TAK-085 Entered into Phase 3 Clinical Programs

December 14, 2009, Osaka, Japan and Lysaker, Norway --- Takeda Pharmaceutical Company Limited (Osaka, Japan, "Takeda") and Pronova BioPharma ASA (OSE: PRON.OL) (Lysaker, Norway, "Pronova") today announced that the advancement of TAK-085 (Compendial name: omega-3 acid ethyl esters 90 (Ph. Eur.)) for the treatment of hypertriglyceridemia into phase 3 clinical programs in Japan.

 

Takeda and Pronova entered into a license and supply agreement and Pronova granted Takeda an exclusive development, marketing and distribution right in Japan. TAK-085 is a highly concentrated preparation of the ethyl esters of omega-3 fatty acids which are predominantly a combination of ethyl esters of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). TAK-085 has already been approved and is commercially available in the U.S. (marketed as LovazaTM), for the treatment of the adult patients with high triglyceride levels -and major European countries including Italy, France, Germany, Spain and U.K., for the treatment of adjuvant treatment in secondary prevention after myocardial infarction, in addition to other standard therapy (e.g. statins, antiplatelet drugs, betablockers, ACE inhibitors) and adult patients with high triglyceride levels.

 

"The initiation of phase 3 trial for TAK-085 in Japan is an important milestone for our company" said Morten Jurs, Chief Executive Officer of Pronova. "We are very pleased with the execution of the development program of TAK-085 performed by Takeda and are encouraged with the progress of the product into phase 3."

 

"We are glad that the development of TAK-085 has been successful and phase 3 clinical programs can be started, so that we may be able to provide it to patients as a new treatment option for hypertriglyceridemia in Japan," said Nancy Joseph-Ridge, M.D., General Manager, Pharmaceutical Development Division of Takeda."

 

 

 

 

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About Pronova

Pronova BioPharma is a global leader in the research, development and manufacture of marine-originated omega-3 derived pharmaceutical products.  Pronova BioPharma's first commercialized product is branded as Omacor® in a number of countries throughout Europe and Asia and as LovazaTM in the United States.  The product is manufactured at the company's plant in Sandefjord, Norway using a unique and complex process.  A new manufacturing plant in Kalundborg, Denmark was approved by European regulatory authorities in November 2009 and is expected to start commercial deliveries in the first quarter of 2010.

 

About Takeda

Takeda, located in Osaka, Japan, is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. Additional information about Takeda is available through its corporate website, www.takeda.com.

 

 

Takeda Pharmaceutical Company Limited

Seizo Masuda

Corporate Communications Dept.

+ 81 (3) 3278-2037

Masuda_Seizo@takeda.co.jp

 

Pronova BioPharma ASA

Hilde H. Steineger

VP Investor Relations and Communication

+47 48 00 42 40

Hilde.steineger@pronova.com

 

 

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