2009-12-14 08:19:27 -
London, December , 14, 2009
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 OmacorĀ® 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.
Contacts:
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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