Pronova BioPharma ASA : LotrigaÂ® 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 LotrigaÂ® 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:Â LotrigaÂ® 2g
Generic Name:Â omega-3-acid ethyl esters 90
Dosage and Administration:Â 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,
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.
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Source: Pronova BioPharma ASA via Thomson Reuters ONE