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Renaissance's Topicals Top US$1Bn for Mylan Gen 20-5-16 Pg. 1_Gen 18/11/05 Pg. 1 18/05/2016 17:23 Page 1 20 May2016 COMPANY NEWS 2 Renaissance’s topicals Biosimilars maynot be corefor Allergan 2 Japaneses incentives driveSawai growth 2 Concordia buys as it 3 considers its options topUS$1bn for Mylan McKesson expands its Walmartalliance 3 Oncobiologics cuts the 4 price of its IPO ylan has agreed to pay up to US$1.00 billion to acquirethe “topicals-focused specialty Hypermarcas creates three Pharma units 4 Mand generics business” of privately-held North American firm Renaissance from Hendrickson talks up Perrigo’sgenerics 5 RoundTable HealthcarePartners. The price comprises US$950 million in cash at closing – Reddy’sbiosimilars 5 which is expected by the end of the third quarter of 2016, subject to regulatory approval are‘gaining traction’ and other conditions –along with US$50 million in “additional contingent payments”. Glenmark eyes EU Seretide rival launch 6 Renaissance began life in 2010 when RoundTable acquired contract-development and Krka bolsters base as Russian supplier 7 manufacturing organisations (CDMOs) Confab Laboratories of Montreal, Canada,and DPT Laboratories of Texas in the US. Lots of launches help Impax 7 Renaissance’stopicals business –which had sales of around US$370 million in 2015 and to asales rise employs around 1,200 staff–will “bring Mylan acomplementary portfolio of approximately German growth gives Stada’s 8 25 branded and generic topical products, an active pipeline of approximately 25 products, and sales aboost an established US sales and marketing infrastructure targeting dermatologists”. The business Contraceptives cause Richter’spharma fall 8 also offers “an integrated manufacturing and development platform and aleading topicals- focused CDMO”. In particular,Mylan highlighted “twohigh-quality manufacturing sites with MARKET NEWS 9 capabilities and capacity in creams, ointments, aerosols and foams, gels, suspensions, liquids and suppositories” that were “complementary to Mylan’sexisting capabilities”. Renaissance India seeks stronger domestic 9 will retain its sterilesbusiness and an associatedmanufacturing facility. API source “The dermatology and topicals space has long been an area of focus for Mylan,”outlined Europe reviews plan forsingle SPC study 9 chief executive officer Heather Bresch, “and one that we have targeted for expansion.” GPhA cautions over US 10 Renaissance wasa“strong and growing business in avery attractive category”, she added, Medicarerevamp which was“highly complementary to Mylan’sexisting assets and the pending addition of the Danish agency aims to explain biosimilars 10 Meda dermatology portfolio” (Generics bulletin,19February 2016, page 1). Mylan president RajivMalik said the Renaissance business’ “broad and durable portfolio, PRODUCT NEWS 11 exciting pipeline of topical products, and strong manufacturing and research and development capabilities” would give Mylan “critical mass in the dermatology and topicals area”. “Welook Adamed offers OTCsildenafil in Poland 11 forward to welcoming the business’ talented employees to Mylan upon closing.” G Japanese firms will rival Lilly’sZyprexa 12 Actavis wins appeal over US on-sale bar 13 Pfenex’ teriparatide trial 13 set forthis year Sandoz sued over pegfilgrastim FEATURES 15 mgen has filed aUSpatent-infringement lawsuit against Sandoz and its Slovenian Lek Asubsidiary in aNorthern Californiadistrict court overthe generics firm’splanned rivalto Neulasta (pegfilgrastim) that it had accepted for filing by the US Food and Drug Administration UK needs to share success 15 (FDA) towards the end of last year (Generics bulletin,9December 2015, page 17). The originator cites US patents 8,940,878 and 5,824,784, which expire on 8October 2031 and 20 October 2015 REGULARS respectively.The former relates to “a method of purifying proteins that is used in the manufacture of abiological product” while the latter –which expired after Sandoz filed its biosimilar – Events – Our regular listing 11 claims “a biological product, the use of abiological product, and the manufacture thereof”. Price Watch UK – UK pricing trends 10 Previously,Amgen had sued Sandoz for allegedly failing to followthe patent-dispute People – Epirus’ chief departs as 16 resolution provisions of the US Biologics Price Competition and Innovation Act (BPCIA) in firm changes tack collaboratively identifying Neulasta patents that may be asserted as infringed (Generics bulletin, 18 March 2016, page 11). However, the latest filing states that the twofirms agreed in April that the twopatents should be “properly included in anyimmediate infringement action”, which PUBLISHED WEEKLY has followed within 30 days of the agreement as per the BPCIA’s strictures. Amgen is seeking Next issue –27May 2016 declarations of infringement, damages and an injunction against Sandoz. The litigation is the latest in aseries of biosimilars and BPCIA-related lawsuits between the twofirms. G Gen 20-5-16 Pgs. 2-16_Layout 1 18/05/2016 17:22 Page 2 COMPANY NEWS BUSINESS STRATEGY/FIRST-QUARTERRESULTS ANNUAL RESULTS/RESULTSFORECAST Biosimilars may not Japanese incentives be corefor Allergan drive Sawai growth iosimilars might not play amajor part in Allergan’sfuture, the overnment promotionofgenerics in Japan helped to push up Bfirm’spresident and chief executive officer,Brent Saunders,told GSawai’ssales by more than asixth in the firm’sfinancial year investors. “Long term, Idonot think biosimilars will necessarily be ended 31 March 2016, as the country worked towards agoal of 60% acore part of our strategy,” he stated, pledging to devote “the vast volume penetration by generics of the off-patent pharmaceuticals majority of our research and development dollars” to the group’s market by March 2017 (Generics bulletin,5June 2016, page 1). core therapeutic categories. “Demand continued to expand as aresult of the policytopromote “The wayIthink about biosimilars, at least overthe next few the use of generics,”Sawai commented, as its sales climbed by 17.1% years, is that for Allergan, we have made most of the investment already to ¥123 billion (US$1.13 billion). While this fell slightly short of the and we have seen good success with most of the programmes [being firm’sexpected figure of ¥124 billion, the company’soperating profit developed] in collaboration with Amgen,”Saunders explained. sailed past its ¥22.0 billion forecast, growing by 12.1% to ¥23.2 billion “Wemay continue to invest in the partnership with Amgen, “due to underspending on selling, general and administrative expenses”. because it has been agood collaboration,”hecontinued. “Wemay Sawai’soperating margin fell by 0.8 percentage points to 18.8%. look at selective opportunitiestoparticipate on aone-offbasis.” Research and development spending grewbyalmost athird to Noting that Allerganpossessed its ownbiologics development ¥8.02 billion, while advertising costs dropped by 1.5% to ¥2.07 billion. capabilities through the former Eden Biodesign site in Liverpool, UK, Among Sawai’s“core products”, volumes grewby11.0% and Saunders said the firm would “participate in the commercialisation” sales increased in value by 11.4%, with the Japanese firm citing in of the biosimilarcandidates being developed through the oncology particular “steady growth” in volumes from cardiovascular and alliance it formed with Amgen more than four years ago (Generics gastrointestinal drugs that each accounted for around aquarter of sales bulletin,13January 2012, page 21). volumes, as well as central nervous system treatments that made up The partners intend to file for biosimilar Avastin (bevacizumab) in just overatenth of units sold. Europe and the US and to get Phase III data on biosimilar Herceptin “Sales through wholesalers expanded,”Sawai commented, as the (trastuzumab)this year (Generics bulletin,13May 2016, page 13). channel accounted for 56.1% of the firm’stotal sales at ¥69.3 billion. Cetuximab and rituximab are in pre-clinical development. Agencies made up 35.3% of sales with ¥43.6 billion, while the remainder Allergan’sbiosimilars interests do not form part of the Actavis came from marketing alliances and other channels. generics operation that the group expects to divest to Teva for US$40.5 Outlining forecasts for its financial year ending 31 March 2017, billion by the end of June (Generics bulletin,13May 2016, page 1). Sawaisaid it expected sales to growby15.8% to ¥143 billion and Highlighting the recent launches of generic Crestor (rosuvastatin) operating profit that would be ahead by 7.8% to ¥25.0 billion –slightly in the US and pemetrexedininternationalmarkets, Allergansaid the higher than the long-term forecastsitset out last year of sales hitting Actavis business had 92 US first-to-file prospects,including generic ¥134 billion and operating profit reaching ¥23.0 billion in the year Abraxane (protein-bound paclitaxel) and Xifaxan (rifaximin). ending March 2017. In the first quarter of this year,Allerganreported sales by its Research and development spending would decelerate, growing ‘discontinued’ global generics business down by aquarter to US$1.26 by just overafifth –21% –to¥9.70 billion as advertising costs grow billion, while operating profit was30% lower at US$251 million. G by 6.2% to ¥2.20 billion, Sawaipredicted. G 20 May2016 Issue 263 Individual subscriptions Te rms &Conditions: These can be viewedinfull at An annual subscription comprises: www.Generics-bulletin.com/subscribe. Editor: Aidan Fry ■ 46 Generics bulletin online editions No partofthis publication maybecopied, reproduced, Deputy
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