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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”.