TAK-085 Entered into Phase 3 Clinical Programs
(Thomson Reuters ONE) - December 14, 2009, Osaka, Japan and Lysaker, Norway --- TakedaPharmaceutical Company Limited (Osaka, Japan, "Takeda") and PronovaBioPharma ASA (OSE: PRON.OL) (Lysaker, Norway, "Pronova") todayannounced that the advancement of TAK-085 (Compendial name: omega-3acid ethyl esters 90 (Ph. Eur.)) for the treatment ofhypertriglyceridemia into phase 3 clinical programs in Japan.Takeda and Pronova entered into a license and supply agreement andPronova granted Takeda an exclusive development, marketing anddistribution right in Japan. TAK-085 is a highly concentratedpreparation of the ethyl esters of omega-3 fatty acids which arepredominantly a combination of ethyl esters of eicosapentaenoic acid(EPA) and docosahexaenoic acid (DHA). TAK-085 has already beenapproved and is commercially available in the U.S. (marketed asLovazaTM), for the treatment of the adult patients with hightriglyceride levels -and major European countries including Italy,France, Germany, Spain and U.K., for the treatment of adjuvanttreatment in secondary prevention after myocardial infarction, inaddition to other standard therapy (e.g. statins, antiplatelet drugs,betablockers, ACE inhibitors) and adult patients with hightriglyceride levels."The initiation of phase 3 trial for TAK-085 in Japan is an importantmilestone for our company" said Morten Jurs, Chief Executive Officerof Pronova. "We are very pleased with the execution of thedevelopment program of TAK-085 performed by Takeda and are encouragedwith the progress of the product into phase 3.""We are glad that the development of TAK-085 has been successful andphase 3 clinical programs can be started, so that we may be able toprovide it to patients as a new treatment option forhypertriglyceridemia in Japan," said Nancy Joseph-Ridge, M.D.,General Manager, Pharmaceutical Development Division of Takeda." # # #About PronovaPronova BioPharma is a global leader in the research, development andmanufacture of marine-originated omega-3 derived pharmaceuticalproducts. Pronova BioPharma's first commercialized product isbranded as Omacor® in a number of countries throughout Europe andAsia and as LovazaTM in the United States. The product ismanufactured at the company's plant in Sandefjord, Norway using aunique and complex process. A new manufacturing plant in Kalundborg,Denmark was approved by European regulatory authorities in November2009 and is expected to start commercial deliveries in the firstquarter of 2010.About TakedaTakeda, located in Osaka, Japan, is a research-based global companywith its main focus on pharmaceuticals. As the largest pharmaceuticalcompany in Japan and one of the global leaders of the industry,Takeda is committed to striving toward better health for individualsand progress in medicine by developing superior pharmaceuticalproducts. Additional information about Takeda is available throughits corporate website, www.takeda.com.Contacts:Takeda Pharmaceutical Company LimitedSeizo MasudaCorporate Communications Dept.+ 81 (3) 3278-2037Masuda_Seizo(at)takeda.co.jpPronova BioPharma ASAHilde H. SteinegerVP Investor Relations and Communication+47 48 00 42 40Hilde.steineger(at)pronova.com # # #http://hugin.info/137506/R/1360669/332108.pdfThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 14.12.2009 - 08:15 Uhr
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