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The publication/s are the intellectual property of the Publisher, OTC Publications Ltd and are protected by English copyright, trademark and other laws. 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 18/4/14 Pg. 1_Gen 18/11/05 Pg. 1 15/04/2014 20:12 Page 1 18 April 2014 COMPANY NEWS 2 Sun makes US$4 billion Mylan misses out on 2 move to gain Meda Pamplona fund takes control of Alvogen 3 Bioton benefits as sales 4 bid to snap up Ranbaxy of insulin boom Sun seeks synergies from Ranbaxy deal 5 un Pharmaceutical Industries intends to create the world’s fifth-largest generics player, Latvia’sOlainfarm sees 6 Sand India’s leading pharma company,bypaying around US$4.0 billion forits rival, upside to crisis Ranbaxy.The deal comprises US$3.2 billion of equity,and US$800 million of assumed debt. FDAcancels Hikma’sEatontown warning 7 Based on Ranbaxy contributing US$1.8 billion to the combined group’spro forma 2013 turnoverofUS$4.2 billion, the proposed all-share transaction values Ranbaxy at 2.2-times sales. Julphar strikes deal to sell MSD’sdrugs 8 The US will makeupjust under half of the combined group’sturnover, India 22% and the rest of the world 31%. Pro forma earnings before interest, tax, depreciationand amortisation MARKET NEWS 9 (EBITDA) were US$1.2 billion last year. “The combined entity will have operations in 65 countries, 47 manufacturing facilities Additional identifiers should applytoall 9 across five continents, and asignificant platform of specialty and generic products marketed GPhA questions basis for 10 globally,including 629 abbreviated newdrug applications (ANDAs),”commented Sun, adding labelling proposal that within the ANDAtotal wasapipeline of 184 filings that included “high-value first-to-files”. Spain amends rules on reference prices 11 Ranbaxy will contribute around US$500 million to the combined group’sUSturnoverof Portuguese advances 12 more than US$2 billion, and will account for two-thirds of the group’sUS$900 million sales bolster penetration in emerging markets, excluding India. Ranbaxy will also strengthen Sun’sminor presence Italyleads EU fiveonbiosimilar sales 13 in western Europe through operations in countries including France, Germanyand the UK. The boards of Sun, Ranbaxy and Ranbaxy’smajority shareholder,Daiichi Sankyo, have PRODUCT NEWS 14 approvedthe deal that will see Ranbaxy’sshareholdersreceive 0.8 Sun shares for each Ranbaxy share theyhold. Sun said this implied avalue of Rs457 per Ranbaxy share, apremium of 18% over Ratiopharm obtains Canadian damages 14 Ranbaxy’sshare price in the preceding month. Pending approvals from 75% of shareholders, as UK Herceptin patents defeated by Hospira15 well as from antitrust and other authorities, Sun anticipates closing the deal by the end of this year. Daiichi Sankyo –which will become Sun’ssecond-largest shareholder –has agreed to PTOrefuses reissue 16 indemnify Sun and Ranbaxy for certain costs that may arise from a subpoena issued by the of Copaxone patent NewJerseyAttorney’sOffice, requesting that Ranbaxy produce documents relating to its Toansa Sandoz launches its AirFluSal 17 facility in India that is the subject of aUSFood and Drug Administration (FDA) import alert. G in Norway Forfurther details of the deal, turntopage 5. Remicade suit is filed by Korea’sCelltrion 19 Endo wins appeal on 21 Opana ER injunction Francis replaces Sandoz’ George FEATURES 24 effGeorge will leave his role as head of Sandoz from 1May to succeed Kevin Buehler as US market bounces back 24 Jleader of parent companyNovartis’ Alcon ophthalmics division. He will be succeeded as as value growsbyatenth head of Sandoz by Biogen Idec’sRichard Francis, described by Novartis as “a proven pharmaceuticals and biotechnology leader” who had “held roles of increasing responsibility Unified courtrules revised 26 across several therapeutic areas in both Europe and the US overhis 13-year career” with Biogen. Francis –who most recently served as Biogen Idec’ssenior vice-president for US commercial REGULARS operations –had previously “held leadership roles across commercial and sales in Sanofiand Wyeth”, Novartis noted. As division head of Sandoz, he will join Novartis’ executive committee Pipeline Watch – Memantine 20 and will report directly to the firm’schief executive officer,Joe Jimenez. George –who joined Novartis in 2007 and became head of Sandoz at the end of 2008 –will continue to serveas Events – Our regular listing 22 amember of the committee, while Buehler,who is retiring, will “provide management and Price Watch UK – Our in-depth 23 strategic support on the Alcon business” as part of the transition. look at pricing trends in the UK George’sand Francis’ appointments “place twostrong leaders at the helm of twoleading Novartis businesses”, commented Jimenez. “These newleaders will set the direction for the People – Louw is replaced by 27 next phase of growth for our eye-care and generics businesses, twoofour core growth engines,” Wakeford at Adcock he added, insisting that George and Francis “have the vision and expertise to strengthenour market-leading positions”. G Gen 18/4/14 Pgs. 2-7_Layout 1 15/04/2014 20:12 Page 2 COMPANY NEWS MERGERS&ACQUISITIONS STRATEGICALLIANCES/MANUFACTURING Mylan misses out on Neuland opensplant move to gain Meda to aid APIC alliance ylan has had an undisclosed takeoveroffer for Swedish firm euland Laboratories has opened abulk-drugs manufacturing facility MMeda rejected following initial talks between the twocompanies. Nin India through acollaboration with API Corporation (APIC), a “The board has convened and decided to reject the proposal,”Meda healthcareunit of Mitsubishi Chemical Holdings. “The newfacility said in astatement. “All continued discussions between Meda and –which is located in aNeuland complexinPashamylaram, Hyderabad – Mylan have been terminated without further actions.” is the first manufacturing facility that APIC has established outside Media conjecture prior to the Swedish firm’sannouncement had of Japan,”the Indian group observed. suggested that incorporating Meda –which in 2013 reported group Pursuant to an agreement that the twofirms struck ayear ago sales ahead by 1% to SEK13.1 billion (US$2.00 billion) from speciality (Generics bulletin,22March 2013, page 3), Neuland built and will prescription and OTCbrands, as well as branded generics –within operate the facility that will makeactive pharmaceutical ingredients Mylan’soperations would have created acompanywith amarket (APIs) and intermediatesfor sale through Tokyo-based APIC. capitalisation of around US$23 billion. “This arrangement allows APIC to expand its business in Japan The US firm’sapproach fell in line with chief executive officer in atimely and cost-effective way,”commented Neuland’schairman Heather Bresch’sassertion that Mylan could conduct a“substantial and managing director,Davuluri Rama Rao, “while also helping to transaction” this year (Generics bulletin,7March 2014, page 3). raise Neuland’s profile as aquality supplier of APIs and intermediates Meda blamed lower sales of several products in the US for the to the Japanese market.” G turnoverofits Branded Generics business falling by almost atenth to SEK1.32 billion last year.Prescription Specialty Products sales IN BRIEF grewby2%toSEK8.27 billion, while OTCturnoveradvanced by 4% to SEK3.13 billion and other products added SEK396 million. PHARMANIAGA intends to build aMYR120 million (US$36.7 The Swedish group –which has just agreed to terminate joint million) manufacturingplant in Riyadh, Saudi Arabia, through ventures with Valeant in Canada, Mexico and Australia, giving it the Malaysian company’s50/50 joint venture with local company marketing rights to certain dermatology brands –generated nearly Modern Group. G two-thirds of its 2013 turnoverinwestern Europe. G 2 GENERICS bulletin 18 April 2014 Gen 18/4/14 Pgs. 2-7_Layout 1 15/04/2014 20:12 Page 3 COMPANY NEWS MERGERS&ACQUISITIONS MERGERS&ACQUISITIONS Actavis buys Silomin Pamplona fund takes US$100mn Thai deal control of Alvogen ctavis says it has gained a“top-fiveposition in the Thai generic rivate-equity fund Pamplona Capital Management has acquired a Apharmaceutial market” after acquiring local firm Silom Medical Pmajority stakeinAlvogen for an undisclosed sum. With headquarters Companyfor US$100 million in cash. The privately-held generics firm in NewYork and London, Pamplona manages overUS$6 billion in had “leading positions in the ophthalmic and respiratory therapeutic assets for avariety of clients, including hedge funds and pension funds. categories”, Actavis said, as