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French Authorities Unveil Plans to Bolster Industry

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French Authorities Unveil Plans to Bolster Industry Gen 10-4-15 Pg. 1_Gen 18/11/05 Pg. 1 08/04/2015 17:38 Page 1 10 April 2015 COMPANY NEWS 2 French authorities unveil Latvia’sOlainfarm starts sales in Brazil 2 Amneal finds deal forActavis Australia unit 3 Pharmaniaga pushes into Asia and Europe 4 Te va aims to bolster CNS 5 plans to bolster industry through Auspex Stada intends to license morebiosimilars 6 Indoco will purchase Piramal’sCRO unit 7 “national plan of action to promote generic medicines” has been announced by AFrance’shealth ministry with agoal of encouraging agreater uptakeofgenerics across MARKET NEWS 8 all aspects of the country’shealthcaresystem. Detailed plans published by the ministry emphasise the importance of raising levels of generic prescribing within hospitals, and maintainingthe use of generics in the transition to outpatient careand retirement homes. Canada’sIPO acts to clarify usage claims 8 This would be achieved“while respecting the freedom of prescribers”, the ministry said. GPhA urges adopting alternative 9 Local generics industry association Gemme welcomed the proposals. “This plan seems label plan complete and takes into account all the essential factors,”said Gemme’spresident Pascal Brière. Engagement by all is needed on shortages10 According to the plans, additional savings of around C350 million (US$384 million) will be US must decide upon biologic naming rule 11 able to be achievedthrough increasing by five percentage points the rate of prescribing within Commission calls for 12 France’s répertoire of generic equivalents by 2017. SPC exportevidence Aconvention setting out specific objectiveswas in the process of being signed by all the major players that would be needed to implement the proposed action plan, the health ministry PRODUCT NEWS 13 noted, emphasising that the “common goal” would be to “remove the last obstacles to the use of generic drugs in all situations where such use is possible”. Anational communication campaign Heterohands Stada oncology 13 aimed at both healthcare professionals and the general public would be launched towards the end supplydeal of 2015 to “reinforce trust in the efficacyand quality of generic medicines”, the ministry stated. Te va avoids Belgian bar on quetiapine XR15 Pointing out that the ministry’sproposals “put the patient at the centre” and included “the Apotex can attack Benicar exclusivity 16 participation and collaboration of all healthcareprofessionals”, Gemme also welcomed the plans EMA accepts second Samsung candidate 17 for apublic communication campaign to build trust in generic medicines. The association has Intas introduces its 18 long advocated such ascheme, and twoyears ago launched its ownpublic communication follow-on etanercept campaign to counter misinformation (Generics bulletin,11January 2013, page 8). Australia cuts morereimbursement prices19 European Generic medicines Association (EGA) director general Adrian vanden Hoven observed that the association’slatest reports “have demonstrated that the generic prescribing Otsuka sues FDAonexclusivity forAbilify 21 rate in hospitalsinFrance is still low”, adding:“This is an excellent initiative to focus on positive measures to stimulate access to high-quality treatments for all French patients.” G FEATURES 24 Compliance is crucial as 24 Sun integrates Ranbaxy Arnaud heads Generics for Sanofi anofihas appointed Jean-Marie Arnaud to oversee its C1.81 billion (US$1.95 billion) global REGULARS Sgenerics business in the role of Head of Global Generics. He replaces Jérome Silvestre, who had led Sanofi’scombined generics operation since its inception in November 2013. Silvestre Paragraph IV Watch – Letairis 20 was“recently nominated to another position within the company”, aSanofispokesperson Events – Our regular listing 22 told Generics bulletin.Moreover, Silvestre’srole as president of Sanofi’sZentiva arm – Price Watch UK – UK pricing trends 23 which he had held since 2011 (Generics bulletin,14October 2011, page 23) –would also People – Teva recruits Wright 27 be picked up by Arnaud “in the coming weeks”, the French firm noted. to guide on strategy Arnaud had since September 2013 served as vice-president of Sanofi’sSouth-East Asia business. He boasts an array of experience in Asia-Pacific with the French firm, including as STOP PRESS general manager and representative director in South Korea, and head of marketing in Japan. Mylan on 8April said it had offered Furthermore, Arnaud –who takes up his newrole with Sanofijust weeks after the French firm US$205 per share for Perrigo in acash appointed Olivier Brandicourt to replace Chris Viehbacher as chief executive officer (Generics and shares bid that values Perrigo at bulletin,27February 2015, page 34) –previously worked for four years as foreign trade advisor around US$28 billion. The combined firm at the French Embassy in Japan. would have 2014 pro forma sales of In his newrole, the French firm said, Arnaud would be responsible for “developing the US$15.3 billion. G [company’s] generics business by atargeted development and investment strategy”. This would help Sanofirealise its ambition to be an “international player in generics”. G Gen 10-4-15 Pgs. 2-7_Layout 1 08/04/2015 17:39 Page 2 COMPANY NEWS MERGERS&ACQUISITIONS BUSINESS STRATEGY/ANNUAL RESULTS Rs8bn UCB deal aids Latvia’sOlainfarm Dr Reddy’sinAsia starts sales in Brazil rReddy’sislooking to expand its offerings in South Asia after lainfarm has made progress in Latin America by making its first Dagreeing to acquire for Rs8.00 billion (US$128 million) a Oshipments to Brazil. Ashipment of “almost C55,000 (US$60,000)” “select portfolio” of mature dermatology,respiratory and paediatrics had been made to Brazil in January,the Latvian firm noted, as the firm brands from Belgian originator UCB. The transaction covers said it wasputting “evenmore effort into starting to sell our final “established products” in India, Nepal, Sri Lanka and the Maldives. dosage and chemical products in other regions” following challenges Through the transaction –which is slated to close in the second in local markets. quarter of this year –the Indian firm said it would pick up “market “Wehavemanaged to set yet another sales record in the history leading brands”, including Atarax (hydroxyzine) and Nootropil of Olainfarm,”emphasised the firm’schairman, Valerijs Maligins, (piracetam), as well as Zyrtec (cetirizine) and Xyzal (levocetirizine). announcing group sales that advanced by afifth to C93.7 million in This would “accelerate Dr Reddy’spresence in the high-growth areas of 2014. However, “significant changes in almost all of our keymarkets, dermatology,respiratory,and paediatrics”, helping to “further expand including difficulty to deliverour products to several regions of Ukraine, Dr Reddy’stherapyfootprint into these fast-growing areas”. currencydevaluations in Ukraine, Russia, Kazakhstan and Belarus prevented us from attaining the profit guidance”. Olainfarm’spre- Taking on 350 employees tax profit stalled at C14.9 million. Noting that the business had sales of around Rs1.50 billion in Olainfarm wasalso starting to “pay alot more attention to the 2014, Dr Reddy’sadded that it would also be taking on around 350 identification of potential acquisition targets that have less dependency employees that currently worked for UCB’sIndian business. on CommonwealthofIndependent States (CIS) markets,”Maligins Commenting on the deal, UCB’schief operating officer,Mark revealed, as away of avoiding “instability”. McDade, said “finding the right companyfor our establishedbrands Nevertheless “11 out of 15 countries are growing”, Olainfarm in India” had been “crucial”. observed, with the firm’sturnoveronly falling in Georgia, Kazakhstan, “Dr Reddy’sknowledge of the local market,”McDade said, the UK and Uzbekistan. Increases in the company’stop five countries “combined with its ambitious plans and excellent reputation, convinced ranked by absolute sales rises –Russia, Ukraine, Latvia, Belarus and us theywere the right choice to drive this business forward.” G the Netherlands –provided “90% of total growth in monetary terms”. G 2 GENERICS bulletin 10 April 2015 Gen 10-4-15 Pgs. 2-7_Layout 1 08/04/2015 17:39 Page 3 COMPANY NEWS MANUFACTURING MERGERS&ACQUISITIONS Ipca and Aarti hit by Amneal findsdeal for US import restriction Actavis Australiaunit ndian producers Ipca and Aarti Drugs have been hit by import alerts rivately-held US firm Amneal is lookingtobroaden its footprint Iissued by the US Food and Drug Administration (FDA). Pin Australia after agreeing to buy“substantially all” of Actavis’ Ipca’salert covers its Indian formulationsfacilities in the Indore local generics operation for an undisclosed sum. The deal –which special economic zone near Pithampur and in Piparia, Silvassa. Both would build on the launch of Amneal’sAustralianbusiness in August sites had already been affected by an FDAimport alert imposed on last year,under the leadershipofmanaging director Gavin Upiter –is the firm’sactive pharmaceutical ingredients (APIs) plant in Ratlam, subject to the completion of due diligence and definitive agreements. India, earlier this year (Generics bulletin,6February 2015, page 5). The US firm commented that both companieshad agreed to “work “The companyhas voluntarily decided to suspend API shipments expeditiously to complete the transaction” in order to prevent supply from the Ratlam manufacturing unit for the US market until the FDA disruption for existing purchasers of Actavis’ products. Actavis would, inspection observations issue is resolved,”Ipca said, adding
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