Pronova BioPharma ASA ("Pronova") and Takeda Pharmaceutical Company Limited ("Takeda") today announced that Takeda submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare for TAK-085 (generic name: omega-3-acid ethyl esters 90) for the treatment of hyperlipidemia.
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). It is already on the market in 56 countries including the U.S. and most European countries. 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.
This submission is based on the results of the phase 3 clinical trial to evaluate the efficacy and safety of TAK-085 for patients with hypertriglyceridemia [baseline triglyceride level, 150 to 750 mg/dL], in comparison with an active comparator EPA (eicosapentaenoic acid) product already marketed in Japan. The trial demonstrated that 4g per day (2g twice daily) of TAK-085 was statistically superior to 1.8g per day (0.6g thrice daily, the recommended daily dose) of the EPA, in lowering the percent change from baseline in triglycerides (primary endpoint measured at 12 weeks). TAK-085 was safe and well tolerated, with a safety profile comparable to the EPA.
Pronova and Takeda will continue to work closely together to ensure that upon approval this drug is able to significantly impact the lives of as many patients as possible living with hyperlipidemia in Japan.
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 56 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.