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Bulletin Publishing Group is a division of OTC Publications Ltd Registered Office: 4 Poplar Road, Dorridge, Solihull B93 8DB, UK. Registered in England No 2765878 Gen 6/6/14 Pg. 1_Gen 18/11/05 Pg. 1 04/06/2014 18:35 Page 1
6June 2014
COMPANY NEWS 2 Strong demand gives Sawai sales increase 2 Teva opts forOlafsson Hikma agrees to buy 3 BedfordLaboratories US slump depletes Wockhardt’ssales 4 to head generics unit Pharmstandardseeks to buy Biocad stake 5 Aurobindo benefits from aboom in US 6 Valleant wants talks on 7 evaislooking to realise its recent goal of regaining focus on its generics operations by Allergan approach Testablishing from 1July adedicated Global Generic Medicines (GGM) unit, which will be led by current president of Actavis Pharma, Siggi Olafsson, in the role of president and Rival to Kapvaycapssales decline forPar 8 chief executive officer.Olafsson has just agreed to leave Actavis as part of amanagement Richter agrees stake 9 reshuffle accompanying the firm’sUS$25 billion acquisition of Forest (see page 27). in Curaçao distributor As GGM head, Olafsson will have global responsibility for all of Teva’s existing generic Russian rise allows Krka to move ahead 10 markets, including oversight of portfolio managementand selection, product launches and commercial execution. In addition, his duties will extend to coverTeva’s OTCjoint venture MARKET NEWS 11 with Procter &Gamble. “Consolidating Teva’s regional generics businesses under one roof underscores its strong focus on, and commitment to, its generic businesses,”the firm said. FDA’sclinical guide states bridging terms 11 Speaking to investors last month for the first time since taking the helm at Teva,president EGA and EFPIA join to lobby 12 and chief executive officer Erez Vigodman stated there wasa“significant strategic and economic on EU policy value in global generics leadership”, adding that the firm “must regain focus on its generics Australian industrylauds PBS approach 13 business” (Generics bulletin,16May 2014, page 1). GGM will form one half of Teva’s dual commercial operations alongside the Global Specialty PRODUCT NEWS 14 Medicines (GSM) division that wasformed last year under the stewardship of Robert Koremans (Generics bulletin,3May 2013, page 26). “GGM and GSM will work closely together to Australian appeal blocks 14 realise synergies and leverage Teva’s vast product portfolio in both its innovative and generics Apotex entry businesses,”the Israeli firm commented. Sandoz rolls out its AirFluSal in Korea 16 Teva will also slim its executive committee from 15 to nine members. The companyplans in the near future to name the head of anewly-formed Corporate Development, Strategy and EPO backs Copaxone 17 Innovation group that will be tasked, in part, to lead “emerging market initiatives”. as US lacks launches Chief communications officer,Iris Beck-Codner,now leads anewly established Global Celebrex exclusivity 18 Corporate Marketing Excellence and Communications Group, while Eric Drapé –current is awarded by FDA head of sterile,respiratory and specialty operations –will on 1July become global head of Cobalt Canada cuts Vigamoxmonopoly 19 quality.Drapé will report directly to Vigodman and will work closely with global operations Mylan beats Richter on UK 21 head Carlo De Notaristefani. G dosage patent FEATURES 24 Abbott moves for Chile’sCFR CFR is strategic forAbbott –24 By paying US$3.3 billion for Chile’sCFR, bbott Laboratories is set to more than double its branded generics sales and its presence in Abbott is pursuing its strategy of becoming ALatin America by acquiring Chile’sCFR Pharmaceuticals in adeal worth approximately amajor player in both branded generics US$3.3 billion. The cash transaction –comprising US$2.9 billion for CFR’sshares and US$430 and Latin America. Aidan Fry reports. million of assumed debt –isscheduled to close by the end of September this year. “With its scale and leadership positions in the region, strong commercial and development REGULARS organisations, well-respected leadership team and atrusted portfolio of recognised brands, CFR is one of the leading branded generics companies in Latin America,”commented Miles White, Paragraph IV Watch – Istodax 20 Abbott’schairman and chief executive officer.The deal, he said, would establish US-based Events – Our regular listing 22 Abbott as “among the top 10 pharmaceutical companies” in Latin America. In the first full year after closing, Abbott expects CFR to contribute sales of around Price Watch UK – Our in-depth 23 US$900 million. Last year,the Chilean firm posted aturnoverofUS$768 million through its look at pricing trends in the UK operations in 15 countries.Colombia accounted for 30% of that total following CFR’stakeover People – Celesio’sboard adds 26 of local firm Lafrancol, with Chile adding just overafifth, Peru 16% and Argentina 12% leaders of McKesson (Generics bulletin,4April 2014, page 5). G Forfurther details of the deal, turntopage 24. Gen 6/6/14 Pgs. 2-10_Layout 1 04/06/2014 18:36 Page 2
COMPANY NEWS
BUSINESS STRATEGY/ANNUAL RESULTS ANNUAL RESULTS Jubilant uses funds Strong demand gives to spin pharma unit Sawai sales increase
ubilant LifeSciences says almost US$148 million in funding from awai Pharmaceutical said “healthydemand” for generics and a JWorld Bank member International Finance Corporation (IFC) will Sstrong performance from products listed for reimbursement over help it to spin offits Pharmaceuticals business segment into aseparate the past 12 months enabled it to raise its turnoverby11.6% to ¥89.8 entity and expand access to affordable medicines around the world. billion (US$882 million) in its financial year ended 31 March 2014. Noting that US$110 million of the funding wasfrom IFC’sown Turnoverfrom productslisted during the reported period accounts and the remaining US$37.5 million from partners, Jubilant contributed ¥1.42 billion, or 1.6% of group turnover, well above Sawai’s said the moneywould allowthe firm to “strengthen its generic-drug target of ¥800 million. Sales of drugs listed in the previous 12 months manufacturing facilities in India”. “IFC will also help us strengthen more than doubled to ¥2.30 billion. our quality-assurance and risk-mitigation mechanisms,”the firm added. Cardiovascular drugs remained Sawai’slargest therapeutic The Indian firm’sboard last year approvedtransferring its oral category,making up three-tenths of group turnoverwith an 11.3% dosage form and active pharmaceutical ingredients (APIs), as well as sales rise to ¥26.9 billion. Sales of blood-related productsincreased by its shares in Belgian and US subsidiaries, into aseparate holding overaquarter to ¥9.15 billion, while turnoverfrom central nervous company(Generics bulletin,15November 2013, page 2). system drugs grewby17.9% to ¥6.19 billion. Sales by Jubilant’sPharmaceuticals segment grewby2%toRs27.3 The Japanese generics specialist’sgross margin declined by a billion (US$463 million) in the Indian firm’sfinancial year ended 31 percentage point to 46.2%, while it increasedits research and March 2014. Solid-dosage formulations sales that were 5% higher at development investment by 13.6% to ¥5.17 billion. A9.8% rise in Rs8.76 billion on stronger generics volumes made up just under athird operating profit to ¥19.1 billion reduced the firm’soperating margin of that total, while API turnoverclimbed by 4% to Rs5.28 billion. The by 0.3 points to 21.3%. other Rs13.2 billion came from injectables contract-manufacturing, Forits current financial year ending in March 2015, Sawaiis radiopharmaceuticals,allergy therapies and drug-development services. forecasting an operating profit up by atenth to ¥21.0 billion on Pharmaceuticals accounted for 47% of group turnoverahead by turnover18.0% higher at ¥106 billion as drugs such as docetaxel, 12% to Rs58.0 billion. Jubilant’sLife Science Ingredients segment valsartan and zoledronic acid are lined up for reimbursement listing contributed the other Rs30.8 billion. G this month (see page 14). G
2 GENERICS bulletin 6June 2014 Gen 6/6/14 Pgs. 2-10_Layout 1 04/06/2014 18:36 Page 3
COMPANY NEWS
BUSINESS STRATEGY/ANNUAL RESULTS MERGERS&ACQUISITIONS Sun strikes deal to Hikma agrees to buy pay for pantoprazole Bedford Laboratories
un Pharma will supply generics to an undisclosed third party “at a ikma has agreed to buy“assets of Bedford Laboratories”, the Snegotiated discounted price” in return for aUS$400 million Hgeneric injectables business owned by Boehringer Ingelheim’s contribution to damages owed to Pfizer after the Indian firm’sat-risk US Ben Venue subsidiary,inadeal worth up to US$300 million. This launch of generic Protonix (pantoprazole) in the US. The supply deal includes “a large product portfolio, intellectual-property rights, will run for an undisclosed “specified period”. contracts for products marketed under licence, rawmaterial inventories, To account for the agreed discount on future sales, Sun took a astrong research and development and business-development pipeline, Rs25.2 billion (US$438 million) provision in the fourth quarter of and anumber of employees across keybusiness functions”. its financial year ended 31 March 2014. Nevertheless, the firm posted The purchase price comprises an upfront cash payment of US$225 a9.7% rise in annual pre-tax profit to Rs47.3 billion. million, as well as US$75 million in “contingent cash payments” Ayear ago (Generics bulletin,28June 2013, page 17), the based on performance-related milestonesoverafive-year period. At Indian companyagreed to pay US$550 million in damages to Pfizer. the same time, Hikma has struck an “exclusivity deal” with Boehringer Discussing awarning letter recently issued by the US Food to “acquire substantially all of the assets” of the Ben Venue production and Drug Administration (FDA) against Sun’sbulk cephalosporins facility in Bedford, Ohio, which the Jordanian firm said was“one facility in Karkhadi, India, Sun’smanaging director Dilip Shanghvi of the largest sterile injectablemanufacturing sites in the world”. Combining aportfolio of 84 Bedford products with 63 injectables Annual sales Change Proportion already marketed by Hikma would create “the largest portfolio of (Rs millions) (%) of total (%) generic injectableproducts in the US”, aspokesperson for Hikma told Generics bulletin,noting that Hikma wascurrently the third-largest US 97,844 +59.0 60 US supplier of generic injectables by volume. India 36,918+24.5 23 “Bedford also brings aunique and attractiveresearch and Rest of World 19,084 +25.0 12 development pipeline of 27 products, of which 16 are filed and pending Formulations 153,847 +44.5 95 approvalfrom the US Food and Drug Administration (FDA),”the firm Bulk Drugs 8,010 +6.1 5 stated. As well as “numerous paragraph IV opportunities”, Hikma said Other 138 +89.2 – Bedford’spipeline also included “several exciting business-development projects, including licensing and co-development partnerships”. Sun Pharma 161,995 +42.0 100 Last year,Boehringer announced plans to cease production at Bedford by the end of 2013, adding that it was“exploring strategic Figure 1:Breakdown by region and business of Sun Pharma’s gross sales in its financial year ended 31 March 2014 (Source –Sun Pharma) options” for the business after concluding that it would taketoo much time and investment to address manufacturing problems (Generics said the plant accounted for “less than 1%” of group turnoverthat bulletin,18October 2013, page 3). Production had been suspended increased by 42% in the firm’sfinancial year ended 31 March 2014 at the end of 2011 after deficiencies at the Ben Venue facility were to Rs162 billion on agross basis and Rs160 billion in net terms. identified by the FDA, wiping around C300 million (US$408 million) Among deficiencies identified at the plant –which has been the offBoehringer’soperating profit in 2012 (Generics bulletin,3May subject of an FDAimport alert since March (Generics bulletin,21 2013, page 8). However, at the start of 2013 the firm reached aconsent March 2014, page 3) –were alack of “complete data” in laboratory decree with the FDAallowing it to continue marketing more than records, “unofficial testing” and “unacceptable data-handling practices”. 100 drugs (Generics bulletin,1February 2013, page 3). The “data-integrity issues” at Karkhadi, Shanghvi admitted, could “Bedford’simpressive product portfolio and deep pipeline will raise FDAconcerns about quality standards at other Sun facilities. The significantly increase the scale and scope of our rapidly-growing US Indian firm –which has just announced plans to close its Caraco site injectables business,”said Hikma’schief executive officer,Said in the US (Generics bulletin,16May 2014, page 2) –was strengthening Darwazah. “The large number of high-value, niche and differentiated its systems and controls across its manufacturing network, he stressed. products we are acquiring will strengthen our market position in the Once Sun had completed its proposed US$4.0 billion merger with US and will benefit patients by bringing back products to the market Indian rivalRanbaxy (Generics bulletin,18April 2014, page 1), that are currently in short supply.” the group would conduct “a full internal manufacturing review”, Moreover, Hikma said, the deal would “leverage Hikma’s Shanghvi promised. Excluding Ranbaxy,Sun expects to achieve group FDA-approvedinjectable manufacturing capacity in the US, Portugal sales growth of 13% to 15% in its current financial year ending March and Germany, as well as its expertise in sterile liquid, lyophilised 2015, with 25 abbreviated newdrug applications (ANDAs) to be filed and cytotoxic production, bringing scale benefits and cost synergies”. in the US during the 12-month period. Having submitted 27 ANDAs An “initial tranche” of around 20 products would be transferred in the year ended March 2014, the firm finished the period with 344 to Hikma’ssites as soon as the transaction wasclosed, the Jordanian ANDAs approvedand 134 pending final approval. firm said, with aviewtorelaunching these between 2015 and 2017. Recent acquisitions, such as of Takeda’sURL generics business These would be “prioritised based on the strength of the market need, and dermatology specialist Dusa, helped to push up Sun’sUS the ease of transfer,and the expected gross margin contribution”. Formulations sales by 59.0% to Rs97.8 billion. By 2017, Hikma said it expected sales from the acquired assets to The group grewits turnoverfrom Indian branded generic reach around US$150 million, up from US$19 million in 2013. Formulations by aquarter to Rs36.9 billion (see Figure 1). Even before striking the Bedford deal, Hikma expected to Bulk-drugs turnoverrose by 6.1% to Rs8.01 billion as Sun devoted increase its global Injectables sales by more than afifth this year to resources to “increased captive consumption”. G around US$650 million. G
6June 2014 GENERICS bulletin 3 Gen 6/6/14 Pgs. 2-10_Layout 1 04/06/2014 18:36 Page 4
COMPANY NEWS
MANUFACTURING ANNUAL RESULTS US seizes products US slump depletes from Alkem’s Ascend Wockhardt’s sales
SMarshals have seized unapproveddrugs valued at US$11.2 million ales in the US sliding by just overaquarter to Rs21.5 billion Ufrom Alkem subsidiary Ascend Laboratoriesand its distributor S(US$365 million) were almost entirely responsible for Wockhardt’s Masters Pharmaceuticals. The seizure –carried out at the request of group turnoverfalling by 14% to Rs48.3 billion in its financial year ended the US Food and Drug Administration (FDA) and an Ohio attorney- 31 March 2014 (see Figure 1). Pre-taxprofit halved to Rs8.91billion. general –covered products includingpramoxine otic drops, Despite the setback in the US –caused by the ongoing impact of hydrocortisone suppositories and urea creams and lotions. “None of import alerts issued to Wockhardt’splants in Chikalthana and Waluj, these products have been provensafe or effective for their intended India, by the US Food and Drug Administration (FDA) –the firm uses,”the FDAstated. Following an inspection of Ascend’ssite in November last year, Region Annual sales Change Proportion the FDAhas filed acomplaint in an Ohio district court accusing the (Rs millions*) (%) of total (%) firm of marketing drugs without approvedindications. G US 21,500 -26 45 India/Emerging 13,000-327
MERGERS&ACQUISITIONS/FIRST-QUARTERRESULTS UK 9,640 +3 20 Ireland 1,760 -15 4 Pfizer reaches impasse on AZ France 1,450 +6 3 Other 950 –2 fizer “does not intend to makeanoffer for AstraZeneca” after the Europe 13,800 –29 PUK-based company’sboard's rejectedthe US originator’s improved, final proposal of £55.00 (US$91.92) per share. Upon making its final Wockhardt 48,300 -14 100
approach to establish the world’slargest pharmaceutical company *rounded to the nearest Rs10 million –comprising £24.76 in cash and 1.747 shares in the combined entity –Pfizer ruled out making ahostile takeoverbid. “Wecontinue to Figure 1:Breakdown by region of Wockhardt’s sales in its financial year ended believe that our final proposal wascompelling and represented full 31 March 2014 (Source –Wockhardt) value for AstraZeneca, based on the information that wasavailable to signalled its intent to expand in the US by submitting 17 abbreviated us,”stated Pfizer’schairman and chief executive officer,Ian Read. newdrug applications (ANDAs) during the financial year. In the first quarter of this year,turnoverfrom Pfizer’snewly In Europe, Wockhardt reported turnoverofRs13.8 billion, the operationalGlobal Established Pharmaceutical (GEP) business segment majority of which came from UK sales that rose by 3% to Rs9.64 –comprising off-patent drugs, mature brands and all products sold billion as reported, butfell by 4% on alocal-currencybasis. in emerging markets –fell by 13% to US$5.99 billion, or 53% of Introducing 26 newproducts in its domestic market could not offset group turnoverdownby9%toUS$11.4 billion. The originator blamed asignificant sales decline in the Indian firm’semerging markets region, in part generic competition to Viagra (sildenafil) in Europe. G as the twocombined suffered asales drop of 3% to Rs13.0 billion. G
6June 2014 Issue 213 monthlyinJuly, August, December and January, and Subscription enquiries: delivered by air mail – and afreeweeklyemail As left, or [email protected] Editor: Aidan Fry newsflash News@Genericsbulletin published 46 Deputy Editor: David Wallace Te rms &Conditions: No partofthis publication maybe times ayear.Individual annual subscriptions in Europe copied, reproduced, stored in aretrieval system, distributed Assistant Editor: Liudmila Kotko cost £620 (additional copies at the same address or transmitted by anymeans, including electronic,mechanical, Business Reporter: Dean Rudge £395); outside Europe £650 (£425). photocopying or recording, without the prior written permission of the publisher,orunder the terms and conditions Production Controller: Debi Minal The 20 Generics bulletin newsletters arenow available of aGlobal Site Licence or of alicence issued by the Copyright Production Editor: Jenna Meredith as adigital edition, Generics bulletin-i,for either Licensing Agency (CLA) in London, UK, or rights bodies in Director of Subscriptions: ValDavis Apple or Android mobile devices at acost of £895. other countries that have reciprocal agreements with the CLA. Awards Manager: Natalie Cornwell This subscription includes News@Genericsbulletin. Neither maythis publication be exported, distributed or Acombined annual subscription to Generics bulletin Managing Director: MikeRice circulated by anymeans outside the staff who work at the (hard-copynewsletter plus weekly email newsflash)and address to which it is sent by the publisher without the Editorial enquiries: GENERICS bulletin, Generics bulletin-i (digital edition)costs £1,095. prior written permission of the publisher. 4Poplar Road, Dorridge,Solihull, Single hard-copynewsletters cost £50 each. Subscription West Midlands B93 8DB, UK. While due carehas been taken to ensurethe accuracy of rates maybeadjusted to coverany period and can be Website: www.generics-bulletin.com information contained in this publication, the publisher makes backdated. Subscriptions mayonlybecancelled at expiry. Te l: +44 (0)1564 777550 Fax: +44 (0)1564 777524 no claim that it is free of errorand disclaims anyliability whatsoeverfor anydecisions or actions taken as aresult Corporate subscriptions: Global Site Licences are E-mail: [email protected] of its contents. Advertising enquiries: available to companies.These provide in-house electronic As above,[email protected] access forstaff to Generics bulletin or Generics ©OTC Publications Ltd.All rights reserved. Generics bulletin® bulletin-i and [email protected] ask for is registered as atrademark in the European Community. SUBSCRIPTIONS aquotation. Such licences aresupplied strictlyonthe ISSN 1742-0784. Individual subscriptions: A GENERICS bulletin condition that both publications arethe intellectual Companyregistered in England No 2765878. annual subscription includes this hard-copynewsletter property of the copyright holder,OTC Publications Ltd, Printed by Warwick Printing CompanyLimited, published 20 times ayear – twice monthly, except and areprotected by copyright, trademark and other laws. Leamington Spa CV31 1QD, UK.
4 GENERICS bulletin 6June 2014 Gen 6/6/14 Pgs. 2-10_Layout 1 04/06/2014 18:36 Page 5
COMPANY NEWS
BUSINESS STRATEGY/ANNUAL RESULTS MERGERS&ACQUISITIONS/FIRST-QUARTERRESULTS Ciplamakes plans to Pharmstandardseeks build businessinUS to buy Biocad stake
ipla is aiming within ayear to have begun operating adedicated harmstandard has announced plans to acquire for an undisclosed CNorth American division. The Indian firm revealed that it had Psum a20% stakeinfellowRussian firm Biocad, the developer “started to build ateam, as we look to go live”bythe end of March of the first biosimilarmonoclonal antibody (mAb) to receive approval 2015, adding that that one of its keystrategic priorities wasto“build from Russia’sMinistry of Health. The latter’srivaltoRoche’s front-end in select keyinternationalmarkets”. At the same time, the MabThera (rituximab) –which it will market under the name AcellBia companyislooking to further strengthenits position in its “home –was registered last month following a“detailed analysis of clinical markets” of India and South Africa. efficacyand safety” that found no “significant” differencesbetween North American sales ahead by almost afifth to Rs7.40 billion itself and Roche’sbrand (Generics bulletin,2May 2014, page 15). (US$125 million) contributed 7% of Cipla’soverall turnoverthat rose The cancer treatment had Russian sales of RUR8.5 billion (US$248 by 22% to Rs101 billion in its financial year ended 31 March 2014 million) in 2012, Biocad said. (see Figure 1). The firm has expanded its pipeline in the region from “Pharmstandard views the acquisition as an investment of [a] 35 to more than 50 products, “including several keyrespiratory products strategic nature,”commented the firm’schief executive officer,Igor and other complexgenerics”. During the year,the firm made 16 filings Krylov, adding that the deal would be financed using the firm’sown and received13approvals in the region. funds. In addition to the 20% stakeBiocad plans to cede to India contributed two-fifths of Cipla’stotal turnoverasthe firm’s Pharmstandard, the former has also agreed to sell a50% staketoan domestic sales rose by 17% to Rs39.7 billion following the launch affiliate of Moscow-based investor Millhouse, subject to approvalby of its Etacept (etanercept) biological treatment for rheumatoid arthritis Russia’sfederal anti-monopoly service. The remaining 30% of Biocad will remain in the hands of its founder and chief executive officer, Annual sales Change Proportion of Dmitri Morozov. (Rs millions) (%) total (%) Sales of the licensed-in MabThera original dropping by more than athird to RUR269 million contributed to Pharmstandard’sthird-party India 39,650+17 39 product sales slipping by 15.2% to RUR2.60 billion during the first International 25,120+30 25 quarter of this year.The Russian firm blamed alack of government South Africa 7,740 +26 8 tenders, which also depleted sales of Coagil (eptacog alfa) and North America 7,400 +19 7 Infibeta (interferon beta). Europe 5,780 +40 6 Pharmstandard’sown sales of Prescription Pharmaceuticals rose APIs 7,660 +29 8 by 5.8% to RUR1.58 billion, bolstered by branded prescription Other 6,750 –7turnoverincreasing by atenth to RUR1.38 billion. Sales of the firm’s Phosphogliv(glycyrrhizic acid) –which accounted for aquarter of Cipla 101,000 +22 100 all Prescription turnover–rose by more than four-fifths to RUR394 million, while its Octolipen (alpha-lipoic acid) brand and its diabetes Figure 1:Breakdown by region of Cipla’s sales in its financial year ended 31 March 2014, rounded to the nearest Rs10 million (Source –Cipla) treatment Formetine (metformin) also aided growth, as their sales increased by 48.1% to RUR57.8 million and 41.6% to RUR53.0 (Generics bulletin,19April 2013, page 12). And in South Africa – million respectively.Non-branded sales totalled RUR187 million, where Cipla completed its acquisition of Cipla Medpro last July representinga17.7% drop (see Figure 1). (Generics bulletin,12July 2013, page 2) –asales increase of more An unfavourable cold and flu season –which caused sales of its than aquarter took the firm’stotal to Rs7.74 billion. anti-cold and flu remedy Arbidol to drop by 35% to RUR1.24 billion – Cipla said it had nowcompleted its integration with Cipla Medpro, led to Pharmstandard’sOTC sales falling by aquarter to RUR3.03 adding that the business was“on track” to deliver“synergies from scale billion. As aconsequence, the Russian firm’sgroup sales slipped by to drive procurement effectiveness and effective cost-management”. almost afifth to RUR7.47 billion, including RUR167 million from Sales through the Indian firm’sInternational segment grewby bulk substances and RUR99.9 million from medical equipment. G three-tenths to Rs25.1 billion. Cipla said its “pan-Africa network of partners”now offered “unique access to the continent”,noting that First-quarter sales Change Proportion of Africa contributed aquarter of the company’stotal turnover. (RUR millions) (%) total (%) In Europe –where Cipla said it had established a“lean front-end OTC3,028 -25.2 41 presence in priority markets” –arise of two-fifths took sales to Rs5.78 billion. Respiratorylaunches would be akey area of focus in Branded 1,389 +10.0 19 this region, the companystated. And active pharmaceutical ingredient Unbranded 187 -17.7 2 (API) sales grewby29% to Rs7.66 billion as the firm continued to Prescription 1,576 +5.8 21 “drive cost efficiencies and process-improvement initiatives”. Third-party products 2,600 -15.2 35 Meanwhile, Cipla has also announced that it is investing in US- Active substances 167 -35.0 2 based drug-development firm Chase Pharmaceuticals through the Indian firm’sCipla NewVentures investment unit, as well as collaborating Medical equipment 100 -64.4 1 with Chase to develop an Alzheimer’sdisease treatment. Cipla’schief Pharmstandard 7,471 -18.3 100 executive officer,Subhanu Saxena, said the investment in Chase was “consistent with Cipla NewVentures’ mission to build more innovation- Figure 1:Breakdown by product type of Pharmstandard’s sales in the first quarter led business streams for Cipla in future”. G of 2014 (Source –Pharmstandard)
6June 2014 GENERICS bulletin 5 Gen 6/6/14 Pgs. 2-10_Layout 1 04/06/2014 18:36 Page 6
COMPANY NEWS
ANNUAL RESULTS ANNUAL RESULTS Dr Reddy’sboosted Aurobindo benefits by line of launches from aboom in US
ine US launches helped Dr Reddy’stoimprove its North American lmost doubling its US Formulations sales enabled Aurobindo Ngenerics sales by 46% to Rs55.3 billion (US$932 million) in the APharma to increase its gross turnoverby37.7% to Rs82.6 billion company’sfinancial year ended 31 March 2014. “Major” molecules (US$1.39 billion) in its financial year ended 31 March 2014. “Weare introduced included azacitidine, decitabine and zoledronic acid, as well also making steady progress on our differentiated product offerings, as extended-release divalproexand a23mg presentation of donepezil. especially with our parenterals gaining traction in advanced The Indian firm’sUSinjectablesportfolio generated sales of geographies,”commented managing director Narayanan Govindarajan. US$225 million as Dr Reddy’ssaid it wascontinuing to maintain Having submitted 67 abbreviated newdrug applications (ANDAs) leadership positions for “key,limited-competition” molecules. This during its financial year,Aurobindo took its cumulative US filings to included capturing 58% of the decitabine market and 44% for 336 as of 31 March 2014. Of that total, the Indian firm held final azacitidine, as well as holding 65% of the market for zoledronic acid or tentative approvals for 191 ANDAs. 5mg/100ml and 35% for the 4mg/5ml version. The companyalso said Recent final approvals secured by the firm in the US include it wasmaking progress on capturing agreater share of the market for moxifloxacin 400mg tablets as well as repaglinide tablets in 0.5mg, other “key molecules” such as metoprolol and atorvastatin. 1mg and 2mg strengths. Aurobindo also obtained tentative approvals Global Generics sales advanced by more than aquarter to Rs105 for memantine tablets and atazanavir capsules. billion, drivenlargely by the US rise butalso by turnoverfrom emerging European Formulations sales climbed by 43.6% to Rs6.72 markets that grewbyjust overafifth to Rs27.2 billion. In Russia – billion (see Figure 1). From 1April this year,the Indian group has incorporated operations in sevenwestern European countries that it Annual sales Change Proportion of acquired from Actavis in a C30 million (US$41 million) deal (Rs millions) (%) total (%) (Generics bulletin,3February 2014, page 1). Formulations turnoverinAurobindo’sRest of the World region North America 55,303 +46 42 rose by 11.3% to Rs4.63billion. The region includes the Indian Russia/CIS 19,819 +17 15 group’sbusiness in Canada –which recently obtained approvals for India 15,713+812 carvedilol tablets, montelukast chewable tablets and omeprazole Europe 6,970 -10 5 delayed-release capsules –aswell as its operation in South Africa, Rest of world 7,359 +33 6 which gained clearance to market alendronic acid, betahistine and Global Generics 105,164 +27 80 bisoprolol tablets, along with ampicillin powder for injection. Pharma Services, APIs 23,974 -22 18 Aurobindo has also just set up asubsidiary in Colombia. Proprietary Products/other 3,032 +1 2 Includingglobal antiretroviral sales that grewby12.0% to Rs8.40 billion, Aurobindo increasedits total gross Formulationssales Dr Reddy’s132,170 +14 100 by 58.8% to Rs53.8 billion, or almost two-thirds of group turnover. Theother third came from the group’sActive Ingredients business Figure 1:Breakdown by region and business of Dr Reddy’s Laboratories’ sales in segment, which posted a12.9% turnoverrise to Rs28.6 billion. its financial year ended 31 March 2014 (Source –DrReddy’s) A27.8% advance to Rs9.78 billion in sales of bulk semi-synthetic where sales rose by 16% to Rs16.3 billion –DrReddy’ssaid it wasthe penicillins more than compensatedfor a6.6% decline to Rs8.75 billion “fastest-growing among the top 20 pharma companies”. Meanwhile, in turnoverfrom bulk cephalosporins. Sales of non-betalactam an increase of 22% in the Commonwealth of Independent States (CIS) active ingredients climbed by just overafifth to Rs10.1 billion. to Rs3.5 billion wasdrivenby“continuing momentum in existing On anet basis, Aurobindo increased its group turnoverby38.3% products coupled with select launches from an in-licensed portfolio”. to Rs81.0 billion. The Indian firm more than quadrupled its pre-tax In India, 11 launches helped generics sales to growby8%to profit to Rs15.3 billion. G Rs15.7 billion, including Rs1.13 billion from biosimilars. But European turnoverdropped by atenth to Rs6.97 billion (see Figure 1). Business Annual sales Change Proportion of Sales through its Pharmaceutical Services and Active Ingredients segment (Rs millions) (%) total (%) (PSAI) division dropped by more than afifth to Rs24.0 billion, “partly US 34,028 +94.2 41 on account of ahigh base [comparison], and partly on account of Europe 6,721 +43.6 8 subdued demand”. “The PSAI business had atough year”, acknowledged Rest of world 4,634 +11.3 6 chairman Satish Reddy,adding that the past fewquarters had been Antiretrovirals 8,402 +12.0 10 “challenging for the business”. Formulations 53,785+58.8 65 Along with Proprietary Products and other sales that crept ahead by 1% to Rs3.03 billion, group sales increased by 14% to Rs132 billion. Semi-synthetic penicillins 9,778 +27.8 12 Earnings before interest, tax, depreciation and amortisation (EBITDA) Cephalosporins 8,754 -6.6 11 grewby19% to Rs33.2 billion, or aquarter of the firm’soverall sales. Non-betalactam 10,110 +21.3 12 Having increased its spending on research and development by Active ingredients 28,642 +12.9 35 62% to Rs12.4 billion –representing 9.4% of the firm’stotal sales – Dossier income 165 -78.3 – Dr Reddy’ssaid the next twelvemonths would see the firm increase Aurobindo 82,592 +37.7 100 this proportion to between 10% and 11% as it invested in developing complexgenerics such as injectables or topical drugs, as well as Figure 1:Breakdown by business segment of Aurobindo Pharma’s sales in its biosimilars and proprietary products. G financial year ended 31 March 2014 (Source –Aurobindo)
6 GENERICS bulletin 6June 2014 Gen 6/6/14 Pgs. 2-10_Layout 1 04/06/2014 18:36 Page 7
COMPANY NEWS
HALF-YEARRESULTS/RESTRUCTURING MERGERS&ACQUISITIONS Takeover takes toll Valeant wantstalks on Adcock’s profit on Allergan approach
egal and professional costs, as well as “negative commercial effects”, aleant has raised its offer for AllergantoUS$72.00 plus 0.83 Valeant Lresulting from a“protracted contest for shareholder control” led Vshares for each Allerganshare. But the revised bid is contingent Adcock Ingram to post apre-tax loss on aturnoverthat advanced by on “prompt good-faith negotiations” on merging the twofirms. 3.4% to ZAR2.42 billion (US$231 million). As part of the deal, Valeant’spartner –and Allergan’slargest The ZAR18.9 million pre-tax loss also reflected “margin pressures shareholder with a9.7% holding –Pershing Square has agreed to forego through an under-recovery of increasing input and overhead costs” all cash, thereby giving up “US$600 million of value” to sweeten the amid exchange-rate fluctuations, as well as preoccupation of “certain deal for other Allerganshareholders. keymanagement” with the takeoverbattle for the firm that eventually The latest offer represents an increase of almost aquarter in the sawlocal conglomerateBidvest defeat an approach from Chile’sCFR. cash component from the US$58.30 per share that had previously been Under newownership and management after Bidvest became the on the table. Valeant had initially bid US$48.30 in addition to 0.83 of its firm’slargest shareholder,the South African companyisnow ownshares for each Allerganshare held (Generics bulletin,2May “implementing substantive changes to its internal structures and 2014, page 3). processes” to create “more defined butdecentralised business units”. Since Valeant first made its unsolicited approach,relations between The South African group’sdomestic sales fell by 1.7% to ZAR2.19 the twocompanies’ boards have become increasingly acrimonious. billion on “a sharp slow-down in the OTCand prescription generics Valeant and Pershing Square have threatened to seek the removalof portfolios”.Domestic Prescription turnoverincreased by 13.8% to “some or all of the Allerganboard members” (Generics bulletin, ZAR975 million as “the branded portfolio performed well, butsales 16 May 2014, page 3), while Allerganteamed up with twofinancial in the generics portfolio were disappointing”. Strong competition consultants to highlight concerns about Valeant’sbusiness model, such contributed to a19.0% tumble in OTCsales to ZAR734 million, while as the size of the Canadian firm’s“real” organic growth, its ability Hospital turnoverrose by 3.5% to ZAR482 million. to promote products of Allergan’sscale and the sustainability of its But turnoverinthe rest of Africa and India doubled to ZAR242 “serial acquisition and cost-cutting” strategy. million as Adcock consolidated its acquisitions of Zimbabwe’sDatlabs Meanwhile, Valeant has struck an agreement with Nestlé to sell and India’sCosme. India contributed ZAR106 million to that total. G all rights to five dermatology fillers and toxins for US$1.4 billion. G
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COMPANY NEWS
ANNUAL RESULTS FIRST-QUARTERRESULTS Zydus grows amid a Rival to Kapvay caps filing frenzy in the US sales decline for Par
ydus Cadila increasedits group gross sales by 14.7% to Rs72.1 ntroducing extended-release clonidine and dexmethylphenidate in Zbillion (US$1.23 billion) in its financial year ended 31 March 2014 Ithe US contributed US$11.1 million and US$8.99 million respectively as the Indian companyfiled 50 US abbreviated newdrug applications to ParPharmaceutical’sturnoverthat dipped by 0.4% to US$289 (ANDAs) in the US during the 12-month period. million in the first quarter of this year. It total, the firm has to date submitted 227 ANDAs. Receiving 15 Having launched arivaltoConcordia’sKapvay (clonidine) ANDAapprovals during the financial year took Zydus’ approvedUS extended-release tablets in October last year,Par said it had benefitted portfolio to 91 products. The ANDAfilings total included initial from “no competition” through to the end of March 2014. submissions from the Nesher generics business that the group acquired The US firm also introduced an alternative to Novartis’ Focalin XR from KV three years ago (Generics bulletin,30June 2011, page 3). (dexmethylphenidate) extended-release capsules during the fourth Sevenlaunches helped the Indian firm to record a44.0% leap in quarter of last year (Generics bulletin,6December 2013, page 29). US Formulations sales to Rs21.7billion. Zydus said it ranked as the These launches pushed up Par’stotal generics turnoverby0.4% eighth-largest generics companyinthe US, measured by prescriptions to US$274 million (see Figure 1). dispensed (Generics bulletin,18April 2014, page 25). Greater competition reduced Par’ssales of both budesonide enteric- US Formulations sales accountedfor three-tenths of group turnover. coated tablets and metoprolol extended-release tablets by around a Another 44%, or Rs31.9 billion, came from the company’soperations quarter to US$37.3 million and US$14.1 million respectively.But the firm’sturnoverfrom propafenone sustained-release capsules rose by Annual sales Change Proportion almost aquarter to US$21.1 million as Parwas “single-source generics (Rs millions) (%) of total (%) supplier” during the quarter. India 31,880+6.7 44 Acompetitor exiting the market in June last year helped to drive up Par’sdivalproexsales to US$20.4 million, while rivals’ supply US 21,704 +44.0 30 problems doubled the firm’sturnoverfrom bupropion extended-release Europe 3,902 +5.5 5 tablets to US$16.3 million. Brazil/Mexico 2,462 +3.3 3 Par’slamotrigine sales halved, while introducing digoxin earlier Japan 541 -10.3 1 this year –along with the impact of injectables acquired through the Emerging Markets 3,673 +17.2 5 US$488 million takeoverofJHP in February –failed to compensate APIs 2,857 +10.9 4 fully for sharp falls in sales of fentanyl patches, modafinil and rizatriptan. Animal Health/others565 +26.1 1 Par’sStrativa brands division suffered a12.2% turnoverslide Exports 35,703 +27.9 50 to US$15.3 million on lower volumes for its Megace ES (megestrol Joint ventures 4,499 -11.3 6 acetate) brand. Parcould soon face competition to the weight-loss treatment after aMaryland district court earlier this year ruled that akey Zydus Cadila 72,082 +14.7 100 patent wasinvalid (Generics bulletin,21March 2014, page 16). A71.2% increase in researchand development spending to US$34.6 Figure 1:Breakdown by business and region of Zydus Cadila’s gross sales in its financial year ended 31 March 2014 (Source –Zydus Cadila) million combined with intangible-asset impairments of US$41.8 million “for twoproducts not expected to achieve their originally in India, where formulations sales advanced by 6.1% to Rs24.6 billion. forecasted operating results” to takePar to aUS$34.2 million operating Zydus said it had achieved“amilestone year” in India as more loss. The generics division accounted for around two-thirds of that than 75 product launches included the diabetic dyslipidaemia treatment loss, and Strativa the other third. G Lipaglyn (saroglitazar), “India’sfirst newchemical entity (NCE) to reach the market”. Product/ First-quarter sales Change Proportion of Sales in Europe –where Zydus claims to be in the top 10 generics division (US$ millions) (%) total (%) players in France, and in the top 20 in Spain –rose by 5.5% to Rs3.90 Budesonide 37.3 -25.9 13 billion, butthe firm’sturnoverinJapan fell by atenth to Rs541 million after Zydus announced earlier this year that it would discontinue its Propafenone SR 21.1 +23.0 7 operations in the country (Generics bulletin,3February 2014, page 3). Divalproex20.4 –7 By contrast, the Indian group is working to establish a“profitable Bupropion ER 16.3 +98.0 6 business” in Mexico by next year.Seven launches during the financial Metoprolol ER 14.1 -27.2 5 year after its Mexican commercial operations started in June 2013 Clonidine ER 11.1 –4 helped to generate local sales of Rs109 million. Brazilian turnover Lamotrigine XR 10.1 -49.6 4 slipped by 1.3% to Rs2.35 billion. Dexmethylphenidate 9.0 –3 Emerging markets sales in Africa and the Asia-Pacific region Others134.3 -13.9 46 advanced by 17.2% to Rs3.67 billion, while Zydus’ global active ParGenerics 273.8 +0.4 95 pharmaceutical ingredients (APIs) turnoverrose by just overatenth to Rs2.86 billion. Strativa 15.3 -12.2 5 Including non-sales income, group turnoverincreased by 13.6% ParPharma 289.1 -0.4 100 to Rs72.2 billion. A2.1% reduction to Rs4.61 billion in research and development expenses helped to improve Zydus’ pre-tax profit by Figure 1:Breakdown by product and division of Par Pharmaceutical’s sales in the 16.5% to Rs9.42 billion. G first quarter of 2014 (Source –Par)
8 GENERICS bulletin 6June 2014 Gen 6/6/14 Pgs. 2-10_Layout 1 05/06/2014 09:22 Page 9
COMPANY NEWS
ANNUAL RESULTS MERGERS&ACQUISITIONS/FIRST-QUARTERRESULTS Towa reaches target Richter agrees stake for sales, not profits in Curaçao distributor
urnovergrowth of 11.1% to ¥61.4 billion (US$608 million) edeon Richter is expanding its presence in Latin America by Tenabled Towa Pharmaceutical to exceed its ¥61.3 billion sales Gagreeing to buyamajority stakeinits Curaçao-based female target for its financial year ended 31 March 2014. But a0.2% dip healthcare distributor Mediplus. The acquisition of Mediplus –which in operating profit to ¥7.71 billion meant the Japanese generics currently offers arange of the Hungarian firm’sfemale healthcare specialist’s12.6% operating margin fell well short of the ¥9.0 billion products across Latin America such as Esmya (ulipristal acetate), earnings and 14.7% margin goals that the firm had set earlier this year including in Bolivia, Chile, Ecuador and Peru –follows the purchase (Generics bulletin,7March 2014, page 11). of majoritystakes in female healthcare firms in Brazil and Mexico. Towa said it had benefitted from aspikeindemand ahead of a Under the terms of the agreement, the Hungarian firm will acquire sales-tax increase in April 2014, as well as from asteady increase an initial 51% stakeinMediplus before subsequently acquiring the to ¥2.5 billion in turnoverfrom products launched in the 12 months remaining 49% overthe next three years. Richter will provide an ended March 2013, such as orally-disintegrating pitavastatin. initial cash lump sum, as well as sales milestone payments based on Drugs introduced in the year to March 2014 “started right”, with certain performance-related targets to the Latin American firm. combined sales of ¥1.9 billion. Richter’scontinued focus on pushing its female healthcareproducts Amlodipine remained the Japanese firm’slargest molecule with in Latin America helped sales in the region to rise by more than half sales ahead by ¥1.0 billion to ¥7.2 billion. Towa also enjoyed growth to C4.7 million (US$7.86 million) in the first quarter of this year. US from atorvastatin and lansoprazole, more than offsetting aslight fall sales were ahead by 55.1% to C10.7 million due to astrong uptake in sales of pravastatin. in sales of the emergencycontraceptive Plan B(levonorgestrel). Around three-fifths of Towa’s sales were to dispensing pharmacies, Combined, however, Latin America and the US accounted for with general practitioners accounting for almost athird and hospitals 8%. only 6% of pharma turnoverthat slipped by 2.3% to C246 million The group’sgross margin fell by almost apercentage point to (see Figure 1) as aresult of aturnoverdip of 16.6% to C96.5 million 49.3%, while an 18.3% increase to ¥5.30 billion in researchand in Russia and the Commonwealth of Independent States (CIS). In development spending –aswell as higher advertising, packaging and Russia, Richter said that destocking as aresult of stockpiling in the freight costs –contributed to the lower operating profit. G fourth quarter of last year caused sales to drop by more than afifth to C64.0 million, while “a more strict receivables control and voluntary shipment restrictions” coupled with political unrest in Ukraine led turnovertodrop by 23.1% to C14.3 million. Sales in the European Union (EU), excluding Hungary,increased by 8.4% to C83.8 million as aresult of improvedturnoverinGermany. In the Hungarian group’sdomestic market, “marginal changes to the price regulations system” did not negatively affect its performance as sales rose by 2.7% to C30.9 million, or by 6.9% to HuF9.53 billion (US$42.5million) in local-currencyterms. In its domestic currency, total Pharmaceutical sales rose by 1.8% to HuF75.8 billion. IncludingRichter’sWholesale &Retail business group turnover fell by 1.0% to C287 million. Higher clawback liabilities, along with increased research and development spending, contributed to Richter’s operating profit falling by 35.2% to C33.3 million. G
First-quarter sales Change Proportion of (C millions) (%) total (%) Russia/CIS 96.5 -16.6 34 European Union* 83.8 +8.4 29 Hungary 30.9 +2.7 11 US 10.7 +55.1 4 China 10.2 +6.3 4 Latin America 4.7 +51.6 2 Rest of World 9.1 +2.2 3 Pharmaceutical 245.9 -2.3 86 Wholesale &Retail 47.8 +7.9 17 Eliminations/Other -6.6 –-2 Gedeon Richter 287.1 -1.0 100
*excluding Hungary
Figure 1: Breakdown of Gedeon Richter’s sales in the first quarter of 2014 (Source –Gedeon Richter)
6June 2014 GENERICS bulletin 9 Gen 6/6/14 Pgs. 2-10_Layout 1 04/06/2014 18:36 Page 10
COMPANY NEWS
FIRST-QUARTERRESULTS IN BRIEF SANOFI has signed a“strategic agreement forpromoting anew Russian rise allows generics portfolio in the Middle East”through the Globalpharma subsidiary of investment firm Dubai Investments. “Products will be commercialised under ajoint entity to better meet the needs of patients within the United Arab Emirates and the wider region,”Dubai Krka to move ahead revealed, adding that the twofirms were “currently in the process of validating this agreement with the relevant authorities”. rise of afifth in Russian turnoverdespite “slowing economic growth Aand the depreciation of the rouble” enabled Krka to increase its COHERUS BIOSCIENCES has raised US$55 million from a group turnoverby1%to C298 million (US$408 million) in the first group of investors including private-equity firm KKR. “The capital quarter of this year.InRussia –where sales totalled C84.6 million – resources provided by our investors will allowustoprosecute our “the main drivers of sales growth were prescriptionpharmaceuticals”, development plans, optimise our partnering strategies and deliver as central nervous system drugs put in astrong performance. Russia essential therapeutics to patients faster,” commented the US-based accounted for the majority of turnoverthat advanced by 16% to biosimilars developer’spresident and chief executive officer, C116 million in Krka’sEast Europe region (see Figure 1). DennyLanfear. The group benefitted from double-digit sales growth in Belarus, Moldova and Uzbekistan, butsales slipped by 3% to C13.2 million in XELLIA PHARMACEUTICALS –the Danish anti-infectivesspecialist Ukraine. “Order placement, product supply and payments have been –isinvesting CrK11.5 million (US$2.0 million) in expanding its normal so far, despite the difficult situation in the country,” Krka said. research and development centre in Zagreb, Croatia. The expansion With sales 2% lower at C62.1 million, Central Europe made up just will more than double the site’sfootprint to over1,250 sq m. overafifth of Krka’sgroup turnover. The decline waslargely due to a 73% slide to C3.2 million in the Czech Republic amid price cuts. INDOCO says it is still waiting for the US Food and Drug In the region’slargest market, Poland, introducing the Meaxin Administration (FDA) to approve its sterile ophthalmics plant (imatinib) oncology drug helped to produce 3% sales growth to C31.5 in Goa, India. “Recent communications with the FDAgiveus million. TurnoverinHungary almost doubled to C11.0 million, while confidence that the process is moving in the right direction,”the Indian firm insisted,having earlier this year stated that it had resolved Region/ First-quarter sales Change Proportion of outstanding issues relating to a‘Form 483’ list of observations Product line (C millions) (%) total (%) issued by the FDAfollowing an inspection of the facility in 2013 East Europe 116.2 +16 39 (Generics bulletin,3February 2014, page 7). The Goa plant earlier Central Europe 62.1 -2 21 this year receivedaEuropean Union (EU) good manufacturing West Europe 59.8 -8 20 practice (GMP) approvalfrom the Czech Republic’sState Institute for Drug Control (SUKL). Exports increasing by 16.3% to Rs2.54 South-East Europe 34.2 ±0 11 billion (US$43.2 million) in Indoco’sfinancial year ended 31 March Slovenia 19.3 -9 7 2014 helped to push up the Indian firm’soverall sales by 14.5% to Overseas markets 6.5 -36 2 Rs7.17 billion. Domestic turnoverrose by 13.4% to Rs4.61 billion. Krka 298.0 +1 100 LANNETT has been added to the S&P SmallCap 600 Index that Prescription 248.3 +2 83 tracks the performance of firms representingmore than 3% of Non-prescription 31.0 -9 10 available US market capital. President and chief executive officer Animal Health 10.9 ±0 4 Arthur Bedrosian said inclusion in the stock market indexwould Resorts, tourism, other 7.8 +16 3 “increase our visibility within the investment community”.
Figure 1:Breakdown by region and product line of Krka’s group sales in the first ACTAVIS UK has revised and re-launched its Accumulator quarter of 2014 (Source –Krka) Scheme –the company’sgenerics purchasing loyalty programme sales in Slovakia movedahead by aquarter to C8.8 million. But lower for pharmacists and dispensing doctors that covers over750 sales of seasonal products reduced Krka’sturnoverinLithuania. generics –introducing a“simpler three-tier discount band model” Another fifth of group turnovercame from West Europe, where with lower entry thresholds and net pricing. The re-launch follows sales fell by 8% to C59.8 million. “This wasexclusively the result of astudy by an independentmarket research firm among 18 pharmacies, the continued decrease in sales via unaffiliated companies, mainly in which demonstrated that “clear transparent pricing and time-saving” France, Italy and Germany,”Krka stressed, adding that sales by its were twoofthe most “important factors when purchasing medicines”. ownsubsidiaries in the region had increased by 29%. TurnoverinSouth-East Europe stalledat C34.2 million, although STRIDES ARCOLAB met its forecasts by recording a turnover “sales growth wasrecorded in Romania, Serbia, Macedonia, Kosovo of Rs13.8 billion (US$232 million) in the 15 months ended 31 and Albania”. A5%rise to C12.5 million in Romania wasoffset in March 2014. Sales in regulated markets reached Rs5.06 billion “in part by an 8% fall to C7.3 million in Croatia. spite of delayed approvals in the US”, while turnoverinemerging In its domestic market, the Slovenian group suffered from markets totalled Rs3.35 billion, “drivenbystrong expansion in the legislation that introduced reference prices for therapeutic groups African business” that spans 27 countries. Launching malaria such as ACE-inhibitors and statins. Prescription drugs accounted treatments contributed to Rs5.34 billion in Institutional sales. for half of Slovenian sales that fell by 9% to C19.3 million. A15% sales rise in South Africa and turnovermore than doubling NIPPON CHEMIPHAR said higher sales of amlodipine, lansoprazole in Malaysia after Krka wonatender for Kamiren (doxazosin) failed to and rabeprazole enabled it to increase its Generics sales by 3.3% to prevent a36% turnovertumble to C6.5 million in Overseas Markets, ¥24.4 billion (US$237 million) in the Japanese company’sfinancial as sales in the Middle East were depleted by import restrictions in Iran. year ended 31 March 2014. Group sales fell by 0.2% to ¥31.9 billion.G Krka improvedits operating profit by 8% to C63.0 million. G
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MARKET NEWS
PRICING&REIMBURSEMENT BIOLOGICALDRUGS Heumann breaks into FDA’s clinical guide Germany’s big three states bridgingterms
orrent Pharma’sGerman subsidiary,Heumann, brokethe dominance ridging data to justify the use of anon-US-licensed reference Tof Germany’sbig three generics players as the AOKgroup of Bproduct in clinical studies to showbiosimilarity will always have funds announced the winners in its 13th tender round that saw504 to include analytical data comparing the biosimilar,the US-licensed regional supply contracts handed out for 56 active ingredients or reference product and the non-US-licensed original, according to adraft combinations with combined annual sales through AOKfunds of guidance on ‘clinicalpharmacology data to support ademonstration around C1.1 billion (US$1.5 billion). of biosimilarity to areference product’ released for comment by the While each molecule wasdivided into eight regional bidding lots, US Food and Drug Administration (FDA). the AOKtypically awarded contracts to the same supplier in each Bridging data is also likely to include pharmacokinetic (PK) and, region. The contracts will run from 1October 2014 to 30 September if appropriate, pharmacodynamic (PD) data for all three products. The 2016, largely replacing the AOK’seighth and ninth tender rounds. guideline states that, “as ascientific matter”, analytical studies and With atotal of 55 contracts,Heumann accounted for almost one “at least one clinical PK study” to demonstrate biosimilarity will have in nine of the deals awarded by the AOKgroup that insures around to include “an adequate comparison” of the biosimilardirectly with 24 million Germans. Among the firm’ssuccesses were exclusive supply the US-licensed reference product. deals for galantamine, irbesartan/hydrochlorothiazide, letrozole, “For PK similarity assessments, asingle-dose, randomised crossover levofloxacin, olanzapineand telmisartan. study is generally the preferred design,”the guideline notes. However, However, Germany’sbig three remained major AOKpartners. it adds, aparallel-group design would be appropriatefor products with Stada led the waywith atotal of 62 contracts awarded, followed long half-livesorfor which repeated exposure can lead to an increased closely by Teva with 60. Stada’sexclusive deals included the active immune response that could affect PK and PD similarity assessments. ingredients bezafibrate, naproxen, raloxifene and tilidine/naloxone, Where it is safe, human PK and PD studies should be conducted while Teva secured sole-supply status for drugs such as atorvastatin, in healthyvolunteers because there are likely to be fewer “potentially gentamicin, lovastatin and ribavirin. confounding factors” such as concomitant diseases and medications. Pushed into fourth place by Heumann, Sandoz gained 51 supply Doses should be selected “to provide clinically meaningful and deals for drugs such as estradiol and rivastigmine. In fifth place waslocal interpretable data”, while subcutaneousroutes of administration are likely central nervous system specialist Neuraxpharm with 43 contracts that to be the most sensitive for detecting clinically meaningfuldifferences. covered ingredients includingclozapine, fluphenazine and ticlopidine. Discussing PK measures, the guideline says for intravenous studies Sanofiand its Winthrop generics label captured almost 8% of the area under the blood-plasma curveextrapolated to infinity (AUC0-∞) contracts awarded with 40 deals, ahead of felloworiginator Pfizer “will be considered the primary endpoint”. But for subcutaneous with 27 contracts (see Figure 1). Successful bids to supply candesartan studies, the co-primary endpoints will be maximum concentration and valsartan in combination with hydrochlorothiazide helped Krka’s (Cmax) and the area under the curve(AUC). Stressing that using one TadPharma to secure 23 contracts,while Glenmark gained 20, including or more PD markers could “reduce residual uncertainty”, the draft four from ajoint national deal with Aurobindo to supply quetiapine. states that such markers should be compared by determining the area Forthree molecules –candesartan, metformin and metoprolol – under the effect curve(AUEC). the AOKeschewed its usual practice by handing contracts to three “Modelling and simulation tools can be useful when designing suppliers per region (Generics bulletin,7March 2014, page 17). aPKand/or PD study,” the guidance continues, noting that biosimilar The AOKsaid it had awarded deals to 27 companies in total. applicants could use simulations to analyse publicly-available data Addressing concerns that such tenders could lead to market shortages, on the reference drug’sdose- or exposure-response relationship. Where the AOKsaid the funds checked carefully suppliers’ capacity and such data is not available, asmall study may be needed to “determine gave firms strong financial incentivestoavoid shortages. G the optimally informativedose”. The guidance outlines “three keyconcepts” in establishing biosimilarity –exposure and response assessment based on PK and Others, 123 Stada, 62 PD profiles; evaluation of residual uncertainty using “a risk-based approach” and based on “the totality of the data”; and assumptions about analytical quality and similarity following “extensive and robust comparative structural and functional studies”. Teva,60 Comparative analytical characterisation may,itsays, lead to one of four assessments. If found ‘not similar’, acandidate is unlikely to be Glenmark, 20* suitable for the 351(k) biosimilar regulatory pathway,while a‘similar’
Tad, 23 determination suggests “further information is needed”, such as on glycosylation. But a“highly similar”candidate would meet the statutory standard for analytical similarity,thus supporting “targetted Pfizer,27 Heumann, 55 and selected” animal and human trials. And if abiosimilar candidate could be shown to be “highly similar with fingerprint-likesimilarity”, Sanofi, 40 the approach to studies could be “more targetted and selective”. *includes four contracts Sandoz, 51 from ajoint award with Neuraxpharm, 43 Intended as “one in aseries” of documents the FDAisdeveloping Aurobindo for quetiapine to implement the 2009 Biologics Price Competition and Innovation Figure1:The number of supply contracts awarded to each company in the 13th (BPCI) Act, the guidance concludes that clinical pharmacology studies tender round runbyGermany’s AOK group of funds (Source –AOK) will form “part of astepwise process” for demonstrating biosimilarity. G
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MARKET NEWS
REGULATORY AFFAIRS IN BRIEF FDA –the US Food and Drug Administration –has published EGA and EFPIA join guidance for industry on stability testing for abbreviated newdrug applications (ANDAs). Taking the form of aquestion-and-answer document, the guidance covers drug master files (DMFs), manufacturing and packaging issues, amendments to pending to lobby on EU policy ANDAs and requirements for stability studies.
he European Generic medicines Association (EGA) and brand GREECE’s Ministry of Health has failed to correct aseries of pricing Tindustry body the European Federation of Pharmaceutical Industries errors despite recommendations to do so from its pharmaceutical and Associations (EFPIA) have united to lobby on an integrated pricing committee, according to local pharmaceutical industry European industrial policyfor pharmaceuticals. association SFEE. These included “several generics for which Three “priority action points” set out by the twoassociations reference prices and the rate of price reduction relative to corresponding include urging the EU to “recognise that medicines are essential to patented products have been misapplied”, SFEE noted. The ministry improve patient outcomes and equity of access to healthcareacross had “repeatedly ignored” the pricing committee’srecommendations, Europe”. At the same time, the EGA and EFPIA suggest that the SFEE said, “thereby increasing the risk of supply shortages in the European authorities should “support amore sustainable and predictable market at the expense of Greek patients”,partly by encouraging business environment to incentivise the pharmaceutical industry to manufacturers to export products rather than sell them domestically. invest in bringing better and more cost-effective treatments to patients”. Finally,the twoassociations underline the need to “foster an environment ABPI –the Association of the British Pharmaceutical Industry – that will makethe EU an attractiveglobal hub for pharmaceutical has published a ‘position paper’ on biosimilars calling for “robust research and manufacturing”. patient safety monitoring” and “clear guidance and information to Pointing out that the generics industry wasalready “investing in educate prescribers and patients” about the differences between newresearch and manufacturing sites across Europe”, EGA president biologics and small-molecule medicines.The brand industry Nick Haggar insisted that “we can accelerate this with adynamic association also insists that automatic substitution is not appropriate European pharmaceutical industrial policythat combines support for for biosimilars,while anytenders involving biologics should “not research and manufacturing” with “newsustainable market models seek to source asingle product only”, because “not all biological for specialty products likebiosimilar medicines”. medicines may be suitable for all patients”. Moreover, the ABPI “EFPIA and EGA are looking forward to partnering with the next recommends,“extrapolation of indications for biosimilar products European Parliament and Commission to improve EU health outcomes should be evaluated by regulators on acase-by-case basis”. and economic prosperity,” the twoassociations stated. “Anintegrated European industrial policyfor pharmaceuticals will makehealth systems EGA –The European Generic medicines Association –has joined more sustainable and, most importantly,improve patient access to with its Japanese counterpart, the Japanese Generic Medicines the highest quality medicines.” Association (JGA), to “promote regulatory cooperation on generic Meanwhile, the EGA has announced that a‘Connecting the Dots: and biosimilar medicines” as part of free trade negotiations between Accessing Patients’ workshop will takeplace on 26 June during the the European Union and Japan. The EGA said its lobbying efforts association’s20th annual conferenceinMadrid, Spain, covering shifts were particularly focused on “the single development for the approval in healthcare communications due to the adoption of social media of biosimilarand complexspecialty generic medicines to avoid the and mobile technology. unethical duplication of clinical studies and on the mutual recognition Led by EGA government affairs manager Julie Chauvet along of good manufacturing practice (GMP) inspections”. with Doris Casares, communications director of Spanish industry association AESEG, the 90-minute English-language workshop will HEALTH CANADA has invited industry stakeholders to submit cover“innovation in atraditionally conservative sector” and today’s comments on drug shortage notification as part of aconsultation “informed, empowered, connected, global and collaborative”patient. G running until 5July.Currently,Canadian manufacturers and importers are expected to notify Health Canada of anticipated and actual shortages “to allowmaximum time for the healthcare system to react”. Noting that this voluntary system had been in place for two INTELLECTUAL PROPERTY years, the agencysaid it was“agood time to takestock of the current approach, to determine whether it is meeting the needs of the UK acts to implement UPC healthcaresystem and to chart the most effective path forward”. unified patent court (UPC) in Europe movedcloser to reality after Aan Intellectual Property Act that creates powers for the UK to MHRA –the UK’sHealthcare products Regulatory Agency–has implement the UPC agreement receivedroyal assent in May. seized 3.6 million doses of counterfeit and unlicensed medicines Measures in the act are set to come into force from October this year with avalue of £8.6 million (US$14.5 million) as part of acrackdown and be implemented in full by late 2015. on medicines being illegally traded overthe internet.Co-ordinated The UPC agreement will takeeffect three months after 13 countries – through Interpol, the operation waspart of aglobal effort that resulted which must include France, Germanyand the UK –havedeposited in worldwide seizures totalling approximately £18.6 million. instruments of ratification with the European Commission. France did so in March this year,but Germanyhas not ratified the agreement. US LEGISLATION covering interchangeable biosimilar substitution As part of the UK legislation, the government is promising “the in Delaware has been passed after being approvedbythe state House expansion of the existing patent opinions service to give businesses of Representativesand Senate. Praising the “critical legislation”, involved in potential patent litigation an impartial viewonthe strength brand industry association the Biotechnology Industry Organization of their case on amuch wider range of issues”. Furthermore, the UK (BIO) welcomed its inclusionof“transparent communication on Intellectual Property Office (IPO) will be allowed to share information all biologic medicines dispensed”. G on unpublished patent applications with other national patent offices. G
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MARKET NEWS
GENERIC SUBSTITUTION PRICING&REIMBURSEMENT French insurer seeks Australian industry substitution answers lauds PBS approach
“targeted campaign” to investigate French doctors’ reasons for ustralia’s government is “right not to impose anyfurther pricing Amarking certain prescriptions as ineligible for generic substitution Areform” on the country’s Pharmaceutical Benefits Scheme (PBS), is to be carried out by local health insurer CNAM, according to France’s according to the country’sGeneric Medicines industry Association generics industry association, Gemme. Citing an article published in (GMiA). Following abudget announcement, the association said it French newspaper Le Figaro,Gemme said CNAM had indicated that “welcomes the government’scontinued investment in medicines on the campaign would aim to identify “atypical” examples of French the PBS and the absence of anyfurther PBS pricing reform”. doctors marking prescriptions as “non-substitutable”. Areviewpublished by Australia’sNational Commission of Audit While Gemme said it agreed with French doctors’ group CSMF had recently suggested that the Australian government could ensure that the insurer should not “interfere” with prescription, the generics its PBS reimbursement system remained affordable by introducing association repeated its recommendation that doctors who marked tenders to procure generics “at more favourable prices” by capitalising prescriptions as non-substitutable should be required to specify the on its “single-buyer status” (Generics bulletin,16May 2014, page 15). particular patient requirements that justified the measure. Such information –which could be added confidentiallyand “in Existing policies aredriving savings an appropriate form” –would guarantee that the measure wasbeing But the GMiA insisted that the Commission had not recognised used properly,said Gemme, which has previously suggested that French “the significant and ongoing savings that are being drivenbyexisting doctors were marking prescriptions as non-substitutable on awide policies”,adding that it was“madness to consider overhauling asystem scale (Generics bulletin,18November 2011, page 21). that is already driving significant savings and is designed to drive Previously,Gemme has failed in lobbying efforts to convince the continual and ongoing future savings”. authorities that prescriptions marked by doctors as non-substitutable “The GMiA looks forward to ongoing constructive dialogue with should be verified by asecond medical opinion (Generics bulletin, government to sustain access to quality medicines through the PBS, 13 January 2012, page 17). including through the development of anational generics medicines Gemme had urged that this rule should be adopted to ensure that policy,”said GMiA chairman Mark Crotty. G prescribing doctors were acting within the law, which insists that a handwrittennote must mark each line of the prescription as unable to be substituted for reasons specific to the patient. REGULATORY AFFAIRS/TRADE AGREEMENTS Nevertheless, Gemme said, doctors marking prescriptions as non-substitutable wasnot the most significant obstacle to France’s “weak use of generic medicines”. Instead, the association said, alack EU pushes for harmonisation of trust in generics among the general public and alarge proportion of armonising requirements for authorising biosimilars and prescriptions falling outside the country’s répertoire of generic equivalents Hstreamlining generic approvalsystems should be keyareas of were the main “structural causes” of France’sgenerics market declining focus as the European Union (EU) and the US negotiate aTransatlantic in value and volume in the first quarter of this year (Generics bulletin, Trade and Investment Partnership (TTIP), the European Commission 16 May 2014, page 14). has stated in an EU position paper on pharmaceuticals. Committing Meanwhile, Gemme has cited the results of aFrench survey to “converging systems for the authorisation of biosimilars”, the conducted by local market researcher Ifop as evidence that an Commission says, could produce a“potential increase of approved information campaign backed by national authorities is needed to biosimilars in the US and limit the number of diverging requirements improve public trust in generics. to demonstratethe quality,safety and efficacyofthese products”. The Commission also suggests that streamlining authorisation Four-fifths accept generics systems for generics could include “the development or review, if need Ifop’ssurvey found that 80% of just overathousand French adults be, of respective guidelines in particular as regards bioequivalence, surveyed in January would accept ageneric if it wasdispensed by a biowaivers and the use of reference medicines”. pharmacist.This comprised 60% that would takethe generic “willingly”, Meanwhile, the US Generic Pharmaceutical Association (GPhA) along with 20% that would accept ageneric “with acertain reticence”. has insisted that patent linkage and exclusivity periods that unnecessarily The remaining fifth comprised 8% that would refuse ageneric and delay access to generics should have no place in the Trans-Pacific 12% that said their response would depend on the medicine. Partnership (TPP) free-trade agreement that is currently being negotiated. “Confidence in generic medicines is improving very slowly,” “Importantly,trade agreements should not constrain job growth Gemme acknowledged, pointing out that the rise in public trust since in the US by blocking or delaying exports of generic drugs to foreign the previous Ifop survey conducted in late 2013 –which found that markets,”the GPhA said, suggesting that “anyfinal agreement should 57% of people “systematically accepted” generic substitution (Generics support the US-based generics industry and open foreign markets for bulletin,10January 2014, page 11) –was “very limited”. generic products”. “Trust remains fragile,”Gemme said, insisting that confidence in Médecins Sans Frontières (MSF) said TPP negotiators needed generics should be bolstered by better information to the public and to “fix the serious threats to access to medicines in the draft agreement”. to healthcare professionals.Aninformation campaign supported by “Problematic intellectual-property rules that would block or delay access the French authorities was“more necessary than ever,and would to affordable generic versions of medicines –including data exclusivity be favourably received”, the association stated, adding that amore for biologicmedicines and weaker patentability criteria –remain in “systematic” use of generics in France could save up to C2billion the draft negotiating text,”the lobbying group maintained, insisting (US$2.7 billion) annually. G that “the TPP as it stands is abad deal for access to medicines”. G
6June 2014 GENERICS bulletin 13 Gen 6/6/14 Pgs. 14-21_Layout 1 04/06/2014 18:37 Page 2
PRODUCT NEWS
SUBSTITUTION EPILEPSY DRUGS Germany consults on Australian appeal bars to substitution blocks Apotex entry
nterestedparties have until 23 June to respond to adraft list of potexhas been restrained from supplying pregabalin capsules in Iproducts to be excluded from automatic generic substitution in AAustralia after Pfizer overturned an earlier ruling that had denied Germany. The list drawn up by Germany’sfederal joint committee, the the originator an interlocutory injunction to protect its Lyrica brand G-BA, includes ciclosporin soft-gel capsules and oral solution, as (Generics bulletin, 4 April 2014, page 14). well as digoxin, levothyroxine and phenytoin tablets. “Weconsider that the primary judge erred in his assessment of Having invited input from professional and industry bodies the existence and strength of the prima facie case, which necessarily including generics association Pro Generika, the G-BAsaid responses affected his assessment of the balance of convenience,”apanel of should be supported by literature, such as “relevant studies”. Anysuch three appeals judges stated. response, the committee added, would not be considered confidential. Primary judge John Griffiths had not been convinced that Apotex’ While the umbrella body of Germany’sstatutory health insurance pregabalin capsules –indicated for treating seizures, but not for treating funds, GKV-Spitzenverband, had earlier this year finally reached a pain –would have infringed Pfizer’sAustralianmethod-of-use patent compromise with the country’spharmacists association, the DAV, on a 714,980, which covers methods of treating pain and expires on 16 list of exceptions (Generics bulletin,3February 2014, page 9), July 2017. Pfizer had not proven, he said, that there wasnomarket legislation that came into effect on 1April transferred responsibility in Australia for using pregabalin to treat seizures.And in anycase, he for compiling the list to the G-BA. added, the balance of convenience favoured Apotex, not least because The G-BAretained ciclosporin and phenytoin from the compromise the generics firm had soughtrevocation of the ‘980 patent. between GKV-Spitzenverband and the DAV, while it added beta- But the appeals judges were convinced by Pfizer’sevidence that acetyldigoxin, digitoxin and digoxin tablets, and well as levothyroxine “less than 0.25%” of Lyrica’sAustraliansales were for seizures, sodium tablets, including those in combination with potassium iodide. rather than for the patented use of treating pain, so the generic was Salts, esters, isomers and other derivativesare generally considered likely to be prescribed for the patented use. to be the same ingredient, the G-BAstated. The committee’scriteria Apotexhad also produced “no evidence at all” to showwhether for includingspecific ingredients is based mainly on the potential doctors would followthe firm’srequest to include the seizure for “minor changes in dose or plasma concentration” leading to indication on prescriptions for Apotex-Pregabalin, while Griffiths clinically relevant changes in efficacyorserious adverse reactions. had made an error in rejecting evidence that pharmacists would Acknowledging that it had not conducted “a complete examination substitute the generic for Lyrica. of all available medicines”, the G-BAsaid further active ingredients Turning to the balance of convenience, the appeals judges gave could subsequently be added to the list of exceptions. Among the product “considerable weight” to Pfizer’sestablished market for Lyrica as an groups that it intends to consider for inclusion are immunosuppressants – analgesic in maintaining “the status quo” by granting an injunction. “in particular the ingredient tacrolimus” –anticonvulsants and extended- “The usual undertaking as to damages is likely to provide Apotexwith release opioid analgesics, aswell as inhaled treatments for asthma an adequate remedy should it prevail at the final hearing,”theysaid, and chronic obstructive pulmonary disease (COPD) and dermatology noting that consolidatedrevocation and infringement proceedings drugs for psoriasis. G would be heard in October this year. G
ANTIHYPERTENSIVES AUTHORISED GENERICS Japanese firms plan launches Canada corrects pricing board awai and Towa plan to launch generic rivals to Novartis’ Diovan anada’sPatented Medicines Prices ReviewBoard waswrong S(valsartan) and Merck, Sharp &Dohme’sPreminent (losartan/ Cto treat Sandoz as an originator in line with the firm’sstatus as hydrochlorothiazide) antihypertensive brands this month. Towa noted asubsidiary of Novartis, aFederal Court in Ontario, Canada, has that it would launch valsartan tablets and orodispersible tablets in ruled. The decision allows Sandoz to continuewith its application 20mg, 40mg, 80mg and 160mg strengths, adding that Diovanhad for judicial reviewofthe Board’sdemands for pricing information. annual sales of around ¥88 billion (US$866 million) in Japan. Despite acknowledging that “Sandoz holds no patents and only Orodispersible ambroxol is also among Sawai’splanned launches enters the market once other generics are already there,”the Board had for June, along with carvedilol, docetaxel for intravenous infusion, nevertheless concluded in 2012 that Sandoz’ ability to launch authorised and zoledronic acid. generics of Novartis’ drugs at atime dictated by its parent brought Meanwhile, local firm Aska Pharmaceutical has struck a Sandoz within the definition of a‘patentee’ as stipulatedinthe country’s distribution deal with Takeda for an authorised generic version of the Patent Act. This, the board reasoned, obliged Sandoz to submit originator’s Blopress (candesartan). Takeda has licensed the Blopress information on the prices of its generic medicines likeanoriginator, patent to Aska, and the brand companywill buythe authorised generic as “anydifferent conclusion would permit patent holders to evade the from Aska and distribute it to wholesalers. Board’sjurisdiction simple by creating asubsidiary generic company”. Noting that Aska –which established its generics division in However, Federal Judge James O’Reilly determined that “Sandoz October last year –had already obtained approvalfor the authorised generally operates in amarket where no one holds amonopoly, and generic from Japan’sMinistry of Health, Labour and Welfare (MHLW), no one can takeundue advantage of amonopoly position by charging Takeda said Aska was“currently applying for listing on the National excessive prices.”“Generally speaking,”hecontinued, “generic Health Insurance (NHI) price list for June 2014”. G companies either help create or join acompetitive marketplace.” G
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PRODUCT NEWS
RESPIRATORY DRUGS IN BRIEF ACTAVIS and Teva have from the start of June begun shipping Sandoz rolls out its ‘day one’ generic rivals to Lundbeck’s Cipralex (escitalopram)5mg, 10mg and 20mg tablets in the UK. The firms’ launches followthe expiry of supplementaryprotection certificates (SPCs) for the selective serotonin-reuptakeinhibitor in certain major European Union (EU) AirFluSal in Korea markets (Generics bulletin, 16 May 2014, page 24).
andoz has launched its AirFluSal Forspiro (fluticasone/salmeterol) MALLINCKRODT has had its newdrug application(NDA) for its SrivaltoGlaxoSmithKline’s(GSK’s) Seretide brand in South Korea. ‘MNK-155’candidate –anextended-release formulation of Sujun Park, Sandoz’ Korean head, called the launch “a milestone in hydrocodone/acetaminophen –accepted for filling by the US Food our strategy of bringing our world class innovative inhaler to patients and Drug Administration (FDA). The firm has paid US$5 million in Korea”, following approvalearlier this year (Generics bulletin, to pain and neurology disorder specialist Depomed –which licensed 7March 2014, page 21). its Acuform drug-delivery technology to Mallinckrodt to South Korea has approvedboth the 50µg/250µg and 50µg/500µg formulate the pain treatment –onacceptance of the NDA, with a strengths “for the continuous treatment of patients above four years further US$10 million due to Depomed on FDAapproval. of age with persistent asthma or for symptomatictreatment of chronic obstructive pulmonary disease”. SANTEN PHARMACEUTICAL has struck an agreement with Merck AirFluSal Forspiro has previously been launched in several &Cotoacquire nine ophthalmic products in Japan, Europe and European markets, including Norway, where the generics firm was the Asia-Pacific region for an upfront payment of approximately recently allowed to continuemarketing the respiratory device after a US$600 million, as well as certain undisclosed sales milestone local court denied GSK’srequest to restrict access to the respiratory payments. The deal –which is expected to close “in afew months”, treatment. “The issue wasrelated to the colour of the device,”aSandoz subject to certain closing conditions –covers several versions of the spokesperson told Generics bulletin, adding that the decision was originator’s Cosopt (dorzolamide/timolol), Trusopt (dorzolamide) still open to appeal. and Timoptic (timolol)brands, along with Merck’s Saflutan However, GSK recently defended apreliminary injunction in (tafluprost)and Taptiqom (tafluprost/timolol). The brands have Germanythat requires requiring Sandoz to restrictthe marketing of combined sales in the three markets of around US$400 million. AirFluSal Forspiro due to the generics firm’suse of the colour purple that resembled the originator’sViani Diskus device. G ENDO has acquired the worldwide rights to Zogenix’ Sumavel DosePro (sumatriptan)needle-free injectable drug-delivery system for an upfront cash payment of US$85 million. The US firm’s agreement for the acute migraine treatment also includes additional NARCOLEPSYDRUGS Actavis settles over Nuvigil cash payments based on certain undisclosed sales milestones. TEVA UK has issued arecall for abatch of its paclitaxel 6mg/ml ctavis will be able to launch aUSrivaltoTeva’s Nuvigil 16.7ml concentratefor solution for infusion injectablefollowing A(armodafinil) 100mg and 200mg tablets from 1June 2016 – or alabelling error affecting the product’sexpiry date. earlier under certain circumstances –after striking asettlement agreement with the Israeli firm’sCephalon subsidiary.Subsequently, MYLAN has begun shipping its generic version of Eli Lilly’s Zyprexa Actavis will be able to launch 50mg, 150mg and 250mg strengths Zydis (olanzapine)5mg, 10mg, 15mg and 20mg orally-disintegrating 180 days after the 100mg and 200mg versions are launched. tablets (ODT) following final US Food and Drug Administration “Based on available information, Actavis believesitisa‘first (FDA) approval. The ODT form of the schizophrenia and bipolar applicant’ to file an abbreviated newdrug application(ANDA) for the disorder treatment had total US sales of around US$121 million for generic versions of 100mg and 200mg Nuvigil and expects to be entitled the 12 months ended 31 March 2014. The US firm has also launched to 180 days of generic market exclusivity,” the firm stated. Nuvigil atovaquone/proguanil 62.5mg/25mg and 250mg/100mg tablets, had annual US sales of around US$437 million, Actavis added. which is equivalent to GlaxoSmithKline’s Malarone brand. Just overayear ago, aDelaware district court upheld a US polymorph patent that protects Nuvigil until June 2024, in the face of EMA’S –the European Medicines Agency’s–Pharmacovigilance obviousness attacks by Actavis, Apotex, Lupin and Sandoz (Generics Risk Assesment Committee (PRAC) has begun reviewing bulletin, 19April 2013, page 17). Mylan previously settled litigation hydroxyzine-containing medicines following “concernsraised about with Teva overthe patent, allowing it to launch 50mg, 150mg and the effects of those medicines on the heart”. At the same time, the 250mg tablets from the start of June 2016. G committee has started reviewing Corlentor/Procoralan (ivabradine)after astudy showed “a small butsignificant increase in the combined risk of cardiovascular death or non-fatal heart attack”.
ANTIFUNGALS SANOFI will attempt to switch Eli Lilly’sblockbuster erectile- dysfunction treatment Cialis (tadalafil)from prescriptiontonon- Aceto ships US fluconazole prescription status in Australia, Canada, Europe and the US under ceto has quickly benefitted from its recent US$100 million the terms of alicensing agreement struck between the twofirms. Aacquisition of US generics player Pack Pharmaceuticals by launching from the latter’spipeline US rivals to Pfizer’sDiflucan MEDIS’generic esomeprazole capsules have been restricted by an (fluconazole) 50mg, 100mg and 200mg tablets. The antifungal, which Australian interim injunction as part of alawsuit overAstraZeneca’s Aceto has launched through its Rising Pharmaceuticals generics arm, Australian patent 688,074. While the originator claims that the generic had US sales of around US$57 million for the 12 months ended 31 versions infringe the patent, Medis argues that the patent is invalid. G March 2014, according to IMS Health data. G
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PRODUCT NEWS
ONCOLOGY DRUGS MULTIPLE SCLEROSISDRUGS Actavis beats patent EPO backs Copaxone on Alimta in Europe as US lacks launches
ctavis’ proposed rivaltoEli Lilly’sAlimta (pemetrexeddisodium) eva has welcomed adecision by the European Patent Office (EPO) Awould not infringe the originator’s vitamin-dosage regimen patent Tthat upholds the validity of its European process patent EP2,177,528 that expires in June 2021, the High Court of England and Wales has covering Copaxone (glatiramer acetate). “The EPO specifically ruled, openingthe door for Actavis to launch its alternativesalt form determined that claims 1-12 of the ‘528 patent are valid”, Teva stated, when asupplementaryprotection certificate (SPC) linked to the noting that any“infringing follow-on glatiramer products” would pemetrexedcompound patent expires in December next year. not be able to compete against the multiple-sclerosisbrand until the Furthermore, the UK court granted non-infringement declarations ‘528 patent expires on 9September 2025. regarding the dosage regimen patent in France, Italy and Spain Mylan, Synthon and an “unidentified third party” –represented (Generics bulletin, 14 December 2012, page 1). by German lawfirm Henkel, Breuer &Partner –had filed the opposition The UK ruling –against which Lilly plans to appeal –comes proceeding, Teva noted. shortly after aGerman court found that Actavis’ pemetrexeddipotassium Meanwhile, generic competition to Copaxone has so farfailed to salt would infringe the European vitamin-dosage regimen patent materialise in the US, after all eight patents listed against the brand EP1,313,508 under the doctrine of equivalents (Generics bulletin, in the US Food and Drug Administration’s(FDA’s) Orange Book 2May 2014, page 14). expired on 24 May. Disagreeing with the German ruling, UK Judge Richard Arnold The US Supreme Court has agreed to reviewanappeals court said the Düsseldorf court had “treated the [patent] claims as amere ruling involving Mylan and Sandoz that found that Teva’s US patent guideline”. Furthermore, the evidence and arguments in the twocases 5,800,808 –which claims aprocess for manufacturing glatiramer were different. acetate and runs until 1September 2015 –was “indefinite” due to Arnold defined the keyissue in the case as whether the expression ambiguity in the use of the term ‘molecular weight’ (Generics bulletin, ‘pemetrexeddisodium’ in the ‘508 patent meant only the disodium 4April 2014, page 1). However, the Supreme Court refused the Israeli salt –asargued by Actavis –orrather pemetrexeddiacid and anysalt firm’smotion to stay the earlier ruling after Teva failed to demonstrate that waspharmaceutically acceptableand sufficiently soluble, as “a likelihood of irreparable harm from denial of astay” (Generics Lilly had contended. bulletin,2May 2014, page 13). Siding with Actavis, he pointed out that Lilly could have sought abroader claim. “Construing the claim as extending to anyform of US courtdenied Teva’s motion pemetrexedwhich is pharmaceutically acceptableand sufficiently Moreover, aColumbia district court has also granted the FDAa soluble would not provide areasonable degree of certainty for third motion to dismiss acase filed by Teva arguing that the agencyhad parties,”hestated. improperly denied acitizen petition in which the Israeli firm had called Having ruled out direct infringement of the French, Italian, Spanish for clinical trials to be arequirement for approving generic glatiramer. and UK designations of the ‘508 patent, Arnold acknowledged that The FDAhad argued that the motion waspremature and thus outside Lilly wasarguing for indirect infringement because pemetrexedsalts of the court’sjurisdiction. such as diacid, dipotassium and ditromethamine were “an essential Mylan had previously stated that it planned to introduce the first element of the invention” once reconstituted and diluted. generic rivaltoCopaxone “at market formation”, butacknowledged But he agreed with Actavis that the patent wasnot infringed. “It that approvalmay not come immediately upon patent expiry on 24 is no answer to say that pemetrexedions on their ownconstitute an May (Generics bulletin, 16 May 2014, page 19). essential element of the invention, as this is just another wayofsaying Teva’s president and chief executive officer,Erez Vigodman, that the claim does not require pemetrexedions,”Arnold ruled. recently warned that anygeneric launch would run the risk of “billions” Noting that Actavis’ “preferred candidate” waspemetrexeddiacid in damages should the US Supreme Court rule in the Israeli firm’s made at its site in Nerviano, Italy,Arnold said the generics firm had favour (Generics bulletin, 16 May 2014, page 29). Earlier this year, demonstrated “a real commercial interest”inobtaining under English the companyestimated that each month of delay in US generic lawdeclarations of non-infringements against the French, Italian and competition would contribute around US$78 million to its turnover, with Spanish designations of the ‘508 patent. Teva’s annual sales for 2014 projected to be US$500 million higher if “Even if French, Italian and Spanish lawisthe applicablelaw no rivals are launched (Generics bulletin, 10 January 2014, page 4). G respectively,” Arnold concluded, “Actavis is entitled to adeclaration of non-infringement in respect of the French, Italianand Spanish designations of the patent.” G ANTIBACTERIALS Venus gets anod in Australia CARDIOVASCULAR DRUGS enus Remedies has pushed up the number of countries in which Vit can market its meropenem injectable to 35 by obtaining an Prasco makes NeoProfen deal Australian marketing authorisation for the anti-bacterial agent from rasco Laboratories has reached an agreement with Recordati the local Therapeutic Goods Administration (TGA). Psubsidiary Recordati Rare Diseases for the rights to distribute The Indian firm –which has secured the approvalwith marketing and supply aUSauthorised generic of the latter’s NeoProfen partner Lupin –plans to launch meropenem in Australia by the third (ibuprofen lysine) injectable. The Italian originator acquired the quarter of this year, into apenems market that it says is worth around brand as part of adeal with Lundbeck at the end of 2012. G US$15 million ayear. G
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PRODUCT NEWS
BIOLOGICALDRUGS ANALGESICS NZ’s Pharmac funds Celebrex exclusivity Sandoz’ somatropin is awarded by FDA
andoz’ Omnitrope (somatropin) will be the only reimbursed version he US Food and Drug Administration (FDA) has approvedTeva’s Sof the growth hormone in NewZealand from the start of 2015 TUS rivals to Pfizer’sCelebrex(celecoxib) 50mg, 100mg, 200mg until the end of 2017, under asole-supply deal approvedbylocal and 400mg capsules, awarding the Israeli firm 180-day exclusivity pharmaceutical management agencyPharmac. Available in 5mg, 10mg for all butthe lowest strength. Under asettlement agreement struck and 15mg strengths, Sandoz’ version will be listed from 1July 2014, with the originator,Teva can launch from December 2014. while Pfizer’sGenotropin brand will be delisted from reimbursement At the same time, the FDAhas approvedMylan’s50mg capsules after asix-month transition period, on 1January 2015. Omnitrope will with joint 180-day exclusivity.But the firm has just reached asettlement then have sole subsidised supply status until 31 December 2017. and licensing deal with Pfizer that will allowittolaunch all four Subsidised prices for Omnitrope range from NZ$109.50 (US$94.60) strengths “at earliest market formation, not later than December 2014”. for the injectable 5mg cartridge to NZ$328.50 for the 15mg strength. Actavis previously struck asimilar deal. “All existing patients will need to change from Genotropin to The agency’sapprovals came after aWest Virginia district court Omnitrope to continue to receive fully-funded somatropin,”Pharmac denied arequest by Actavis, Mylan and Lupin for apreliminary confirmed. Moreover, the agencynoted, “every patient who currently injunction overthe FDA’shandling of exclusivity for generic versions of receivesfunded Genotropin –whether adult or paediatric–will be the analgesic. The court supported the position outlined by the FDAin visited by an educator from Sandoz during the transition period, who arecent letter to celecoxib abbreviated newdrug application(ANDA) will teach them howtouse the Omnitrope auto-injector”. filers stating that the agencywould not treat an earlier appeals court Following feedback on the agreement that had been solicited by ruling on an original –but later reissued –Celebrexpatent as triggering Pharmac earlier this year (Generics bulletin, 4 April 2014, page 17), Teva’s exclusivity for the “single bundle of patent rights represented by the agencysaid it had made certain changes to the initial funding the original and reissued patent” (Generics bulletin,2May 2014, page 1). arrangements. This included waiving patient co-payments for Omnitrope Maintaining that the FDAhad “seriously erred” in awarding Teva during the six-month transition period, as well as applying a‘brand sole exclusivity for most strengths based on achallenge to US patent switch’ fee to pharmacists dispensing Omnitrope from 1January 5,760,068, Mylan said it wasappealing the district court’sdecision 2015 to 31 March 2015. G and would proceed with alawsuit against the agency. G
18 GENERICS bulletin 6June 2014 Gen 6/6/14 Pgs. 14-21_Layout 1 04/06/2014 18:37 Page 7
PRODUCT NEWS
GASTROINTESTINAL DRUGS OPHTHALMIC DRUGS Norway refuses Krka CobaltCanada cuts esomeprazole appeal Vigamox monopoly
rka has been refused leave to appeal to Norway’sSupreme Court ctavis’ Cobalt affiliate in Canada has cut the monopoly period Koveraruling that the Slovenian firm’sesomeprazole infringed Afor Alcon’sVigamox (moxifloxacin) 0.5% eyedrops after winning Norwegian patent NO307,378 held by AstraZeneca. invalidity or non-infringement rulings against twoofthe three patents Earlier this year, anappeals court in Oslo, Norway, found that the listed against the antibiotic brand. ‘378 patent covered esomeprazole with an optical purity of more than Alcon and its partner Bayer had sought an order prohibiting 98% enantiometric excess (Generics bulletin, 14February 2014, Canada’sMinister of Health from issuing aNotice of Compliance page 17). Krka had argued that the ‘378 patent only covered athreshold (NOC), or marketing authorisation, to Cobalt for ageneric version of above 99.8% and that the optical purity of the Slovenian firm’sproduct Vigamox until after three patents had expired. These were: Canadian fell between the twofigures. compound patent 1,340,114 that expires on 3November 2015; The appeals court’sruling upheld an earlier decision by alocal monohydrate patent 2,192,418 that expires on 9December 2016; and commercial court in 2012 (Generics bulletin, 18May 2012, page 19), formulation patent 2,342,211, which runs until 29 September 2019. as aresult of which Krka wasordered to pay AstraZeneca C1.9 million Cobalt conceded infringement of the ‘114 and ‘211 patents, but (US$2.60million) to compensate the originator for lost profits. Krka argued that both were invalid. The generics firm insisted its process had sold esomeprazole in Norway between October and December 2010 for making moxifloxacin drops did not infringe the ‘418 patent which before being blocked by an interim injunction (Generics bulletin, was, in anycase, invalid on several grounds. 14 January 2011, page 21). Judge Michael Phelan found that data cited in the ‘114 patent Acknowledging the Supreme Court’srefusal of Krka’srequest expiring next year had “soundly predicted” the utility of moxifloxacin for leave to appeal, the Slovenian firm stated that this meant “the in “having high antibacterial action”. Nor were the disclosed compounds dispute regarding esomeprazole in Norway is closed”. G obvious, he said in issuing an order prohibiting Cobalt getting an NOC until the patent expired. But Phelan refused to grant asimilar order on the ‘418 patent MIGRAINE REMEDIES/UROLOGY DRUGS because Alcon had failed to showthat Cobalt’sproductionprocess used the monohydrate form. Turning to the later expiring ‘211 method-of-use patent, Phelan Galenicum targets almotriptan ruled that the patent “relates to the known compound moxifloxacin pain’sGalenicum is poised to offer the migraine remedy almotriptan being used for aknown use –treating and preventing ophthalmic Sin its domestic market upon patent expiry after the Barcelona-based infection –ataconcentration known to be effective”. Thus, Cobalt’s firm secured approvalfrom Spain’sdrug evaluation committee, Codem. obviousness attack wasjustified. G Furthermore, Galenicum is seeking marketing authorisations for the benign prostatic hyperplasia treatment dutasteride in 17 European Union (EU) member states –Bulgaria, Croatia, the Czech Republic, INJECTABLE DRUGS Finland, France, Germany, Greece, Hungary and Italy, aswell as Latvia, Lithuania, Malta, Portugal, Romania, Slovakia, Slovenia and Spain. G Hospira recalls two in the US ospira has recalledtwo of its injectables in the US following Hreports of particles being present in the solution. IMMUNOSUPPRESSANTS One lot of the firm’sdobutamine 250mg/20ml –originally distributed in August and September last year –was recalled after a Chiesi backedfor Envarsus chip in aglass vial and glass particulate within the solution were talian firm Chiesi Farmaceutici has receivedapositive opinion from identified. And abatch of Hospira’slabetalol 100mg/20ml multi- Ithe committee for human medicinal products (CHMP) within the dose vials wasalso recalled after it wasconfirmed that embedded European Medicines Agency(EMA) regarding the company’s stainless steel particulate wasfound in the glass vial and iron oxide marketing authorisation for Envarsus (tacrolimus). “The CHMP, on particles were floating in the solution. the basis of quality, safety and efficacydata submitted, considers there Hospira confirmed that said it had not receivedreports of any to be afavourable benefit-to-risk balance for Envarsus,”the European adverse events associated with the issue. G agencysaid on recommending granting the marketing authorisation for the liver- and kidney-transplant rejection treatment. G
ATTENTIONDEFICIT HYPERACTIVITY DISORDER DRUGS CARDIOVASCULAR DRUGS/RESPIRATORY DRUGS Actavis extends Concerta deal ctavis has extended until the end of 2017 its exclusive agreement France adds to its répertoire Ato distribute an authorised generic of Janssen’sConcerta urobindo’srivaltoMeda’sFlecaine (flecainide) 50mg tablets have (methylphenidate) extended-release tablets in the US. The current Abeen added to France’s répertoire of substitutable generic equivalents. deal for the attention deficit hyperactivity disorder (ADHD) drug – At the same time, Sandoz’smometasone 50µg nasal spray has been first agreed in November 2010 (Generics bulletin, 12November listed as equivalent to Merck, Sharp and Dohme’sNasonexoriginal. G 2010, page 19) –isdue to end on 31 December 2014. G
6June 2014 GENERICS bulletin 19 Gen 6/6/14 Pgs. 14-21_Layout 1 04/06/2014 18:37 Page 8
PARAGRAPH IV WATCH Fresenius is the first to target Istodax
nrecent years, the hyper-competitive nature of the US market for Igeneric drugs has been highlighted by several instances in which KEY DETAILS: ISTODAX numerous generic applicants have submitted abbreviated newdrug Brand: Istodax applications (ANDAs) on the very first day possible. The Hatch- Active ingredient: romidepsin Waxman legislative framework offers the potential for alucrative 180-day generic drug exclusivity to the first filer of an ANDAthat Delivery form: 10mg/vial injectable includes aparagraph IV patent challenge. Products covered by anew Brand owner: Celgene chemical entity (NCE) exclusivity offer aknown first-possible filing Annual US brand sales: US$50 million date that will ensure first-filer status. Generics companies have often found these obvious targets to be irresistible. First paragraph IV 5November 2013 However, when more than one paragraph IV ANDAissubmitted filing submitted to FDA: on the same day, the applicants share eligibility for the exclusivity. Examples of this include Lilly’sEffient (prasugrel) tablets, which Known paragraph IV Fresenius Kabi appears to have drawn 13 ANDAfilers on the first day possible, and filers: UCB’sVimpat (lacosamide) tablets, which attracted at least 16 US Patents at issue – 7,608,280 –22August 2021 applicants. The value of the exclusivity necessarily declines with each 7,611,724 –22August 2021 additional entrant into the market, so it may be in the best interests of generic companies to seek development targets that are likely to District court locations: Delaware see fewer challengers. Litigation reference: Celgene et al vs Fresenius Kabi USA – Celgene’sIstodax (romidepsin) lymphoma treatment may be a 1:14-cv-00571 case in which ageneric challenger has managed to avoid the crowd. The NCE exclusivity for romidepsin will expire on 5November Figure1:Paragraph IV challenges to Celgene’s Istodax (romidepsin) in the US 2014. ANDAs with paragraph IV certifications to at least one patent (Source –Thomson Reuters) may be submitted exactly one year before the expiration of the NCE, on the so-called‘NCE -1’ date. 177 180 PATENT As expected, the FDAreports that the first ANDAwith a 156 160 CHALLENGES paragraph IV certification for ageneric version of Istodax wasfiled 148 148 on the NCE-1 date of 5November 2013. Givenrecent history, it 140 would not have been surprising if several companies filed ANDAs for 120 115 romidepsinproducts at that time. It appears, however, that only Fresenius Kabi did so. 100 88 80 80 72 69 Filed suit over two patents 60 Celgene and its partner Astellas receivednotification of the 49 40
Fresenius ANDAon18March 2014, and on 30 April 2014 filed asuit Number of patent challenges in aDelaware district court alleging infringingoftwo crystalline patents 20 that expire in August 2021 (see Figure 1). Astellas is the assignee of 0 the patents-in-suit and Celgene holds an exclusive licence. Par Teva Lupin One might reasonably ask whyIstodax has attracted such limited Actavis Mylan Sandoz Apotex attention from generics companies. Celgene reported 2013 US sales Sun Pharma Dr Reddy’s Aurobindo of Istodax ahead by just 4% to amodest US$50 million, which – Figure2:Numbers of compounds subject to patent challenges by company,as along with the drug’sintravenous route of administration –clearly recorded by Thomson Reuters to 31 March 2014 (Source –Thomson Reuters) stand out as reasons whymanygeneric companies might have shied away from developing the oncology drug. have fermentation capability plus the capacity to handle cytotoxic Furthermore, the FDAreports only twoactive drug master files compounds. At current sales levels, the consumption volume of (DMFs) for the romidepsin active ingredient, held by India’sConcord romidepsinisquite small, so the cost of developing non-infringing Biotech and by Sicor,asubsidiary of Teva, the most prolific romidepsinmight be difficult for an independent manufacturer to paragraph IV filer (see Figure 2). justify,” Thomson Reuters observes. “The limited availability of the active ingredient could be an When attempting to differentiate themselves from others, generic indication of lowinterest by generics players, butitislikely also the drug companies frequentlytout their intention to seek out niche result of technical challenges posed by romidepsin itself,”comments products that offer barrierstoentry for potential competitors, such Thomson Reuters, which compiles adatabase of paragraph IV as complexformulations or scarce active ingredients that may be certifications and resulting litigation. difficult to obtain. Fornow, itseems that Fresenius Kabi may well “Toproduce the compound, aningredients manufacturer must have done just that. G
Thomson Reuters draws on strategic intelligence and competitive analysis information on the US generics industry to create Newport Premium™, the criticalproduct-targeting and global business-development system from the industry authority on the global generics market. Forfurther details contact Benjamin Burck, Thomson Reuters API Intelligence, 215 Commercial Street, Portland, Maine 04101, USA. Tel: +1 207 871 9700 x35. Fax: +1 207 871 9800. E-mail: [email protected]. Website: scientific.thomsonreuters.com/newport.
20 GENERICS bulletin 6June 2014 Gen 6/6/14 Pgs. 14-21_Layout 1 04/06/2014 18:37 Page 9
PRODUCT NEWS
BIOLOGICALDRUGS ORAL CONTRACEPTIVES Biocad gets approval Mylan beats Richter on Russian rituximab on UK dosage patent
iocad has receivedanapprovalfrom Russia’sministry of health ylan has convinced the Patents Court of England and Wales that Ballowing the firm’sbiosimilar version of Roche’sMabThera Mthe local part of Richter’sEuropean patent 1,448,207 is invalid (rituximab) monoclonal antibody(mAb) to be marketed under the due to obviousness. The ‘207 patent –which has apriority date of name AcellBia. The Russian firm’sversion wasregistered following November 2001 –covers adosage regimen of using asingle 1.5mg a“detailed analysis of clinical efficacyand safety” that concluded that dose of levonorgestrel as an emergencycontraceptive. there were “no significant differences in the pharmacological action, Having decided that the relevant person skilled in the art wasa efficiencyand safety of biosimilarrituximab and MabThera” (Generics clinician working in specialist contraceptive services, Judge Philip bulletin,2May 2014, page 15). Sales noted that the ‘207 patent claimed “a newregimen for use of “After exhaustive analyses of the clinical trial efficacyand safety adrug, levonorgestrel, which wasalready known to be an effective data in patients with B-cell lymphoma,”Biocad said, “the experts of the emergencycontraceptive when used in atwo-dose regimen”. Research Center for Expertise of Medicinal Products at the Russian Aprior-art ‘Killick’ report on World Health Organization (WHO) Ministry of Health arrivedataconclusion on the absence of substantive research published in 2000 would have “made it obvious that use of a differencesbetween Biocad’srituximab biosimilar and the originator single dose of 1.5mg of levonorgestrel within 72 hours of intercourse medicinal product.”In2012, Russia had spent more than US$300 waslikely to be aviable method of emergencycontraception”. million on MabThera, Biocad noted. Furthermore, Sales added, the report rendered it obvious that “such aregimen could be pursued and investigated with areasonable or Bevacizumab and trastuzumab in pipeline fair expectation of success”. Biocad’srituximab –developed through a“successful public- While the Killick report had erroneously mentioned asingle 1.5g private partnership” involving the Russian health ministry –is levonorgestrel dose, Sales said the skilled person would have recognised manufactured in a“new, ultra-modern Neudorf facility set in aspecial this as amistakeand would have easily established that a1.5mg dose economic district outside St Petersburg”. had been intended. Biosimilar versions of Roche’sHerceptin (trastuzumab) and Addressing the aims of the patent system to incentivise innovation, Avastin (bevacizumab) being produced at the same facility were Sales said additional work to complete the WHO’sresearch wasnot currently finishing clinical trials, the Russian firm observed, adding sufficient to justify amonopoly on asingle-dose regimen. G that it also had “10 more mAb-based biosimilar and original products in the pipeline”. Biocad recently presented data at the American Society of Clinical Oncology’s(ASCO’s) annual meeting indicating that a ANALGESICS “full spectrum of physicochemical and pre-clinical studies” had showed equivalence of the firm’s‘BCD-022’ trastuzumab and ‘BCD-021’ Actavis offers US Exalgo rival bevacizumab candidates to the reference brands. Last year,Biocad struck afive-year deal with Turkey’s Kocak ctavis will soon commence shipping its generic rivals to Farma to supply rituximab (Generics bulletin, 20September 2013, AMallinckrodt’sExalgo (hydromorphone) 8mg, 12mg and 16mg page 16). Under the terms of the deal, Kocak can import the ingredient, extended-release tablets after receiving final US Food and Drug produce the finished-dosage forms and market the drug domestically. G Administration (FDA) approval. The nod follows asettlement struck with the originator twoyears ago (Generics bulletin,3February 2012, page 18) that had stipulatedthat Actavis could launch the analgesic from as early as 15 November last year. ONCOLOGY DRUGS As Generics bulletin went to press, Actavis had not disclosed plans to gain approvalfor, and to launch, a32mg strength of extended- Sun settles Gleevec lawsuit release hydromorphone, despite having been permitted to do so from un Pharma will be able to launch aUSrivaltoNovartis’ Gleevec 15 May under the terms of aseparate settlement struck between the S(imatinib mesylate) tablets from 1February 2016 under the terms twofirms last year (Generics bulletin,8March 2013, page 19). of apatent-litigation settlement. The Indian firm already holds a Although the FDAacknowledged that Actavis may be eligible tentative approvalfor its version of the treatment for chronic myeloid for 180-day exclusivity, the agencyhas deferred adecision on whether leukaemia, which generated US sales of US$1.94 billion last year Actavis has forfeited its right –due to having failed to obtain tentative for Novartis. G approvalwithin 40 months of filing its abbreviated newdrug application (ANDA) –until another generic filer is eligible for approval. Exalgo had US sales of around US$230 million for the 12 months ended 28 February 2014, according to IMS Health data. ALZHEIMER’SDISEASE DRUGS Meanwhile, Actavis has been sued by AstraZeneca and Bristol- Myers Squibb (BMS) after filing an ANDAcontaining aparagraph IV Korea’s SK defeats Novartis certification against the originators’ Onglyza (saxagliptin) 2.5mg KChemicals is claiming victory overNovartis in the firms’ dispute and 5mg tablets. The brand firms’ action has triggered a30-month SoverSouth Korean patents protecting the originator’sExelon stay of final FDAapprovalfor the firm’srivaltoOnglyza –which (rivastigmine) patches. The Korean companysaid its “differentiated had US sales of around US$532 million for the 12 months ended technology”had convinced the Seoul central district court that its 28 February 2014 –running until 31 January 2017. Similar Onglyza SID710 patches did not infringe twoNovartis patents. G suits involveAurobindo, Glenmark and Wockhardt. G
6June 2014 GENERICS bulletin 21 Gen 6/6/14 Pg. 22_Layout 1 04/06/2014 18:38 Page 2
EVENTS
JUNE 19-21 November 2014 25-27 June ■ 17th IGPAAnnual Conference ■ 20th EGA Annual Miami,USA Conference This three-day event is being organised by the US Generic Pharmaceutical Association (GPhA) and is the global event of the worldwide generics industry.Itisthe Madrid,Spain annual joint meeting of the Canadian, European, Japanese, South African and US The European Generic medicines generics industry associations, the CGPA, EGA, JGA, NAPM and GPhA. Topics covered Association’s(EGA’s)three-day annual will include market trends, regulatory developments and intellectual property.There will conference will look at topics including be speakers from companies such as Actavis, Hospira, Mylan, Sandoz and Teva,along the current regulatory environment, access with opportunities to network. to medicines and implementing safety Contact:Jennifer Nguyen, GPhA.Tel:+1202 249 7127. features. Speakers will include representatives E-mail: [email protected]. Website: www.gphaonline.org. from organisations such as the World Health Organization (WHO) and firms including Actavis, Mylan and Sopharma. 25-26 September 27-29 October Contact:Lucia Romagnoli, GPAConferences. ■ 2nd Annual ■ GPhA Fall Technical Tel: +44 7562 876 873. E-mail: [email protected]. BiosimilarsAsia Conference Register onlineatwww.egagenerics.comor Singapore Maryland, USA www.gpaconferences.com/ega14.htm. This is atwo-day meeting with discussion This three-day GPhA conference will look at topics which will include emerging the current regulatory and technical issues 26-28 June markets, commercialising biosimilars, and their impact on the generics industry. ■ CPhI China manufacturing and clinical trials. The Contact:GPhA. Shanghai,China conference will include case studies Tel: +1 202 249 7127. looking at clinical trials and patient safety E-mail: [email protected]. Co-located with P-MEC, ICSE, LABWorld, as well as presentations on demonstrating Website: www.gphaonline.org. InnoPack and BioPh, this three-day trade biosimilarity and CMC considerations. showwill provide an insight into the latest industry trends with over2,200 exhibitors. Contact:OxfordGlobal. NOVEMBER Tel: +65 657 02208. Contact:UBM. E-mail: [email protected]. 11-12 November Tel: +31 204 099 544. Website: www.biosimilarsasia-congress1.com. E-mail: [email protected]. ■ 3rdAnnual World Biosimilar Website: www.cphi.com/china. Congress Europe OCTOBER Geneva, Switzerland JULY Covering the latest developments in the 6&7-9October biosimilarsmarket, this two-day event will 24-25 July ■ CPhI Pre-Connect Conference include keynote presentations as well as case ■ Legal &RegulatorySummit &CPhI Worldwide studies and interactive discussion formats. on Generic Drugs Paris,France Contact:Terrapinn. New Yo rk,USA CPhI Worldwide is an exhibition and Tel: +44 207 092 1000. E-mail: [email protected]. Looking at legaland regulatory changes networking opportunity which will also Website: www.terrapinn.com. within the industry,this event will cover include the co-located events iCSE, P- MEC and Innopack. The event will be issues including 180-day generic market 17-18 November exclusivity and biosimilars strategies. preceded by the Pre-Connect Conference ■ EuroPLX 56 Contact:American ConferenceInstitute. taking place in the same location. Tel: +1 212 352 3220. Contact:UBM Information. Nice,France E-mail: [email protected]. Tel: +44 207 921 8039. This meeting provides aforum for Website: www.americanconference.com. E-mail: [email protected]. business-development decision makers to Website: www.cphi.com. discuss and negotiate collaborative agreements, in-licensing, marketing and SEPTEMBER distribution of patented medicines, 13-15 October generics, biosimilars, OTCproducts, 17 &18-19 September ■ 11th TOPRA Annual medical devices and food supplements. ■ Biosimilars Global Symposium Contact:Raucon. Congress 2014 Europe Brussels,Belgium Tel: +49 6222 9807 0. London, UK Arranged by The Organisation for E-mail: [email protected]. Preceded by aworkshop covering regulatory Professionals in Regulatory Affairs Website: www.europlx.com. guidelines and clinicaldevelopment, this (TOPRA) in conjunction with Belgium’s two-day event will look at issues Federal Agencyfor Medicines and Health including patient access, manufacturing, Products (FAMHP), this event will cover We also publish interchangeability,and emerging markets. current and forthcoming regulatory issues. Contact: Paradigm Global Events. Contact:TOPRA. OTC bulletin Tel: +44 207 193 3485. Tel: +44 207 510 2560. E-mail: [email protected]. E-mail: [email protected]. Visit www.OTC-bulletin.com Website: www.paradigmglobalevents.com. Website: www.topra.org.
22 GENERICS bulletin 6June 2014 Gen 6/6/14 Pg. 23_Layout 1 04/06/2014 18:39 Page 3
PRICE WATCH ...... UK Concessions cover more“short supplies” harmacybody,the Pharmaceutical Services Negotiating Committee have been out of pocket as the products’ Drug Tariffreimbursement P(PSNC), said it was“still in discussion with the UK Department prices in category M–based on actual historical market prices –were of Health on anumber of generic medicines in short supply” when £2.03 and £2.37. The 40mg tablet form, however, wasincategory A– it published the latest May list of monthly price concessions containing based in part on Actavis’ and Teva’s price lists –and its £2.23 Drug 17 products covering 11 ingredients. Tariffprice exceeded its average trade price even after a72% price hike. Pharmacists dispensing co-tenidone or co-amilofruse, for example, Not that price concessions completely eliminate the possibility of would have been reimbursed at concessionaryprices, rather than pharmacists dispensing at aloss. The concessionaryprice of £5.00 for according to the Drug Tariff. However, one surprising omission from the co-tenidone 50mg/12.5mg tablets exceeded the average trade price of list published on 14 May wasvalsartan, which in the 80mg strength shown £4.36, although pharmacists’ average dispensing margin would have in Figure 1saw its average trade price rise by 62% to £3.19 (US$5.34). been less than 13%. But the £4.32 concessionaryprice for co-amilofruse Similarly,the valsartan 40mg and 160mg strengths in Figure 3 2.5mg/20mg wasless than the average market price of £4.88, meaning experienced average trade price rises of over70%. Pharmacists pharmacists on average would have dispensed at aloss. dispensing the twohigher-strength capsule forms of valsartan would The biggest average monthly price cuts are shown in Figure 2. G
BIGGEST FALLERS BIGGEST RISERS Product/Strength/Pack size Lowest Change Average Change Product/Strength/Pack size Lowest Change Average Change price (%) price (%) price (%) price (%) Ciprofloxacintabs 750mg 10 £0.56 +4 £1.41 -24 Co-tenidone tabs 100mg/25mg 28 £0.50 ±0 £4.47 +205 Aspirin Disp tabs 300mg 32 £0.19 +19 £0.35 -22 Co-tenidone tabs 50mg/12.5mg 28 £0.37 ±0 £4.36 +198 Cimetidine tabs 800mg 30 £1.26 -12 £3.03 -18 Co-amilofruse tabs 5mg/40mg 28 £0.79 +36 £5.09 +179 Rivastigmine caps 1.5mg 56 £2.99 -14 £6.56 -17 Valsartan caps 160mg 28 £1.99 ±0 £4.28 +75 Co-amoxiclavtabs 250mg/125mg 21 £4.19 -33 £7.22 -16 Co-amilofruse tabs 2.5mg/20mg 28 £3.94 +1171 £4.88 +73 Levofloxacin tabs 500mg 10 £2.27 +9 £6.68 -15 Valsartan tabs 40mg 7£0.32 ±0 £1.25 +72
Figure1(below): Comparison between the periods 1-30 April 2014 and 1-27 May 2014 and 1-27 May 2014 in lowest and average UK trade prices of about 748 2014 of the lowest and average UK trade prices of fast-moving generics. Each commonly-dispensed generics. The basket specifically excludes the ‘fast movers’ average price was calculated from at least 33 data points. Figure2(above) and shown below,but includes other presentations of the same products. Each average Figure3(above right): Biggest changes recorded between the periods 1-30 April price was calculated from at least 17 data points (Source –WaveData).
FAST MOVERS FAST MOVERS Product/Strength/Pack size Lowest Change Average Change Product/Strength/Pack size Lowest Change Average Change price (%) price (%) price (%) price (%) Anastrozole tabs 1mg 28 £0.94 -2 £1.71 +11 Pioglitazone tabs 15mg 28 £0.45 -4 £0.92 +9 Atorvastatin tabs 20mg 28 £0.64 -2 £0.91 +6 Pramipexole tabs 700µg 30 £0.66 -20 £2.70 +11 Buprenorphine tabs 2mg 7£0.64 -16 £1.81 -7 Quetiapine tabs 25mg 60 £0.56 +4 £1.03 +7 Candesartan tabs 8mg 28 £0.65 -3 £1.00 -2 Rabeprazole tabs 10mg 28 £0.99 ±0 £1.73 ±0 Cilostazol tabs 100mg 56 £18.95 -3 £23.23 -1 Raloxifene tabs 60mg 28 £6.50 -13 £9.89 -4 Clopidogrel tabs 75mg 28 £0.93 -2 £1.21 ±0 Riluzole tabs 50mg 56 £22.50 -18 £34.16 -3 Cyclizine tabs 50mg 100 £8.49 ±0 £10.59 +2 Risedronate tabs 35mg 4£0.44 -6 £0.73 +3 Desloratadine tabs 5mg 30 £0.51 +19 £0.97 +8 Rizatriptan tabs 10mg 3£1.32 ±0 £2.92 +27 Desogestrel tabs 75µg 84 £2.25 +2 £3.12 +6 Sildenafil tabs 100mg 4£0.42 ±0 £0.68 +4 Donepezil tabs 10mg 28 £0.72 -3 £1.28 +4 Telmisartan tabs 80mg 28 £1.05 -14 £1.86 -3 Dorzolamide eyedrops 2% 5ml £1.18 +3 £1.82 +1 Tolterodine tabs 2mg 56 £1.66 ±0 £2.83 +8 Entacapone tabs 200mg 30 £5.65 -5 £6.30 -1 Topiramate tabs 25mg 60 £1.99 ±0 £2.60 ±0 Esomeprazole tabs 40mg 28 £2.79 +19 £3.76 -5 Valsartan caps 80mg 28 £0.86 ±0 £3.19 +62 Exemestane tabs 25mg 30 £3.14 ±0 £5.70 +17 Venlafaxine tabs 75mg 56 £1.69 -2 £2.35 +2 Irbesartan tabs 75mg 28 £0.54 ±0 £0.82 ±0 Zolmitriptan tabs 2.5mg 6£0.42 ±0 £0.88 +6 Latanoprost eyedrops .005% 2.5ml £0.92 +11 £1.49 +5 Lercanidipine tabs 10mg 28 £0.62 -6 £1.03 +4 WANT MORE LIKE THIS? Letrozole tabs 2.5mg 14 £0.99 ±0 £1.53 ±0 Detailed product price comparisons and other price analyses are Levetiracetam tabs 500mg 60 £2.84 +12 £4.42 +6 available at www.wavedata.net. Losartan tabs 100mg 28 £0.57 +2 £0.91 +11 To find out more about subscribing, please email your contact details to Memantine tabs 10mg 28 £5.65 -13 £8.26 -7 [email protected] and quote ‘GB online enquiry’ in the title line. Montelukast tabs 10mg 28 £1.17 +4 £1.65 +3 ■ Forfurther information see www.wavedata.co.uk. Mycophenolate tabs 500mg 50 £9.22 +9 £11.23 +1 Alternatively,contact Charles Joynson at Naratriptan tabs 2.5mg 6£0.74 ±0 £1.26 -6 WaveData Limited, UK. Tel: +44 (0)1702 425125. Olanzapine tabs 5mg 28 £0.33 ±0 £0.71 +3 E-mail [email protected].
6June 2014 GENERICS bulletin 23 Gen 6/6/14 Pg. 24_Layout 1 04/06/2014 18:39 Page 2
BUSINESS STRATEGY CFR is strategic forAbbott
By paying US$3.3 mid the current wave of consolidation in the Business Annual sales Change Proportion pharmaceuticals industry,itisnot unusual for a billion for Chile’sCFR, A segment (US$ millions) (%) of total (%) companytobethe hunter and the hunted at the Nutrition 6,740 +4.3 31 Abbott is pursuing its same time. But rarely has anycompanygone from being on the cusp of amajor deal to being on the brink of Medical Devices 5,460 -0.6 25 strategy of becoming being bought out as quickly as CFR Pharmaceuticals. Keyemerging markets 2,358 +1.5 11 Within weeks of the Chilean company’sprotracted amajor playerin Other markets 2,616 -6.5 12 attempt to takeoverSouth Africa’sAdcock Ingram EstablishedPharma 4,974 -2.9 23 falling apart (Generics bulletin,7March 2014, page both branded generics Diagnostics 4,545 +5.9 21 3), the family-owned firm had reached a“definitive and Latin America. agreement” to be acquired by US-based Abbott for Abbott 21,848 +1.6 100 around US$3.3 billion. Aidan Fryreports. Once Abbott acquires the holding company Figure2:Breakdown by business segment and region of Abbott’s sales in 2013 (Source –Abbott) controlled by the Weinstein family that indirectly owns 72.6% of CFR’sshares and conducts acash tender Business Annual sales Change Operating for the Chilean firm’soutstanding shares, it will mark segment (US$ millions) (%) margin (%) the end of CFR’spush to become “an authentic multinational pharmaceutical company, the first of Specialty Pharma 483.2 +44.4 29.1 Latin American origin”. ComplexTherapeutics164.8 +20.1 3.6 Having pushed beyond the Americas by forming Health &Wellness 85.6 +71.6 19.0 ajoint venture in Thailand and Vietnam in 2007, CFR Others 34.3 -30.1 12.0 acquired aminority stakeinthe UK’sAllergy CFR 767.9 +34.5 21.8 Therapeutics in 2009, followed in 2010 by deals for Fada Pharma and Laboratorios Northia in Argentina. Figure3:Breakdown by business segment of CFR Pharmaceuticals’ Astock market placement of 24.1% of its share sales and operatingmargin in 2013 (Source –CFR) capital in May 2011 raised more than US$300 million, helping the firm to fund purchasesofholdings in opportunity to expand CFR’sproduct portfolio into Vietnam’sDomesco and Canadian injectables specialist these markets,”remarked White. Uman Pharma (Generics bulletin,18 November 2011, Almost two-thirds –orUS$483 million (see page 12). Then aUS$562 million move for Lafrancol Figure 3) –ofCFR’s2013 turnovercame from its in 2012 made CFR Colombia’sleading pharmaceuticals Specialty Pharma segment, which houses therapeutic player,adding to the firm’sleadership in Chile and units such as the Drugtech neurology and psychiatry Peru (Generics bulletin,14September 2012, page 3). business, Gynopharm women’shealth group and As can be seen from Figure 1, Colombia accounted Neumobiotics pneumology and allergy operation. for 30% of CFR’sgroup turnoverthat grewby34.5% Just overafifth, or US$165 million, of group sales to US$768 million last year following the Lafrancol were generated by the ComplexTherapeutics segment, deal. Chile made up just overafifth of group sales, which covers injectables, includingbiological drugs Peru 16%, Argentina 12% and Venezuela 10%. and Canada’sUman. The Health &Wellness OTC Revealing that when Abbott had approached CFR segment had 2013 sales of US$85.6 million, while the Chilean firm “definitely wasnot for sale”, the US other operations contributed US$34.3 million. firm’schairman and chief executive officer,Miles White, White said CFR’sportfolio of almost 700 molecules pointed out that the deal would more than double the and around 7,800 registered products –promoted by US firm’sbranded generics presence in Latin America, asales network of more than 2,300 representatives– making it atop-10 pharma player was“well aligned” with Abbott’stherapeutic focus on Others in the region through CFR’s women’shealth, central nervous system, cardiovascular US$87.0m presence in 15 countries. and respiratory diseases, as well as “complexinjectables +2% Colombia US$226.5m According to White, CFR’s for institutional use”. “CFR has abalanced portfolio Venezuela +304% geographic footprint of brands that are recognised and trusted by both US$74.7m +16% complemented the strong physicians and consumers,”heinsisted. presence in Brazil and Mexico Furthermore, White pointed out, Abbott would gain of Abbott’sEstablished the Chilean firm’smanufacturing and development sites Pharmaceuticals division, which in Argentina, Chile, Colombia and Peru. But last year suffered a2.9% sales rationalisation and cost-cuttingwere not major factors Argentina US$95.2m slide to US$4.97 billion (see in the transaction, he stressed, stating: “This is not at +3% Figure 2), of which US$2.36 all asynergy play.” billion came from 14 “key “This is aunique asset in this market, providing Peru Chile emerging markets” such as amulti-countryfootprint in one transaction, and at the US$123.0m US$161.5m Brazil, China and Russia same time providing astrong complementary fit +14% -2% (Generics bulletin,3February with our existing business,”White concluded. “The 2014, page 6). business we are acquiring shares our vision of the Figure1:Breakdown by countryofCFR Pharmaceuticals’ turnover that rose by 34.5% to US$768 million in 2013 “Abbott’spresence in Brazil opportunity that exists in branded generics, and is (Source –CFR) and Mexico presents an executing the model successfully”. G
24 GENERICS bulletin 6June 2014 Partnerships Grow Businesses
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RESHUFFLES RESHUFFLES Dr Reddy’sreshapes Celesio’s boardadds top leadership roles leaders of McKesson
rReddy’shas changed its leadership structure by appointing vice- elesio’ssupervisory board has announced several keychanges it Dchairman Satish Reddy to serve ascompanychairman alongside Cwill make toits senior management team next month following GV Prasad as chief executive officer (CEO). Reddy –the son of the US pharmaceutical wholesaler and retailer McKesson completing its company’sfounder,Anji Reddy,who died last year –takes overhis acquisition of more than 75% of the German group’sshares earlier role from Prasad, who wasappointed chairmanalongside his existing this year (Generics bulletin,14February 2014, page 5). CEO responsibilities ayear ago, at the same time as Satish Reddy From 16 July,McKesson’scurrent president of its SpecialtyHealth became vice-chairman (Generics bulletin,19April 2013, page 23). division, MarcOwen,will lead Celesio in the position of chairman Prasad would “provide leadershiptothe companyinanexecutive of the management board, replacing incumbent chairman and chief role”, Dr Reddy’ssaid, adding that he had also been appointed co- financial officer, Marion Helmes.She will retain her responsibilities chairman and managing director.Reddy said the decision to separate as finance head until the same day,atwhich time Alain Vachon,who the chairman and CEO roles would allowthe firm to “give further is currently senior vice-president and chief financial officer of focus to distinct activities”. McKesson US Pharmaceutical, will succeed her. At the same time, the firm’spresident of Global Generics, Moreover, Helmes has on an acting basis become Celesio’schief Abhijit Mukherjee,has been appointed chief operating officer,taking operating officer,following the resignation of Martin Fisher late last overthe role from Reddy.He will have responsibility for both the month. Following the divestment of her roles to Owen and Vachon Global Generics and Pharmaceutical Services and Active Ingredients next month, she would “consult with Celesio for abrief period to (PSAI) business segments with Dr Reddy’s. G support the transition to newleadership”, the German group said. G
APPOINTMENTS APPOINTMENTS Finox marks nod for Bemfola BioMarin’s Bell joinsCoherus wiss firm Finox Biotech has marked its recent marketing oherus has added another senior figure to its management team, Sauthorisation for the infertility treatment Bemfola (follitropin alfa) Cnaming Lisa Bell as its senior vice-president of global by appointing three newsenior executivestoits management team. regulatory affairs. She joins the US-based biosimilars specialist just Amgen’s Nicole Stigemar,who spent sevenyears with Merck weeks after Michael Fleming wasnamed as head of commercial Serono before joining Amgen, has been appointed as the firm’s strategy (Generics bulletin,16May 2014, page 31). executive vice-president of marketing and business development. Bell joins Coherus from BioMarin Pharmaceutical, where she “Nicole brings adeep understanding of the fertility market and wasglobal head of regulatory,pharmacovigilance, medical writing customers as well as an unrivalled understandingofemerging markets and development quality assurance. Commenting on her appointment, to the company,”Finox commented. Coherus’ chief executive officer,DennyLanfear,said Bell “brings Meanwhile, former managing director of women’shealth at astrong strategic, scientific and global mind-set” to the biologics Gedeon Richter UK and Ireland, KenShields,has been appointed to firm’sregulatory strategy. G the position of head of European commercial operations for Finox. And Voisins Consulting’s chief operating officer, Luigi Marro,has IN BRIEF been named as the Swiss firm’schief financial officer. G SOUTH AFRICA’s President, Jacob Zuma, has retained Aaron Motsoaledi as the country’sMinister of Health for asecond term and chosen JoePhaahla as Deputy,following South Africa’sfifth APPOINTMENTS national general elections.Motsoaledi –who wasearlier this year alleged to have accused originators of a“satanic plot” to derail Acino rings strategy changes measures that would improve access to medicines (Generics bulletin, cino has recruited afurther three senior executivesfrom Takeda 3February 2014, page 8) –has served in the role since 2009. APharmaceuticals International, naming from 16 May Konstantin Bakaykin as head of business development and Kalle Känd as its GEDEON RICHTER has elected János Csák and Kriszta Zolnay head of emerging markets and strategy,aswell as Geir Myklebust to the firm’sboard of directorsfor athree-yearperiod following as head of projects and process improvement from 27 May. its recent annual general meeting. Also until 2017, the firm has re- Takeda’sformer head of emerging markets, Jostein Davidsen, elected incumbent directors William de Gelsey, Erik Bogsch and has nowtaken the helm as Acino’snew chief executive officer,having László Kovács,along with Gábor Perjés and Szilveszter Vizi. earlier this year agreed to succeed former head Peter Burema following his sudden departure late last year (Generics bulletin,7 AMERISOURCEBERGEN has expanded its board of directorsto March 2014, page 30). 11 by electing Gregory Wasson,president and chief executive Meanwhile, Acino’shead of quality, Stefan Bier,has left his role officer of Walgreens, to its board. Wasson’selection took place under with immediate effect to “take upnew challenges”. The Swiss firm the “long term” distribution partnership that the twofirms struck stated that “until further notice” senior members of the firm’squality last year (Generics bulletin,5April 2013, page 4). G unit would assume responsibility for group-wide quality assurance. G
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RESHUFFLES Actavis reveals plansfor post-Forest future ctavis’ chairman and chief executive officer, Paul Bisaro,will take brands, generics and biosimilars researchand development. Aon the newly-created role of executive chairman of the company Siggi Olafsson,current president of Actavis Pharma, will on 1 after Actavis completes its acquisition of Forest Laboratories, under July leave the companytojoin rivalTeva,where he will lead the plans that have been set out by the company. The former made a Israeli firm’snewly established Global Generic Medicines (GGM) US$25 billion approach for the US-based brands companyearlier this unit as president and chief executive officer (see front page). year (Generics bulletin,7March 2014, page 1). Pursuant to an agreement that Actavis has reached with him, In his newrole, Bisaro will “oversee the development of the Olafsson will on departing the companyreceive alump sum payment company’sbrand, generic, branded generic and OTCbusiness growth “equal to the sum of twotimes his current annual base salary and two strategies”, Actavis said, as well as the “identification and execution times his annual cash incentive bonus”, along with US$4 million in of mergers and acquisitions”. aretention bonus agreed upon last year (Generics bulletin,6December Forest’scurrent chief executive officer and president, Brent 2013, page 39). These terms were subject to Olafsson leaving the Saunders,will hold the same title at Actavis. Saunders –who will report firm no later than 31 December,aswell as his contract with Actavis to Bisaro and will join the board of directors –“will have responsibility not being terminated for ‘cause’ by his employer. for leading Actavis’ approximately US$15 billion global pharmaceutical Furthermore, Actavis said, Olafsson would before departing business”, including all commercial and business functions. His the companysupport David Buchen,Actavis’ current chief legal current responsibilities only beganinOctober,having joined Forest officer,ashe takes on the newly-created position of commercial from Valeant’sBausch &Lomb where he had since March 2010 vice-president for North AmericanGenerics and International. served as the firm’schief executive officer.He has, however, sat on Alongside Buchen, Forest’scurrent vice-president for sales and Forest’sboard of directorsfor the past three years. marketing, Bill Meury,will take onthe responsibilities of commercial vice-president for North Americanbrands. Both Buchen and Meury Stewarttakes chief operating role will report to Saunders. Meanwhile, Robert Stewart,Actavis’ president of global Bisaro said Actavis had announced the newmanagement structure operations, will become chief operating officer,and will report to before the Forest acquisitionhad closed so that the firm could Saunders. Stewart –who has served in his current position since April “seamlessly operate as one global companyonday one”. By more 2012, having joined the firm three years earlier as senior vice-president effectively defining the “cascading organisation”, Bisaro said, Actavis of global operations –will retain his current responsibilities, including would “remove uncertaintyduring the integration-planning phase prior for quality,the supply chain, and procurement, as well as for global to close”, as well as ensuring “continuity of management”. G
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