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Mylan Has US$4 Billion to Spend on Acquisitions

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Mylan Has US$4 Billion to Spend on Acquisitions Gen 2/11/12 Pg.1_Gen 18/11/05 Pg. 1 31/10/2012 20:03 Page 1 2November 2012 COMPANY NEWS 2 Mylan has US$4 billion Sanofi doubles in US on 2 authorised rivals Watson sells stakeinBrazil’sMoksha8 3 Pharmstandardsees no need to change 4 to spend on acquisitions Mylan will buy SMS’ Indian oncologysite 5 Strides submits 28 ANDAs in aquarter 6 Bedfordisshipping limited US supplies 7 ylan has awar-chest of morethan US$4 billion available to fund acquisitions that Bupropion problems cost 8 Mextend its geographic presence or add product categories and technologies, according Impax US$2mn to the US-based group’schief executive officer,Heather Bresch. “Thereare many compelling UK’sAesica aims for£340mn by 2015 9 opportunities out thereand we arelooking at all of them,”she stated, identifying dermatology and topical, injectable and respiratory drugs as areas in which Mylan might strikedeals. MARKET NEWS 10 In recent years, Bresch noted, Mylan had largely been focusing on reducing its debt and maximising the global asset base it had gained by acquiring Merck KGaA’s generics operation Substitution planned this year in Ireland 10 and Indian raw-material specialist Matrix, both in 2007, as well as on building on its purchase of Bioniche to gain entry to the injectables sector. Belgian brand deal is queried 10 Paying offdebt had givenMylan “increased financial flexibility” to pursue acquisitions, by FeBelGen Bresch stated, adding that an annual free cash flowofaround US$700 million had allowed the firm India will onlygrant licences under INNs 12 to reduce its ratio of debt to earnings before interest, tax, depreciation and amortisation (EBITDA) UK refers one moreSPC dispute to ECJ 13 to 2.6-to-1. While senior management wasprepared to exceed the firm’slong-term gearing target Stada and Te va lead SpectrumK contracts13 of 3-to-1, it would aim to return to that levelwithin 18 months of anydeal, she added. Australia will review 14 Acquisitions were just one wayinwhich Mylan would more than double its annual earnings- patent extensions per-share to US$6 by 2018, Bresch insisted. She revealed the firm would soon establish a foothold in Thailand to complementthe commercial unit it recently set up in India. And agenerics PRODUCT NEWS 16 alliance with Pfizer in Japan would come into effect later this year or early in 2013, she added (Generics bulletin,3September 2012, page 1). Watson makes FDAapproveActos rival 16 The first global Phase III clinical trial through Mylan’sbiosimilars partnership with Biocon had begun for arivaltoHerceptin (trastuzumab) in October,Bresch pointed out, while the firm AET aims forHumira via 17 BioXpress deal had recently launched oral contraceptives in Canada and Germanythrough its alliance with India’sFamy Care. Mylan is also investing in the manufacturing network for the Institutional FDAaddsUS$2.7mntotacrolimus trial 17 business unit it set up on the basis of the Bioniche injectables deal (see page 5). G Sandoz enrols forUSstudy on 18 epoetin alfa Te va first in line forEUimatinib approval 21 FEATURES 22 FDA publishes GDUFAfee rates ser fees payablebygenerics firms wishing to submit products for registration in the US Hikma’sInjectables unit 22 Ubetween October 2012 and September 2013 have been published by the US Food and Drug turns gazetowards France – Administration (FDA) in the country’s Federal Register.For an abbreviated newdrug application Hikma believesamix of geographic and (ANDA), the fee is US$51,520, whilst the prior approvalsupplement (PAS) fee is US$25,760. portfolio expansion will drive double-digit The fee payable by owners of drug master files (DMFs) referenced after 1October in generic sales growth by its US$450 million drugsubmissions is US$21,340. Meanwhile,aseparate fee applicable to existing ANDAs Injectables division. Aidan Fry reports. awaiting approvalinthe FDA’sbacklog as of 1October 2012 has been calculated at US$17,434. According to the Generic Drug User Fee Amendments (GDUFA) signed into US lawearlier REGULARS this year (Generics bulletin,13July 2012, page 9), the FDAmay collect US$299 million in generic druguser-fees for the year ending 30 September 2013. The backlog fee –which, Paragraph IV Watch – Ganirelix 20 according to GDUFA, should contribute US$50 million of this total –was calculated based on Events – Our regular listing 22 the FDA’sassertion that there were 2,868 ANDAs in the backlog on 1October. Of the remaining US$249 million, GDUFAspecifies that 24% –orUS$59.8 million –must Price Watch UK – Our in-depth 23 be funded through ANDAand PASfees, and that the PASfee must be equal to half the ANDA look at pricing trends in the UK fee. The ANDAand PASfees were therefore calculated based on the FDA’sestimates that 1,160 People – EU’scommissioner 27 ‘full application equivalents’ (FAEs) and 576 PASs would be receivedduring the first year of Dalli quits after probe the user-fee programme. DMF fees will account for 6% –orUS$14.9 million –ofthe US$249 million, with the final figure based on the FDA’sestimate that 700 DMFs will be referenced. G Gen 2/11/12 Pgs.2-8_Layout 1 31/10/2012 20:04 Page 2 COMPANY NEWS STRATEGICALLIANCES THIRD-QUARTER RESULTS Mitsubishi Tanabe Sanofi doublesinUS ends Choseido deal on authorised rivals apanese brand companyMitsubishi Tanabe Pharma and oral-dose arketing authorised generics of its Lovenox (enoxaparin) and Jgenerics specialist Choseido Pharmaceutical have dissolved their MAprovel(irbesartan) helped Sanofitomore than double its US generics strategic alliance after acknowledging that the results of the generics sales at constant exchange rates to C70 million (US$91.1 deal had “not met their initial expectations”. million) in the third quarter of 2012. This helped partially to offset In 2008, Mitsubishi Tanabe agreed to increase its 10% holding declining brand sales in the US, where sales of Lovenox dropped by in Choseido to amajority stakethrough adeal that the originator said almost two-thirds to C55 million and turnoverfrom Aproveland Avalide would help it build aproduct portfolio,sales network and manufacturing (irbesartan/hydrochlorothiazide) plummeted by 83.7% to C16 million. base, supported by Choseido’s“wealth of business experience and solid Sanofi’soverall generics turnoverrose by 14.9% to C479 million base in the generic drug industry” (Generics bulletin,2June 2008, at constant exchange rates, drivenpartly by European sales climbing page 3). The agreement wasaimed at positioning Choseido as a by almost aquarter to C138 million. Meanwhile, in emerging markets – manufacturing companyfor Mitsubishi Tanabe’sgenerics operations. which represented more than half of the brand company’stotal generics Since the deal wasstruck, Mitsubishi Tanabe said it had “taken sales –turnoveredged ahead by just 0.8% to C262 million. Sales in aggressive steps, working to enhance the line-up of generic drugs, the rest of the world contributed C9million after rising by 14.3%. expand the sales system, and establish amanufacturing platform that However, Sanofi’sgroup turnoverslipped by 3.1% to C9.04 billion can accommodate producing alarge variety of goods in small quantities”. as Pharmaceuticals sales declined by 4.3% to C7.04 billion, largely due “Mitsubishi Tanabe Pharma’sholdings of Choseido Pharmaceutical to competition from generics that wiped C448 million offthe originator’s stock have been transferred to Hiasaki Harima, the president and sales. This was“primarily due to generic competition to Eloxatin chief executive officer of Choseido,”the brand companyconfirmed. (oxaliplatin) in the US”, Sanofisaid. Mitsubishi Tanabe’sgenerics subsidiary,Tanabe Seiyaku Hanbai, Sanofi’s“expected loss of market exclusivity” on Eloxatin –after “continues to supply medical institutions with the Choseido the companystruck adeal with several generics firms allowing them Pharmaceutical products at this point”, the originator noted. However, the to launch oxaliplatin under licence from 9August this year (Generics firm and its subsidiary said theywould “rapidly re-evaluate their generic bulletin,9April 2010, page 17) –led US brand sales for the quarter drug business strategies” and create a“newframework”. G to decline by 74.7% to C72 million. G 2 GENERICS bulletin 2November 2012 Gen 2/11/12 Pgs.2-8_Layout 1 31/10/2012 20:04 Page 3 COMPANY NEWS MERGERS&ACQUISITIONS DIVESTMENTS Alvogen will acquire Watson sells stake Korean firmKunwha in Brazil’s Moksha8 S-based generics specialist Alvogen has agreed to acquire a atson has sold its stakeinMoksha8 back to the Brazilianbrands Umajority share in South Korean companyKunwha Pharmaceuticals Wand branded generics firm for US$47 million, twoyears after for an undisclosed fee. Alvogen plans to complete the deal through a acquiring the minority share. The move comes as Moksha8 enters combination of buying newshares issued by Kunwha and acquiring into astrategic alliance with Forest Laboratories which will give the existing shares owned by the Korean firm’schairman, Hongsun Chang, originator the option to acquire the Brazilian firm in twoyears. and related parties. At the same time, however, Watson is “expanding its ongoing Alvogen said the transaction represented the next step in its strategy sales and marketing collaboration” with Moksha8 by licensing five “to establish apresence in attractive generic pharmaceutical markets branded generic central nervous system (CNS) treatments to the globally”. The US-based companyintends to use Kunwha as “a centre Braziliancompany. These will be developed for marketing in Brazil of excellence and aplatform for Alvogen’sproducts and support services and Mexico in exchange for royalties and milestone payments. in the Asia-Pacific region as Alvogen enters other regional markets Twoyears ago, Watson paid US$30 million for astakeinMoksha8 in the coming years”. (Generics bulletin,15October 2010, page 3). The deal also included “This transaction is an important step in our strategy to build a an agreement for Watson to manufacture and supply certain products strong regional player in the exciting Asia-Pacific region,”insisted to Moksha8 for the Brazilian and Mexican markets.
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