Pronova BioPharma ASA ("Pronova") and Takeda Pharmaceutical Company Limited ("Takeda") today announced that the Japanese Ministry of Health, Labour and Welfare has approved a New Drug Application (NDA) of Lotriga granular capsule 2g (generic name: omega-3-acid ethyl esters 90) for the treatment of hyperlipidemia.

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 ethyl ester). 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 the 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.

The results of the phase 3 clinical trial conducted in Japan upon submission, has evaluated the efficacy and safety of Lotriga for Japanese patients with hypertriglyceridemia [baseline triglyceride level, 150 to 750 mg/dL], 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 equally, and 4g (2g twice daily) of Lotriga was statistically superior to the EPA, in lowering the percent change from baseline in triglycerides. Lotriga was safe and well tolerated, with a safety profile comparable to the EPA.

Upon approval, Pronova and Takeda are confident that Lotriga will be able to contribute to patients living with hyperlipidemia in Japan as a valuable new treatment option.

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.
Indication: Hyperlipidemia

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

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.www.takeda.com

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