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16 January2015

COMPANY NEWS 2 Sandoz closes in on US Abdi Ibrahim teams with Algerian player 2 Kremers deal falters 3 after US FDAaction Tianyin teams up to tackle its troubles 4 filgrastim biosimilar nod Apotex and Panacea allyovertwo drugs 5 US business booms to aid Zydus Cadila 6 andoz has taken amajor step towards securing the first approvalthrough the US Strides starts work on Malaysian facility 7 Sbiosimilar pathway after an advisory panel to the US Food and Drug Administration Walgreens completes 8 (FDA) recommended the agency should approve the company’s EP2006 filgrastim Alliance Boots deal candidate with all the same indications as its reference product, Amgen’s Neupogen. “Weare pleased with the Oncologic Drugs Advisory Committee’s(ODAC’s)recommendation MARKET NEWS 9 to approve our biosimilarfilgrastim and we look forward to continuing to work with FDAas it completes its reviewof our filing,”said Sandoz’ Mark McCamish. If the agencyfollows Suspensions in EU followGVK review 9 the committee’snon-binding advice, Sandoz proposes to market biosimilarfilgrastim pre- Four firms shareinSouth African tender 11 filled syringes in the US under the brand name Zarxio. Abriefing documentfor the ODAC meeting on 7January stated that “considering the Te va takes top spot among AOKawards 12 totality of the evidence, the data submitted by the applicant showthat EP2006 is highly similar GPhA voices concern 13 to US-licensed Neupogen. The clinical data have shown that there are no clinically meaningful over TPP provisions differencesbetween EP2006 and US-licensed Neupogen, suggesting that EP2006 should receive Russia mayconsider compulsorylicensing 14 licensure for each of the five indications for which Neupogen is currently licensed”. The proposed commercial product was“analytically highly similar” albeit with a“slightly PRODUCT NEWS 15 lower” protein content than Neupogen, an issue that “may be resolved by manufacturing and control strategies”. In response, Sandoz submitted additional data analysing the protein- FDAaccepts Apotex’ filing 15 concentration levels of clinical and commercial EP2006 batches against Neupogen licensed of pegfilgrastim in the US and European Union (EU). The FDAdeclared its satisfaction that commercial and Zydus Cadila debuts adalimumab in India 17 clinical batches of EP2006 had “the same strength” as US-licensed Neupogen. Furthermore, a reanalysis of immunogenicity data confirmed that EP2006 and Neupogen had “similarly low To rrent and Reliance 18 rates of anti-drug antibody(ADA) in treated subjects”. strikebiologics deal To support its application, Sandoz submitted five clinical studies for subcutaneous doses Sandoz’ filgrastim is introduced in Japan 19 between 1µg/kg and 10µg/kg. Twotrials used US-licensed Neupogen as the reference product US firms introduce their Celebrex rivals 20 to demonstrate safety and efficacyusing endpoints including pharmacokinetics and absolute NZ awards Remicade 21 neutrophil count. The other three trials used EU-approvedNeupogen. G sole supplyto2020 Sandoz appeal fails over US etanercept 22 Te va eyes EU launch 23 INNs become mandatoryinFrance forCopaxone 40mg octors in France must use the international non-proprietary names (INNs) of medicines on Dall prescriptions from 1January,under legislation issued by the country’shealth ministry. FEATURES 26 The requirement –first outlined in apackage of measures introduced in 2011 –was confirmed in adecree published in France’s Official Journal towards the end of last year.Brand names Eastern expansion and OTC26 may still be used alongside INNs. featurefor Mylan in Europe Catherine Bourrienne-Bautista of France’sgenerics industry association, Gemme, told Te va is to makemorefrom28 Generics bulletin that strict INN prescribing would help to develop the use of off-patent less sales in fewermarkets medicines 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, REGULARS Bourrienne-Bautista suggested. However, the impact of the change would be limited, she acknowledged. France’sgenerics industry already benefits from amechanism of pharmacy Events – Our regular listing 24 substitution for all eligible prescriptions. Price Watch UK – Our in-depth 25 While the requirement to use INNs entered into force at the start of this year,Bourrienne- look at pricing trends in the UK Bautista predicted that electronicprescribing software used by doctors would not be ready to People – Endo seeks aleader for 30 incorporate the change for around six months. She also acknowledged the reticence on the part its Qualitest unit of certaindoctors to accept the newrequirement. Local medical union CSMF has described the measure as “an extra complication for doctors”. G Gen 16-1-15 Pgs. 2-8_Layout 1 13/01/2015 16:19 Page 2

COMPANY NEWS

MANUFACTURING STRATEGICALLIANCES Reddy’sand Ipca to Abdi Ibrahim teams halt Canada exports with Algerian player

rReddy’sLaboratories and Ipca Laboratories have agreed to urkey’s Abdi Ibrahim has formed apartnership with leading DHealth Canada’srequest that theyquarantine certain products TAlgerian pharmaceutical player RemedePharma. As part of the manufactured in India due to “data-integrity concerns”. deal, the Turkish companyhas undertaken to open by the beginning “In keeping with the current regulations of Health Canada,” of 2016 alocal facility that complies with good manufacturing Reddy’sstated, “the companyhas voluntarily placed under quarantine practice (GMP) standards. all active pharmaceutical ingredients (APIs), and formulations based Operating under the name Abdi Ibrahim RemedePharma, the on APIs, produced at our API facility in the Srikakulam district of venture will “unite the power of the twocompanies to produce and Andhra Pradesh.” market avariety of products addressing awide range of treatments”. Stressing that it wasworking with the agencytowards reaching As part of the agreement, Abdi Ibrahim –which has operated in a“satisfactory resolution”, Reddy’ssaid it believedits products met Algeria since 1999 –has acquired shares in RemedePharma. “intended quality standards” and posed no risk to health. “The synergy created by the combination of RemedePharma’s The move to quarantine drugs had, the Indian companyadded, “no knowledge of the Algerian market dynamics and our company’sfocus implication on anyactivity at the plant” at present, so would not affect on international targets will makeimportant achievements,”stated the group’soperations or financial results. Abdi Ibrahim’schairman, Nezih Barut. The group, he pointed out, Similarly,Ipca –which is already subject to an import ban on APIs nowboasted production facilities in Algeria, Kazakhstan and Turkey. made at its plant in Ratlam, India (Generics bulletin,17October 2014, RemedePharma’sowner,Lamine Bousteila, said the Turkish group’s page 8) –said it did not “generate anymaterial business” in Canada expertise would be “invaluable” in constructing the GMP-compliant from its affected formulationsfacility in Indore, Pithampur. facility and expanding the Algerian firm’sproduct portfolio. Describing the voluntary quarantine as a“precautionary step in Just overUS$50 million of Abdi Ibrahim’s2013 turnoverof viewofUSFood and Drug Administration (FDA) audit observations TL813 million (US$349 million) came from international markets. made regarding good manufacturing practice (GMP) deficiencies at Having established its ownoperations in Algeria, Azerbaijan, Georgia the said manufacturing unit”, Ipca stressed it was“fully committed” and Kazakhstan, the group towards the end of last year struck a to resolving the issue at the earliest opportunity. G licensing deal with Saudi Arabia’sDeef. G

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COMPANY NEWS

MERGERS&ACQUISITIONS MERGERS&ACQUISITIONS Sun and Ranbaxy to Kremers deal falters divestseven in India after US FDA action

un Pharma and Ranbaxy have cleared ahurdle in their bid to US$1.53 billion transaction through which Kremers Urban Sclose on their proposed US$4 billion merger by agreeing to divest APharmaceuticals (KU) –the US generics arm of Belgian biopharma sevenfinished-dose formulations on the orders of the Competition firm UCB –was due to be acquired by private-equity firms Advent Commission of India (CCI). The deal –which wasfirst announced International and Avista Capital Partners has been terminated by the in April (Generics bulletin,18April 2014, page 1) –now requires firms, following action taken by the US Food and Drug Administration approvalfrom the US Federal Trade Commission (FTC). (FDA) overthe generics firm’slocal rivaltoJanssen’sConcerta According to the prospective partners, the products to be divested (methylphenidate) extended-release tablets. “constitute less than 1% of the combined entity’srevenues in India”. The FDArecently stripped KU of its ‘AB’ bioequivalence rating To gain the CCI’sapproval, Sun has agreed to divest its Tamlet for its generic version of Concerta following concerns overwhether (tamsulosin/tolterodine) brand, which holds around athird of the generic rivals to the brand –also including aversion marketed by Indian market, with Ranbaxy’sRoliflo holding nearly two-thirds and Mallinckrodt –were equivalent (Generics bulletin,5December 2014, Intas aminor share. page 23). UCB said it had “mutually agreed” with Advent and Avista Ranbaxy will divest its distribution rights to Eligard (leuprorelin) as to terminate the acquisition agreement, which wasannounced in the combined entity would control up to 90% of the market. November and had been expected to close in the first quarter of next Furthermore, Ranbaxy must sell its Rosuvas EZ (rosuvastatin/ezetimibe), year (Generics bulletin,14November 2014, page 1). Terlibax (terlipressin)and OlanexF(olanzapine/fluoxetine) brands, “Weare disappointed that we could not complete the transaction along with its Raciper L(levosulpiride/esomeprazole) and Triolvance as planned at this time, butbelieve that the mutual termination is (olmesartan/amlodipine/hydrochlorothiazide)combinations, due to the right step to allowtime for the needed evaluation of the best way combined market shares of up to 95%. forward,”said UCB’schief financial officer,Detlef Thielgen. Noting that the firm was“working on clarifying the situation No significant overlap in API portfolios around extended-release methylphenidate”, including performing Potential competition to Sun’sin-licensedsitagliptin-based Istavel additional bioequivalence studies requested by the FDA, Thielgen said and Istamet brands wassufficient to outweigh the danger of Ranbaxy UCB would “continue the divestiture process for Kremers Urban”. discontinuing development of rivals in its pipeline, the CCI decided. George Stevenson would continue to serveaspresident and chief Moreover, the watchdog said, “horizontal overlap in active executive officer of KU, the firm said. G pharmaceutical ingredients(APIs) is insignificant to raise any competition concern”, with Sun and Ranbaxy deriving only 5% and 6% respectively of their turnoverfrom selling APIs to third parties. RESULTSFORECAST “[This approval] revalidates our viewthat the Sun Pharma and Ranbaxy businesses complement each other with limited product Teva awaits Copaxonerivals overlap,”commented Sun’smanaging director,Dilip Shanghvi, “and will offer acomprehensive product basket to enable future growth.” wo substitutable rivals to Teva’s Copaxone (glatiramer acetate) Last year,the Indian firms quashed speculationthat theyhad been T20mg/ml are expected by the Israelifirm to be launched in the US directed by the CCI to divest certain businesses within their operations in September 2015. An earlier entry could reduce Teva’s operating to receive final approval(Generics bulletin,3November 2014, income by US$30 million to US$50 million per month, the firm noted. page 3). This followed the CCI reaching a prima facie opinion in As aresult, Teva anticipates its global Copaxone sales falling by September that the combination “was likely to have an appreciable US$400-US$500 million to US$3.5-US$3.7 billion from an estimated adverse effect on competition”, after Sun and Ranbaxy had published US$4.1 billion in 2014. details of the merger pursuant to the CCI’srequest. G In 2015, Teva anticipates generics sales of between US$9.1 billion and 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 adecline of around 5% from an estimated US$9.8 MERGERS&ACQUISITIONS billion in 2014 (see page 28). Following a1%dip to US$20.0-US$20.3 billion last year,Teva’s Ghana’s Dannex gets Starwin group turnoverisset to fall by around another US$1.0 billion this year rivately-owned Dannexhas taken acontrolling 71.3% stakeinits to US$19.0-US$19.4 billion. Specialty brands other than Copaxone PfellowGhanaian pharmaceuticals player Starwin Products, making are set to contribute around US$4.5 billion –upfrom US$4.3 billion it “the leader in the pharmaceutical sector” in Ghana. in 2014 –asthe firm rolls out DuoRespSpiromax (budesonide/ Stressing that the deal would give Dannex“abigger balance formoterol) and Lonquex (lipegfilgrastim), in Europe. OTCand other sheet”, thereby helping the firm to cope with “uncertainties in the products should add about US$1.6 billion. marketplace”, managing director YawOpare-Asamoah hailed Starwin’s The 2015 mid-point turnoverforecast of US$19.2 billion assumes strong brand, staffand board. Joining forces would, he said, give the US$700 million of negative currencyshifts as well as aUS$400- firms “a stronger presence in West Africa”. US$500 million hit from newgeneric entrants with generic Pulmicort Through ashare issue, Dannexpaid GHS5.57 million (US$1.74 (budesonide) in the US during the first half of this year. million) to add just over68.6% to its existing 2.69% stakeinStarwin. But Teva expects better margins from its generics business to lift In 2013, Accra-based Starwin achievedaturnoverofaround GHS6.7 its group operating profit by atenth to around US$5.70 billion in 2014, million through brands such as Paraking (paracetamol) syrup. G with aslight improvement to US$5.7-US$5.9 billion this year. G

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COMPANY NEWS

STRATEGICALLIANCES STRATEGICALLIANCES Breckenridge works Tianyin teams up to with MSN forthe US tackleits troubles

reckenridge Pharmaceutical has entered into amulti-product ianyin Pharmaceutical (TPI) is exploring an alliance with Bagreement with India’sMSN Laboratories. The Hyderabad-based Tundisclosed private and state-owned companies in China as it seeks companywill develop, manufacture and supply abbreviated newdrug to meet the challenges of “intensified market competition and policy application (ANDA) drugs for Breckenridge to market in the US changes amid ongoing healthcare reforms in China”. under its ownlabel. TPI plans to hold amajority stakeinthe alliance,which will focus Under the deal –which is aimed at developing “multiple first- on the Chinese branded generics and active pharmaceutical ingredients to-file paragraph IV ANDAs” –the twofirms have agreed to develop (APIs) producer’s“core product portfolio”, such as antiviral and an oral antibiotic with US brand sales of US$644 million and a immunology drugs, as well as modernised traditional Chinese medicines cardiovascular drug with US generics sales of US$35 million. The including cardiovascular agent Ginkgo Mihuan liquid. partners said theyhad already collaborated on twofirst first-to-file By combining its salesforce with that of its partners, TPI expects paragraph IV submissions which were pending approval. to drive up sales. The alliance will be based on the firm’sfacility in During 2014, privately-held Breckenridge –part of Spain’sEsteve Qionglai, China, for which it anticipates obtaining acertificate from group –filed 23 paragraph IV patent challenges in the US. Privately- China’sFood and Drug Administration (SFDA) imminently.Any owned MSN holds more than 130 drug master files (DMFs) to deal will exclude TPI’sJiangchuan macrolide APIs plant. supply bulk drugs in the US. G “Continuouspricing pressure and restrictive sales practices” caused TPI to reporting aturnoverslide of athird to US$9.73 million in the first quarter of its financial year ending 30 June 2015. The firm ANTITRUST INVESTIGATIONS blamed increasedresearch and development spending on GingkoMihuan Lannett gets second subpoena for its operating profit experiencing asimilar fall to US$1.42 million. G

annett has been served with agrand jury subpoena seeking BUSINESS STRATEGY/MANUFACTURING Lcorporate documents “relating to corporate, financial and employee information, communications or correspondence with competitors Nanolekopens Russian site regarding the sale of generic prescriptionmedications, and the marketing, sale or pricing of certain products”. ussian biopharmaceutical companyNanolek has opened its Amonth earlier,the US generics specialist’ssenior vice-president Rmanufacturing site in KirovOblast, Russia, as part of astrategy of sales and marketing had receivedasimilar subpoena as part of a to produce alternativestoaround 55 imported brands in Russia. federal investigation into possible antitrust violations within the US Having invested RUB4.0 billion (US$64 million) in the factory – generics industry (Generics bulletin,5December 2014, page 12). which will have annual capacity of around 35 million bottles and 42 “The companymaintains that it has acted in compliance with million pre-filled syringes –the firm intends initially to make all applicable laws and regulations, and intends to cooperate with antihistamines, antihypertensivesand statins. In the longer term, it the federal investigation,”Lannett commented. G will offer central nervous system, HIV and oncology drugs. G

16 January2015 Issue 224 Individual subscriptions Te rms &Conditions: These can be viewedinfull at www.Generics-bulletin.com/subscribe. Editor: Aidan Fry An annual subscription comprises: ■ 20 Generics bulletin newsletters; No partofthis publication maybe copied, reproduced, Deputy Editor: David Wallace ■ AND at least 46 weekly News@Genericsbulletin stored in aretrieval system, distributed or transmitted Assistant Editor: Liudmila Kotko electronic newsflashes containing the week’stop by anymeans, including electronic,mechanical, Business Reporter: Dean Rudge news stories (currentlydelivered by email). photocopying or recording, without the prior written Production Controller: Debi Minal permission of the publisher,orunder the terms and Choice of formats conditions of aGlobal Site Licence or of alicence Production Editor: Jenna Meredith The 20 Generics bulletin newsletters are available: issued by the Copyright Licensing Agency (CLA) in Director of Subscriptions: ValDavis ■ EITHER as the digital Generics bulletin-i for London, UK, or rights bodies in other countries that Group Sales Manager: Anisa Shan online access by desktop,and tablet and smartphone. have reciprocal agreements with the CLA. Awards Manager: Natalie Cornwell Mobile devices can have Apple or Android Neither maythis publication be exported, distributed Managing Director: Mike Rice operating systems. or circulated by anymeans without the prior written ■ OR in traditional hard-copyprint format, permission of the publisher. While due care has been taken to ensure the accuracy Editorial enquiries: GENERICS bulletin, delivered by airmail. of information contained in this publication, the 4Poplar Road, Dorridge,Solihull, Corporate and multiple subscriptions publisher makes no claim that it is free of errorand West Midlands B93 8DB, UK. Global Site Licences are available to companies. disclaims anyliability whatsoeverfor anydecisions or Website: www.Generics-bulletin.com These provide in-house electronic access forstaff to actions taken as aresult of its contents. Te l: +44 (0)1564 777550 Fax: +44 (0)1564 777524 Generics bulletin and News@Genericsbulletin. ©OTC Publications Ltd.All rights reserved. E-mail: [email protected] Please ask foraquotation. Generics bulletin® is registered as atrademark in Advertising enquiries: the European Community. Discounted multiple subscriptions are available to As above,[email protected] ISSN 1742-0784. Generics bulletin-i at the same location. SUBSCRIPTIONS Companyregistered in England No 2765878. Subscription rates are published at Subscription enquiries: Printed by Warwick Printing CompanyLimited, www.Generics-bulletin.com/subscribe. Contact [email protected] Leamington Spa CV31 1QD, UK.

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COMPANY NEWS

MANUFACTURING STRATEGICALLIANCES Ranbaxy’s Dewas is Apotex and Panacea pulled up over GMP ally over two drugs

ood manufacturing practice (GMP) deficienciesincluding “the potexhas struck an agreement with Indian firm Panacea Biotec Gdesign and operation of the cleanrooms”and “controls for Ato develop, manufacture and market two“high-barrier-to-entry” preparation of components and equipment” at the cephalosporin- oncology generics in the US, Canada, Australiaand NewZealand. producing unit of Ranbaxy’sDewas manufacturing facility in Madhya Both drugs would be developed using Panacea’sproprietary nano- Pradesh, India, have led German authorities to state the plant does not particle,liposomal and micro-particle drug delivery systems, the comply with GMP requirements. The same facility is also subject to Indian firm said. The generics’ reference productscombined had terms of aUSFood and Drug Administration (FDA) consent decree. current sales of around US$1 billion, it added. However, the Indian firm described as “misleading” suggestions “The strategic alliance wasinitially establishedfor adrug-delivery- that it had been banned from exporting all cephalosporinformulations. based drug for which Panacea had receivedresearch fees,”Panacea “The development pertains only to the company’scephalosporin explained, noting that that development was“progressing on priority”. injectables unit at Dewas,”Ranbaxy said of the inspection from German “Panacea and Apotexhavenow further expanded the scope of the regulators –aswell as those from Australia, Canada and other parts of collaboration,”the Indian firm said, adding that the partners intended Europe –inJune last year.“Well before that time, the firm had decided to broaden the collaboration in the future “by adding newdrug-delivery- to stop producing cephalosporin injectables at Dewas,”Ranbaxy stated. based complexgenerics”. “Since then, the agencies have approvedall our facilities for Under the terms of the agreement, Panacea will develop, manufacturing dosage forms and active pharmaceutical ingredients manufacture and supply the generics to the Canadian firm, which will (APIs) at Dewas, including for oral cephalosporins, with only the in turn be responsible for regulatory affairs, managing patent litigation exception of the cephalosporin injectable unit,”the Indian firm added. and marketing the products. The Indian firm said it would receive Noting that its decision to discontinue injectable cephalosporin upfront and milestone payments from Apotex, along with ashare of “would not have asignificant impact on business”, Ranbaxy stressed the development costs. “Profit post-commercialisation of the products that “the current approvals coverall other dosage forms and API units shall be shared at apre-agreed ratio between both firms,”Panacea said. at Dewas, including those producing penem API and injectables, and Apotex’ chief business officer,StevenLydeamore, said such oral cephalosporins”. strategic partnerships enabled the Canadian companytocompete in Meanwhile, French authorities have declared in the EudraGMDP difficult-to-makegenerics “where Apotexdoes not have its own database that Medreich’sUnit Vfacility in Bollaram, India, does not manufacturing capabilities”. comply with GMP requirements for sterile and non-sterile betalactam Describing the alliance with Apotexas“one of the cardinal antibiotics. An inspection conducted in May 2014 found 58 deficiencies, milestones in our global generics strategy”, Panacea’sjoint managing one of which –related to “data falsification” –was categorised as director,Rajesh Jain, said the Indian firm planned to use its nano- “critical”, while 29 were viewed as “major”. particle, liposome and micro-particle drug-delivery technologies to “The statement of non-compliance previously issued is maintained, strengthen its presence in the oncology arena. and the site should not be named on anymarketing authorisations “This collaboration reflects the shared belief that the development whilst this statement remains in place,”the French authorities said, and commercialisation of drug-delivery-based, high-barrier-to-entry adding that Medreich had not distributed batches of finished products products will not followatypecast brand or generic model, and will in the European Union (EU) since an inspection carried out in early require significant innovation, technical expertise, infrastructure and 2013 had uncovered several deficiencies. investment to achieve the desired ends,”Panacea stated. G Discovery of “10 major deviations from EU GMP” –including overwriting undesirable sample results –haveled Italy’smedicines agencytodeclare that Sri Krishna Pharmaceuticals’ Unit II bulk BUSINESS STRATEGY granules facility in Nacharam near Hyderabad, India, does not comply with GMP standards. The Italian agencysaid it had no concern over the quality of finished drugs because the facility made only intermediate Vanc can importinto Canada granules for formulation into drugs that were subject to further testing. anada’sVanc Pharmaceuticals says it has reached a“keystep” Due to “data-integrity concerns”, Health Canada has asked Ctowards rolling out its generic and OTCdrugs portfolio after being importers to quarantine products made using bulk drugs made at the issued with aDrug Establishment License (DEL) by local regulatory Sri Krishna site near Hyderabad. “This action comes in light of recent agencyHealth Canada. This, the Vancouver-based companysaid, information from trusted regulatory partners that raised concerns about would allowittoimport drugs from its facilities in China and India, the reliability of the laboratory data generated at this site,”the Canadian and then to distribute them in Canada. agencyexplained. “Wehavepartnered with leading global generics manufacturers,” Alist of affected products –which the Canadian agencyintends to stated Vanc’schief executive officer,Arun Nayyar.Having just received update –identifies Teva’s Ratio-Oxycocet(oxycodone/acetaminophen) Notices of Compliance (NOCs), or marketing authorisations, for 22 tablets as “medically necessary”, and thus subject to “appropriate ingredients or combinations from Health Canada (Generics bulletin, testing to address anypotential safety concerns”. 5December 2014, page 24), Vanc –which used to operate under Among the affected products not deemed medically necessary the name Nova –reiterated that it intended to launch its generic are several Teva drugs that contain acetaminophen –known as portfolio in the second quarter of 2015. paracetamol in other countries –either alone or in combination.Also The Canadian firm –which subsequently claimed to have boosted affected are acetaminophen-based brands marketed by Jamp, Novartis, its portfolio to 30 molecules –has named Aman Parmar as chief Pro Doc, Riva and Trianon. G financial officer.Hetakes overfrom Jamie Lewin, who has resigned. G

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COMPANY NEWS

SECOND-QUARTERRESULTS IN BRIEF ABBOTT has completed its RUB16.7 billion (US$305 million) US business booms acquisition of Russian branded generics supplier Veropharm.By taking overGarden Hills, aholding companythat owned 98% of Veropharm, Abbott has established alocal manufacturing base in Russia, including afacility that is currently under construction. Abbott to aid Zydus Cadila said the cash deal would give it “an offering in the field of oncology” in Russia and would complement its existing portfolio in therapeutic aunching four products helped Zydus Cadila to increase its US areas such as cardiovascular,central nervous system, gastroenterology Lsales by 67.6% to Rs8.02 billion (US$131 million) in the Indian and women’shealth drugs (Generics bulletin,11July 2014, page 1). firm’sfinancial second quarter ended 30 September 2014. The US –in which the firm secured six approvals during the three-month period – IGI LABORATORIES has closed aUS$125 million bond offering accounted for 38% of the Indian group’sturnover, which advanced to institutional buyers. The US specialty generics specialistexpects by 21.2% to Rs21.1 billion. to raise net proceeds of around US$120 million from the convertible The Indian companyintroduced 16 newproducts, includingline senior notes, which bear afixed interest rate of 3.75% and will extensions, in its domestic market, where Formulations sales ahead mature in December 2019. It will use the proceeds for “general by 8.7% to Rs6.81 billion made up the bulk of total local turnover corporate purposes”, including for “strategic transactions”. that rose by 10.5% to Rs8.84 billion. Twolaunches in Mexico took the firm’slocal marketed portfolio AUROBINDO PHARMA has completed aUS$132.5 million deal to 12 out of 17 drugs it has approvedinthe country to date. But for the brands, manufacturing, personnel and commercial Latin American sales nevertheless slipped by 1.1% to Rs647 million. infrastructure assets of bankrupt US food supplements maker Natrol European sales fell by 17.5% to Rs777 million, while turnover (Generics bulletin,5December 2014, page 5). The Indian firm – in Japan wasnegligible following the firm’sdecision to discontinue which already operates in the US OTCmarket through its Aurohealth local operations (Generics bulletin,3February 2014, page 3). The subsidiary –intends to improve the acquired business’ profitability company’ssales in emerging markets declined by 4.3% to Rs885 by “combining the strength of both enterprises in creating afully million, while its turnoverfrom active pharmaceutical ingredients integrated nutraceuticals platform in the US and other international (APIs) and animal health products also decreased (see Figure 1). markets”. “Natrol comes with certain well-established brands and Lower finance costs helped Zydus Cadila to post a71.2% an extensive distribution network, consisting of retail pharmacychains increase in pre-tax profit to Rs3.45 billion. G and specialty health-food stores, to help us tactically position ourselves in the US nutraceuticals space,”commented Aurobindo’s Second-quarter sales Change Proportion managing director,NGovindarajan. The US supplements maker is (Rs millions) (%) of total (%) also set to open amanufacturing site near its headquarters in India 8,835 +10.5 42 Chatsworth, California. US 8,020 +67.6 38 DR DATSONS has secured board approvaltonegotiate Hong Kong- Europe 777 -17.5 4 based investor Leaders Group Asia taking amajority stakeinthe Latin America 647 -1.1 3 Indian bulk drugs and formulations provider.Noting that due diligence Japan 2-98.3 – and antitrust approvalwould “takeabout six months”, Datsons said Emerging Markets 885 -4.3 4 the proposed deal aligned with Leaders Group Asia’s“interests and APIs 630 -14.6 3 supplies of products to manycountries in Africa and South America”. Animal Health/others132 -1.6 1 Exports 11,093 +33.5 53 LUPIN has appealed against the European Commission’sdecision to Joint ventures 1,136 +6.4 5 fine the Indian firm C40.0 million (US$47.6 million) overapatent- litigation settlement involving Servier’s(perindopril). Lupin contends Zydus Cadila 21,064 +21.2 100 that the Commission applied “a wholly noveland incorrectlegal test” in basing its case around payment of a‘significant inducement’. Figure1:Breakdown by business and region of Zydus Cadila’s gross sales in its financial second quarter ended 30 September 2014 (Source –Zydus Cadila) Furthermore, the Indian firm argues, “the Commissionbreached the principle of equal treatment in comparison with the fine imposed on Krka”. Krka wasfined C10.0 million (Generics bulletin,8 August 2014, page 14). MERGERS&ACQUISITIONS ANI PHARMACEUTICALS has closed aUS$144 million bond McKesson and Celesio merge offering.The US specialtydrugs developer expects net proceeds cKesson and Celesio say theycan now“operate as an integrated from the 3.00% convertible senior notes to be around US$138 Mcompany” after acourt in Stuttgart, Germany, approvedthe million, which it will use largely to fund development and marketing registration of adomination and profit and loss transferagreement. of its pipeline as well as to “acquire complementary businesses, Once the agreement is registered, anewly-formed global procurement products and technologies”. team will deal with manufacturing suppliers to both companies. The twofirms aim to create “a global leader in pharmaceutical HOVIONE said a pre-approvalinspection of its active pharmaceutical purchasing and distribution”, with aturnoverofoverUS$170 billion ingredients (APIs) plant in Loures, Portugal, led to the US Food through operations in more than 20 countries. The combined entity and Drug Administration (FDA) issuing aForm 483 containing three will servearound 120,000pharmacyand hospital locations in the US, observations. The Portuguese firm –which has pledged to improve Canada, Brazil and Europe. That total includes more than 12,000 its quality systems at Loures and other sites –said the inspection outlets that the group either owns or covers as part of abanner or covered twonew drug application (NDA) filings. G franchise network of community pharmacies. G

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COMPANY NEWS

STRATEGICALLIANCES MANUFACTURING Chemiphar lines up Strides starts work ventureinVietnam on Malaysian facility

ippon Chemiphar expects to “increasegroup-wideproduction trides Arcolab’sStelis Biopharma subsidiary has broken ground Ncapacity and reduce manufacturing costs” by establishing ajoint Son building a13,000 sq mbiologics facility in Johor,Malaysia. venture with Vietnamese companyMST Pharm from March 2015. The Indian company–which is investing RM201 million (US$60 Initially,the venture –tobeformed through the Japanese firm’s million) in the facility –expects to complete construction and installation wholly-owned subsidiary,Nihon Pharmaceutical –will focus on within 24 months, allowing commercial operations to begin in mid-2017. manufacturing drugs for the Japanese market. But Chemiphar intends Stelis’ site on the Bio-XCell biotechnology park will incorporate to “expand sales channels to Vietnam and other Asian companies”. “single-use bioprocessing technology with both mammalian and The Japanese generics supplier will hold a60% stakeinthe new microbial manufacturing suites”. The companyplans to manufacture entity,which will be located in Vietnam’sBinh Duong province. G and market its “pipeline of biosimilars and biobetters”, using avariety of delivery forms includingcartridges, pre-filled syringes and vials. After acquiring acontrolling stakeinBangalore-based Inbiopro BUSINESS STRATEGY Solutions at the end of 2010, Strides boosted its pipeline through a2013 deal with Pfenex(Generics bulletin,3May 2013, page 7). The company Cipla sells its Chinese stake has identified emerging markets such as in Asia, the Middle East and the Commonwealth of Independent States (CIS) as “initial target markets”. ipla has entered into adefinitive agreement through its Meditab The Malaysian plant –which will house aresearch and development Csubsidiary to sell the Indian group’sentire 48.22% shareholding unit for conducting scale-up and process-development work –will also in China’sJiangsu Cdymax Pharmaceuticals. The purchaser in the provide contract manufacturing and clinical supplies. US$18.5 million deal is an affiliate of one of Jiangsu’sother When Strides signed aUS$34.4 million “build-and-lease” shareholders. The transaction is subject to regulatory approvals in China. agreement with the Bio-XCell park almost twoyears ago (Generics The Indian companyoffered no explanation for its decision to bulletin,5April 2013, page 7), the partners said theyaimed to have sell its minority holding. Cipla first acquired its stakeinthe Chinese both the researchand manufacturing facilities “operational by the bulk-drugs producer in February 2012. G end of 2014”. G

16 January2015 GENERICS bulletin 7 Gen 16-1-15 Pgs. 2-8_Layout 1 13/01/2015 16:19 Page 8

COMPANY NEWS

DISTRIBUTION/RETAILING TRADE AGREEMENTS Walgreens completes EU says TTIP would Alliance Boots deal aid biosimilar moves

algreens Alliance Boots is nowoperating as acombined company ostering the development and approvalofbiosimilars “such as Wafter the US drugstore chain’sshareholdersapprovedashare swap Fvaccines and insulin”, improving and accelerating generic approval that sawWalgreens become awholly-owned subsidiary of the retailing mechanisms, and improving access to paediatric medicines and drugs and distribution giant. The combined entity will be based in the US for rare diseases are among the European Commission’skey goals as it and will trade on the Nasdaq stock exchange under the symbol WBA. negotiates aTransatlanticTrade and Investment Partnership (TTIP) Having taken a45% stakeinAlliance Boots more than twoyears free-trade agreement with the US. ago (Generics bulletin,29June 2012, page 3), Walgreens has now Unveiling aseries of factsheets on the TTIP’s24chapters covering acquired the remaining 55% for around US$5.3 billion in cash and market access, regulatory cooperation and rules –aswell as certain 144.3 million shares. proposed legaltexts –European Union (EU) Trade Commissioner Spanning more than 25 countries, Walgreens Boots Alliance will Cecilia Malmström insisted the disclosures made on 7January marked operate over12,800 retail stores in 11 countries and servemore than “a first in EU trade policy” by publishing specific legalproposals 180,000 pharmaciesand other healthcarecentres through anetwork whilst negotiating abilateral trade agreement. of over340 distribution centres. The combined entity will be led by Stefano Pessina as acting chief TTIP will not disturb IP balance executive officer after Walgreens boss GregWasson announced plans to Atwo-page pharmaceuticals factsheet states that the EU and US retire once the merger wascompleted. Having joined the US company each have a“solid and comprehensive intellectual-property (IP) rights as an intern in 1980, Wasson took various positionsofincreasing system” that enables originators to thrive.“We will not negotiate any seniority before being appointed president and chief operating officer IP rules that change this delicate balance or put more strain on already in 2007. Twoyears later,hewas named chief executive officer,and stretched national health budgets,”itpledges. also that year took aseat on the firm’sboard of directors. G EU member states will retain control overpricing and reimbursement decisions, the Commissionpromises, while TTIP will not influence EU rules on publishing data from clinical trials. Rather,the EU’spharmaceutical goals for TTIP include to “work BUSINESS STRATEGY/ANNUAL RESULTS together on our requirements for approving biosimilars” and to Eagle chases after Treanda “streamline systems for authorising generic drugs”. Other goals include: recognising each other’sgood manufacturing practice (GMP) SinjectablesspecialistEagle Pharmaceuticals believesithas inspections; exchanging information between regulators; and Umovedcloser to offering an alternative to Teva’s Treanda strengthening collaboration under the International Conference on (bendamustine) brand after aclinical trial found Eagle’sEP-3102 Harmonisation (ICH). ready-to-dilute version wasbioequivalent to the original, butcould The International Generic Pharmaceutical Alliance (IGPA) is be administered more quickly. currently pushing for full participation as amember of the ICH steering Since July,Eagle has held tentative US approvalfor its EP-3101 committee (Generics bulletin,5December 2014, page 21). G bendamustine formulation, butorphan drug exclusivity for Treanda blocks final approvaluntil September this year.But having secured its ownorphan drug designation for chronic lymphocytic leukaemia REGULATORY AFFAIRS and non-Hodgkin’slymphoma, Eagle believesitmay be able to circumvent Teva’s exclusivity by proving that its version of the CDER plans switching guide chemotherapyagent is superior and deserves adifferent label. At the end of October 2014, Teva’s lawsuit against Eagle over etails of “considerations in demonstrating interchangeability to US Treanda patent 8,791,270was consolidated in aDelaware district Dareference product” and of labelling are among four biosimilarity court with 25 other suits that the originator had brought against 16 draft guidances that the Center for Drug Evaluation and Research generic challengers. Atrial is scheduled for 30 November this year, (CDER) within the US Food and Drug Administration (FDA) intends following aclaim-construction hearing in March. to publish during 2015. The other twowill address statistical approaches Eagle –which focuses on the hybrid 505(b)(2) newdrug to evaluating analytical similarity data for supporting biosimilarity application (NDA) regulatory pathway –ispreparing to submit an NDA demonstrations and additional questions and answers on implementing for ready-to-use bivalirudin, the active ingredient in The Medicines the 2009 Biologics Price Competition and Innovation Act. Company’sAngiomax anticoagulant. Forgenerics, the CDER intends to guide industry on draft package Sales of, and royalties from, argatroban sold by partners The insert labelling to support abbreviated newdrug application(ANDA) Medicines Companyand Sandoz accounted for about US$15 million approvals and on refusals to receive ANDAs due to typographical of Eagle’sturnoverthat rose by 40% to US$19.1 million in its financial errors and misplaced files. Furthermore, it will issue guidelines on year ended 30 September 2014. The August 2014 launch of Ryanodex complete assessments and checklists for type II drug master files (dantrolene)added US$0.2 million, while most of the remainder came (DMFs) under the Generic Drug User Fee Amendments (GDUFA). from adeal with Hikma overdiclofenac/misoprostol tablets. Several other proposed CDER guidances relate to risk evaluation Eagle –which raised around US$46.1 million through an initial and mitigation strategies (REMS). Topics to be covered include public offering (IPO) in February last year –more than doubled its modifying and revising REMS, using DMFs for shared-system REMS operating loss to US$18.8 million, largely as aresult of higher research and submitting study protocols for drugs for REMS for reviewby and development spending. G the CDER’sOffice of Generic Drugs (OGD). G

8 GENERICS bulletin 16 January2015 Gen 16-1-15 Pgs. 9-14_Layout 1 13/01/2015 16:40 Page 3

MARKET NEWS

REGULATORY AFFAIRS REGULATORY AFFAIRS GPhA lauds FDA for Suspensions in EU limiting REMS abuse follow GVK review

raft guidanceissued by the US Food and Drug Administration arketing authorisations based on data from studies conducted by D(FDA) aimed at helping generics applicantstoobtain samples of MGVK Biosciences have been suspended by certain European reference products that are governed by arisk evaluation and Union (EU) member states as a“precautionary measure” pending a mitigation strategy (REMS) has been welcomed by the US Generic reviewbythe European Medicines Agency(EMA) of the Indian Pharmaceutical Association (GPhA). The document describes “how contract research organisation’ssite in Hyderabad, India. to obtain aletter from the FDAstating that bioequivalence study In mid-December,Germany’sBfArM agencyissued alist of 80 protocols contain safety protections comparable to applicable drugs such as candesartan, clopidogrel,escitalopram and irbesartan REMS for areference listed drug (RLD)”. for which it had suspended marketing authorisations. Among the 15 “FDAisaware of instances in which aRLD sponsor has refused marketing-authorisation holders affected were Dr Reddy’sand its to sell adrug product to aprospective abbreviated newdrug application Betapharm subsidiary,Mylan Dura, Ranbaxy’sBasics and Stadapharm, (ANDA) applicant seeking to conductthe testing needed to obtain as well as Lupin’sHormosan and Torrent’sHeumann. approval, and the RLD sponsor has cited the REMS ‘elements to assure But as of 8January,BfArM had been forced to scale down that safe use’ (ETASU) as justification,”the agencystates in the draft list to 53 products. And of those 53, 21 had not had their marketing guidance document. authorisations suspended due to legalchallenges filed by firms including The FDAsaid it had, on request, reviewed bioequivalence study Alfred Tiefenbacher,Fair-Med, Hormosan, Mylan Dura, Panacea protocols proposed by ANDAapplicants to assess whether they Biotec and Stadapharm.Afurther 17 were Betapharm productswhich provided the necessary safety protections “in the interest of facilitating were not currently marketed and for which authorisations were prospective generic applicants’access to RLD supplies”. suspended as of 19 December. “When the agencyhas determined that comparable protections No appeals had been launched against suspensions for 15 products existed, FDAhas issued letters to the RLD sponsors stating so, and from Ranbaxy’sBasics, Micro Labs, Unichem Laboratories and indicating that the FDAwould not consider it to be aviolation of the Welding, the German agencysaid. REMS for the RLD sponsor to provide the drug product to the France’sANSM agencyhas suspended 25 marketing authorisations. prospective ANDAapplicant,”the FDAnoted. While this wasnot a Belgium’sAFMPS confirmed that it had suspended four marketing legalrequirement, the agencyemphasised, the guidance wasintended authorisations, while Luxembourghas also taken action. to clarify the process “if aprospective ANDAapplicant chooses to Marketing authorisations suspended in France coverescitalopram request such aletter”. sold by Abbott and Zydus, Biogaran’sand Mylan’sebastine, and desloratadine marketed by Arrow, Cristers,Medipha, Teva and Zydus. Letter issued after study review Cristers and Zydus have also had marketing authorisations for ibuprofen According to the guidance, the prospective ANDAapplicant suspended, while Mylan has also seen suspensions for candesartan, should submit draft bioequivalence study protocols to the FDAby donepezil, rizatriptan and trimetazidine. Zydus has also had amarketing e-mail, based on the provisions of the reference drug’slabelling and authorisation for tramadol/paracetamol suspended in France. ETASU as detailed on the agency’sonline REMS listing. Suspensions in Belgium include Mylan’scandesartan and The FDA’sOffice of Generic Drugs (OGD) will reviewthese esomeprazole, along with desloratadine marketed by Apotexand Teva. protocols, and either recommend revisions or confirm that the protocols Several months ago, firms with marketing authorisations that had are comparable to the ETASU. The ANDAapplicant will then be been approvedinEurope on the basis of clinical work carried out by directed to notify the agencyiftheywish to have the FDAissue a GVK were asked to contact local European regulators, following letter to the RLD sponsor. “serious concerns” raised by France’sANSM after an inspection Welcoming the guidance, the GPhA’s president and chief that bioequivalence trials at the Hyderabad facility had not been executive officer,Ralph Neas, said the agencyhad taken “helpful conducted according to good clinical practice since 2008 (Generics steps to address, and hopefully limit, scenarios in which some brand bulletin,8August 2014, page 15). Shortly afterwards, the EMA’s drug companies misuse REMS programmestothwart competition committee for human medicinal products (CHMP) beganareview from more affordable generic drugs”. of GVK to determine which medicines were affected by ANSM’s Last year,astudy commissioned by the GPhA found that inspection findings (Generics bulletin,3October 2014, page 8). abuse by brand companies of REMS and ‘restricted access drug’ GVK said it believedthat the studies conducted were “in accordance programmestodenygenerics firms access to product samples was with good clinical practice guidelines”. “Weare working with our costing the US healthcare system US$5.4 billion annually (Generics clinical development customers to provide newdata that meets all bulletin,8August 2014, page 15). regulatory requirements,”the firm added. Giventhat the authorities The report by Matrix Global Advisors also warned that, after had concluded that the bioequivalence studies conducted at the biosimilars enter the US market, similarabuse could lead to around Hyderabad plant were not sufficient to support marketing authorisations, US$140 million in lost savings for every US$1 billion in biologics sales. GVK said it expected that the marketing-authorisation holders would “The FDAguidance comes at atime when this issue is also have to repeat studies “in the next 12-15 months”. receiving elevated attention in Congress,” Neas noted. Representatives Commenting on the suspensions, the European Generic medicines Steve Stivers and Peter Welch had introduced abill for the Fair Access Association (EGA) said it was“very concerned about the allegations for Safe and Timely (FAST) Generics Act, Neas observed, “which of data falsification”, adding that “to date, there is no evidence of any effectively prohibits companies from adopting restricted-accesspractices risk posed to human health by the medicines concerned”. EGA members to avoid generic competition”.This, Neas said, was“amanoeuvre that are “actively cooperating with EU and national competent authorities to comes at the expense of patient access to affordable medicines”. G ensure that patient safety and access to treatment will be ensured”. G

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REGULATORY AFFAIRS PRICING&REIMBURSEMENT EGA and Efpia ally on Four firms sharein counterfeiting battle South African tender

he European Generic medicines Association (EGA) will join the our generics firms –Aspen Pharma, Cipla Medpro, Mylan and TEuropean Stakeholders Model (ESM) established to implement FSonkePharmaceuticals –will share athree-yeartender for anti-counterfeiting elements of the European falsified medicines antiretrovirals in South Africa worth overZAR10 billion (US$855 directive,the association has announced in conjunction with brand million) in total, the country’sDepartment of Health has announced. industry organisation the European Federation of Pharmaceutical The deals coveraperiod running from 1April 2015 to 31 March 2018. Industries and Associations (Efpia). The twobodies called the EGA’s Sonkewon the largest share of the tender with ZAR3 billion, while participation in the ESM “another positive step in the pharmaceutical Mylan wasawarded aZAR2.8 billion share. Aspen followed with an industry’sunited effort to combat counterfeiting”. award worth ZAR2.5 billion while Cipla will enjoyaZAR2 billion EGA director general Adrian vanden Hovensaid the association share of the antiretrovirals tender. was“proud to join forces with Efpia”, as well as with the European As part of the award, Mylan noted that it would supply South Association of Pharmaceutical Full-line Wholesalers (GIRP), the Africa with triple-therapyfixed-dose combination (FDC) drugs, having European Association of Euro-Pharmaceutical Companies (EAEPC) previously been selected as a“leading supplier” of atenofovir/ and the Pharmaceutical Group of the European Union (PGEU). “Now emtricitabine/efavirenz FDC tablet for the previous tender covering it is time for us to work with the support of European Union (EU) and 2013 and 2014 (Generics bulletin,14December 2012, page 9). national authorities to get the system up and running effectively,” he Aspen noted that it had been awarded aquarter of the tenofovir/ added, “while maintaining access to safe medicines.” emtricitabine/efavirenz FDC, “which will be used to treat upwards of 80% of first-line adult treatment”. The South African firm also secured ESM membership is EGA ‘milestone’ shares of awards for abacavir solution, and atazanavir,nevirapine and Welcoming the EGA’s membership of the ESM as a“milestone” tenofovir tablets, as well as capturing all of the tender awards for for the group, Efpia director general Richard Bergström emphasised darunavir 600mg tablets, etravirine 100mg tablets, and stavudine that “by joining together,wecan best protect patients and their security”. capsules in 15mg, 20mg and 30mg strengths. The cost of arepository for unique identifiers on packaging had Also among the 41 presentations covered by the tender were previously provedastumbling block on an alliance (Generics efavirenz tablets, lamivudine tablets and oral solution, zidovudine bulletin,20June 2014, page 28). tablets and azidovudine/lamivudine combination. Meanwhile, the twogroups have also called for measures to Cipla noted that its ZAR2 billion share wasits “third tender win “stimulate healthyand sustainable generic and biosimilarmedicines in the last year”, following twoprevious awards in South African competition” to be included in an “integrated life sciences strategy” tenders in 2014, including arespiratory contract. by the European Union (EU). Vanden Hovensaid the pharmaceutical During the antiretrovirals tender process, the Department of sector was“apartner for better health and for growth and jobs” in Health also receivedbids from AbbVie, Adcock Ingram, Aurobindo, Europe. “Weneed adecisive pharmaceutical industry strategy to Emcure and Macleods, as well as from Merck, Sharp &Dohme, boost our manufacturing capacities to serveEurope,”headded. G Sanofiand its Zentiva subsidiary,and Specpharm. G

ANTITRUST LITIGATION INTELLECTUAL PROPERTY/REGULATORY AFFAIRS FTC persistsover AndroGel Canada plans linkage changes eals struck on AndroGel (testosterone) and TriCor (fenofibrate) ealth Canada plans to amend the country’sPatented Medicines Dbetween Teva and AbbVie in the US amounted to apayment not H(Notice of Compliance), or PM (NOC), patent-linkage regulations to compete, the US Federal Trade Commission (FTC) has contended in light of recent court rulings. A“strict interpretation” of recent in afiling made as part of an antitrust case brought by the state decisions on patents claiming single active ingredients found in regulator in aPennsylvania district court. combination drugs could, the agencyfears, force it to change its practice Opposing amotion tabled by defendants Teva,AbbVie and Besins, on listing certainpatents on its patents register. to dismiss acharge of engaging in an illegalrestraint of trade (Generics The planned amendments –tobepublished for comment in the bulletin,19September 2014, page 12), the FTC insisted adispute country’sofficial gazette on an as-yet undecided date –are intended to overanAndroGel formulation patent expiring in 2020 amounted to “confirm established Health Canada practices in relation to the policy “a sham patent-infringement suit”. “The defendants’ failure to account intent of the NOC regulations and clarifythe listing requirements as they for these allegations is fatal to their motion,”the Commission maintained. relate to single medicinal ingredients found in combination drugs”. G The FTC argued that its restraint of trade allegations were similar to those considered by the US Supreme Court in its ruling on the IN BRIEF Commission’sdispute with Actavis overAndroGel. Insisting that the defendants had effectively agreed apayment for Teva not to compete FDA –the US Food and Drug Administration –has issued aseries with AndroGel, the FTC said: “Their primary argument –that the of product-specific bioequivalence guidelines for generics. More complaint fails to allege a‘payment’ –rests on the defendants’ insistence than 30 newrecommendations were added to the agency’slist of that the simultaneously executed contracts on TriCor and AndroGel bioequivalence guidances at the end of December,while afurther 22 were entirely independent, pro-competitive deals and that AbbVie was existing documents were revised. G unaware of Teva’s difficulties with its generic TriCor product.” G

16 January2015 GENERICS bulletin 11 Gen 16-1-15 Pgs. 9-14_Layout 1 13/01/2015 16:40 Page 6

MARKET NEWS

PRICING&REIMBURSEMENT IN BRIEF FRANCE has modified reference prices for just under 400 generic Teva takes top spot groups in the country’s répertoire of equivalents from 1January 2015, following adecision by the economic committee for healthcare products (CEPS). Referenceprices –or tarifs forfaitaires de responsabilité (TFRs) –are applied by CEPS to product groups among AOK awards listed in France’s répertoire of generic equivalents in which generics are failing to achieve target penetration rates. eva’s bidding group with its affiliate, Ratiopharm, led the field in Tsecuring supply contracts in the 14th tender round run by leading FDA –the US Food and Drug Administration –has confirmed German statutory health insurance fund, the AOK. Sanofi’sZentiva that its Office of Pharmaceutical Quality (OPQ) within the Center and Stada’sAliud were also among the most successful participants. for Drug Evaluation and Research (CDER) will officially start “For 103 of the 116 active ingredients or combinations for which operations this month, led by acting director Janet Woodcock. The we had sought bids, we were able to reach supply deals with 29 OPQ will aim to “enhance the reviewprocess” for abbreviated new pharma companies,”noted the AOK’schief negotiator,Christopher drug applications (ANDAs) by offering “real-time communication” Hermann. No deals could be struck for molecules including cefixime, between the applicant and the FDAinadvance of formal action. entacapone, hydrocortisone and octreotide. Of the 103 active ingredients covered by supply contracts, 88 were EBG –the European Biosimilars Group –has told aDrug Information awarded on an exclusive basis across eight regions. Teva captured 20 Association (DIA) conference in Berlin, Germany, that no scientific of those, including deals to provide the AOKacross Germanywith evidence exists to suggest switching to and from comparable captopril, diclofenac, efavirenz, gabapentin and meloxicam. biopharmaceuticals creates safety concerns. EBG coordinator When the two-year contracts under the AOK’s14th round come Suzette Koxadvised doctors to reviewscientific data contained in into effect on 1June this year,Zentiva will become the fund’sexclusive European Public Assessment Reports (EPARs) to guide decisions supplier of 10 molecules, such as alfuzosin, fexofenadine, glimepiride on interchangeability. and ibuprofen. Aliud picked up nine exclusive contracts for drugs including GERMAN exceptions to automatic pharmacy substitution have ibandronate, lormetazepam, metoclopramide and nifedipine. Citalopram, come into effect following publication of alist of products in the lamotrigine and sertraline are among the six molecules for which Mylan country’sfederal gazette, the Bundesanzeiger.Excluded from will be the AOK’sexclusive supplier,while Torrent’sHeunet/Heumann substitution are beta-acetyldigoxin, digitoxin and digoxin tablets, label secured four exclusive deals for azathioprine, escitalopram, as well as tablet forms of phenytoin and levothyroxine sodium. finasteride and indapamide. The latter includes combinations with potassium iodide. Tacrolimus Aurobindo picked up three nationwide exclusive deals, while hard capsules are excluded, as are ciclosporin soft-gel capsules Aristo, Sandoz’ Hexal, Glenmark and Neuraxpharm each secured two. and oral solution (Generics bulletin,3October 2014, page 10). For15active ingredients or combinations, the AOKchose to award supply contracts to up to three companies (Generics bulletin,17 ROMANIA’s generics industry association, APMGR, has launched October 2014, page 10). Among such drugs were: the antihypertensives a national campaign aimed at providing information and education amlodipine and losartan; the antibiotics cefaclor,ceftriaxone, cefuroxime on the safety,quality and efficacyofgenerics, in partnership with and ciprofloxacin; the proton-pump inhibitor omeprazole; the the country’smedicines agencyANMDM. Meanwhile, APMGR cholesterol-lowering agent simvastatin; and neuroleptic risperidone. has urged Romania’sgovernment to considermodifying the country’s pharmaceutical clawback as part of health budget debates. Combined sales of C2billion Identifyingbisoprolol, escitalopram, ibuprofen, omeprazole MHRA –the UK’sMedicines and Healthcare products Regulatory sertraline and simvastatin as the best-selling molecules covered by Agency–has issued anew ‘orange guide’ and ‘green guide’ the latest deals, the AOKsaid the 103 active ingredients included in the containing information and legislation relating to the manufacture supply contracts had acombined annual turnoverthrough the fund and distribution of medicines. The guides include revised European of around C2billion (US$2.4 billion). Union (EU) guidelines on good distribution practice. The AOK’s14th tender round will largely replace its 10th and 11th rounds for which contracts expire this year.Atpresent, the fund EMA –the European Medicines Agency–has published its work has under contract 259 off-patent molecules or combinations with programme and budget for2015.Among the agency’sgoals are combined annual sales of more than C5billion. Since 2007, the AOK “enhancing cooperation within the European medicines regulatory claims, tenders have saveditmore than C3.6 billion. network, as well as with European and international partners” and Hermann insisted there was“no alternative” to tenders, especially increasing transparencyand access to data. as funds’ medicines outlay had risen by almost atenth in the first nine months of 2014. GPhA –the US Generic Pharmaceutical Association –has welcomed Noting that draft legislation passed by Germany’sfederal cabinet the findings of aUSSenate committee on ageing that has highlighted on 17 December last year would relax certain penalties for doctors who the role of generics in slowing healthcare spending growth, particularly prescribed adisproportionate levelofexpensive medicines, Hermann within the Medicare Part Dinsurance programme.Areport feared that doctors would prescribe fewer substitutable medicines. recommends“finding innovative ways to expand generic drug usage Quoting IMS Health data, German generics industry association among low-income subsidy beneficiaries”. Pro Generika said generics had savedthe country’shealth insurance funds more than C11 billion in the first 10 months of 2014, and had CANADA’s Patented Medicine Prices ReviewBoard (PMPRB) accounted for 68% of all prescriptions dispensed. Over the same has concluded that “prices of generic drugs in Canada have declined period, Pro Generika observed, atotal of 69 companies had launched significantly since 2010”. This wasmainly due to ‘more rigorous’ 992 newproducts ranging across 12 single substances and two provincial generic reimbursement policies, the PMPRB concluded. G combination drugs. G

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MARKET NEWS

LABELLING TRADE AGREEMENTS EGA backs EMA on GPhA voicesconcern biosimilar labelling over TPP provisions

iosimilar labelling must be consistent with that of the reference Trans-Pacific Partnership (TPP) trade deal being negotiated between Bproduct, the European Generic medicines Association (EGA) has Athe US and several other countries “fails to strikethe right balance insisted as part of a‘position statement’ presented by the association’s between fostering innovation and ensuring expedited access to more European Biosimilars Group (EBG). affordable medicines” in its current form, according to the US Generic Addressing the DIA biosimilars conference in Berlin, Germany, Pharmaceutical Association (GPhA). in December on behalf of the EBG, Sandoz’ ElkeGrooten expressed Insisting that the TPP “does too much to extend already generous “full support for the European Medicines Agency(EMA) approach on monopolies enjoyed by brand-name drugs, and too little to ensure biosimilarlabelling”, which requires consistent labelling. that safe, low-cost generic versions are available to patients as soon as Having earlier this year refuted suggestions by originator legally possible”, GPhA president and chief executive officer Ralph association EuropaBio that the current approach to labelling was Neas said that “every intellectual-property provision affecting insufficient and that biosimilar labels should reflect extra data relating pharmaceuticals proposed in the TPP –including patent linkage, to the extent of ‘biosimilarity’ demonstrated for each claimed indication patent-term extensions, and exclusivity provisions –would delay the (Generics bulletin,3October 2014, page 6), the EGA insisted that launch of generic drugs to the detriment of patients, healthcare the current system was“adequate, reliable, safe and transparent”. budgets and the generics industry”. Prescribers and patients were already able to safely and effectively Moreover, Neas said, the TPP would delay the entry of biosimilars use biosimilars, Grooten pointed out, while the public wasable to by ‘locking in’ 12-year data exclusivity for biological brands despite retrieve data on howindividual biosimilars had been evaluated by the recent domestic US proposals to reduce this term to sevenyears. EMA, as well as post-authorisation information. “Trade agreements are supposed to open markets,”Neas observed, Deviations in product information could in fact create adding: “The current TPP opens markets for big pharma butcloses “unnecessary confusion and deepen the misinterpretation of the them for generics.” biosimilarity concept”, Grooten argued, concluding that “continuation The GPhA has signed aletter to US President Barack Obama of labels consistent between the reference product and biosimilar expressing these “deep concerns” overthe TPP alongside groups medicines is amust”. G such as Médecins Sans Frontières (MSF) and Oxfam. G

16 January2015 GENERICS bulletin 13 Gen 16-1-15 Pgs. 9-14_Layout 1 13/01/2015 16:40 Page 8

MARKET NEWS

INTELLECTUAL PROPERTY REGULATORY AFFAIRS Problem settlements Russia may consider remain low in the EU compulsorylicensing

nly 8% of patent settlements concluded between generics firms and ussia should consider issuing compulsory licences for domestic Ooriginatorsinthe European Union (EU) in 2013 contained alimit Rfirms to produce generic versions of certain patented medicines, on generic market entry as well as a“value transfer” from the originator according to local member of parliament SergeyKalashnikov. to the generics firm, according to the latest monitoringreport published In aletter to the country’sPrime Minister,Dmitry Medvedev, by the European Commission. The figure wasalmost unchanged from Kalashnikov urged Russia’snational authorities to followthe 7% in 2012 (Generics bulletin,10January 2014, page 15). example that had been set by countries including Brazil, India, Following its fifth round of monitoring, the Commissionconcluded Indonesia, and Thailand, and adopt acompulsory licensing that the 8% figure –representing just 11 of the 146 patent settlements mechanism for vital AIDS, cancer and hepatitis medicines. agreed during 2013 –indicated that such settlements, which might Furthermore, Kalashnikov said, introducing compulsory licensing attract competition lawscrutiny, “have stabilised at alow level”. would bolster domestic production of pharmaceutical substances, for Of the 146 settlements concluded, 45% –or66–did not include which production had currently been suspended due to currency anylimitation on generic market entry,while 47% –69–limited devaluation of the Russian rouble. generic market entry butdid not include a“value transfer”. Meanwhile, Russia’sMinistry of Health has outlined plans to Meanwhile, the Commission noted, statements made by certain create an online portal to inform doctors and patients about equivalents industry stakeholders during the Commission’searlier pharmaceutical to brands. It will list brands and their international non-proprietary sector inquiry –indicating that the Commission would be “forcing names (INNs), along with available alternatives. companies to litigate each patent dispute until the end” –had proved The listing –which is due to be launched in the first half of this to be “unfounded”, giventhe increase in the number of settlements year as part of awider healthcare information system –will also provide overall. The figure of 146 in 2013 compared to 24 per year between detailed information on each drug’scomposition, dosage form, storage January 2000 and June 2008, the Commission observed. conditions, expiry date and instructions for use. Doctors and pharmacists However, brand industry body the European Federation of will have expanded access to the system, allowing them to detect Pharmaceutical Industries and Associations (Efpia) said that patent whether products contain narcotic and psychotropic substances or settlements were “a symptom of afragmented and partly inefficient other additional characteristics. enforcement regime in Europe as faraspharmaceutical patent disputes Health authorities insisted that the scheme would “facilitate the at the point of generic entry are concerned”. work of doctors in terms of implementingmandatory prescribing Urging the Commission to “tackle the root cause rather than the by INN rather than by brand name”, as well as serving as areference symptoms”, Efpia said it should consider an early-resolution mechanism resource to support prescribing decisions. Meanwhile, patients who that would address patent disputes “sufficiently in advance of generic knewaproduct’sbrand name would be able to identify cheaper launch to increase legalcertainty for all stakeholders”. G alternatives, the authorities added. G

REGULATORY AFFAIRS REGULATORY AFFAIRS GPhA backs biosimilar rules Ukraineplans for recognition egislation that would allowinterchangeable biologics in the US to arketing authorisations granted in Australia, Canada, the European Lbe automatically substituted by pharmacists has been proposed by MUnion, Japan or the US should be automatically recognised in the US Generic Pharmaceutical Association (GPhA). The “compromise Ukraine through amutual-recognition procedure, according to the automatic substitution legislation” –which GPhA president and chief country’sPrime Minister,Arseniy Yatsenyuk. He stressed that the executive officer Ralph Neas noted had been introduced as state government intended to takethis “unprecedented step” to “stop legislatures prepared for their 2015 sessions –includes provisions bureaucratic and corrupt registrations[in Ukraine] of drugs which had directing pharmacists to communicate to doctors details of the already been appropriately authorised in other countries”. dispensed drug “within areasonable time”. However, the Ukrainian Association of Pharmaceutical Producers Calling the compromise language “a vast improvement over2012 insisted that such areform should not covergenerics. G language that we strongly opposed,and which originallyerected numerous barrierstothe automaticsubstitution of interchangeable biologics”, Neas insisted that state legislation “must be in place to allow PRICING&REIMBURSEMENT automatic substitution when the US Food and Drug Administration (FDA) approvesthe first interchangeable biologics in this country”. Morecuts hit Australia’s PBS Meanwhile, proposals by the FDAtoamend labelling regulations to require electronic distribution of prescribing information to health statutory 16% price reduction for drugs facing competition from professionals have also been welcomed by the GPhA. “This information Atheir first generic equivalents has been applied from December to could include critical details necessary for effective use of the product several products listed on Australia’sPharmaceutical Benefits Scheme or timely updates to safety information,”the association pointed (PBS). Treatments affected include oral adefovir,celecoxib, clindamycin out. “This means that manufacturerscan provide electronic updates and dipyridamole/aspirin, as well as oxycodone, raloxifene and the to labels in weeks, rather than the months or even years nowrequired hydrochlorothiazide component of valsartan/hydrochlorothiazide. for paper labels.” G The 16% cut has also been applied to dorzolamide/timolol eyedrops. G

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PRODUCT NEWS

ERECTILEDYSFUNCTIONDRUGS BIOLOGICALDRUGS Sandoz rivals Cialis FDA accepts Apotex’ with Braziliandeal filing of pegfilgrastim

andoz is claiming the first launch of aBrazilian generic rivalto potexsays the US Food and Drug Administration (FDA) has SEli Lilly’sCialis (tadalafil) 5mg and 20mg tablets ahead of local Aaccepted for filing its application for abiosimilar rivaltoAmgen’s patent expiry in March through alicensing agreement with the Neulasta (pegfilgrastim) neutropenia treatment. The Canadian firm – originator.André Brázay,Sandoz’ Brazilian country head, said the deal which developed the drug through apartnership with India’sIntas meant the firm was“the only companyinBrazil to have both sildenafil Pharmaceuticals –believesitisthe first firm to have had adossier and tadalafil molecules, keyproducts to meet the needs of patients accepted for reviewunder the FDA’s351(k) biosimilarpathway for with erectile dysfunction”. the long-acting formulation of filgrastim. “Aspart of the agreement, Sandoz will be responsible for Noting that it would market the biosimilarpegfilgrastim in the marketing and the packaging of the product under the Sandoz brand US through its ApoBiologix division, the Canadian companycited in Brazil,”the firm observed. Sandoz’ range of men’shealthcare IMS Health data that showed Neulasta as having US sales of around products in Brazil also includes doxazosin and leuprorelin. G US$3.6 billion in 2013. Six years ago, Apotexextended its collaboration with Intas to coverpegfilgrastim (Generics bulletin,13February 2009, page 17). BIOLOGICALDRUGS The twofirms had almost ayear earlier struck acollaboration deal in North America and Europe. This has seen Intas provide from its UK alters biosimilars position plant in Moraiya, India, the biological active substance for the Grastofil (filgrastim) pre-filled syringes for which Apotexsecured apan-European position statement issued by the UK’sNational Institute for health marketing authorisation in October 2013 (Generics bulletin,1 Aand Care Excellence (NICE) has “updated the body’smethods November 2013, page 14). for providing guidanceand advice on biosimilarmedicines, as their “Weare very pleased to be at the forefront of companieswho will availability and use on the UK National Health Service (NHS) grows”. introduce high-quality biosimilar products into the US marketplace,” Biosimilarscould offer “considerable cost savings, especially as they commented Apotex’ president and chief executive officer,Jeremy Desai. are often used to treat long-term conditions”, NICE acknowledged. “Our entry into this newfrontier of medicine in the US,”headded, “Over the past 10 years there has been arapid worldwide increase “is awatershed event in Apotex’ 40-year history of providing in the number of biological medicines that have receivedregulatory quality,affordable medicines.” G approval,”NICE observed. “Although biosimilars are already used to some extent in the NHS, and NICE has previously included biosimilars in its technology appraisal on the human growth hormone somatropin, ONCOLOGY DRUGS it is likely that their availability and use will become more widespread overthe next fewyears.” Biosimilarswill “usually be considered in the context of amultiple India backs sorafenib licence technology appraisal in parallel with their reference products in the ndia’sSupreme Court has upheld lower court rulings that a indication under consideration”, the position statement explains. “NICE Icompulsory licence issued to Natco Pharma for ageneric version technology appraisals will use the name of the active drug substance, of Bayer’sNexavar (sorafenib) cancer treatment is legal. including reference products and brand-named similar biological “In the facts of the present case, we are not inclined to interfere,” medicinal products in its documentation where appropriate, to inform the Supreme Court judges stated in dismissing Bayer’s‘special leave’ clinical decision-making.” petition to appeal against aBombay High Court’sruling from last year. Atechnology appraisal remit referred by the UK’sDepartment In that ruling (Generics bulletin,8August 2014, page 20), the of Health to NICE enables the regulator “to decide to apply the same Bombay court had found that Bayer had supplied the liver- and kidney- remit, and the resulting guidance, to relevant licensed biosimilar cancer drug to only around 200 patients, meaning “the reasonable products which subsequently appear on the market”, according to the requirement of the public” in India wasnot being met. position statement. Evidence summaries will use brand names Furthermore, the court observed, Bayer wascharging around “because substitutability and interchangeability cannot be assumed”. Rs284,000 (US$4,464) for amonth’scourse of 120 tablets, while Evidence summaries, NICE emphasised, “do not make Natco –which pays Bayer aroyalty of 7% on sales –had set aprice recommendations, hence the decision regarding the choice of biosimilar of just Rs8,800 per month. “The patented drug is not being offered or originator biologic for an individual patient rests with the clinician”.G at areasonably affordable price by the petitioner,” it added. G IN BRIEF IN BRIEF FARMAK has extended its range of prescription drugs in Ukraine by HOSPIRA’s 50mg/10ml and 100mg/20ml presentations of oxaliplatin launching its tranexamic acid as well as dexketoprofen solutions and its 30mg/5ml and 100mg/16.7ml strengths of paclitaxel have been for injection under the brand names Gemotran and Keywer.The firm added to Japan’sNational Health Insurance (NHI) price list. Both is offering its anti-fibrinolytic agent Gemotran in 50mg/5ml and drugs were approvedbythe country’sMinistry of Health, Labour and 100mg/5ml doses, while anti-inflammatorydrug Keywer comes in Welfare (MHLW) in August (Generics bulletin,5September 2014, 50mg/2ml vials as well as in 25mg tablets.The companyhas also page 20). The injectables specialisthas alocal oncology co-promotion introduced its Vial Tear (tetryzoline) 10ml ophthalmic eyedrops. G agreement with Mochida. G

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PRODUCT NEWS

ALZHEIMER’SDISEASE DRUGS BIOLOGICALDRUGS Actavis told to keep Zydus Cadila debuts selling Namenda IR adalimumab in India

ctavis has been thwarted in its plans to withdrawthe immediate- ydus Cadila says it has become “the first companyanywhere in Arelease formulation of its Alzheimer’sdisease treatment Namenda Zthe world” to launch abiosimilar rivaltoAbbVie’sHumira (memantine) from the US market in order to more swiftly transition (adalimumab)blockbuster after introducing the autoimmune diseases patients to the extended-release formulation, Namenda XR, after a treatment in India following approvalfrom the Drug Controller General US district court issued apreliminary injunction requiring the company of India (DCGI). Humira had global sales of around US$10.7 billion to continue distribution. Actavis would have pulled Namenda IR from in 2013, making it the world’sbest-selling drug, Zydus observed. the US market on January 12015. Developed at the Indian firm’sZydus Research Centre, Zydus Having immediately appealed this ruling, Actavis has been awarded said its adalimumab was“a‘fingerprint match’ with [Humira] in terms an expedited appeal by the US Court of Appeals, meaning afurther of safety,purity and potency”. The Indian companyhas established decision will nowbemade by 16 February 2015. But the appeals court anew division called Zydus Biovation to market its adalimumab – refused to lift the preliminary injunctionwhile Actavis’ appeal is pending. which it has giventhe fantasy name Exemptia –and said the launch The lawsuit had been brought against Actavis by NewYork would be supported by “scientificsymposia to highlight the gaps in attorneygeneral Eric Schneiderman, who last year described the the current management of autoimmune disorders”. company’splan to ‘forcibly’ switch patients to the extended-release Zydus said Exemptia waspresented as a40mg subcutaneous formulation of Namenda formed “part of an anticompetitive strategy injection, administered once aweek on alternating weeks, typically over designed to maintain high drug prices” (Generics bulletin,3October the course of six months. Around 12 million patients in India suffered 2014, page 16). from diseases treatable with adalimumab,the Indian firm stated. Patents protecting Namenda IR –which Actavis obtained through its multi-billion dollar deal for US originator Forest Laboratories 24 biologics in pipeline last year –expire in July 2015, butgeneric rivals, once available, “The biosimilar of adalimumab is part of Zydus’ robust biologics will not be automatically substitutable for Namenda XR, and will programme,which has the largest number of monoclonal antibodies require adoctor’sapproval. under development in India,”the Indian companysaid, noting that this The extended-release formulation, having been launched by Forest programme comprised 24 biologic drugs, “including biosimilars and in June 2013, had sales of US$136 million in the US firm’sfinancial three novelbiologics”. year ended 31 March 2014. Namenda IR, meanwhile, enjoyed sales Humira’sUScomposition patent is expected to expire in December of US$1.54 billion. 2016, while patent protection in most European Union (EU) states is “The present Forest sales programme is consistentwith an accepted expected to end in April 2018. industry practice of a‘soft switch’ when anew product is introduced,” Stada recently announced that it wasintalks with Swiss firm said NewYork District Judge Robert Sweet, “a practice that maintains mAbxience to in-license abiosimilar version of Humira (Generics consumer choice before and after generic entry into the market.” bulletin,5December 2014, page 22), while Momenta recently Rejecting Actavis’ argument that “allowing them to engage in the ‘hard revealed that it wasdeveloping adalimumab with Baxter (Generics switch’ will allowincreased innovation in the long term, [due to] bulletin,3November 2014, page 20). G greater financial resources”, Sweet ruled that “providing financial rewards for anticompetitive conduct is not in the public interest”. “The irreparable injury has been established, the balance of OPHTHALMIC DRUGS hardships tips markedly in the favour of the State, and the public interest is best served by preliminary relief maintaining the status quo,”he concluded. Actavis said it was“prepared to manage its business in Wilshiresued on alcaftadine away that…minimises anyfinancial impact”. G ilshire Pharmaceuticals –the US generics subsidiary of US-based Woriginator Arbor Pharmaceuticals –has been sued by Allergan and its partner Vistakon in aUSdistrict court after filing an abbreviated DERMATOLOGICALDRUGS newdrug application(ANDA) for ageneric version of the former’s Lastacaft (alcaftadine) 0.25% ophthalmic solution. Oxarol rivals barredinJapan Thetreatment for itching associated with conjunctivitis is currently shielded by twoUSpatents: US composition patent 5,468,743 that hree firms distributing generic Oxarol (maxacalcitol) ointment in expires in April 2016, and US method-of-use patent 8,664,215 that TJapan, along with the active pharmaceutical ingredient (API) expires in October 2029. importer,must cease their respectiveactivities after losing apatent- US market exclusivity for Lastacaft –which wasone of several infringement lawsuit against originator Chugai Pharmaceutical in a products revealed by the US Food and Drug Administration to have Tokyodistrict court. receivedaparagraph IV challenge last year (Generics bulletin,3 Japanese distributors Iwaki, Pola Pharma and Takata, bulk-drug November 2014, page 16) –runs until July 2015. importer DKSH, and API manufacturer Cerbios-Pharma, have in As the first to file acomplete ANDAcontaining aparagraph IV response filed arequest for patent invalidation against the keratosis certification, Wilshire said that it believeditwas eligible for 180-day treatment with the Japan Patent Office following the verdict. Chugai – US generic market exclusivity. which is majority-owned by Swiss originator Roche –had filed the “Weare excited about the continued development of our pipeline, lawsuit against the Japanese companies almost twoyears ago and alcaftadine represents another keymilestone for Wilshire,” (Generics bulletin,8March 2013, page 20). G commented companypresident Scott White. G

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PRODUCT NEWS

BIOLOGICALDRUGS BIOLOGICALDRUGS Celltrion is too early Torrent and Reliance on infliximab attack strike biologicsdeal

nattack launched by Celltrion against three method-of-use patents orrent Pharmaceuticals will license versions of adalimumab, Aprotecting Janssen’sRemicade (infliximab) in the US has been Tcetuximab and rituximab from Reliance Life Sciences to market dismissed by aNew York district court because the South Korean in India, under an exclusive 10-year deal struck between the two firm’spreparations to introduceaUSbiosimilar version are “simply companies. Under the terms of the deal, Reliance will develop and not at astage that can support adeclaratory judgement action”. supply the biologicals to Torrent after obtaining“all necessary Earlier this year,Celltrion filed acomplaint insisting that US regulatory approvals”. patents 7,846,442, 8,298,537 and 8,383,120 –held by the Kennedy Pointing out that it would be “the only companytomarket these Trust for Rheumatology Research and covering the use of anti- biosimilars in India other than Reliance Life Sciences”,Torrent also tumour necrosis factor (TNF) antibodies such as Remicade alongside noted that it had gained a“strong position” in oncology and methotrexate –were invalid. This, Celltrion argued, wasbecause the dermatology in India since creating dedicated divisions for these patents claimed “the same invention or obvious variations of the segments in 2011 and 2012. The deal with Reliance wasexpected to invention Kennedy claimed in [an] earlier,now expired patent” “significantly boost its presence in these segments in the coming (Generics bulletin,18April 2014, page 19). years”, Torrent predicted. While Kennedy argued that Celltrion had not establishedthe “Reliance Life Sciences will manufacture these products at its existence of acontroversy because the South Korean firm had “not facility in Navi Mumbai and supply to Torrent Pharma for aperiod yet engaged in meaningful preparation to conduct potentially of 10 years,”Torrent stated. “Torrent Pharma has in the past launched infringing activity”, Celltrion insisted that it had “substantially the biosimilar darbepoetin under the brand name of Darbatitor,which prepared” to bring its Remsima product to the US market. is used during dialysis,”the Indian companynoted. G But District Judge Paul Crotty decided in Kennedy’sfavour, concluding that Celltrion was“simply too farfrom receiving US Food and Drug Administration (FDA) approvalfor the exercise of declaratory DERMATOLOGY DRUGS judgement jurisdiction to be proper”. While Celltrion has initiated the filing process for its infliximab with the FDA(Generics bulletin,5September 2014, page 17), Crotty Amneal’sOracea reviews fail observed that the potential for patent infringement would only be mneal has failed in an attempt to challenge US patents protecting realised if this applicationwas accepted for review, approvedbythe ASupernus Pharmaceuticals’ Oracea (doxycycline) rosacea treatment FDA, and receivedapprovalfor the same use as Remicade before through inter partes review. The generics firm had claimed before patent expiry.While these steps were “not wholly speculative or the patent trial and appeal board of the US Patent and Trademark unlikely”, Crotty acknowledged, theydemonstrated that anycurrent Office (PTO) that US patents 8,206,740, 8,394,405, and 8,394,406 – court opinion would have to be based on hypothetical facts. which relate to “once-daily,sub-antimicrobial formulations of The potential dispute between the parties “has not yet ripened into doxycycline” –were invalid due to obviousness. acontroversy”, Crotty stated. And even if the threat of injury was “Amneal has failed to persuade us that the prior art it cites for “sufficiently demonstrable”, he added, “the court would still exercise disclosure of immediate-release/delayed-release ratios actually discloses its discretion to decline to hear this case in light of the existence of such ratios,”the board said. Without evidence that the claimed ratio the Biologics Price Competition and Innovation Act (BPCIA) statutory wasknown or could have been reached through routine framework for the resolutionofpatent disputes”. experimentation, the board concluded, “Amneal’schallenge fails”. G There wasnoreason to believe,Crotty said, that the BPCIA’s dispute-resolution procedure would be “insufficient to resolveany patent disputes here”. Labelling as “untenable” Celltrion’scontention ANTIHYPERTENSIVES that the case wasboth ripe for reviewyet also should not be subject to BPCIA provisions because “the time has not yet arisen for the parties to engage in the necessary information-exchange process”, Crotty stated: MoreDiovan rivals enter US “Celltrion’sattempt to skirt the BPCIA’s dispute-resolution mechanisms eading generics players such as Lupin, Mylan and Teva have while reaping the benefits of its approvalprocess is improper.” Lbegun shipping further US rivals to Novartis’ Diovan(valsartan) While Celltrion had argued that the dispute was“not appropriate 40mg, 80mg, 160mg and 320mg tablets following final US Food for the BPCIA pathway because Kennedy is not the reference product and Drug Administration (FDA) approval. sponsor,but the patent owner”, Crotty said the BPCIA pathway “does The firms will compete for US market share with Ranbaxy, which provide for alevel of involvement by the patent owner”. Moreover, he launched the first generic version of the antihypertensiveblockbuster said, for the dispute to become ‘ripe’, Celltrion would have to resolve last year after anear two-year wait (Generics bulletin,11July 2014, anypatent disputes with Janssen to enable it to market its infliximab. page 19). Sandoz has an authorised generic. Celltrion had previously challengedRemicade patents held by Meanwhile, India’sJubilant Life Sciences has receivedfinal FDA Janssen that protect the brand until 2018, butrecently withdrewthe approvaland said it expected to launch “immediately”, while Aurobindo litigation (Generics bulletin,3November 2014, page 1). said its approvedvalsartan tablets were “ready for launch”. Actavis, “Should Celltrion have aripened patent dispute against Kennedy Alembic, Hetero Labs and Torrent also hold final approvals for once it properly engages in the BPCIA dispute-resolution procedures valsartan tablets, while Dr Reddy’shas tentative approval. and once it is further along the pathway towards approval,”Crotty Citing IMS Health data, Mylan said the four strengths of valsartan concluded, “Celltrion may litigate those issues at that time.” G tablets had annual US sales of around US$2 billion. G

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PRODUCT NEWS

WEIGHT-LOSSTREATMENTS BIOLOGICALDRUGS Par megestrol ruling Sandoz’ filgrastim is overturned on appeal introduced in Japan

ruling that found aUSpatent protecting ParPharmaceutical’s andoz has launched filgrastim in Japan in 75µg, 150µg and 300µg AMegace ES (megestrol acetate) brand until April 2024 invalid due Ssyringes. The biosimilar will be jointly marketed with Sawai. to obviousness has been vacated by the US Court of Appeals and Early last year,Sandoz became the “first companytosecure remanded to the Maryland district court for further consideration. approvalfor twobiosimilars in Japan” when it receivedalocal marketing The litigation –which also involves TWiPharmaceuticals – authorisation for its filgrastim (Generics bulletin,4April 2014, page revolves around US patent 7,101,576, which claims amethod of 13). At the time, Sandoz noted that its filgrastim had been approved treating wasting –such as from anorexia or cachexia –inhumans “for the same range of indications as the reference product”, Kyowa by administering an oral suspension of megestrol acetate once daily. Kirin’sGran neutropenia treatment. Although the appeals court said it would “agree with the district Sandoz had filed an application with the Japanese health authority court’sanalysis on motivation to combine, reasonable expectation of for its EP2006 filgrastim candidate –sold in other markets as Zarzio – success, and objective indicia of non-obviousness”, it found that the in early 2013 (Generics bulletin,3May 2013, page 15). Approvalfor lower court had applied the “incorrect standard for inherencyinits Sandoz’ filgrastim in Japan follows the firm’slaunch of the country’s obviousness analysis”. first biosimilar,somatropin, towards the end of 2009 (Generics To rely on inherencytoestablish the existence of aclaim limitation bulletin,16October 2009, page 1). in prior art, the appeals court said, aparty must meet a“high standard”. Meanwhile, Sandoz has announced data from aPhase III trial that The limitation at issue “necessarily must be present, or the natural has “demonstrated similarity of its investigational biosimilar filgrastim result of the combination of elements explicitly disclosed by the compared to the US-licensed reference product, Amgen’sNeupogen”. prior art”, the court insisted. The study –which wasdesigned to “compare the efficacyand safety However, because the district court had not required Taiwan’s of the investigational biosimilar and the reference product with respect TWiPharmaceuticals to present evidence sufficient to prove inherency to mean duration of severe neutropenia following cycle-1 chemotherapy” under this standard, the appeals court said, it had to remand the case –supports aUSfiling that has just been unanimously backed for for “further analysis”,adding that the district court should also “consider approvalbyaUSFood and Drug Administration (FDA) advisory TWi’sother grounds for invalidity”. G committee (see front page). G

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PRODUCT NEWS

ANALGESICS/ARTHRITIS DRUGS IN BRIEF TEVA has receivedUSFood and Drug Administration (FDA) US firms introduce approvalfor its Granix (tbo-filgrastim)neutropenia treatment in the form of an injection for self-administration by patients and caregivers. The Israeli firm plans alaunch in “early 2015”. At the same time, the agencyhas approvedTeva’s QNASL (beclomethasone their Celebrexrivals dipropionate)40µg nasal aerosol for treating allergic rhinitis in children aged between four and 11 years. ctavis, Mylan and Teva have launched rivals to Pfizer’sCelebrex A(celecoxib)50mg, 100mg, 200mg and 400mg capsules in the US. ANSM –France’smedicines agency–has added rivals to Pierre The generics firms had separate settlement deals with the originator Fabre’s Drill Toux Seche (dextromethorphan)15mg/5ml oral to begin shipping the arthritis treatment after aUSdistrict court last solution to the country’s répertoire of generic equivalents. Other year invalidated reissued US patent RE44,048 that protected Celebrex reference brands added to the répertoire include HRA Pharma’s until December 2015 (Generics bulletin,21March 2014, page 1). Norlevo (levonorgestrel)750µg tablets and Septodont’s Septanest Indian player Lupin had also reached asettlement, and has launched (adrenaline)solution. an authorised generic in all four strengths. Teva said Celebrexhad US sales of around US$2.56 billion for FDA –the US Food and Drug Administration –has issued draft the 12 months ended October 2014, according to IMS Health data. guidance for generic versions of extended-release oral budesonide. Only the Israeli firm holds approvals for celecoxib abbreviated new The guidance sets out recommended fed and fasting in vivo studies drug applications (ANDAs) in all four strengths. Mylan and Lupin hold as well as an in vitro comparative dissolution study. approvals for the lowest strength and tentative approvals for the three higher strengths. Actavis has tentative approvals for all four. RATIOPHARM has receivedapositive opinion recommending However, Actavis, Lupin and Mylan have had their paths to granting amarketing authorisation for the Teva subsidiary’s approvalfor all strengths of generic Celebrexunblocked, after an clopidogrel 75mg tablets by the Committee for Human Medicinal appeals court judges reversed adistrict court ruling from last year Products (CHMP) within the European Medicines Agency(EMA). supporting aUSFood and Drug Administration (FDA) exclusivity decision. The agencyhad awarded Teva 180-day exclusivity for three LANNETT has receivedUSFood and Drug Administration (FDA) celecoxib strengths on the basis that an earlier appeals court ruling approvalfor its rivaltoOak Pharmaceuticals’ Cosopt (dorzolamide/ on an original –but later reissued –Celebrexpatent had not triggered timolol)2%/0.5% ophthalmic solution. Claiming that total US sales Teva’s exclusivity (Generics bulletin,6June 2014, page 18). for dorzolamide/timolol 2%/0.5% solution were around US$123 “Congress has spoken directly regarding the court-decision trigger,” million in the year ended October 2014, Lannett noted that the eye the appeals judges pointed out. “The statute makes plain that the drops “add anew dosage form to our product offering”. The firm 180-day exclusivity runs from ‘the date of adecision of acourt in an expects to launch “in the coming months”. action ... holding the patent which is the subject of the [paragraph IV] certification to be invalid or not infringed’.” G PHARMAC –New Zealand’sPharmaceutical Management Agency –has awarded asole-supply deal for escitalopram 10mg and 20mg tablets to Air FlowProducts until 30 June 2016 under arecent tender. ANTI-INFLAMMATORY DRUGS Mylan’s Loxalate version will be delisted from reimbursement. Mylan aims at Orapred ODT ACTAVIS and Gedeon Richter have announced that the US Food and Drug Administration (FDA) has acknowledged receipt of Actavis’ ylan has launched US rivals to Shionogi’sOrapred ODT newdrug application(NDA) resubmission for cariprazine.The M(prednisolone) orally-disintegrating tablets in 10mg, 15mg and schizophrenia treatment’sNDA is due to be reviewed by the 30mg strengths, as well as ageneric version of Hikma Maple’sRobaxin second quarter of 2015. (methocarbamol) 1,000mg/10ml injectable. The orodispersible prednisolone tablets –for which Mylan will enjoy180-day exclusivity – NISSAN CHEMICAL says it has filed complaints in adistrict court have been launched into abranded US market worth US$19.9million in Osaka, Japan, asking Kyorin Rimedio and SanwaKagaku in the year ended September 2014 according to IMS Health, while Kenkyusho –two generic marketing-authorisation holders for rivals methocarbamol 100mg/ml had annual sales of US$15.1 million. to Livalo (pitavastatin)–to“cease and desist from infringing upon Meanwhile, Mylan has receivedtentative approvalfor paediatric the patent rights relating to acertain crystal form of the active formulations of abacavir/lamivudine from the US Food and Drug pharmaceutical ingredient (API) of Livalo”. Similar litigation has Administration (FDA) under the US President’sEmergencyPlan For previously been filed in 2014 against Sawai, Yoshindo, Nissin, Nippon AIDS Relief (PEPFAR). The antiretroviral wasapprovedin60mg/ Chemiphar,Sagami, Nichi-Ikoand Kotobuki. And in 2013, the same 30mg and 120mg/60mg strengths. G complaint waslevelled at Daito, Mochida, Kobayashi Kako, Meiji Seika Pharma, Towa,Tsuruhara and Kaken.

IMPAX has receivedUSFood and Drug Administration (FDA) RESPIRATORY DRUGS approvalfor the firm’s Rytary (carbidopa/levodopa)extended- Infa can offer glycopyrrolate release capsules.“The FDAapprovalofRytary is an important new development for the treatment of Parkinson’s disease,”said Impax’ nfagroup’sSifavitor site has secured acertificate of suitability (CoS) president and chief executive officer,Fred Wilkinson, adding that the Ifrom the European Directorate for the Quality of Medicines and health drug wasdesigned to reduce the amount of time when symptoms are (EDQM) for bulk glycopyrronium bromide. The Italian active not controlled. Impax expects to launch 23.75mg/95mg, 36.25mg/145mg, pharmaceutical ingredients (APIs) producer said glycopyrrolate would 48.75mg/195mg and 61.25mg/245mg versions in February. G expand its broad respiratory portfolio. G

20 GENERICS bulletin 16 January2015 Gen 16-1-15 Pgs. 15-23_Layout 1 13/01/2015 16:41 Page 9

PRODUCT NEWS

BIOLOGICALDRUGS ANTIBIOTICS NZ awards Remicade Four Cubicin patents solesupply to 2020 deemed invalid in US

iosimilar rivals to Janssen’sRemicade (infliximab) will not be Sgeneric rivals to Cubist Pharmaceuticals’ Cubicin (daptomycin) Bable to be listed for reimbursement in NewZealand until March U500mg intravenous injectablefor infusion may reach the market 2020 at the earliest, after the country’sPharmaceutical Management four years earlier than scheduled, after aUSdistrict court ruling Agency, Pharmac, agreed an exclusive five-year hospital supply deal involving Hospira resulted in four of the antibiotic brand’sfiveUS with the originator.This will see Pharmac fund the brand from 1 patents that run until 2020 being declaredinvalid. Reissued US patent March 2015 until 29 February 2020. RE39,071, that expires on 15 June 2016, still shields Cubicin, which From 1January 2015, the reimbursement price of the 100mg had US sales of US$908 million in 2013. The originator said it autoimmune disease treatment has dropped by more than athird from intended to appeal against the ruling. NZ$1,227 (US$952) to NZ$806 per pack. “Pharmac sawanopportunity Delaware district Judge Gregory Sleet wasconvinced by Hospira’s to reduce the price of infliximab following expiration of the patent arguments that US patents 6,468,967 and 6,852,689 –which both and subsequent launch of biosimilar rivals overseas, and the likelihood expire in September 2019 –and US patents 8,058,238 and 8,129,342, these would become available in NewZealand,”explained the body’s that expire in November 2020, were obvious. Moreover, Sleet ruled, director of operations, Sarah Fitt. certain claims of the ‘967 and ‘238 patents had been anticipated by According to the agency, spending on infliximab in NewZealand prior art. Hospira also provedsecondary considerations of obviousness stands at around NZ$15 million per year and is “growing rapidly”. for all four patents. The deal came following acall from Pharmac for pricing proposals However, the US firm failed in its bid to persuade the district from suppliers of infliximab,including biosimilarsuppliers. G court to revise its construction of the term ‘daptomycin’ according to the “stereochemistry of the amino acids that comprise the compound”. Addressing the ‘967 and ‘689 dosing patents, Sleet said both were obvious because prior art –USpatent 5,912,226 and a1992 ATTENTIONDEFICIT HYPERACTIVITY DISORDER DRUGS ‘Woodworth’ research article –“offered the base elements of the claimed invention”. Secondary considerations such as commercial Actavis ships rival to Intuniv success did not change that finding, he added. ctavis has begun shipping generic rivals to Shire’sIntuniv The Woodworth articlealso “disclosed each of the elements of A(guanfacine) 1mg, 2mg, 3mg and 4mg extended-release tablets the claims of the ‘967 patent, expressly or inherently”, rendering in the US with 180-day exclusivity.The launch honours asettlement the ‘967 patent invalid as anticipated. reached between the twofirms twoyears ago, under which Shire will receive a25% royalty on Actavis’ gross profits from sales during its Daptomycin purification methods wereobvious exclusivity period (Generics bulletin,3May 2013, page 1). Citing Turning to the ‘238 and ‘342 purity patents, Sleet said the claimed data from IMS Health, Actavis said the attention deficit hyperactivity methods of purifying daptomycin would have been obvious as of disorder treatment achievedUSsales of around US$668 million in the patents’ priority dates, thus rendering them invalid. “Hospira the 12 months ended 30 June 2014. has establishedaprima facie case that both micelle filtration and Soon after Actavis’ agreement, Israeli firm Teva settled litigation anion exchange chromatographywould have been obvious methods with the UK-based originator allowing it to launch either its own of purifying daptomycin to one skilled in the art,”hestated. generic version or an authorisedgeneric pursuant to Actavis’ But Sleet determinedthat the reissued ’071 patent wasvalid, exclusivity period expiring (Generics bulletin,28June 2013, page rejecting athree-prongedargument from the US firm. Hospira had 23). Parand Sandoz have also reached settlement agreements with argued that the patent’s‘Certificate of Correction’ wasinvalid, Shire overgeneric guanfacine. G along with arguments that the patent wasinvalid for lack of written description and improper recapture. Hospira had submitted its initial daptomycin ANDAinFebruary 2012, and receivedfinal US Food and Drug Administration (FDA) EPILEPSY DRUGS approvalearlier this year (Generics bulletin,17October 2014, Par challenges Trokendi XR page 20). The US firm has also submitted a505(b)(2) hybrid newdrug application (NDA) for a350mg injectableformulation of daptomycin, ar has become the latest generics player to challenge patents which has receivedtentative approvalfrom the FDA. Pprotecting Supernus Pharmaceuticals’ Trokendi XR (topiramate) Last year,Cubist sued Strides Arcolab in aUSdistrict court after extended-release capsules in the US. The generics firm joins Actavis the Indian firm sent aparagraph IV challenge alleging non-infringement (Generics bulletin,17October 2014, page 21) and India’sZydus Cadila or invalidity against Cubicin’sfiveUSpatents. Moreover, pursuant (Generics bulletin,5December 2014, page 23) in filing aparagraph IV to asettlement deal reached with Cubist three years ago, Teva may abbreviated newdrug application (ANDA) seeking to market aUS launch rivals to Cubicin from 24 December 2017 (Generics bulletin, rivaltoTrokendi XR ahead of patent expiry in 2027. 22 April 2011, page 18). Meanwhile, TWiPharmaceuticals has filed aparagraph IV ANDA As Sleet delivered his verdict, Cubist announced that it had agreed for ageneric version of Supernus’ Oxtellar XR (oxcarbazepine) to be taken overbyUSoriginator Merck &Coinadeal worth US$9.5 extended-release capsules. The epilepsy treatment also enjoys US patent billion. Merck stated that the Cubicin ruling would not affect its protection until 2027. Actavis wasalso 18 months ago sued in aUS decision to buyCubist, insisting that the transaction wasexpected to districtcourt for filing an ANDAfor generic oxcarbazepine extended- “add more than US$1 billion of revenue to its 2015 base, with strong release capsules (Generics bulletin,6September 2013, page 23). G growth potential thereafter”. G

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PRODUCT NEWS

BIOLOGICALDRUGS IN BRIEF APOTEX will have to defend itself against aUSpatent-infringement Sandoz appeal fails action brought by Cipla and Meda in abid to defend their Dymista (azelastine/fluticasone)nasal spray for the treatment of symptoms caused by seasonal allergies. The suit filed in aDelaware district court alleges that the Canadian firm’sabbreviated newdrug application over US etanercept (ANDA) infringes US patents 8,163,723 and 8,168,620, the latest of which expires in 2026. US court wasright to denySandoz adeclaratory ruling that the Afirm’splanned biosimilar rivaltoAmgen’sEnbrel (etanercept) ARTERIUM has launched in Ukraine its glimepiride 2mg, 3mg does not infringe twopatents protecting the brand, the US Court of and 4mg tablets. Available in blister packs of 30 tablets, the diabetes Appeals has decided. drug will be marketed under Dimaryl brand name. Around ayear ago, anorthern Californiadistrict court rejected Sandoz’ motion for aruling confirming that the company’s“assertedly TEVA has introduced in the US arivaltoNovartis’ Exforge HCT biosimilarproduct” did not infringe US patents 8,063,182 and (amlodipine/valsartan/hydrochlorothiazide)triple-combination 8,163,522 (Generics bulletin,6December 2013, page 23). Judge antihypertensive.Noting that the original had US sales of US$158 Maxine Chesneyagreed with the originator’s claim that the court million in the year ended September 2014, Teva said it expected lacked the authority to consider abiosimilar patent dispute “until to enjoy180-day generic market exclusivity. after such time as an application for US Food and Drug Administration (FDA) approvalofthe biosimilarproduct has been filed”. BIOCAD has presented positive Phase III results for its Extimia (empegfilgrastim)long-acting granulocyte-colonystimulating No real or immediate injury factor (G-CSF) for treating patients suffering from chemotherapy- Affirming Chesney’sruling, the appeals court said Sandoz “did induced neutropenia in Russia. Pointing out that it had invested not allege an injury of sufficient immediacyand realitytocreate around US$3 million in developing Extimia –which is due to be subject matter jurisdiction”. launched in late 2015 –Biocad claimed its novelproduct wasthe Sandoz’ complaint relied on Amgen’sassertion that the patents first domestic G-CSF candidate. covered Enbrel, that the originatorintended to invoke the patents against competitors, and that Sandoz sought to market arivalproduct, STRIDES ARCOLAB plans in the near future to introduce the the appeals court noted. However, it pointed out, “Sandoz had not –as calcitriol 0.25µg and 0.5µg soft-gel capsules for which it has just it still has not –filed an application for approvalofits contemplated receivedapprovalfrom the US Food and Drug Administration (FDA). product by the FDA”. The Indian firm –which is making the capsules at its oral-dose “Sandoz has not shown that it will suffer an immediate and facility in Bangalore, India –valued the US market for calcitriol substantial adverse impact from not being able to seek or secure a capsules at around US$50 million. patent adjudication before filing an application for FDAapproval,”the appeals court concluded. “Sandoz cannot lawfully enter the market BIOTON has granted Brazilian companyBiomm exclusive rights nowanyway, wholly apart from the ‘182 and ‘522 patents, so there to market the Polish firm’srecombinant human insulins in Brazil. is no question of its taking immediate action that risks building up The 15-year supply deal will begin once the products have been infringement liability.” registered locally. However, the court emphasised that it would not address Sandoz’ ability to seek adeclaratory judgement on the matter “if and when it MYLAN has introduced in the US ageneric version of Novartis’ files an FDAapplication under the Biologics Price Competition Vivelle-Dot (estradiol)transdermal system. The generics firm is and Innovation Act (BPCIA)”. G offering five strengths of the twice-weekly treatment for conditions linked to the menopause, such as vasomotor symptoms and hypoestrogenism.Sandoz responded by launching an authorised CARDIOVASCULAR DRUGS generic of sister companyNovartis Pharma’sbrand, which had sales France upholds fine on Sanofi of US$263 million in the year ended September 2014. F-SINTEZ has claimed the launch of Russia’sfirst generic version anofihas failed in its appeal against adecision by France’s of Janssen-Cilag’s Velcade (bortezomib)3.5mg lyophilised powder SCompetition Authority to fine the firm C40.6 million (US$47.9 for injection.According to the Russian firm, the multiple myeloma million) for “denigrating” generic rivals to the originator’sPlavix treatment –marketed under the Boramilan brand name –was (clopidogrel) brand. In 2013, the Authority found that Sanofihad included in anational reimbursement list. pursued a“comprehensive strategy” aimed at limiting competition and promoting the firm’sown authorised generic (Generics bulletin, JUBILANT LIFE SCIENCES has receivedfinal approvals for two 7June 2013, page 22). abbreviated newdrug applications (ANDAs) from the US Food AParis appeals court upheld the Authority’sfine, based on its and Drug Administration (FDA). The Indian firm has receiveda conclusion that Sanofihad abused its dominant market position through nod for mycophenolate 250mg capsules and 500mg tablets – astrategy that included convincing doctors to mark Plavix prescriptions equivalent to Roche’s Cellcept brand –which has annual US as ‘non-substitutable’, as well as urging pharmacists to substitute the sales of around US$245 million, along with aversion of Merck’s brand with an authorised generic rather than anyother competitors. Maxalt (ritzatriptan)5mg and 10mg tablets. Teva –which wasaparty to the appeal proceedings –had in 2010 asked the Authority to issue an injunction against Sanofi. However, CONSILIENT HEALTH is claiming afirst-to-market UK launch of at that time the Authority concluded that the originator’spractices generic Abilify (aripiprazole) 5mg, 10mg, 15mg and 30mg tablets. The did not pose asufficiently immediate and serious threat to take antipsychotic had 2013 UK sales of £84 million (US$127 million).G urgent measures(Generics bulletin,28May 2010, page 15). G

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PRODUCT NEWS

MULTIPLE SCLEROSISDRUGS GASTROINTESTINAL DRUGS Teva eyesEUlaunch Ranbaxy welcomes for Copaxone 40mg ruling on US Nexium

eva expects to launch its 40mg/ml strength of Copaxone (glatiramer jury verdict in US multi-district antitrust litigation overasettlement Tacetate) in Europe “as early as the first quarter of 2015”, having Abetween Ranbaxy and AstraZeneca for the originator’s Nexium just received“apositive outcome in the decentralised procedure” for (esomeprazole) has been welcomed by the companies. “The lawsuits the three-times-a-week formulation of its branded multiple sclerosis alleged that Ranbaxy’sApril 2008 patent settlement agreement with treatment. Using the UK as areference member state, Teva said it had AstraZeneca concerning esomeprazole magnesium violated US antitrust receivedapositive assessment report from the country’sMedicines laws,”the Indian firm noted. AstraZeneca said it had always maintained and Healthcare products Regulatory Agency(MHRA) as well as all that the allegations were “without merit”. concerned member states involved in the procedure. The jury found that AstraZeneca exercised market power within “Granting of national authorisations will happen in the near future,” the relevant market, that the settlement included “a large and unjustified Teva said, revealing that it intended to initially launch the 40mg/ml payment by AstraZeneca to Ranbaxy”, and that the settlement was Copaxone in Denmark, Germanyand the Netherlands. “Launches in “unreasonably anti-competitive”. But without the settlement, the jury other European Union (EU) countries are expected throughout 2015,” concluded, AstraZeneca would not have agreed that Ranbaxy could the Israeli firm stated. launch ageneric before 27 May 2014, the earliest expiry date of the Around ayear ago, Teva launched the higher 40mg/ml strength disputed patents (Generics bulletin,2June 2008, page 15). of Copaxone in the US, soon after receiving approval(Generics bulletin,3February 2014, page 7). “The newformulation reduces Challenged FDA on esomeprazole the total number of injections by almost 60%”, Teva noted, “while Ranbaxy recently launched achallenge against the US Food and maintaining the known benefits of once-daily Copaxone 20mg/ml.” Drug Administration (FDA) after the agencystripped the firm of tentative Meanwhile, Teva’s Canadian affiliate has announced that it will be abbreviated newdrug application(ANDA) approvals for esomeprazole “the sole generic supplier” of rivals to Roche’sTarceva (erlotinib) after along with valganciclovir (Generics bulletin,5December 2014, page receiving aNotice of Compliance (NOC), or marketing authorisation, 27). Dr Reddy’sand Endo have both launched valganciclovir tablets, from Health Canada for arivaltothe lung-cancer drug, which has competing with Roche’sValcyte original that Dr Reddy’ssaid had US annual Canadian sales of around C$15 million (US$13.1 million). G sales of around US$440 million in the year ended October 2014. G

16 January2015 GENERICS bulletin 23 Gen 16-1-15 Pg. 24_Layout 1 13/01/2015 16:42 Page 2

EVENTS

JANUARY MARCH settlements. The forum will also offer networking opportunities. 21 January 4-5March Contact:Lucia Romagnoli, GPAConferences. ■ 8th EGA Pharmacovigilance ■ World Generic Medicines Tel: +44 7562 876 873. E-mail: [email protected]. Discussion Forum Congress Europe 2015 Register onlineatwww.egagenerics.comor London, UK Madrid,Spain www.egaevents.org. This European Generic medicines Topics covered at this two-day conference Association (EGA) event will takethe will include growth strategies, pricing, APRIL form of adiscussion forum and look at biosimilars, legalissues and market trends. topics including pharmacovigilance Contact:Health Network Communications. 13-15 April legislation with speakers from the industry Tel: +44 207 092 1210. ■ DIA 27th Annual as well as from agencies. E-mail: customerservices@healthnetwork Contact:Lucia Romagnoli, GPAConferences. communications.com. EuroMeeting Tel: +44 7562 876 873. Website: www.healthnetworkcommunications.com. Paris,France E-mail: [email protected]. Issues to be covered at this three-day event Register onlineatwww.egagenerics.comor 9-10 March include innovation, clinical trials legislation www.egaevents.org. ■ EuroPLX 57 and medical devices. There will be speakers Cascais, Portugal from firms includingAmgen and Sanofi. 22-23 January This meeting provides aforum for business- Contact:DIA. ■ 14th EGA Regulatory& development decision makers to discuss and Tel: +41 61 225 5151. Scientific Affairs Conference negotiate agreements, in-licensing, marketing E-mail: [email protected]. Website: www.diaeurope.org. London, UK and distribution of patented medicines, This two-day conference will followthe generics, biosimilars, OTCproducts, EGA’s Pharmacovigilance Forum. Both medical devices and food supplements. 20-21 April events are at the same venue in London. Contact:Raucon. ■ 3rdAnnual Biosimilars & Topics covered at both meetings will Tel: +49 6221 426296 0. Biobetters Congress include risk-management plans, periodic E-mail: [email protected]. London, UK safety update reports, signal detection, Website: www.europlx.com. joint studies and inspections. This event will address topics including 12-13 March market access and strategies within the Contact:Lucia Romagnoli, GPAConferences. industry.Presentationswill provide Tel: +44 7562 876 873. ■ 7th Pharmeet information on emerging markets as well E-mail: [email protected]. Mallorca, Spain as global commercialisation strategies. The Register onlineatwww.egagenerics.comor This two-day event is designed to offer development of biosimilars and biobetters www.egaevents.org. delegates the opportunity to network as will be the focus of day two. well as the chance to strikelicensing deals for awide range of products Contact:OxfordGlobal. FEBRUARY Tel: +44 1865 248455. including biosimilars. E-mail: [email protected]. 9-11 February Contact:PharMeet. Website: www.oxfordglobal.co.uk. Tel: +34 91 637 0660. ■ GPhA 2015 Annual Meeting E-mail: [email protected]. Miami,US Website: www.pharmeet.com. 23-24 April This is athree-day meeting of the US ■ 13th EGA International Generic Pharmaceutical Association 26-27 March (GPhA) which will look at regulatory issues BiosimilarsConference ■ 11th EGA Legal and opportunities for the industry.There London, UK will also be networking opportunities. Affairs Forum This meeting is organised by the EGA Contact:GPhA. Brussels,Belgium and will covertopics including industry Tel: +1 202 249 7127. This is atwo-day event organised by the developments and regulatory issues for E-mail: [email protected]. EGA which will look at issues including the biosimilars industry. Website: www.gphaonline.org. litigation, regulatory matters and patent Contact:Lucia Romagnoli, GPAConferences. Tel: +44 7562 876 873. E-mail: [email protected]. 16-19 September 2015 Register onlineatwww.egagenerics.comor ■ 18th IGPAAnnual Conference www.egaevents.org. Toronto, Canada This three-day event is being organised by the Canadian Generic Pharmaceutical 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 executiveshavethe opportunity to takepart in conference workshops, and listen to industry experts discuss current issues regarding the international pharmaceutical sector during afull schedule of plenary SAVE THE DATE ... sessions. There are also opportunities to network. The Global Generics &Biosimilars Contact:Julie Ta m, CGPA.Tel:+1416 223 2333. Awards 2015 will be held on Tu esday E-mail: [email protected] Website: www.igpa2015toronto.com. 13 October 2015 in Madrid, Spain.

24 GENERICS bulletin 16 January2015 Gen 16-1-15 Pg. 25_Layout 1 13/01/2015 13:32 Page 3

PRICE WATCH ...... UK Antihypertensiveprices under pressure ecember wasaquiet month for recently-launched products in However, just as the market for one type of antihypertensive seemed Dcategory Mofthe Drug Tariffofpharmacyreimbursement prices. to be settling down, another wasstarting to takeoff. As Figure 1shows, lowest and average price changes were lowor Average prices for plain fosinopril tablets shot up by four-and non-existent, with only ahandful of items experiencing double-digit five-times last month, making amockery of their Drug Tariff price changes at the year-end. reimbursement prices. Pharmacists would have been reimbursed £1.92 Irbesartan 75mg in 28-tablet packs wastypical, with no movement (US$2.90) for dispensing the 10mg strength last month, buttheywould in its lowest or average price. Versions of the antihypertensivecombined have paid atrade price of £8.38 for it (see Figure 3). with hydrochlorothiazide (HCT), however, told adifferent story.Falls Curiously,neither fosinopril strength appeared in the list of price in their average prices of about athird were some of the highest concessions granted by the Department of Health for December – recorded in the month (see Figure 4). overriding Drug Tariffprices for products with high trade prices –but Average prices for valsartans with HCT fell even faster,reversing lisinopril 20mg with HCT 12.5mg wasgiven alate listing on 23 their upward price movement of afew months ago. At that time, with December.The concession reflected adoubling of the product’saverage monthly price increases of 50%, theywere in Figure 3among the trade price to £3.40 –compared with aDrug Tariffprice of £1.70 – biggest risers (Generics bulletin,3November 2014, page 25). butat£11.52, the concession meant pharmacists were easily in pocket. G

RECENT LAUNCHES FAST MOVERS Product/Strength/Pack size Lowest Change Average Change Price offers as at 31 December price (%) price (%) Product/Strength/Pack size October November December Amorolfine lacquer 5% 5ml £3.74 ±0 £5.39 -11 Omeprazole caps 20mg 28 122 141 102 Atorvastatin tabs 20mg 28 £0.48 -4 £0.91 +8 Fluoxetine caps 20mg 30 101 102 87 Candesartan tabs 8mg 28 £0.38 +9 £0.78 -1 Lansoprazole caps 15mg 28 97 106 85 Cilostazol tabs 100mg 56 £9.20 -8 £18.20 +3 Warfarin tabs 1mg 28 85 97 85 Cyclizine tabs 50mg 100 £7.85 +1 £10.84 +3 Alendronate tabs 70mg 496106 84 Desloratadine tabs 5mg 30 £0.35 -10 £0.80 -2 Amitriptyline tabs 25mg 28 80 87 84 Desogestrel tabs 75µg 84 £1.72 ±0 £2.59 ±0 Citalopram tabs 10mg 28 91 93 84 Donepezil tabs 10mg 28 £0.60 -9 £1.17 +6 Tramadol caps 50mg 100 86 114 81 Entacapone tabs 200mg 30 £4.65 -3 £5.56 -2 Atorvastatin tabs 40mg 26 93 94 80 Escitalopram tabs 10mg 28 £0.70 -3 £1.21 +6 Ramipril caps 10mg 28 94 91 78 Hydroxychloroquine tabs 200mg 60£3.30 ±0 £4.23 +3 Irbesartan tabs 75mg 28 £0.25 ±0 £0.74 ±0 Latanoprost eyedrops .005% 2.5ml £0.95 ±0 £1.59 +6 BIGGEST RISERS Memantine tabs 10mg 28 £1.09 -13 £2.81 -1 Product/Strength/Pack size Lowest Change Average Change Montelukast tabs 10mg 28 £0.99 ±0 £1.62 +4 price (%) price (%) Naratriptan tabs 2.5mg 6£1.25 +5 £1.56 ±0 Fosinopril tabs 10mg 28 £1.25 +6 £8.38 +424 Quetiapine tabs 25mg 60 £0.45 -4 £1.11 +4 Fosinopril tabs 20mg 28 £1.55 -1 £8.03 +294 Rabeprazole tabs 10mg 28 £1.33 ±0 £1.85 -1 Lisinopril+HCT tabs 20/12.5mg 28 £0.89 +7 £3.40 +123 Raloxifene tabs 60mg 28 £4.19 +16 £6.25 -5 Mefenamic acid tabs 500mg 28 £1.65 ±0 £5.21 +86 Riluzole tabs 50mg 56 £13.99 ±0 £26.73 +5 Hypromellose drops 0.3% 10ml £0.23 -4 £0.79 +71 Rizatriptan tabs 10mg 3£0.86 ±0 £2.67 +13 Dipyridamole tabs 100mg 84 £3.40 +10 £7.26 +49 Sildenafil tabs 100mg 4£0.39 ±0 £0.68 +2 Telmisartan tabs 80mg 28 £0.80 -10 £1.83 +1 Tolterodine tabs 2mg 56 £1.44 -7 £2.37 ±0 BIGGEST FALLERS Zolmitriptan tabs 2.5mg 6£0.42 +8 £0.98 +5 Product/Strength/Pack size Lowest Change Average Change price (%) price (%) Figure1(above): Comparison between the periods 1-30 November and 1-31 December 2014 of UK trade prices of the most recently-launched generics listed in categoryM Valsartan+HCT tabs 80/12.5mg 28 £1.09 ±0 £2.11 -39 of the Drug Tariffofpharmacy-reimbursement prices. Averages calculated from at Valsartan+HCT tabs 160/25mg 28 £1.99 +18 £2.92 -37 least 30 data points. Figure2(top right): Ranking of fastest-moving products subject to the most price offers made to independent UK pharmacists (one strength per Irbesartan+HCT tabs 150/12.5mg 28 £0.99 ±0 £1.86 -33 ingredient; offers recorded by 31 December). Figure3(centreright) and Figure4 Irbesartan+HCT tabs 300/25mg 28 £1.39 -7 £2.44 -31 (bottom right): Biggest average trade-price changes between 1-30 November and 1-31 December 2014. Averages calculated from at least 20 data points. Data for Figures 2, Irbesartan+HCT tabs 300/12.5mg 28 £1.39 -4 £2.47 -30 3and 4fromabasket of about 750 commonly-dispensed generics. Recently-launched Nitrofurantoin tabs 100mg 28 £2.05 -18 £4.36 -29 products in Figure1excluded from Figures 3and 4(Source –WaveData).

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

16 January2015 GENERICS bulletin 25 Gen 16-1-15 Pgs. 26-27_Layout 1 13/01/2015 13:31 Page 2

BUSINESS STRATEGY Eastern expansion and OTC featurefor Mylan in Europe

Expanding in Central she reaches the first anniversary of joining the company-branded generics market in 2013. The Mylan in the role of president of Europe, Jacek share by volume was19.5% in Italy,where the firm and EasternEurope AGlinka is clear about what attracted him to make marketed 186 retail products in 351 strengths. and exploring options the switch from Poland’sPolpharma –the global Stressing the need to takeatailored approach to manufacturing, distribution and marketing platforms every European country,Glinka said Mylan would in the over-the-counter that the group could offer.“Mylan has all the ingredients consider both organic and inorganic strategies as it to makeaperfect pharma company,”Glinka insisted. looked to expand in Central and Eastern Europe. “In (OTC) sector are Speaking exclusively to Generics bulletin,Glinka some countries you could pursue an organic route, in among the priorities noted that Mylan had, until around sevenyears ago, others you would have to acquire something to become focused on the US. But after the purchasesofMerck ameaningful player,” he commented. for Mylan Europe, the KGaA’s generics division and of Matrix in 2007 – “Today’sgenerics market is very fragmented, so followed by several other acquisitions –the company there is alot of room for organic development, and for business’ president, had become the third-largest generics player in Europe that Mylan is extremely well positioned,”he said. “We Jacek Glinka, told with 2013 generics sales in the firm’sEurope, Middle have more than 1,300 molecules in our portfolio, over East and Africa (EMEA) region of US$1.50 billion, 2,000 in the pipeline, more than 35 manufacturing plants Aidan Fry. equal to 22% of group sales (see Figure 1) . around the world and several research and development While acquisitions such as Merck Generics have centres offering the vast majority of delivery technologies.” givenMylan acommercial presence in more than 20 “But the market is also consolidating alot, so as European countries, that regional footprint covers much as we like organic growth, we expect to pursue predominantly Western and Central Europe, led by external opportunities as well.”Since going global France which accounted for around atenth of group through Merck Generics and Matrix in 2007, Glinka global turnoverthat reached US$6.91 billion last year. observed, Mylan had continued to expand through Glinka –who served as Polpharma’schief acquisitions, not least by paying around US$1.65 billion executive officer in twostints up to 2013, having for Strides Arcolab’sAgila injectables business at the previously worked at leading managementconsultancies end of 2013 (Generics bulletin,10January 2014, page 3). (Generics bulletin,1November 2013, page 23) – and Mylan’sglobal management team recognised the Abbott deal adds scale in Europe need to expand the company’sscale and reach in Europe Mylan’slatest major transaction, announced midway to help achieve the group’slong-term growth targets. through last year,isits US$5.3 billion deal to acquire “We want to increase our presence in the eastern Abbott’sspecialty and branded generics business in Jacek Glinka part of Europe. There are still afew territories that ‘developed markets’ other than the US (Generics we do not cover, and there are some countries where bulletin,10January 2014, page 3). As part of the deal, we are not amarket leader,which is the status we Mylan intends to re-domicile via aholding company aspire to reach in Europe,”he stated. based in the Netherlands. In the Czech Republicand Slovakia, Mylan Through the all-share transaction that is scheduled claims to be among the top-10 industry players, but to close early this year,Mylan will gain aportfolio of it is outside the top 10 in Greece, Hungary and Poland, more than 100 specialty and branded generic products and has no direct presence further east. in five major therapeutic areas: cardio/metabolic; “We are the market leader in France, and we rank gastrointestinal; CNS/pain; anti-infective/respiratory; second in Italy and third in Portugal, while in Belgium, and women’sand men’shealth. “With astrong presence the Netherlands, Sweden and the UK we are in the in Europe, Japan, Canada, Australia and NewZealand, top five,according to IMS data. But there are many the assets are expected to provide approximately US$1.9 countries where we are not in the top five,” Glinka stated. billion in annual additional revenues,”Mylan stated. In France, Mylan’sbroad portfolio of 261 products Commenting on the proposed transaction, Glinka in 759 dosage forms gave it aleading 27% share of said the deal would not only add scale to Mylan’s European operation, butalso strengthen its hand in Business Annual sales Reported Constant-currency operating in both brand-led and substitution- or segment (US$ millions) change(%) change (%) tender-drivenmarkets. “Today you can say Mylan is slightly better positioned towards tender and substitution North America 3,011 -7 -7 models, because of the infrastructure we have developed EMEA 1,500 +11 +8 so far. Ibelieve the Abbott deal will give us an enhanced Rest of World 1,365 +3 +14 balance and infrastructure to better address both models.” Other 26 -18 – “A major part of the business being acquired is in Generics 5,901 -1 +1 Europe,”Glinka pointed out. “It will roughly double the Specialty 1,009 +19 +19 size of our business in Europe.” Abbott’sportfolio would be important in expanding Mylan 6,909 +2 +4 Mylan’sfootprint in Central and Eastern Europe, he said. “Probably this wasthe capabilitythat wasmissing, even Figure1:Breakdown by business segment and region of Mylan’s sales in 2013 (Source –Mylan) where we had our owncommercial infrastructure, it

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wasnot sizeable enough to be able to address 100% of the market,”he acknowledged, adding that the Championing HIV therapyinEurope enhanced commercial platform would allowMylan to roll out its existing global portfolio, as well as future aving twoyears ago introduced its first antiretroviral (ARV) treatment for growth drivers such as respiratory and biological drugs, HHIV/AIDS in Europe by launching lamivudine film-coated tablets in Italy and throughoutthe region. the UK, Mylan has set out to become “a champion” of access to effective diagnosis Highlighting Mylan’scorporate mission of and treatment throughout the continent. Building on its global experience in the field providing access to high-qualitymedicines to 7billion –two-fifths of patients receiving treatment in developing countries depend on the people, Glinka stressed that the firm wascommitted company’sARVs–the firm is seeking to broaden awareness and available solutions. to operating “in all countries and all segments in With aEuropean portfolio of four ARVdrugs, includingcombinations, marketed Europe”. While major generics rivals had divested to date, Mylan has HIV franchises in countries including Belgium, the Czech operations in Western Europe or voiced reluctance to Republic, France, Italy,the Netherlands, Poland, Spain and the UK. “We have participate in tenders, Mylan intended to adapt its started to build aconsiderable presence, and there is more to come,”promised business model to local market needs. Jacek Glinka, president of Mylan Europe. “In almost every country,the government is In rolling out its European ARVportfolio, the companyisworking closely with pursuing cost-cutting initiatives,”Glinka recognised. patients’ groups and professionalsocieties such as the European Association of However, he stressed, there were opportunitiesto Hospital Pharmacists (EAHP) and the UK’sHIV pharmacyassociation, the HIVPA. grow, not only in Central and Eastern Europe, but Forexample, in Spain, Mylan’slocal subsidiary is working with regional also in Western European countries such as Italy that authorities and pharmacies to provide several services, such as HIV screening and had limited generic usage. “Even in countries that are personalised service doses (PDS) to improve patient compliance (Generics bulletin, not growing, we are able to expand by improving our 8August 2014, page 21). market share. If you add to that the opportunities “Mylan is the world’slargest manufacturer of active pharmaceutical ingredients presented by markets we have still to enter,and (APIs) for HIV treatments,”Glinka pointed out, adding that this gave the group a segments like the OTCsector,we have plenty of scope.” “huge advantage” in ensuring reliability of supply.“We have aglobal portfolio of Mylan’schief executive officer Heather Bresch approximately 50 ARVproducts, and we are working on developing most of the recently said the companywould build upon the Abbott important HIV molecules,”he stressed. G portfolio to explore non-prescription opportunitiesin Europe (Generics bulletin,5September 2014, page 5). 700 marketed products and afurther 350 in development. Glinka echoed Bresch’senthusiasm. “Abbott gives While Mylan already had substantial hospital us asmall step towards building apresence in the OTC businesses in France, Italy,Portugal, Spain and the segment,”he said, noting that Mylan had only a UK, it planned to expand into other countries. “This relatively small non-prescription portfolio at present. is very much part of our vision for Central and Eastern However, he declined to be drawn on howMylan Europe,”Glinka revealed. Europe would address the OTCopportunity. Astrong base in hospitals would be vital for rolling In general, Glinka explained, Mylan waslooking out Mylan’spipeline of biosimilar monoclonal for business-development and in-licensing deals that antibodies and insulins that the firm is developing with would expand its European portfolio. While the group India’sBiocon, he stressed. Noting that Mylan had could offer most delivery forms –including in attractive identified biologics as akey growth driver, Glinka niche segments such as dermatology and ophthalmics – pointed out that the partners had recently introduced it wasimpossible to invest in every technology or their first biologic, Hertraz (trastuzumab), in India, project, he pointed out. “Our infrastructure, know-how and were preparing for European launches. and relationships with physicians, pharmacists and “Unlike some companies that are pulling out, wholesalers offer aunique opportunity for manyfirms Mylan believesEurope is agood place to invest in to find the right home for their products,”he argued. manufacturing,”he stated, pointing to the respiratory Through adeal struck with Pfizer three years ago and injectables sites in Ireland, Poland and the UK. “Abbott gives us a (Generics bulletin,18November 2011, page 1), Mylan Furthermore, the group has oral solid-dose packaging acquired exclusive global rights to develop and market facilities in Meyzieu, France, and Komárom, Hungary. small step towards ageneric version of GlaxoSmithKline’sAdvair/Seretide The French site wasdedicated to the sizeable local Diskus (salmeterol/fluticasone) using Pfizer’sdry- market, Glinka explained, while the Komárom plant building apresence in powder inhaler platform.And last year,Mylan struck on Hungary’sborder with Slovakia enabled Mylan the OTCsegment” an alliance with UK-based respiratory specialist to adapt quickly to shifts in demand throughoutEurope. Prosonix (Generics bulletin,2May 2014, page 13). “Wheneverpossible, you want to bring the bulk “We have invested heavily in becoming amajor product as close as possible to the customer and do player in respiratory.” Aformer Pfizer site in Sandwich, packaging on demand. In tender-drivenmarkets like UK, leads global respiratory research and development, Germany, this is acritical capability,because otherwise while manufacturing is centred in Dublin, Ireland. you risk afailure to deliver–incurring high penalties Through the Agila transaction, Mylan also gained –orwriting-offstock if your bid fails,”he said. an injectables plant in Warsaw, Poland, to add to a “Mylan is the best positioned to be competitive similar facility in Galway, Ireland, that it picked up in the tender environment, because of the scale and through aUS$550 million move for Bioniche in 2010. flexibility of our manufacturing base,”he maintained. “The Polish facility will have an important role And for this, vertical integration through Matrix’ in servicing local customers, butwe would also like active pharmaceutical ingredients (APIs) wascrucial. to utilise it for other markets,”Glinka explained. The “Today,Mylan manufactures around 80% of its Agila deal, he noted, had givenMylan not only global finished products internally,” he stated. “When we first sterile production capacity,but also one of the largest bought Merck Generics, approximately 70% was generic injectable portfolios and pipelines, with around produced externally,sowe have made great progress.” G

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BUSINESS STRATEGY Teva is to makemorefrom less sales in fewermarkets

Streamlining its global aving midway through last year recruited Siggi CIS Olafsson to lead Teva’s newly created Global ~US$0.4bn US supply chain, altering HGeneric Medicines (GGM) unit, the Israeli Russia ~US$4.2bn ~US$0.3bn European business group’spresident and chief executive officer,Erez Vigodman, set the former Actavis executive atough Japan, Asia models and focusing task. Over the three-year period from 2013 to the end ~US$0.7bn of 2015, the Generics operation is to improve its on the most promising operating profit by six-and-a-half percentage points emerging markets are to around 27% by the end of 2015. Olafsson’soperational colleagues are lending a among the strategies hand as part of an efficiencydrive,not least through aplan to achieve an average cost per 1,000 tablets of Teva intends to employ less than US$10 and to migrate within five years 60% Canada of the group’sproductioncapacity to low-cost locations Europe ~US$0.5bn to raise the bottom ~US$3.4bn offering 1,000 tablets for US$6-US$7. Latin America line of its global Even if Teva gets greater control of its cost of ~US$0.6bn goods, Olafsson and his team still have their work cut generics business. Figure1:Breakdown by region of Teva’s Generics sales totalling out to drive up margins during aperiod when the group’s US$9.91 billion in 2013 (Source –Teva) Aidan Fryreports. generics sales are forecasted to decline by at least 4%. The multi-faceted solution that Olafsson and his two-fifths and athird respectively of 2013 generics sales team have devised includes: optimising Teva’s generics of US$9.91 billion (see Figure 1), the business also had portfolio to focus on the most profitable drugs; filling sizeable operations in countries including Canada, in portfolio gaps through business-development deals; Russia and Japan, as well as in parts of Latin America. capitalising on the group’sactive pharmaceutical “Teva has atop-three position in more than half of the ingredient (API) capabilities; and refocusing the 60 countries in which we operate,”hepointed out. business’ strategy in ‘growth’, or emerging, markets. Boosted by better performances in Europe and Presenting the Generics unit’sbusiness strategy Russia, the Generics business made significant strides and outlook to investors, Olafsson pointed out that in improving its operating margin during 2014. Teva’s market-leading position with an estimated The 22.9% Generics segment margin reported for global generics turnoverofUS$9.8 billion last year the third quarter of 2014 –derivedfrom gross profit less carried with it an inherent levelofcomplexity. sales and marketing costs and research and development “Wehave53finished-dose manufacturing plants, expenses, butexcluding general and administration delivering more than 1,000 molecules across 35,000 expenses, amortisation and certain other items –was stock-keeping units (SKUs),”heobserved. In abid to sevenpercentage points higher than the 15.9% achieved simplify this supply chain, Teva is currently closing or in the third quarter of 2013 (see Figure 2). divesting several sites as it looks to shift production to And having closed 2013 with afourth-quarter the lowest-cost locations. margin of 19.2%, Teva believesthe Generics segment “Weare much more focused on which markets we improvedits margin by around four percentage points operate in and howweplay in those markets,”Olafsson in 2014. If the segment hit the mid-point of Teva’s 2015 maintained. “Weare taking decisions much faster.” forecast of asegment margin between 25.0% and 29.0%, While the US and Europe accounted for around it would reach around 27%, roughly on apar with Teva’s peers, Olafsson noted. The mid-point of Generics sales guidance for 2015, Gross
 profit
 margin Segment

profit margin US$9.3 billion, implies adecline of around US$500 million, or 5%, from the US$9.8 billion Teva expects 50 46.0%  44.3% 43.1% 43.5% 41.6% to report for 2014 (see Figure 3). And the drop since 39.5% 2013, when Generics sales narrowly exceeded US$9.9 40  billion, will be around 6%, as adverse currencyshifts

27.0% and anticipated competition on generic Pulmicort  30 22.9% (budesonide) in the US –the group’sbest-selling 21.2% 19.2% 20.8% generic –during the first half of this year more than 20 15.9% outweigh the effect of product launches.

Profit margin (%) “From 2017 onwards, we will start to growthe top  10 line again,”Olafsson promised, highlighting the important role emerging, or ‘growth’, markets would 0 play.“We nowhaveastrategy in place for howwe Q3 13 Q4 13 Q1 14 Q2 14 Q3 14 2015 mid-point     are going to growinto these markets. We want to be Figure2:Gross profit and operatingprofit margins for Teva’s Generics business unit between the bigger in fewer markets, that is howwewill get the thirdquarters of 2013 and 2014, with the mid-point of 2015 margin forecasts (Source –Teva) best return on our investment.”

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“In our growth markets, we are focusing on the big countries,”heexplained. “Weare not going to be US$20.0bn –US$20.3bn US$19.0bn –US$19.4bn in every market, we will select around 10 in which we 1.9 1.55 –1.7 will probably have to makeinorganic movestogrow.” OTC/Other
4.1 Olafsson outlined that fast-growing ‘BRIC’ 3.5 –3.7 countries –Brazil, Russia, India and China –were Multiple sclerosis priorities while the firm would takeaselective approach 4.3 4.25 –4.65 
to ‘tier one’ markets such as Argentina, Indonesia, Mexico, South Korea, Turkey and Venezuela. Specialty
excluding Addressing Teva’s position in Latin America, multiple sclerosis 9.8 9.1 –9.5 Olafsson said the firm had strong operationsinChile Generics and Peru, butwas relatively weak in Brazil and 
Mexico.“Werank number 81 in Brazil, and that is no position for Teva to be in that market,”headmitted. 2014 2015 However, faced with high valuations for local takeover  targets, Teva would pursue organic growth from Figure3:Forecasts for sales by Teva’s product lines in 2014 and 2015 (Source –Teva) complexgenerics, OTCand branded specialty products while waiting for the right inorganic opportunity. over60% of the business, and globally the top-three “In Russia, we are number five in terms of generics customers are getting close to 50%,”henoted. companies. Iwould love to be in the top three in Russia. Citing IMS Health data showing that Teva was We are quite big due to our Specialty business, butwe generating greater value and shedding less volume than still have room to grow,”hecontinued. its US generics rivals, Actavis and Mylan, Olafsson “Wehavehardly anybusiness in China,”Olafsson said Teva wanted to retain US generics market acknowledged, stressing the need for local scale to leadership and regain the top spot in generic injectables. justify the expense of developing drugs to meet Chinese The prospect of competition to Teva’s best-selling requirements. “You cannot ignore what will, by 2018, generic drug, aversion of Pulmicort (budesonide), be the second largest pharma market in the world.” would all butwipe out sales growth from aroster of In some smaller Asian markets such as Indonesia, up to 30 potential generics launches in the US during Teva would aim to outpace double-digit market growth. 2015, he said. Among potential introductions are generic “Wehaveprioritised our European markets into Aloxi (palonosteron), Oxycontin ER (oxycodone) and those we want to invest more in, and those we might Venofer (iron sucrose), as well as settlement-based want to leave or at least have adifferent business launches of generic Aggrenox (aspirin/dipyridamole), structure,”hecommented. “Our volume strategy has Avodart (dutasteride), Epi-Pen (epinephrine) and Zyvox brought us to a14% market share in the European (linezolid). AlternativestoArixtra (fondaparinux), Union and atop-three position in 20 markets.” Crestor (rosuvastatin),Epzicom (abacavir/lamivudine), “Wewant to be But as Teva shifted its focus to generating value Mozobil (plerixafor) and Nasonex(mometasone) rather than volumes in Europe –such as by taking a could followin2016. bigger in fewermarkets, selective approach to tenders in countries likeGermany Having allocated 47% of its 2014 generics research that is howwewill and the Netherlands –Generics turnoverwould decline and development budget to its US pipeline, Teva intends from US$3.48billion in 2013 to an estimated US$2.6- this year to shift its focus so that three-fifths of an get the best returnon US$3.0 billion in 2015. enlarged budget is devoted to the US. As part of an assessment exercise announced a “Wemight not be at quite the levelofproducts our investment” fewmonths ago (Generics bulletin,14November 2014, pending with regulatory agencies as some of our page 1), the companyhad classified its European competitors, butthe levelofcomplexity and the value generics markets into several buckets. Italy and Poland of the pipeline is second to none,”Olafsson insisted. were among the group of expanding markets in which Among the complex-generics technologies into which Teva planned to invest, while in France and Spain the the firm wasinvesting were nasal suspensions,vaginal firm wasworking to catch up with changing market rings, transdermal patches and thin films, as well as conditions, such as with the introduction of tenders in injectable devices and long-acting injectables. Andalusia. “Weare reducing our product offering in Noting that quality issues had led Teva to scale France to improve profitability,” Olafsson said. back drastically its US generic injectables presence, In major markets likeGermany, Teva waslooking Olafsson said recent launches such as enoxaparin and to improve howithandled tenders. But in some smaller reintroducing discontinued drugs amid shortageswould countries in central Europe –such as Slovakia and raise sales from less than US$100 million in 2014 to Slovenia –orintender-drivenNordic markets, the firm overUS$300 million this year. might have to alter its approach.“Iwould see us perhaps While “first-wave” biosimilars and follow-on changing our business model in Norway,” he revealed. biologics such as filgrastim were generating annual By optimising its footprint, aligning salesforces sales of around US$400 million for Teva,Olafsson with market forces and adjusting its portfolio, Teva admitted that Teva had only a“limited programme” is aiming to improve its European Generics operating for “second-wave” monoclonal antibodies coming margin from 12% in 2013 to at least 20% in 2015. offpatent through to 2021. “Our US operation has seen an increase of more “There is no question we have agap, especially in than 10% in profit between 2012 and 2014,”Olafsson wave two,”herecognised. To fill that gap, Teva was pointed out. This, he said, had been achievedamid looking to use its extensive commercial infrastructure, customer consolidationthat wasputting pressure on research and development expertise and strong balance prices. “The top-three customersinthe US are now sheet to explore partnerships. G

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APPOINTMENTS RESHUFFLES Teva’s Bogda joins Endo seeks aleader Lannett as president for its Qualitest unit

annett has appointed Michael Bogda,formerly head of Teva’s ndo is seeking apermanent head for its Qualitest US generics LAmericas Technical Operations, as its president. He takes those Ebusiness after chief operating officer Don DeGolyer –who presides responsibilities from companychief executive Arthur Bedrosian, overboth Qualitest and the Endo Pharmaceuticals branded arm – who had held the title of president since May 2002. Bedrosian will announced his intention to retire and “pursue other opportunities”. remain as chief executive officer,arole he has served since His announcement came as Endo revealed several senior management January 2006 (Generics bulletin,13January 2006, page 23). team changes in preparation for its US$2.6 billion takeoverofAuxilium “Toaddress our rapid growth, as well as our long-term succession- Pharmaceuticals (Generics bulletin,17October 2014, page 4). planning efforts” said the US firm, which has just reported third- Former Sandoz US head DeGolyer –who had only joined Endo quarter sales that more than doubled to US$93.4 million (Generics in August 2013 (Generics bulletin,9August 2013, page 27) –will bulletin,5December 2014, page 12), “we embarked upon asearch step down from his role on 1March, butwill remain with Endo as for ahigh quality individual and we found one.”Bogda “brings a a“special advisor” to president and chief executive officer Rajiv global perspective,inaddition to extensive operations, merger and De Silva until 1August. De Silva, meanwhile,has announced that acquisitions, and business-integration experience,”Lannett added. both the US generics and brands units, along with the US brands Bogda, 53, had been with Teva since 2008, when the Israeli firm research and development business, will report directly to him. acquired Barr (Generics bulletin,1August 2008, page 1). G Following DeGolyer’sretirement on 1March, Endo’ssenior vice-president of finance, Robert Rush,will on an interim basis take on the newly-created role of general manager of Qualitest.The US APPOINTMENTS firm said Rush –who will report directly to De Silva–had “worked closely with the Endo leadership team and the Qualitest business, Jubilant hires Singh from Sun leading and driving several keygrowth initiatives”. Meanwhile, Endo’ssenior vice-president of corporate affairs and ormer Caraco and Sun Pharma head, Gurpartap Singh Sachdeva, president of Endo Ventures, Blaine Davis,will become senior vice- Fhas joined Jubilant Life Sciences’ Jubilant Pharma as its chief president and general manager of US brands. In the role, Davis – executive officer,reporting to the Jubilant Pharma board of directors. whose current responsibilities as president of Endo Ventures will be He will be based in the US. filled by Robert Cobuzzi,Endo’shead of research and development “[Singh] has worked extensively both in India and in the US in strategy and operations –will support US brands president Brian various leadership roles pertainingtostrategy,mergers and acquisitions, Lortie,who retains his responsibilities. commercial and operations,”the Indian firm commented.Hewas The only announced recruitment from Auxilium sees following previously president of Sun Pharmaceuticals US. the close of the transaction Keri Mattox,head of investor relations Jubilant Pharma emerged as aresult of Jubilant Life Sciences and corporate communications with the US originator,taking on transferring its oral dosage form and active pharmaceutical ingredients the same role with Endo. In her newrole, she will report to chief (APIs) operations, as well as the Indian group’sshares in its Belgian financial officer SukyUpadhyay. and US subsidiaries, into aseparate holding companybased in Meanwhile, Endo’schief legalofficer, Caroline Manogue, Singapore in 2013 (Generics bulletin,15November 2013, page 2). has announced that she will retire from the companyon1July this “Our Pharmaceuticals segment has attained significant scale, and year.“Endo has retained aleading executive search firm to assist in the businesses therein have great potential for growth,”Jubilant claimed. identifying asuccessor,” the US firm noted, adding that Manogue Aseparate operation –Life Science Ingredients –was also spun would continue to serve“through atransition period” once a off, and is co-headed by Pramod Yadav and Rajesh Srivastava. G successor had been named. G

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INDUSTRY ASSOCIATIONS RESHUFFLES Wood takes charge Actavis asks Stewart at Australia’s GMiA to lead generics unit

ustralia’s Generic Medicines industry Association (GMiA) has ctavis’ chief operating officer, Robert Stewart,will assume the Aannounced the appointment of Belinda Wood as the group’schief Anewly-created role of president of Generics and Global Operations executive officer.Former GMiA policyofficer Wood had taken on the following the completionofits US$66 billion merger with US-based role of acting chief executive following the departure of Kate Lynch originator Allergan. Stewart will replace current vice-president for last year (Generics bulletin,5September 2014, page 31). North American Generics and International, David Buchen,who has Citing Wood’s“extensive networks within the industry and in served in the role for barely six months after being promoted from the Canberra”, GMiA chair Mark Crotty said her skill set would be role of chief legalofficer pursuant to Actavis closing on its acquisition “essential to navigating this period of change collaboratively with of Forest Laboratories(Generics bulletin,6June 2014, page 27). government”. Wood has more than 18 years of experience in the “Aligning generics sales and marketing, generics research and pharmaceutical industry. development, and global operations and shared-service optimisation “My immediate focus will be on business certainty for GMiA within one organisation will enable us to capitalise on the members, the efficient approvalofgeneric medicines, greater utilisation interdependencyofall phases of the generics business,”Actavis of less expensive generic medicines and apredictable market-access commented. The firm said Buchen would “continue in his current pathway for biosimilars,”Wood said. While generics delivered “billions responsibilities until closing, when he will assume newresponsibilities of dollars in Pharmaceutical Benefits Scheme (PBS) savings”, she on special projects”,supporting Actavis’ president and chief executive observed, “pricing pressures continue to be felt and will force increasing officer, Brent Saunders,and executive chairman Paul Bisaro. numbers of medicines to be delisted”.“The big challenge for the PBS Both Saunders and Bisaro will keep their respective positions is ensuring fair pricing that secures the supply of less expensive critical with the company, with Allergan’spresident, Doug Ingram,joining medicines,”Wood insisted, “along with the industry that provides them.” Actavis to serveasa“special advisor” to Saunders. But Saunders’ Meanwhile, the GMiA has welcomed the appointment of counterpart at Allergan, David Pyott –who wasoutspoken in his Sussan Ley to replace Peter Dutton as Australia’sminister for health. criticism of potential purchaser Valeant prior to Actavis’ agreement “Welook forward to afresh approach from Ms Ley,”Crotty stated, (Generics bulletin,5December 2014, page 3) –has yet to receive a insisting that it was“time for newthinking when it comes to the PBS”. position in the proposed combination. “While we have not answered Action on a“predictablemarket-entry pathway for biosimilars” was all questions [regarding the proposed structure],”Actavis said, “we also essential, Crotty said. G remain committed to announcing cascading organisational structures as those decisions are made.” In his newrole, Stewart will be supported by a12-strong team of VACANCIES existing Actavis staff, including Andy Boyer,the firm’ssenior vice- president of US generics sales and marketing, who will takeupthe position of head of US generics, and senior vice-president of global EMA seeks executive director manufacturing and supply chain, Wayne Swanton,who will become nowledge of at least twoofficial European Union (EU) languages head of global generics operations. Kand 15 years of professional experience –including five years “in a Moreover, Actavis revealed, the following staffwould assume the high-levelmanagement function” –are among the prerequisites for following responsibilities within its existing generics operation to support applying to become the next executive director of the European Stewart: Hafrun Fridriksdottir,head of generics research and Medicines Agency (EMA). A curriculum vitae and a“motivation letter” development; Lars Ramneborn,head of International generics; Jean- should be submitted in English, French or German, by 28 January. Guy Goulet,president of generics in Canada and Latin America; The EMA has offered its former executive director,Guido Rasi, the Gary Holloway,head of generics in Japan; Dan Motto,head of role of principal adviser in charge of the agency’sstrategy.The EU’sCivil generics business development and portfolio management; and Service Tribunal ruled that aprocedure resulting in Rasi’sappointment Helga Gudlaugsdottir,head of procurement. had been invalid (Generics bulletin,5December 2014, page 35).G Gunni Beinteinsson will lead generics commercial operations, while Anish Mehta will oversee shared services. Valur Ragnarsson IN BRIEF will be responsible for the Medis third-party dossier licensing business, while Chip Phillips will oversee Actavis’ Anda US distribution unit. MALLINCKRODT has asked its president of autoimmune and rare Under its proposed structure, generics will makeupone of Actavis’ diseases, Gary Phillips,toresume his previous role as chief strategy five business operations. Bill Meury,executive vice-president for officer,overseeing business development and licensing across the Actavis’ North American Brands, will become president of Branded US group’sentire portfolio. Autoimmune and rare diseases will Pharma, while David Nicholson will retain his responsibilities as head fall under the remit of president of specialty pharmaceuticals, of Actavis’ Brands Research and Development. Furthermore, Allergan’s Hugh O’Neill,who will assume responsibility for commercial president of Europe, Africa and the Middle East, Paul Navarre,will operations for all specialty pharmaceuticals. join Actavis as president of International Brands, while Philippe Schaison will keep his role as head of the AllerganMedical business. GPhA –the US Generic Pharmaceutical Association –has named Meanwhile, Actavis has appointed Jonathon Kellerman as its Terry Bazyluk as its vice-president of communications.Hejoins global chief compliance officer.Kellerman –who joins the company the US association from government-sponsored mortgage firm from PwC, where he wasapartner in the firm’sPharmaceutical and Freddie Mac, where he washead of executive communications. G Life Sciences Advisory practice –would be an “integral member of the Actavis and Allerganpre-integration planningteam”, Actavis said. G

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