo-filgrastim) neutropenia treatment inthe form of an injection for self-administration by patients andcaregivers. The Israeli firm plans a launch in “early 2015”. At thesame time, the agency has approved Teva’s QNASL (beclomethasonedipropionate) 40µg nasal aerosol for treating allergic rhinitis inchildren aged between four and 11 years.

ANSM – France’s medicines agency – has added rivals to PierreFabre’s Drill Toux Seche (dextromethorphan) 15mg/5ml oralsolution to the country’s répertoire of generic equivalents. Otherreference brands added to the répertoire include HRA Pharma’sNorlevo (levonorgestrel) 750µg tablets and Septodont’s Septanest(adrenaline) solution.

FDA – the US Food and Drug Administration – has issued draftguidance for generic versions of extended-release oral budesonide.The guidance sets out recommended fed and fasting in vivo studiesas well as an in vitro comparative dissolution study.

RATIOPHARM has received a positive opinion recommendinggranting a marketing authorisation for the Teva subsidiary’sclopidogrel 75mg tablets by the Committee for Human MedicinalProducts (CHMP) within the European Medicines Agency (EMA).

LANNETT has received US Food and Drug Administration (FDA)approval for its rival to Oak Pharmaceuticals’ Cosopt (dorzolamide/timolol) 2%/0.5% ophthalmic solution. Claiming that total US salesfor dorzolamide/timolol 2%/0.5% solution were around US$123million in the year ended October 2014, Lannett noted that the eyedrops “add a new dosage form to our product offering”. The firmexpects to launch “in the coming months”.

PHARMAC – New Zealand’s Pharmaceutical Management Agency– has awarded a sole-supply deal for escitalopram 10mg and 20mgtablets to Air Flow Products until 30 June 2016 under a recent tender.Mylan’s Loxalate version will be delisted from reimbursement.

ACTAVIS and Gedeon Richter have announced that the US Food andDrug Administration (FDA) has acknowledged receipt of Actavis’new drug application (NDA) resubmission for cariprazine. Theschizophrenia treatment’s NDA is due to be reviewed by thesecond quarter of 2015.

NISSAN CHEMICAL says it has filed complaints in a district courtin Osaka, Japan, asking Kyorin Rimedio and Sanwa KagakuKenkyusho – two generic marketing-authorisation holders for rivalsto Livalo (pitavastatin) – to “cease and desist from infringing uponthe patent rights relating to a certain crystal form of the activepharmaceutical ingredient (API) of Livalo”. Similar litigation haspreviously been filed in 2014 against Sawai,Yoshindo, Nissin, NipponChemiphar, Sagami, Nichi-Iko and Kotobuki. And in 2013, the samecomplaint was levelled at Daito, Mochida, Kobayashi Kako, MeijiSeika Pharma, Towa, Tsuruhara and Kaken.

IMPAX has received US Food and Drug Administration (FDA)approval for the firm’s Rytary (carbidopa/levodopa) extended-release capsules. “The FDA approval of Rytary is an important newdevelopment for the treatment of Parkinson’s disease,” said Impax’president and chief executive officer, Fred Wilkinson, adding that thedrug was designed to reduce the amount of time when symptoms arenot controlled. Impax expects to launch 23.75mg/95mg, 36.25mg/145mg,48.75mg/195mg and 61.25mg/245mg versions in February. G

IN BRIEF

Actavis, Mylan and Teva have launched rivals to Pfizer’s Celebrex(celecoxib) 50mg, 100mg, 200mg and 400mg capsules in the US.

The generics firms had separate settlement deals with the originatorto begin shipping the arthritis treatment after a US district court lastyear invalidated reissued US patent RE44,048 that protected Celebrexuntil December 2015 (Generics bulletin, 21 March 2014, page 1).Indian player Lupin had also reached a settlement, and has launchedan authorised generic in all four strengths.

Teva said Celebrex had US sales of around US$2.56 billion forthe 12 months ended October 2014, according to IMS Health data.Only the Israeli firm holds approvals for celecoxib abbreviated newdrug applications (ANDAs) in all four strengths. Mylan and Lupin holdapprovals for the lowest strength and tentative approvals for the threehigher strengths. Actavis has tentative approvals for all four.

However, Actavis, Lupin and Mylan have had their paths toapproval for all strengths of generic Celebrex unblocked, after anappeals court judges reversed a district court ruling from last yearsupporting a US Food and Drug Administration (FDA) exclusivitydecision. The agency had awarded Teva 180-day exclusivity for threecelecoxib strengths on the basis that an earlier appeals court rulingon an original – but later reissued – Celebrex patent had not triggeredTeva’s exclusivity (Generics bulletin, 6 June 2014, page 18).

“Congress has spoken directly regarding the court-decision trigger,”the appeals judges pointed out. “The statute makes plain that the180-day exclusivity runs from ‘the date of a decision of a court in anaction ... holding the patent which is the subject of the [paragraph IV]certification to be invalid or not infringed’.” G

ANALGESICS/ARTHRITIS DRUGS

US firms introducetheir Celebrex rivals

Mylan has launched US rivals to Shionogi’s Orapred ODT(prednisolone) orally-disintegrating tablets in 10mg, 15mg and

30mg strengths, as well as a generic version of Hikma Maple’s Robaxin(methocarbamol) 1,000mg/10ml injectable. The orodispersibleprednisolone tablets – for which Mylan will enjoy 180-day exclusivity –have been launched into a branded US market worth US$19.9 millionin the year ended September 2014 according to IMS Health, whilemethocarbamol 100mg/ml had annual sales of US$15.1 million.

Meanwhile, Mylan has received tentative approval for paediatricformulations of abacavir/lamivudine from the US Food and DrugAdministration (FDA) under the US President’s Emergency Plan ForAIDS Relief (PEPFAR). The antiretroviral was approved in 60mg/30mg and 120mg/60mg strengths. G

ANTI-INFLAMMATORY DRUGS

Mylan aims at Orapred ODT

Infa group’s Sifavitor site has secured a certificate of suitability (CoS)from the European Directorate for the Quality of Medicines and health

(EDQM) for bulk glycopyrronium bromide. The Italian activepharmaceutical ingredients (APIs) producer said glycopyrrolate wouldexpand its broad respiratory portfolio. G

RESPIRATORY DRUGS

Infa can offer glycopyrrolate


Biosimilar rivals to Janssen’s Remicade (infliximab) will not beable to be listed for reimbursement in New Zealand until March

2020 at the earliest, after the country’s Pharmaceutical ManagementAgency, Pharmac, agreed an exclusive five-year hospital supply dealwith the originator. This will see Pharmac fund the brand from 1March 2015 until 29 February 2020.

From 1 January 2015, the reimbursement price of the 100mgautoimmune disease treatment has dropped by more than a third fromNZ$1,227 (US$952) to NZ$806 per pack. “Pharmac saw an opportunityto reduce the price of infliximab following expiration of the patentand subsequent launch of biosimilar rivals overseas, and the likelihoodthese would become available in New Zealand,” explained the body’sdirector of operations, Sarah Fitt.

According to the agency, spending on infliximab in New Zealandstands at around NZ$15 million per year and is “growing rapidly”.

The deal came following a call from Pharmac for pricing proposalsfrom suppliers of infliximab, including biosimilar suppliers. G

PRODUCT NEWS


BIOLOGICAL DRUGS

NZ awards Remicadesole supply to 2020

US generic rivals to Cubist Pharmaceuticals’ Cubicin (daptomycin)500mg intravenous injectable for infusion may reach the market

four years earlier than scheduled, after a US district court rulinginvolving Hospira resulted in four of the antibiotic brand’s five USpatents that run until 2020 being declared invalid. Reissued US patentRE39,071, that expires on 15 June 2016, still shields Cubicin, whichhad US sales of US$908 million in 2013. The originator said itintended to appeal against the ruling.

Delaware district Judge Gregory Sleet was convinced by Hospira’sarguments that US patents 6,468,967 and 6,852,689 – which bothexpire in September 2019 – and US patents 8,058,238 and 8,129,342,that expire in November 2020, were obvious. Moreover, Sleet ruled,certain claims of the ‘967 and ‘238 patents had been anticipated byprior art. Hospira also proved secondary considerations of obviousnessfor all four patents.

However, the US firm failed in its bid to persuade the districtcourt to revise its construction of the term ‘daptomycin’ according tothe “stereochemistry of the amino acids that comprise the compound”.

Addressing the ‘967 and ‘689 dosing patents, Sleet said bothwere obvious because prior art – US patent 5,912,226 and a 1992‘Woodworth’ research article – “offered the base elements of theclaimed invention”. Secondary considerations such as commercialsuccess did not change that finding, he added.

The Woodworth article also “disclosed each of the elements ofthe claims of the ‘967 patent, expressly or inherently”, renderingthe ‘967 patent invalid as anticipated.

Daptomycin purification methods were obviousTurning to the ‘238 and ‘342 purity patents, Sleet said the claimed

methods of purifying daptomycin would have been obvious as ofthe patents’ priority dates, thus rendering them invalid. “Hospirahas established a prima facie case that both micelle filtration andanion exchange chromatography would have been obvious methodsof purifying daptomycin to one skilled in the art,” he stated.

But Sleet determined that the reissued ’071 patent was valid,rejecting a three-pronged argument from the US firm. Hospira hadargued that the patent’s ‘Certificate of Correction’ was invalid,along with arguments that the patent was invalid for lack of writtendescription and improper recapture.

Hospira had submitted its initial daptomycin ANDA in February2012, and received final US Food and Drug Administration (FDA)approval earlier this year (Generics bulletin, 17 October 2014,page 20). The US firm has also submitted a 505(b)(2) hybrid new drugapplication (NDA) for a 350mg injectable formulation of daptomycin,which has received tentative approval from the FDA.

Last year, Cubist sued Strides Arcolab in a US district court afterthe Indian firm sent a paragraph IV challenge alleging non-infringementor invalidity against Cubicin’s five US patents. Moreover, pursuantto a settlement deal reached with Cubist three years ago, Teva maylaunch rivals to Cubicin from 24 December 2017 (Generics bulletin,22 April 2011, page 18).

As Sleet delivered his verdict, Cubist announced that it had agreedto be taken over by US originator Merck & Co in a deal worth US$9.5billion. Merck stated that the Cubicin ruling would not affect itsdecision to buy Cubist, insisting that the transaction was expected to“add more than US$1 billion of revenue to its 2015 base, with stronggrowth potential thereafter”. G

ANTIBIOTICS

Four Cubicin patentsdeemed invalid in US

Actavis has begun shipping generic rivals to Shire’s Intuniv(guanfacine) 1mg, 2mg, 3mg and 4mg extended-release tablets

in the US with 180-day exclusivity. The launch honours a settlementreached between the two firms two years ago, under which Shire willreceive a 25% royalty on Actavis’ gross profits from sales during itsexclusivity period (Generics bulletin, 3 May 2013, page 1). Citingdata from IMS Health, Actavis said the attention deficit hyperactivitydisorder treatment achieved US sales of around US$668 million inthe 12 months ended 30 June 2014.

Soon after Actavis’ agreement, Israeli firm Teva settled litigationwith the UK-based originator allowing it to launch either its owngeneric version or an authorised generic pursuant to Actavis’exclusivity period expiring (Generics bulletin, 28 June 2013, page23). Par and Sandoz have also reached settlement agreements withShire over generic guanfacine. G

ATTENTION DEFICIT HYPERACTIVITY DISORDER DRUGS

Actavis ships rival to Intuniv

Par has become the latest generics player to challenge patentsprotecting Supernus Pharmaceuticals’ Trokendi XR (topiramate)

extended-release capsules in the US. The generics firm joins Actavis(Generics bulletin, 17 October 2014, page 21) and India’s Zydus Cadila(Generics bulletin, 5 December 2014, page 23) in filing a paragraph IVabbreviated new drug application (ANDA) seeking to market a USrival to Trokendi XR ahead of patent expiry in 2027.

Meanwhile, TWi Pharmaceuticals has filed a paragraph IV ANDAfor a generic version of Supernus’ Oxtellar XR (oxcarbazepine)extended-release capsules. The epilepsy treatment also enjoys US patentprotection until 2027. Actavis was also 18 months ago sued in a USdistrict court for filing an ANDA for generic oxcarbazepine extended-release capsules (Generics bulletin, 6 September 2013, page 23). G

EPILEPSY DRUGS

Par challenges Trokendi XR


AUS court was right to deny Sandoz a declaratory ruling that thefirm’s planned biosimilar rival to Amgen’s Enbrel (etanercept)

does not infringe two patents protecting the brand, the US Court ofAppeals has decided.

Around a year ago, a northern California district court rejectedSandoz’ motion for a ruling confirming that the company’s “assertedlybiosimilar product” did not infringe US patents 8,063,182 and8,163,522 (Generics bulletin, 6 December 2013, page 23). JudgeMaxine Chesney agreed with the originator’s claim that the courtlacked the authority to consider a biosimilar patent dispute “untilafter such time as an application for US Food and Drug Administration(FDA) approval of the biosimilar product has been filed”.

No real or immediate injuryAffirming Chesney’s ruling, the appeals court said Sandoz “did

not allege an injury of sufficient immediacy and reality to createsubject matter jurisdiction”.

Sandoz’ complaint relied on Amgen’s assertion that the patentscovered Enbrel, that the originator intended to invoke the patentsagainst competitors, and that Sandoz sought to market a rival product,the appeals court noted. However, it pointed out, “Sandoz had not – asit still has not – filed an application for approval of its contemplatedproduct by the FDA”.

“Sandoz has not shown that it will suffer an immediate andsubstantial adverse impact from not being able to seek or secure apatent adjudication before filing an application for FDA approval,” theappeals court concluded. “Sandoz cannot lawfully enter the marketnow anyway, wholly apart from the ‘182 and ‘522 patents, so thereis no question of its taking immediate action that risks building upinfringement liability.”

However, the court emphasised that it would not address Sandoz’ability to seek a declaratory judgement on the matter “if and when itfiles an FDA application under the Biologics Price Competitionand Innovation Act (BPCIA)”. G

PRODUCT NEWS


BIOLOGICAL DRUGS

Sandoz appeal failsover US etanercept

APOTEX will have to defend itself against a US patent-infringementaction brought by Cipla and Meda in a bid to defend their Dymista(azelastine/fluticasone) nasal spray for the treatment of symptomscaused by seasonal allergies. The suit filed in a Delaware districtcourt alleges that the Canadian firm’s abbreviated new drug application(ANDA) infringes US patents 8,163,723 and 8,168,620, the latestof which expires in 2026.

ARTERIUM has launched in Ukraine its glimepiride 2mg, 3mgand 4mg tablets. Available in blister packs of 30 tablets, the diabetesdrug will be marketed under Dimaryl brand name.

TEVA has introduced in the US a rival to Novartis’ Exforge HCT(amlodipine/valsartan/hydrochlorothiazide) triple-combinationantihypertensive. Noting that the original had US sales of US$158million in the year ended September 2014, Teva said it expectedto enjoy 180-day generic market exclusivity.

BIOCAD has presented positive Phase III results for its Extimia(empegfilgrastim) long-acting granulocyte-colony stimulatingfactor (G-CSF) for treating patients suffering from chemotherapy-induced neutropenia in Russia. Pointing out that it had investedaround US$3 million in developing Extimia – which is due to belaunched in late 2015 – Biocad claimed its novel product was thefirst domestic G-CSF candidate.

STRIDES ARCOLAB plans in the near future to introduce thecalcitriol 0.25µg and 0.5µg soft-gel capsules for which it has justreceived approval from the US Food and Drug Administration (FDA).The Indian firm – which is making the capsules at its oral-dosefacility in Bangalore, India – valued the US market for calcitriolcapsules at around US$50 million.

BIOTON has granted Brazilian company Biomm exclusive rightsto market the Polish firm’s recombinant human insulins in Brazil.The 15-year supply deal will begin once the products have beenregistered locally.

MYLAN has introduced in the US a generic version of Novartis’Vivelle-Dot (estradiol) transdermal system. The generics firm isoffering five strengths of the twice-weekly treatment for conditionslinked to the menopause, such as vasomotor symptoms andhypoestrogenism. Sandoz responded by launching an authorisedgeneric of sister company Novartis Pharma’s brand, which had salesof US$263 million in the year ended September 2014.

F-SINTEZ has claimed the launch of Russia’s first generic versionof Janssen-Cilag’s Velcade (bortezomib) 3.5mg lyophilised powderfor injection. According to the Russian firm, the multiple myelomatreatment – marketed under the Boramilan brand name – wasincluded in a national reimbursement list.

JUBILANT LIFE SCIENCES has received final approvals for twoabbreviated new drug applications (ANDAs) from the US Foodand Drug Administration (FDA). The Indian firm has received anod for mycophenolate 250mg capsules and 500mg tablets –equivalent to Roche’s Cellcept brand – which has annual USsales of around US$245 million, along with a version of Merck’sMaxalt (ritzatriptan) 5mg and 10mg tablets.

CONSILIENT HEALTH is claiming a first-to-market UK launch ofgeneric Abilify (aripiprazole) 5mg, 10mg, 15mg and 30mg tablets. Theantipsychotic had 2013 UK sales of £84 million (US$127 million).G

IN BRIEF

Sanofi has failed in its appeal against a decision by France’sCompetition Authority to fine the firm C40.6 million (US$47.9

million) for “denigrating” generic rivals to the originator’s Plavix(clopidogrel) brand. In 2013, the Authority found that Sanofi hadpursued a “comprehensive strategy” aimed at limiting competitionand promoting the firm’s own authorised generic (Generics bulletin,7 June 2013, page 22).

A Paris appeals court upheld the Authority’s fine, based on itsconclusion that Sanofi had abused its dominant market position througha strategy that included convincing doctors to mark Plavix prescriptionsas ‘non-substitutable’, as well as urging pharmacists to substitute thebrand with an authorised generic rather than any other competitors.

Teva – which was a party to the appeal proceedings – had in 2010asked the Authority to issue an injunction against Sanofi. However,at that time the Authority concluded that the originator’s practicesdid not pose a sufficiently immediate and serious threat to takeurgent measures (Generics bulletin, 28 May 2010, page 15). G

CARDIOVASCULAR DRUGS

France upholds fine on Sanofi


Teva expects to launch its 40mg/ml strength of Copaxone (glatirameracetate) in Europe “as early as the first quarter of 2015”, having

just received “a positive outcome in the decentralised procedure” forthe three-times-a-week formulation of its branded multiple sclerosistreatment. Using the UK as a reference member state, Teva said it hadreceived a positive assessment report from the country’s Medicinesand Healthcare products Regulatory Agency (MHRA) as well as allconcerned member states involved in the procedure.

“Granting of national authorisations will happen in the near future,”Teva said, revealing that it intended to initially launch the 40mg/mlCopaxone in Denmark, Germany and the Netherlands. “Launches inother European Union (EU) countries are expected throughout 2015,”the Israeli firm stated.

Around a year ago, Teva launched the higher 40mg/ml strengthof Copaxone in the US, soon after receiving approval (Genericsbulletin, 3 February 2014, page 7). “The new formulation reducesthe total number of injections by almost 60%”, Teva noted, “whilemaintaining the known benefits of once-daily Copaxone 20mg/ml.”

Meanwhile, Teva’s Canadian affiliate has announced that it will be“the sole generic supplier” of rivals to Roche’s Tarceva (erlotinib) afterreceiving a Notice of Compliance (NOC), or marketing authorisation,from Health Canada for a rival to the lung-cancer drug, which hasannual Canadian sales of around C$15 million (US$13.1 million). G

PRODUCT NEWS


MULTIPLE SCLEROSIS DRUGS

Teva eyes EU launchfor Copaxone 40mg

Ajury verdict in US multi-district antitrust litigation over a settlementbetween Ranbaxy and AstraZeneca for the originator’s Nexium

(esomeprazole) has been welcomed by the companies. “The lawsuitsalleged that Ranbaxy’s April 2008 patent settlement agreement withAstraZeneca concerning esomeprazole magnesium violated US antitrustlaws,” the Indian firm noted. AstraZeneca said it had always maintainedthat the allegations were “without merit”.

The jury found that AstraZeneca exercised market power withinthe relevant market, that the settlement included “a large and unjustifiedpayment by AstraZeneca to Ranbaxy”, and that the settlement was“unreasonably anti-competitive”. But without the settlement, the juryconcluded, AstraZeneca would not have agreed that Ranbaxy couldlaunch a generic before 27 May 2014, the earliest expiry date of thedisputed patents (Generics bulletin, 2 June 2008, page 15).

Challenged FDA on esomeprazoleRanbaxy recently launched a challenge against the US Food and

Drug Administration (FDA) after the agency stripped the firm of tentativeabbreviated new drug application (ANDA) approvals for esomeprazolealong with valganciclovir (Generics bulletin, 5 December 2014, page27). Dr Reddy’s and Endo have both launched valganciclovir tablets,competing with Roche’s Valcyte original that Dr Reddy’s said had USsales of around US$440 million in the year ended October 2014. G

GASTROINTESTINAL DRUGS

Ranbaxy welcomesruling on US Nexium


EVENTS


21 January

■ 8th EGA PharmacovigilanceDiscussion ForumLondon, UKThis European Generic medicinesAssociation (EGA) event will take theform of a discussion forum and look attopics including pharmacovigilancelegislation with speakers from the industryas well as from agencies.Contact: Lucia Romagnoli, GPA Conferences.Tel: +44 7562 876 873.E-mail: [email protected] online at www.egagenerics.com orwww.egaevents.org.

22-23 January

■ 14th EGA Regulatory &Scientific Affairs ConferenceLondon, UKThis two-day conference will follow theEGA’s Pharmacovigilance Forum. Bothevents are at the same venue in London.Topics covered at both meetings willinclude risk-management plans, periodicsafety update reports, signal detection,joint studies and inspections.

Contact: Lucia Romagnoli, GPA Conferences.Tel: +44 7562 876 873.E-mail: [email protected] online at www.egagenerics.com orwww.egaevents.org.

9-11 February

■ GPhA 2015 Annual MeetingMiami, USThis is a three-day meeting of the USGeneric Pharmaceutical Association(GPhA) which will look at regulatory issuesand opportunities for the industry. Therewill also be networking opportunities.

Contact: GPhA.Tel: +1 202 249 7127.E-mail: [email protected]: www.gphaonline.org.

4-5 March

■ World Generic MedicinesCongress Europe 2015Madrid, SpainTopics covered at this two-day conferencewill include growth strategies, pricing,biosimilars, legal issues and market trends.

Contact: Health Network Communications.Tel: +44 207 092 1210.E-mail: [email protected]: www.healthnetworkcommunications.com.

9-10 March

■ EuroPLX 57Cascais, PortugalThis meeting provides a forum for business-development decision makers to discuss andnegotiate agreements, in-licensing, marketingand distribution of patented medicines,generics, biosimilars, OTC products,medical devices and food supplements.

Contact: Raucon.Tel: +49 6221 426296 0.E-mail: [email protected]: www.europlx.com.

12-13 March

■ 7th PharmeetMallorca, SpainThis two-day event is designed to offerdelegates the opportunity to network aswell as the chance to strike licensingdeals for a wide range of productsincluding biosimilars.

Contact: PharMeet.Tel: +34 91 637 0660.E-mail: [email protected]: www.pharmeet.com.

26-27 March

■ 11th EGA LegalAffairs ForumBrussels, BelgiumThis is a two-day event organised by theEGA which will look at issues includinglitigation, regulatory matters and patent

settlements. The forum will also offernetworking opportunities.Contact: Lucia Romagnoli, GPA Conferences.Tel: +44 7562 876 873.E-mail: [email protected] online at www.egagenerics.com orwww.egaevents.org.

13-15 April

■ DIA 27th AnnualEuroMeetingParis, FranceIssues to be covered at this three-day eventinclude innovation, clinical trials legislationand medical devices. There will be speakersfrom firms including Amgen and Sanofi.

Contact: DIA.Tel: +41 61 225 5151.E-mail: [email protected]: www.diaeurope.org.

20-21 April

■ 3rd Annual Biosimilars &Biobetters CongressLondon, UKThis event will address topics includingmarket access and strategies within theindustry. Presentations will provideinformation on emerging markets as wellas global commercialisation strategies. Thedevelopment of biosimilars and biobetterswill be the focus of day two.

Contact: Oxford Global.Tel: +44 1865 248455.E-mail: [email protected]: www.oxfordglobal.co.uk.

23-24 April

■ 13th EGA InternationalBiosimilars ConferenceLondon, UKThis meeting is organised by the EGAand will cover topics including industrydevelopments and regulatory issues forthe biosimilars industry.Contact: Lucia Romagnoli, GPA Conferences.Tel: +44 7562 876 873.E-mail: [email protected] online at www.egagenerics.com orwww.egaevents.org.

16-19 September 2015

■ 18th IGPA Annual ConferenceToronto, CanadaThis three-day event is being organised by the Canadian GenericPharmaceutical Association. It is the annual joint meeting of the Canadian, European,Japanese, Jordanian, South African and US generics industry associations, the CGPA,EGA, JAPM, JGA, NAPM and GPhA. Pharmaceutical executives have the opportunity totake part in conference workshops, and listen to industry experts discuss current issuesregarding the international pharmaceutical sector during a full schedule of plenarysessions. There are also opportunities to network.

Contact: Julie Tam, CGPA. Tel: +1 416 223 2333.E-mail: [email protected] Website: www.igpa2015toronto.com.

JANUARY

FEBRUARY

MARCH

APRIL

SAVE THE DATE ...The Global Generics & BiosimilarsAwards 2015 will be held onTuesday13 October 2015 in Madrid, Spain.

Gen 16-1-15 Pg. 24_Layout 1 13/01/2015 16:42 Page 2

PRICE WATCH ............ UK


BIGGEST RISERSProduct/Strength/Pack size Lowest Change Average Change

price (%) price (%)

Fosinopril tabs 10mg 28 £1.25 +6 £8.38 +424

Fosinopril tabs 20mg 28 £1.55 -1 £8.03 +294

Lisinopril+HCT tabs 20/12.5mg 28 £0.89 +7 £3.40 +123

Mefenamic acid tabs 500mg 28 £1.65 ±0 £5.21 +86

Hypromellose drops 0.3% 10ml £0.23 -4 £0.79 +71

Dipyridamole tabs 100mg 84 £3.40 +10 £7.26 +49

BIGGEST FALLERSProduct/Strength/Pack size Lowest Change Average Change

price (%) price (%)

Valsartan+HCT tabs 80/12.5mg 28 £1.09 ±0 £2.11 -39

Valsartan+HCT tabs 160/25mg 28 £1.99 +18 £2.92 -37

Irbesartan+HCT tabs 150/12.5mg 28£0.99 ±0 £1.86 -33

Irbesartan+HCT tabs 300/25mg 28 £1.39 -7 £2.44 -31

Irbesartan+HCT tabs 300/12.5mg 28£1.39 -4 £2.47 -30

Nitrofurantoin tabs 100mg 28 £2.05 -18 £4.36 -29

Figure 1 (above): Comparison between the periods 1-30 November and 1-31 December2014 of UK trade prices of the most recently-launched generics listed in category Mof the Drug Tariff of pharmacy-reimbursement prices. Averages calculated from atleast 30 data points. Figure 2 (top right): Ranking of fastest-moving products subjectto the most price offers made to independent UK pharmacists (one strength peringredient; offers recorded by 31 December). Figure 3 (centre right) and Figure 4(bottom right): Biggest average trade-price changes between 1-30 November and 1-31December 2014. Averages calculated from at least 20 data points. Data for Figures 2,3 and 4 from a basket of about 750 commonly-dispensed generics. Recently-launchedproducts in Figure 1 excluded from Figures 3 and 4 (Source – WaveData).

Detailed product price comparisons and other price analyses are available at www.wavedata.net.

To find out more about subscribing, please email your contact details to [email protected] and quote ‘GB online enquiry’ in the title line.

■ For further information see www.wavedata.co.uk. Alternatively, contact Charles Joynson at WaveData Limited, UK.Tel: +44 (0)1702 425125. E-mail [email protected].

WANT MORE LIKE THIS?

RECENT LAUNCHES

Product/Strength/Pack size Lowest Change Average Changeprice (%) price (%)

Amorolfine lacquer 5% 5ml £3.74 ±0 £5.39 -11Atorvastatin tabs 20mg 28 £0.48 -4 £0.91 +8Candesartan tabs 8mg 28 £0.38 +9 £0.78 -1Cilostazol tabs 100mg 56 £9.20 -8 £18.20 +3Cyclizine tabs 50mg 100 £7.85 +1 £10.84 +3Desloratadine tabs 5mg 30 £0.35 -10 £0.80 -2Desogestrel tabs 75µg 84 £1.72 ±0 £2.59 ±0Donepezil tabs 10mg 28 £0.60 -9 £1.17 +6Entacapone tabs 200mg 30 £4.65 -3 £5.56 -2Escitalopram tabs 10mg 28 £0.70 -3 £1.21 +6Hydroxychloroquine tabs 200mg 60£3.30 ±0 £4.23 +3Irbesartan tabs 75mg 28 £0.25 ±0 £0.74 ±0Latanoprost eye drops .005% 2.5ml £0.95 ±0 £1.59 +6Memantine tabs 10mg 28 £1.09 -13 £2.81 -1Montelukast tabs 10mg 28 £0.99 ±0 £1.62 +4Naratriptan tabs 2.5mg 6 £1.25 +5 £1.56 ±0Quetiapine tabs 25mg 60 £0.45 -4 £1.11 +4Rabeprazole tabs 10mg 28 £1.33 ±0 £1.85 -1Raloxifene tabs 60mg 28 £4.19 +16 £6.25 -5Riluzole tabs 50mg 56 £13.99 ±0 £26.73 +5Rizatriptan tabs 10mg 3 £0.86 ±0 £2.67 +13Sildenafil tabs 100mg 4 £0.39 ±0 £0.68 +2Telmisartan tabs 80mg 28 £0.80 -10 £1.83 +1Tolterodine tabs 2mg 56 £1.44 -7 £2.37 ±0Zolmitriptan tabs 2.5mg 6 £0.42 +8 £0.98 +5

December was a quiet month for recently-launched products incategory M of the Drug Tariff of pharmacy reimbursement prices.

As Figure 1 shows, lowest and average price changes were low ornon-existent, with only a handful of items experiencing double-digitprice changes at the year-end.

Irbesartan 75mg in 28-tablet packs was typical, with no movementin its lowest or average price. Versions of the antihypertensive combinedwith hydrochlorothiazide (HCT), however, told a different story. Fallsin their average prices of about a third were some of the highestrecorded in the month (see Figure 4).

Average prices for valsartans with HCT fell even faster, reversingtheir upward price movement of a few months ago. At that time, withmonthly price increases of 50%, they were in Figure 3 among thebiggest risers (Generics bulletin, 3 November 2014, page 25).

However, just as the market for one type of antihypertensive seemedto be settling down, another was starting to take off.

Average prices for plain fosinopril tablets shot up by four- andfive-times last month, making a mockery of their Drug Tariffreimbursement prices. Pharmacists would have been reimbursed £1.92(US$2.90) for dispensing the 10mg strength last month, but they wouldhave paid a trade price of £8.38 for it (see Figure 3).

Curiously, neither fosinopril strength appeared in the list of priceconcessions granted by the Department of Health for December –overriding Drug Tariff prices for products with high trade prices – butlisinopril 20mg with HCT 12.5mg was given a late listing on 23December. The concession reflected a doubling of the product’s averagetrade price to £3.40 – compared with a Drug Tariff price of £1.70 –but at £11.52, the concession meant pharmacists were easily in pocket. G

Antihypertensive prices under pressure

FAST MOVERSPrice offers as at 31 December

Product/Strength/Pack size October November December

Omeprazole caps 20mg 28 122 141 102

Fluoxetine caps 20mg 30 101 102 87

Lansoprazole caps 15mg 28 97 106 85

Warfarin tabs 1mg 28 85 97 85

Alendronate tabs 70mg 4 96 106 84

Amitriptyline tabs 25mg 28 80 87 84

Citalopram tabs 10mg 28 91 93 84

Tramadol caps 50mg 100 86 114 81

Atorvastatin tabs 40mg 26 93 94 80

Ramipril caps 10mg 28 94 91 78

Gen 16-1-15 Pg. 25_Layout 1 13/01/2015 13:32 Page 3

As he reaches the first anniversary of joiningMylan in the role of president of Europe, JacekGlinka is clear about what attracted him to make

the switch from Poland’s Polpharma – the globalmanufacturing, distribution and marketing platformsthat the group could offer. “Mylan has all the ingredientsto make a perfect pharma company,” Glinka insisted.

Speaking exclusively to Generics bulletin, Glinkanoted that Mylan had, until around seven years ago,focused on the US. But after the purchases of MerckKGaA’s generics division and of Matrix in 2007 –followed by several other acquisitions – the companyhad become the third-largest generics player in Europewith 2013 generics sales in the firm’s Europe, MiddleEast and Africa (EMEA) region of US$1.50 billion,equal to 22% of group sales (see Figure 1) .

While acquisitions such as Merck Generics havegiven Mylan a commercial presence in more than 20European countries, that regional footprint coverspredominantly Western and Central Europe, led byFrance which accounted for around a tenth of groupglobal turnover that reached US$6.91 billion last year.

Glinka – who served as Polpharma’s chiefexecutive officer in two stints up to 2013, havingpreviously worked at leading management consultancies(Generics bulletin, 1 November 2013, page 23) –and Mylan’s global management team recognised theneed to expand the company’s scale and reach in Europeto help achieve the group’s long-term growth targets.

“We want to increase our presence in the easternpart of Europe. There are still a few territories thatwe do not cover, and there are some countries wherewe are not a market leader, which is the status weaspire to reach in Europe,” he stated.

In the Czech Republic and Slovakia, Mylanclaims to be among the top-10 industry players, butit is outside the top 10 in Greece, Hungary and Poland,and has no direct presence further east.

“We are the market leader in France, and we ranksecond in Italy and third in Portugal, while in Belgium,the Netherlands, Sweden and the UK we are in thetop five, according to IMS data. But there are manycountries where we are not in the top five,” Glinka stated.

In France, Mylan’s broad portfolio of 261 productsin 759 dosage forms gave it a leading 27% share of

the company-branded generics market in 2013. Theshare by volume was 19.5% in Italy, where the firmmarketed 186 retail products in 351 strengths.

Stressing the need to take a tailored approach toevery European country, Glinka said Mylan wouldconsider both organic and inorganic strategies as itlooked to expand in Central and Eastern Europe. “Insome countries you could pursue an organic route, inothers you would have to acquire something to becomea meaningful player,” he commented.

“Today’s generics market is very fragmented, sothere is a lot of room for organic development, and forthat Mylan is extremely well positioned,” he said. “Wehave more than 1,300 molecules in our portfolio, over2,000 in the pipeline, more than 35 manufacturing plantsaround the world and several research and developmentcentres offering the vast majority of delivery technologies.”

“But the market is also consolidating a lot, so asmuch as we like organic growth, we expect to pursueexternal opportunities as well.” Since going globalthrough Merck Generics and Matrix in 2007, Glinkaobserved, Mylan had continued to expand throughacquisitions, not least by paying around US$1.65 billionfor Strides Arcolab’s Agila injectables business at theend of 2013 (Generics bulletin, 10 January 2014, page 3).

Abbott deal adds scale in EuropeMylan’s latest major transaction, announced midway

through last year, is its US$5.3 billion deal to acquireAbbott’s specialty and branded generics business in‘developed markets’ other than the US (Genericsbulletin, 10 January 2014, page 3). As part of the deal,Mylan intends to re-domicile via a holding companybased in the Netherlands.

Through the all-share transaction that is scheduledto close early this year, Mylan will gain a portfolio ofmore than 100 specialty and branded generic productsin five major therapeutic areas: cardio/metabolic;gastrointestinal; CNS/pain; anti-infective/respiratory;and women’s and men’s health. “With a strong presencein Europe, Japan, Canada, Australia and New Zealand,the assets are expected to provide approximately US$1.9billion in annual additional revenues,” Mylan stated.

Commenting on the proposed transaction, Glinkasaid the deal would not only add scale to Mylan’sEuropean operation, but also strengthen its hand inoperating in both brand-led and substitution- ortender-driven markets. “Today you can say Mylan isslightly better positioned towards tender and substitutionmodels, because of the infrastructure we have developedso far. I believe the Abbott deal will give us an enhancedbalance and infrastructure to better address both models.”

“A major part of the business being acquired is inEurope,” Glinka pointed out. “It will roughly double thesize of our business in Europe.”

Abbott’s portfolio would be important in expandingMylan’s footprint in Central and Eastern Europe, he said.“Probably this was the capability that was missing, evenwhere we had our own commercial infrastructure, it

BUSINESS STRATEGY


Expanding in Central

and Eastern Europe

and exploring options

in the over-the-counter

(OTC) sector are

among the priorities

for Mylan Europe, the

business’ president,

Jacek Glinka, told

Aidan Fry.

Eastern expansion and OTCfeature for Mylan in Europe

Business Annual sales Reported Constant-currencysegment (US$ millions) change(%) change (%)

North America 3,011 -7 -7EMEA 1,500 +11 +8Rest of World 1,365 +3 +14Other 26 -18 –Generics 5,901 -1 +1

Specialty 1,009 +19 +19

Mylan 6,909 +2 +4

Figure 1: Breakdown by business segment and region of Mylan’s sales in 2013 (Source – Mylan)

Jacek Glinka


was not sizeable enough to be able to address 100%of the market,” he acknowledged, adding that theenhanced commercial platform would allow Mylan toroll out its existing global portfolio, as well as futuregrowth drivers such as respiratory and biological drugs,throughout the region.

Highlighting Mylan’s corporate mission ofproviding access to high-quality medicines to 7 billionpeople, Glinka stressed that the firm was committedto operating “in all countries and all segments inEurope”. While major generics rivals had divestedoperations in Western Europe or voiced reluctance toparticipate in tenders, Mylan intended to adapt itsbusiness model to local market needs.

“In almost every country, the government ispursuing cost-cutting initiatives,” Glinka recognised.However, he stressed, there were opportunities togrow, not only in Central and Eastern Europe, butalso in Western European countries such as Italy thathad limited generic usage. “Even in countries that arenot growing, we are able to expand by improving ourmarket share. If you add to that the opportunitiespresented by markets we have still to enter, andsegments like the OTC sector, we have plenty of scope.”

Mylan’s chief executive officer Heather Breschrecently said the company would build upon the Abbottportfolio to explore non-prescription opportunities inEurope (Generics bulletin, 5 September 2014, page 5).

Glinka echoed Bresch’s enthusiasm. “Abbott givesus a small step towards building a presence in the OTCsegment,” he said, noting that Mylan had only arelatively small non-prescription portfolio at present.However, he declined to be drawn on how MylanEurope would address the OTC opportunity.

In general, Glinka explained, Mylan was lookingfor business-development and in-licensing deals thatwould expand its European portfolio. While the groupcould offer most delivery forms – including in attractiveniche segments such as dermatology and ophthalmics –it was impossible to invest in every technology orproject, he pointed out. “Our infrastructure, know-howand relationships with physicians, pharmacists andwholesalers offer a unique opportunity for many firmsto find the right home for their products,” he argued.

Through a deal struck with Pfizer three years ago(Generics bulletin, 18 November 2011, page 1), Mylanacquired exclusive global rights to develop and marketa generic version of GlaxoSmithKline’s Advair/SeretideDiskus (salmeterol/fluticasone) using Pfizer’s dry-powder inhaler platform. And last year, Mylan struckan alliance with UK-based respiratory specialistProsonix (Generics bulletin, 2 May 2014, page 13).

“We have invested heavily in becoming a majorplayer in respiratory.” A former Pfizer site in Sandwich,UK, leads global respiratory research and development,while manufacturing is centred in Dublin, Ireland.

Through the Agila transaction, Mylan also gainedan injectables plant in Warsaw, Poland, to add to asimilar facility in Galway, Ireland, that it picked upthrough a US$550 million move for Bioniche in 2010.

“The Polish facility will have an important rolein servicing local customers, but we would also liketo utilise it for other markets,” Glinka explained. TheAgila deal, he noted, had given Mylan not only globalsterile production capacity, but also one of the largestgeneric injectable portfolios and pipelines, with around

700 marketed products and a further 350 in development.While Mylan already had substantial hospital

businesses in France, Italy, Portugal, Spain and theUK, it planned to expand into other countries. “Thisis very much part of our vision for Central and EasternEurope,” Glinka revealed.

A strong base in hospitals would be vital for rollingout Mylan’s pipeline of biosimilar monoclonalantibodies and insulins that the firm is developing withIndia’s Biocon, he stressed. Noting that Mylan hadidentified biologics as a key growth driver, Glinkapointed out that the partners had recently introducedtheir first biologic, Hertraz (trastuzumab), in India,and were preparing for European launches.

“Unlike some companies that are pulling out,Mylan believes Europe is a good place to invest inmanufacturing,” he stated, pointing to the respiratoryand injectables sites in Ireland, Poland and the UK.Furthermore, the group has oral solid-dose packagingfacilities in Meyzieu, France, and Komárom, Hungary.

The French site was dedicated to the sizeable localmarket, Glinka explained, while the Komárom planton Hungary’s border with Slovakia enabled Mylanto adapt quickly to shifts in demand throughout Europe.

“Whenever possible, you want to bring the bulkproduct as close as possible to the customer and dopackaging on demand. In tender-driven markets likeGermany, this is a critical capability, because otherwiseyou risk a failure to deliver – incurring high penalties– or writing-off stock if your bid fails,” he said.

“Mylan is the best positioned to be competitivein the tender environment, because of the scale andflexibility of our manufacturing base,” he maintained.And for this, vertical integration through Matrix’active pharmaceutical ingredients (APIs) was crucial.

“Today, Mylan manufactures around 80% of itsfinished products internally,” he stated. “When we firstbought Merck Generics, approximately 70% wasproduced externally, so we have made great progress.” G

BUSINESS STRATEGY

“Abbott gives us a

small step towards

building a presence in

the OTC segment”

Having two years ago introduced its first antiretroviral (ARV) treatment forHIV/AIDS in Europe by launching lamivudine film-coated tablets in Italy and

the UK, Mylan has set out to become “a champion” of access to effective diagnosisand treatment throughout the continent. Building on its global experience in the field– two-fifths of patients receiving treatment in developing countries depend on thecompany’s ARVs – the firm is seeking to broaden awareness and available solutions.

With a European portfolio of four ARV drugs, including combinations, marketedto date, Mylan has HIV franchises in countries including Belgium, the CzechRepublic, France, Italy, the Netherlands, Poland, Spain and the UK. “We havestarted to build a considerable presence, and there is more to come,” promisedJacek Glinka, president of Mylan Europe.

In rolling out its European ARV portfolio, the company is working closely withpatients’ groups and professional societies such as the European Association ofHospital Pharmacists (EAHP) and the UK’s HIV pharmacy association, the HIVPA.

For example, in Spain, Mylan’s local subsidiary is working with regionalauthorities and pharmacies to provide several services, such as HIV screening andpersonalised service doses (PDS) to improve patient compliance (Generics bulletin,8 August 2014, page 21).

“Mylan is the world’s largest manufacturer of active pharmaceutical ingredients(APIs) for HIV treatments,” Glinka pointed out, adding that this gave the group a“huge advantage” in ensuring reliability of supply. “We have a global portfolio ofapproximately 50 ARV products, and we are working on developing most of theimportant HIV molecules,” he stressed. G


Championing HIV therapy in Europe


Having midway through last year recruited SiggiOlafsson to lead Teva’s newly created GlobalGeneric Medicines (GGM) unit, the Israeli

group’s president and chief executive officer, ErezVigodman, set the former Actavis executive a toughtask. Over the three-year period from 2013 to the endof 2015, the Generics operation is to improve itsoperating profit by six-and-a-half percentage pointsto around 27% by the end of 2015.

Olafsson’s operational colleagues are lending ahand as part of an efficiency drive, not least througha plan to achieve an average cost per 1,000 tablets ofless than US$10 and to migrate within five years 60%of the group’s production capacity to low-cost locationsoffering 1,000 tablets for US$6-US$7.

Even if Teva gets greater control of its cost ofgoods, Olafsson and his team still have their work cutout to drive up margins during a period when the group’sgenerics sales are forecasted to decline by at least 4%.

The multi-faceted solution that Olafsson and histeam have devised includes: optimising Teva’s genericsportfolio to focus on the most profitable drugs; fillingin portfolio gaps through business-development deals;capitalising on the group’s active pharmaceuticalingredient (API) capabilities; and refocusing thebusiness’ strategy in ‘growth’, or emerging, markets.

Presenting the Generics unit’s business strategyand outlook to investors, Olafsson pointed out thatTeva’s market-leading position with an estimatedglobal generics turnover of US$9.8 billion last yearcarried with it an inherent level of complexity.

“We have 53 finished-dose manufacturing plants,delivering more than 1,000 molecules across 35,000stock-keeping units (SKUs),” he observed. In a bid tosimplify this supply chain, Teva is currently closing ordivesting several sites as it looks to shift production tothe lowest-cost locations.

“We are much more focused on which markets weoperate in and how we play in those markets,” Olafssonmaintained. “We are taking decisions much faster.”

While the US and Europe accounted for around

two-fifths and a third respectively of 2013 generics salesof US$9.91 billion (see Figure 1), the business also hadsizeable operations in countries including Canada,Russia and Japan, as well as in parts of Latin America.“Teva has a top-three position in more than half of the60 countries in which we operate,” he pointed out.

Boosted by better performances in Europe andRussia, the Generics business made significant stridesin improving its operating margin during 2014.

The 22.9% Generics segment margin reported forthe third quarter of 2014 – derived from gross profit lesssales and marketing costs and research and developmentexpenses, but excluding general and administrationexpenses, amortisation and certain other items – wasseven percentage points higher than the 15.9% achievedin the third quarter of 2013 (see Figure 2).

And having closed 2013 with a fourth-quartermargin of 19.2%, Teva believes the Generics segmentimproved its margin by around four percentage pointsin 2014. If the segment hit the mid-point of Teva’s 2015forecast of a segment margin between 25.0% and 29.0%,it would reach around 27%, roughly on a par withTeva’s peers, Olafsson noted.

The mid-point of Generics sales guidance for 2015,US$9.3 billion, implies a decline of around US$500million, or 5%, from the US$9.8 billion Teva expectsto report for 2014 (see Figure 3). And the drop since2013, when Generics sales narrowly exceeded US$9.9billion, will be around 6%, as adverse currency shiftsand anticipated competition on generic Pulmicort(budesonide) in the US – the group’s best-sellinggeneric – during the first half of this year more thanoutweigh the effect of product launches.

“From 2017 onwards, we will start to grow the topline again,” Olafsson promised, highlighting theimportant role emerging, or ‘growth’, markets wouldplay. “We now have a strategy in place for how weare going to grow into these markets. We want to bebigger in fewer markets, that is how we will get thebest return on our investment.”

BUSINESS STRATEGY


Streamlining its global

supply chain, altering

European business

models and focusing

on the most promising

emerging markets are

among the strategies

Teva intends to employ

to raise the bottom

line of its global

generics business.

Aidan Fry reports.

Teva is to make more fromless sales in fewer markets

US~US$4.2bn

Canada~US$0.5bn

Latin America~US$0.6bn

Europe~US$3.4bn

Japan, Asia~US$0.7bn

Russia~US$0.3bn

CIS~US$0.4bn

Figure 1: Breakdown by region of Teva’s Generics sales totallingUS$9.91 billion in 2013 (Source – Teva)

50

40

30

20

10

0

Pro

fit

mar

gin

(%)

Gross profit margin Segment profit margin

39.5%43.1% 43.5% 41.6%

44.3%46.0%

15.9%19.2% 20.8% 21.2% 22.9%

27.0%

Q3 13 Q4 13 Q1 14 Q2 14 Q3 14 2015 mid-point

Figure 2: Gross profit and operating profit margins for Teva’s Generics business unit between thethird quarters of 2013 and 2014, with the mid-point of 2015 margin forecasts (Source – Teva)


“In our growth markets, we are focusing on thebig countries,” he explained. “We are not going to bein every market, we will select around 10 in which wewill probably have to make inorganic moves to grow.”

Olafsson outlined that fast-growing ‘BRIC’countries – Brazil, Russia, India and China – werepriorities while the firm would take a selective approachto ‘tier one’ markets such as Argentina, Indonesia,Mexico, South Korea, Turkey and Venezuela.

Addressing Teva’s position in Latin America,Olafsson said the firm had strong operations in Chileand Peru, but was relatively weak in Brazil andMexico.“We rank number 81 in Brazil, and that is noposition for Teva to be in that market,” he admitted.However, faced with high valuations for local takeovertargets, Teva would pursue organic growth fromcomplex generics, OTC and branded specialty productswhile waiting for the right inorganic opportunity.

“In Russia, we are number five in terms of genericscompanies. I would love to be in the top three in Russia.We are quite big due to our Specialty business, but westill have room to grow,” he continued.

“We have hardly any business in China,” Olafssonacknowledged, stressing the need for local scale tojustify the expense of developing drugs to meet Chineserequirements. “You cannot ignore what will, by 2018,be the second largest pharma market in the world.”

In some smaller Asian markets such as Indonesia,Teva would aim to outpace double-digit market growth.

“We have prioritised our European markets intothose we want to invest more in, and those we mightwant to leave or at least have a different businessstructure,” he commented. “Our volume strategy hasbrought us to a 14% market share in the EuropeanUnion and a top-three position in 20 markets.”

But as Teva shifted its focus to generating valuerather than volumes in Europe – such as by taking aselective approach to tenders in countries like Germanyand the Netherlands – Generics turnover would declinefrom US$3.48 billion in 2013 to an estimated US$2.6-US$3.0 billion in 2015.

As part of an assessment exercise announced afew months ago (Generics bulletin, 14 November 2014,page 1), the company had classified its Europeangenerics markets into several buckets. Italy and Polandwere among the group of expanding markets in whichTeva planned to invest, while in France and Spain thefirm was working to catch up with changing marketconditions, such as with the introduction of tenders inAndalusia. “We are reducing our product offering inFrance to improve profitability,” Olafsson said.

In major markets like Germany, Teva was lookingto improve how it handled tenders. But in some smallercountries in central Europe – such as Slovakia andSlovenia – or in tender-driven Nordic markets, the firmmight have to alter its approach. “I would see us perhapschanging our business model in Norway,” he revealed.

By optimising its footprint, aligning salesforceswith market forces and adjusting its portfolio, Tevais aiming to improve its European Generics operatingmargin from 12% in 2013 to at least 20% in 2015.

“Our US operation has seen an increase of morethan 10% in profit between 2012 and 2014,” Olafssonpointed out. This, he said, had been achieved amidcustomer consolidation that was putting pressure onprices. “The top-three customers in the US are now

over 60% of the business, and globally the top-threecustomers are getting close to 50%,” he noted.

Citing IMS Health data showing that Teva wasgenerating greater value and shedding less volume thanits US generics rivals, Actavis and Mylan, Olafssonsaid Teva wanted to retain US generics marketleadership and regain the top spot in generic injectables.

The prospect of competition to Teva’s best-sellinggeneric drug, a version of Pulmicort (budesonide),would all but wipe out sales growth from a roster ofup to 30 potential generics launches in the US during2015, he said. Among potential introductions are genericAloxi (palonosteron), Oxycontin ER (oxycodone) andVenofer (iron sucrose), as well as settlement-basedlaunches of generic Aggrenox (aspirin/dipyridamole),Avodart (dutasteride), Epi-Pen (epinephrine) and Zyvox(linezolid). Alternatives to Arixtra (fondaparinux),Crestor (rosuvastatin), Epzicom (abacavir/lamivudine),Mozobil (plerixafor) and Nasonex (mometasone)could follow in 2016.

Having allocated 47% of its 2014 generics researchand development budget to its US pipeline, Teva intendsthis year to shift its focus so that three-fifths of anenlarged budget is devoted to the US.

“We might not be at quite the level of productspending with regulatory agencies as some of ourcompetitors, but the level of complexity and the valueof the pipeline is second to none,” Olafsson insisted.Among the complex-generics technologies into whichthe firm was investing were nasal suspensions, vaginalrings, transdermal patches and thin films, as well asinjectable devices and long-acting injectables.

Noting that quality issues had led Teva to scaleback drastically its US generic injectables presence,Olafsson said recent launches such as enoxaparin andreintroducing discontinued drugs amid shortages wouldraise sales from less than US$100 million in 2014 toover US$300 million this year.

While “first-wave” biosimilars and follow-onbiologics such as filgrastim were generating annualsales of around US$400 million for Teva, Olafssonadmitted that Teva had only a “limited programme”for “second-wave” monoclonal antibodies comingoff patent through to 2021.

“There is no question we have a gap, especially inwave two,” he recognised. To fill that gap, Teva waslooking to use its extensive commercial infrastructure,research and development expertise and strong balancesheet to explore partnerships. G

BUSINESS STRATEGY

“We want to be

bigger in fewer markets,

that is how we will

get the best return on

our investment”


US$20.0bn – US$20.3bn US$19.0bn – US$19.4bn

2014 2015

OTC/Other

Multiple sclerosis

Specialty excludingmultiple sclerosis

Generics

1.9

4.1

4.3

9.8

1.55 – 1.7

3.5 – 3.7

4.25 – 4.65

9.1 – 9.5

Figure 3: Forecasts for sales by Teva’s product lines in 2014 and 2015 (Source – Teva)


Lannett has appointed Michael Bogda, formerly head of Teva’sAmericas Technical Operations, as its president. He takes those

responsibilities from company chief executive Arthur Bedrosian,who had held the title of president since May 2002. Bedrosian willremain as chief executive officer, a role he has served sinceJanuary 2006 (Generics bulletin, 13 January 2006, page 23).

“To address our rapid growth, as well as our long-term succession-planning efforts” said the US firm, which has just reported third-quarter sales that more than doubled to US$93.4 million (Genericsbulletin, 5 December 2014, page 12), “we embarked upon a searchfor a high quality individual and we found one.” Bogda “brings aglobal perspective, in addition to extensive operations, merger andacquisitions, and business-integration experience,” Lannett added.

Bogda, 53, had been with Teva since 2008, when the Israeli firmacquired Barr (Generics bulletin, 1 August 2008, page 1). G

PEOPLE


APPOINTMENTS

Teva’s Bogda joinsLannett as president

Former Caraco and Sun Pharma head, Gurpartap Singh Sachdeva,has joined Jubilant Life Sciences’ Jubilant Pharma as its chief

executive officer, reporting to the Jubilant Pharma board of directors.He will be based in the US.

“[Singh] has worked extensively both in India and in the US invarious leadership roles pertaining to strategy, mergers and acquisitions,commercial and operations,” the Indian firm commented. He waspreviously president of Sun Pharmaceuticals US.

Jubilant Pharma emerged as a result of Jubilant Life Sciencestransferring its oral dosage form and active pharmaceutical ingredients(APIs) operations, as well as the Indian group’s shares in its Belgianand US subsidiaries, into a separate holding company based inSingapore in 2013 (Generics bulletin, 15 November 2013, page 2).

“Our Pharmaceuticals segment has attained significant scale, andthe businesses therein have great potential for growth,” Jubilant claimed.

A separate operation – Life Science Ingredients – was also spunoff, and is co-headed by Pramod Yadav and Rajesh Srivastava.G

APPOINTMENTS

Jubilant hires Singh from Sun

Endo is seeking a permanent head for its Qualitest US genericsbusiness after chief operating officer Don DeGolyer – who presides

over both Qualitest and the Endo Pharmaceuticals branded arm –announced his intention to retire and “pursue other opportunities”.His announcement came as Endo revealed several senior managementteam changes in preparation for its US$2.6 billion takeover of AuxiliumPharmaceuticals (Generics bulletin, 17 October 2014, page 4).

Former Sandoz US head DeGolyer – who had only joined Endoin August 2013 (Generics bulletin, 9 August 2013, page 27) – willstep down from his role on 1 March, but will remain with Endo asa “special advisor” to president and chief executive officer RajivDe Silva until 1 August. De Silva, meanwhile, has announced thatboth the US generics and brands units, along with the US brandsresearch and development business, will report directly to him.

Following DeGolyer’s retirement on 1 March, Endo’s seniorvice-president of finance, Robert Rush, will on an interim basis takeon the newly-created role of general manager of Qualitest. The USfirm said Rush – who will report directly to De Silva – had “workedclosely with the Endo leadership team and the Qualitest business,leading and driving several key growth initiatives”.

Meanwhile, Endo’s senior vice-president of corporate affairs andpresident of Endo Ventures, Blaine Davis, will become senior vice-president and general manager of US brands. In the role, Davis –whose current responsibilities as president of Endo Ventures will befilled by Robert Cobuzzi, Endo’s head of research and developmentstrategy and operations – will support US brands president BrianLortie, who retains his responsibilities.

The only announced recruitment from Auxilium sees followingthe close of the transaction Keri Mattox, head of investor relationsand corporate communications with the US originator, taking onthe same role with Endo. In her new role, she will report to chieffinancial officer Suky Upadhyay.

Meanwhile, Endo’s chief legal officer, Caroline Manogue,has announced that she will retire from the company on 1 July thisyear. “Endo has retained a leading executive search firm to assist inidentifying a successor,” the US firm noted, adding that Manoguewould continue to serve “through a transition period” once asuccessor had been named. G

RESHUFFLES

Endo seeks a leaderfor its Qualitest unit

Gen 16-1-15 Pg. 30-31_Layout 1 13/01/2015 13:29 Page 2

Actavis’ chief operating officer, Robert Stewart, will assume thenewly-created role of president of Generics and Global Operations

following the completion of its US$66 billion merger with US-basedoriginator Allergan. Stewart will replace current vice-president forNorth American Generics and International, David Buchen, who hasserved in the role for barely six months after being promoted from therole of chief legal officer pursuant to Actavis closing on its acquisitionof Forest Laboratories (Generics bulletin, 6 June 2014, page 27).

“Aligning generics sales and marketing, generics research anddevelopment, and global operations and shared-service optimisationwithin one organisation will enable us to capitalise on theinterdependency of all phases of the generics business,” Actaviscommented. The firm said Buchen would “continue in his currentresponsibilities until closing, when he will assume new responsibilitieson special projects”, supporting Actavis’ president and chief executiveofficer, Brent Saunders, and executive chairman Paul Bisaro.

Both Saunders and Bisaro will keep their respective positionswith the company, with Allergan’s president, Doug Ingram, joiningActavis to serve as a “special advisor” to Saunders. But Saunders’counterpart at Allergan, David Pyott – who was outspoken in hiscriticism of potential purchaser Valeant prior to Actavis’ agreement(Generics bulletin, 5 December 2014, page 3) – has yet to receive aposition in the proposed combination. “While we have not answeredall questions [regarding the proposed structure],” Actavis said, “weremain committed to announcing cascading organisational structuresas those decisions are made.”

In his new role, Stewart will be supported by a 12-strong team ofexisting Actavis staff, including Andy Boyer, the firm’s senior vice-president of US generics sales and marketing, who will take up theposition of head of US generics, and senior vice-president of globalmanufacturing and supply chain, Wayne Swanton, who will becomehead of global generics operations.

Moreover, Actavis revealed, the following staff would assume thefollowing responsibilities within its existing generics operation to supportStewart: Hafrun Fridriksdottir, head of generics research anddevelopment; Lars Ramneborn, head of International generics; Jean-Guy Goulet, president of generics in Canada and Latin America;Gary Holloway, head of generics in Japan; Dan Motto, head ofgenerics business development and portfolio management; andHelga Gudlaugsdottir, head of procurement.

Gunni Beinteinsson will lead generics commercial operations,while Anish Mehta will oversee shared services. Valur Ragnarssonwill be responsible for the Medis third-party dossier licensing business,while Chip Phillips will oversee Actavis’ Anda US distribution unit.

Under its proposed structure, generics will make up one of Actavis’five business operations. Bill Meury, executive vice-president forActavis’ North American Brands, will become president of BrandedPharma, while David Nicholson will retain his responsibilities as headof Actavis’ Brands Research and Development. Furthermore, Allergan’spresident of Europe, Africa and the Middle East, Paul Navarre, willjoin Actavis as president of International Brands, while PhilippeSchaison will keep his role as head of the Allergan Medical business.

Meanwhile, Actavis has appointed Jonathon Kellerman as itsglobal chief compliance officer. Kellerman – who joins the companyfrom PwC, where he was a partner in the firm’s Pharmaceutical andLife Sciences Advisory practice – would be an “integral member of theActavis and Allergan pre-integration planning team”, Actavis said. G

PEOPLE


RESHUFFLES

Actavis asks Stewartto lead generics unit

Australia’s Generic Medicines industry Association (GMiA) hasannounced the appointment of Belinda Wood as the group’s chief

executive officer. Former GMiA policy officer Wood had taken on therole of acting chief executive following the departure of Kate Lynchlast year (Generics bulletin, 5 September 2014, page 31).

Citing Wood’s “extensive networks within the industry and inCanberra”, GMiA chair Mark Crotty said her skill set would be“essential to navigating this period of change collaboratively withgovernment”. Wood has more than 18 years of experience in thepharmaceutical industry.

“My immediate focus will be on business certainty for GMiAmembers, the efficient approval of generic medicines, greater utilisationof less expensive generic medicines and a predictable market-accesspathway for biosimilars,” Wood said. While generics delivered “billionsof dollars in Pharmaceutical Benefits Scheme (PBS) savings”, sheobserved, “pricing pressures continue to be felt and will force increasingnumbers of medicines to be delisted”. “The big challenge for the PBSis ensuring fair pricing that secures the supply of less expensive criticalmedicines,” Wood insisted, “along with the industry that provides them.”

Meanwhile, the GMiA has welcomed the appointment ofSussan Ley to replace Peter Dutton as Australia’s minister for health.“We look forward to a fresh approach from Ms Ley,” Crotty stated,insisting that it was “time for new thinking when it comes to the PBS”.Action on a “predictable market-entry pathway for biosimilars” wasalso essential, Crotty said. G

INDUSTRY ASSOCIATIONS

Wood takes chargeat Australia’s GMiA

Knowledge of at least two official European Union (EU) languagesand 15 years of professional experience – including five years “in a

high-level management function” – are among the prerequisites forapplying to become the next executive director of the EuropeanMedicines Agency (EMA). A curriculum vitae and a “motivation letter”should be submitted in English, French or German, by 28 January.

The EMA has offered its former executive director, Guido Rasi, therole of principal adviser in charge of the agency’s strategy. The EU’s CivilService Tribunal ruled that a procedure resulting in Rasi’s appointmenthad been invalid (Generics bulletin, 5 December 2014, page 35).G

VACANCIES

EMA seeks executive director

MALLINCKRODT has asked its president of autoimmune and rarediseases, Gary Phillips, to resume his previous role as chief strategyofficer, overseeing business development and licensing across theUS group’s entire portfolio. Autoimmune and rare diseases willfall under the remit of president of specialty pharmaceuticals,Hugh O’Neill, who will assume responsibility for commercialoperations for all specialty pharmaceuticals.

GPhA – the US Generic Pharmaceutical Association – has namedTerry Bazyluk as its vice-president of communications. He joinsthe US association from government-sponsored mortgage firmFreddie Mac, where he was head of executive communications. G

IN BRIEF

Gen 16-1-15 Pg. 30-31_Layout 1 13/01/2015 13:29 Page 3

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