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Gen 27-02-15 Pg.1_Gen 18/11/05 Pg. 1 25/02/2015 18:33 Page 1 27 February2015 COMPANY NEWS 2 RivalstoRemicade reach Cipla gains ground in 2 North Africa via JVs Actavis intends to adopt Allergan name 3 Te va plans to set up abiologicals facility 4 major European markets Wockhardt resolves faults at US factory 5 Sawai sees turnoverrise 6 faster than profit ivals to the Remicade (infliximab) monoclonal antibody marketed by Janssen and Aurobindo venturetotarget PCV vaccines 7 RMerck arenow available throughout Europe after Celltrion and Hospira seized on Growth in US helps Zydus to advance 8 expiries of paediatric extensions to supplementary protection certificates (SPCs) during Lannett turns gaze to Western Europe 9 February to enter the market (see pages 24 and 28). Russia and Ukraine hit Richter’sresults 10 On 25 February,Celltrion announced launches of its Remsima biosimilar through partners such as Kern Pharma and Mundipharma (see page 26) in Austria, Belgium, Denmark, France, Protopic rival peps Perrigo’sturnover 11 Germanyand Greece, as well as in Italy,Luxembourg, the Netherlands, Spain, Sweden and the To wa cuts its costs to improvemargins 12 UK. The treatment for autoimmune diseases wasnow available in 31 countries, the firm noted. Siegfried sorts out FDAHameln letter 13 Hospira has launched its Inflectra (infliximab) biosimilar monoclonal antibody in Glenmark growsits sales as profits slide 14 several European markets, includingAustria, Denmark, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Spain and Sweden. “Inflectra is nowavailable in 24 European MARKET NEWS 15 countries,”noted the injectables specialist, which already markets infliximab in Central and Eastern Europe, as well as in some smaller Western European markets. FDAreopens debate on label change rule15 In September 2013, the European Commission authorised Remsima and Inflectra for treating France must address declining sales trend 16 inflammatory conditions including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Canada will require 17 adult and paediatric Crohn’sdisease, adult and paediatric ulcerative colitis and plaque psoriasis. shortage notification Global Remicade turnoverahead by 2.9% to US$6.87 billion last year reported by Janssen’s Input is invited over US interchangeability 19 parent group, Johnson &Johnson, included US$1.64 billion in non-US International markets. OGD sets target forANDAaction dates 20 On 17 March, the US Food and Drug Administration’s(FDA’s) Arthritis Advisory Committee will hold apublic meeting to discuss abiologics license application (BLA) that PRODUCT NEWS 21 has been submitted by Celltrion for its CT-P13 proposed rivaltoRemicade. US patent 6,284,471 protecting Remicade until September 2018 has just been rejected Lupin enlists Celon forAmerican Advair 21 upon re-examination by the US Patent and Trademark Office (USPTO). The ‘471 patent – which covers assays using anti-tumournecrosis factor (TNF) antibodies – was one of three Mylan must wait for 22 esomeprazole in US patents for which Celltrion sought adeclaratory judgement of non-infringement last year. However, the twoparties settled the litigation on confidential terms. G Hospira and Pfenex develop ranibizumab 23 Lupin wins appeal on US Trizivir patent 24 Pregabalin dispute will persist in the UK25 Spain’sKern Pharma 26 introduces infliximab Pfizer pays US$17bn for Hospira Momenta is open to abatacept options 27 fizer has agreed to pay around US$17 billion, including assumed debt, to acquire Norwayenjoys steep infliximab price cut 29 Pinjectables specialist Hospira. The US$90-per-share deal has been approvedunanimously by both firms’ boards and is scheduled to close during the second half of this year,subject to FEATURES 32 antitrust clearance and approvalbyHospira’sshareholders. The agreement – which represents a39% premium on Hospira’sclosing price on 4February,and around four-times Hospira’s Pfizer eyes twotop spots 32 annual sales – includes aUS$500 million break-up fee. with Hospira acquisition “Hospira’sbusiness aligns well with our newcommercial structure and is an excellent strategic fitfor our Global Established Pharmaceutical (GEP) business, which will benefit REGULARS from asignificantly enhanced product portfolio in growing markets,”commented Pfizer’s chairman and chief executive officer,Ian Read. Pipeline Watch – Remicade 28 “The expanded portfolio of sterile injectablepharmaceuticals, composed of Hospira’s Events – Our regular listing 30 broad generic sterileinjectables product line, including acute-care and oncology injectables, Price Watch UK – UK pricing trends 31 with anumber of differentiated presentations, as well as its biosimilars portfolio, combined with GEP’sbranded sterile injectables, including anti-infectives, anti-inflammatories and People – Bayer’sBrandicourt 34 leads SanofiasCEO cytotoxics, will create aleading global sterile injectables business,”Pfizer maintained. G Fordetails of the deal, turntopage 32. Gen 27-02-15 Pgs.2-14_Layout 1 25/02/2015 18:33 Page 2 COMPANY NEWS STRATEGICALLIANCES/THIRD-QUARTER RESULTS Ciplagains ground in North Africa via JVs ipla has broadened its presence in North Africa by agreeing to Third-quarter sales* Change Proportion Cestablish joint ventures with the company’sexisting partners in (Rs millions) (%) of total (%) Algeria and Morocco. Through its UK subsidiary,Cipla EU, the Indian firm will hold a Formulations 12,750 -6.2 46 40% stakeinaventure it is creating with its Algerian partner,Biopharm, APIs 1,510 -4.4 5 and a60% stakeinasimilar scheme it is establishing with Cooper Exports 14,260 -6.1 52 Pharma and The Pharmaceutical Institute, Cipla’sallies in Morocco. India 11,990+14.2 43 Both ventures –which are subject to certainregulatory approvals – will be used as avehicle to market Cipla’srespiratory franchise in Other 1,410 –5 the respective countries, and will include the companies supplying Cipla 27,650 +6.5 100 funds to build local manufacturing facilities. The Indian firm is expected to contribute US$6 million of atotal US$15 million in *rounded to nearest Rs10 million Algeria, while it will pour up to US$15 million into its scheme in Figure1:Breakdown of Cipla’s net sales in its financial third quarter ended 31 Morocco, where Cipla will also promote its neurology drugs. December 2014 (Source –Cipla) Meanwhile, Cipla has agreed to acquire for Rs960 million (US$15.4million) a60% stakeinprivately-owned Indian firm Jay to Teva,following the Israeli group’srecent nod for the first US Precision Pharma, an existing supplier of Cipla’srespiratory devices. generic rivaltoAstraZeneca’sNexium blockbuster (Generics bulletin, Jay Precision –which boasts amanufacturing facility in Vasai, 6February 2015, page 17). Maharashtra –had sales of around Rs300 million in its financial year Elsewhere, Cipla’sin-licensing agreement with Teva in South ended 31 March 2014. Slated to close by the end of next month, the Africa though its local Cipla Medpro affiliate for access to “65 new transaction wasaimed at “integrating the value chain and will serve molecules” (Generics bulletin,17October 2014, page 6) has received as aplatform for the development of next-generation respiratory clearance from the country’sCompetition Commission. The Indian devices”, Cipla said. firm has also just been awarded aUS$189 million share in aGlobal Fund antiretroviral tender (see page 27). Indian sales increased by 14% Meanwhile, the founder of the Serum Institute of India, Cyrus In Cipla’sfinancial third quarter ended 31 December 2014, Poonwalla, has revealed that the companyand Cipla had held initial domestic sales rising by 14.2% to Rs12.0 billion helped overcome merger talks following their agreement covering paediatric vaccines single-digit turnoverslips from exports of active pharmaceutical in Europe that wasstruck late last year (Generics bulletin,5 ingredients (APIs) and finished-dose formulations as the Indian December 2014, page 6). “We[Serum Institute] could nevergoup companyimprovedits sales by 6.5% to Rs27.7 billion (see Figure 1). for sale,”hesaid, “but we could merge with acompany, for example However, the Indian firm’sexport sales could soon be bolstered Cipla…there is asmall chance that could happen.” after Cipla announced that it had “gone live”inNorth America,and “Wefirst have to see if the initial partnership bears fruit,” had subsequently introduced its first ‘own-label’ productsinthe region Poonwalla added. “If it movesinthe right direction, maybe we will including doxycycline, meloxicam, topiramate and valaciclovir. takeittothe next stage.” Moreover, Cipla has revealed that it will be supplying esomeprazole Amarginal increase in Cipla’sexpenses wasoffset by the firm’s active pharmaceutical ingredient (API) and finished-dose formulation 6.5% sales rise, as its pre-tax profit rose by 8.3% to Rs4.28 billion. G 27 February2015 Issue 226 Individual subscriptions Te rms &Conditions: These can be viewedinfull at www.Generics-bulletin.com/subscribe. Editor: Aidan Fry An annual subscription comprises: ■ 20 Generics bulletin newsletters; No partofthis publication maybe copied, reproduced, Deputy Editor: David Wallace ■ AND at least 46 weekly News@Genericsbulletin stored in aretrieval system, distributed or transmitted Assistant Editor: Liudmila Kotko electronic newsflashes containing the week’stop by anymeans, including electronic,mechanical, news stories (currentlydelivered by email). photocopying or recording, without the prior written Business Reporter: Dean Rudge permission of the publisher,orunder

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