Pronova opens up Japanese market
Lysaker/Osaka - Pronova Biopharma SA is set on entering the Japanese market with its TAK-085 (omega-3-acid ethyl esters 90) for the treatment of hyperlipidemia. Pronova's partner Takeda Pharmaceutical Company Limited submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare. Their application is the fruit of a long-standing relationship. In 2005, Takeda and Pronova entered into a License and Supply Agreement in which Takeda was granted the exclusive development and marketing rights to this product in Japan. TAK-085, 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). The submission is based on the results of the phase 3 clinical trial to evaluate the efficacy and safety of TAK-085 in comparison with an active comparator EPA product already marketed in Japan. The trial demonstrated that 4g per day of TAK-085 was statistically superior to 1.8g per day of the EPA. The drug is already on the market in 56 countries including the U.S. and most European countries.