Takeda, Pronova BioPharma Advances TAK-085 Into Phase 3 Clinical Study

Takeda and Pronova BioPharma have announced that the advancement of TAK-085 (omega-3 acid ethyl esters 90) for the treatment of hypertriglyceridemia into Phase 3 clinical programs in Japan. Takeda and Pronova entered into a license and supply agreement and Pronova granted Takeda an exclusive development, marketing and distribution right in Japan.

TAK-085 is a highly concentrated preparation of the ethyl esters of omega-3 fatty acids which are predominantly a combination of ethyl esters of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).

TAK-085 has already been approved and is commercially available in the US (marketed as Lovaza), for the treatment of the adult patients with high triglyceride levels -and major European countries including Italy, France, Germany, Spain and the UK, for the treatment of adjuvant treatment in secondary prevention after myocardial infarction, in addition to other standard therapy (statins, antiplatelet drugs, betablockers, ACE inhibitors) and adult patients with high triglyceride levels.

Morten Jurs, chief executive officer of Pronova, said: “The initiation of phase 3 trial for TAK-085 in Japan is an important milestone for our company. We are very pleased with the execution of the development program of TAK-085 performed by Takeda and are encouraged with the progress of the product into phase 3.”

Nancy Joseph-Ridge, general manager of pharmaceutical development division at Takeda, said: “We are glad that the development of TAK-085 has been successful and phase 3 clinical programs can be started, so that we may be able to provide it to patients as a new treatment option for hypertriglyceridemia in Japan.”