Pronova BioPharma ASA : Pronova BioPharma ASA : Lotriga® 2g Now Available for
a Treatment of Hyperlipidemia in Japan
Lysaker, Norway and Osaka, Japan, January 10th, 2013 - Pronova BioPharma ASA
("Pronova") and Takeda Pharmaceutical Company Limited ("Takeda") today
announced that Lotriga® granular capsule 2g (generic name: omega-3-acid ethyl
esters 90) is now available for the treatment of hyperlipidemia in Japan.
Lotriga, discovered by Pronova, is the omega 3-derived prescription drug
containing highly concentrated and purified EPA-E (eicosapentaenoic acid ethyl
ester) and DHA-E (docosahexaenoic acid). It is already on the market in 60
countries including the U.S. and Europe. In 2005, Takeda and Pronova entered
into a License and Supply Agreement in which Takeda was granted an exclusive
development and marketing right to this product in Japan. Lotriga will be the
first prescription medicine in Japan that contains both EPA-E and DHA-E.
In the phase 3 clinical trial conducted in Japan upon submission, the efficacy
and safety of Lotriga for Japanese patients with hypertriglyceridemia
(baseline triglyceride level, 150 to 750 mg/dL) have been evaluated in
comparison with an active comparator EPA (eicosapentaenoic acid, 0.6g thrice
daily, recommended daily dose) product. The trial demonstrated that 2g (once
daily) of Lotriga was equal, and 4g (2g twice daily) of Lotriga was
statistically superior to the EPA, in the percent change of triglycerides from
the baseline. Lotriga was safe and well tolerated, with a safety profile
comparable to the EPA.
CEO Morten Jurs of Pronova, remarked that "We believe Lotriga provides a new
treatment option for hyperlipidemia patients in Japan and we are therefore
very pleased that Takeda has launched Lotriga in the Japanese market. The
launch marks an important milestone in our geographical expansion strategy and
will substantially increase our reach to the patients facing cardiovascular
risks that can gain benefits from this triglyceride reducing treatment."
Masato Iwasaki, Director and Senior Vice President, Pharmaceutical Marketing
Division of Takeda, remarked that "With the launch of Lotriga, we now have a
well-rounded product portfolio in the field of lifestyle diseases such as
diabetes, hypertension and hyperlipidemia. As these diseases are often
concurrent in same patients, we expect that we can contribute further to their
health by providing the treatment regimen in accordance with the individual
Predicted sale of Lotriga in fiscal 2012 is several hundred million yens and
has been included in the latest financial outlook for fiscal 2012, which was
disclosed on October 31st, 2012.
Japanese Brand Name:Lotriga® 2g
Generic Name:omega-3-acid ethyl esters 90
Dosage and Administration:Usually, for adults, 2g of Omega-3-acid ethyl
esters is orally administered immediately after meals once a day. In the case
of high triglyceride level, the dose can be increased 2g twice a day.
About Pronova BioPharma ASA
Pronova is a global leader in research, development and manufacture of lipid
therapies derived from nature. Pronova has developed the first and only EU-
and FDA-approved omega-3 derived prescription drug marketed in 60 countries
and the company is in the process of developing several new, patentable lipid
derivatives. Additional information is available on www.pronova.com.
About Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda 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 strive
towards better health for patients worldwide through leading innovation in
medicine. Additional information about Takeda is available through its
corporate website, www.takeda.com.
Pronova BioPharma ASA
VP Investor Relations and Communications
Takeda Pharmaceutical Company Limited
Corporate Communications Dept. (PR/IR)
This information is subject of the disclosure requirements pursuant to section
5-12 of the Norwegian Securities Trading Act.
This announcement is distributed by Thomson Reuters on behalf of Thomson
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applicable laws; and
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information contained therein.
Source: Pronova BioPharma ASA via Thomson Reuters ONE
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