Omega-3 entered into Phase 3 clinical programs in Japan

Takeda Pharmaceutical Company Limited (Osaka, Japan, “Takeda”) and Pronova BioPharma ASA (OSE: PRON.OL) (Lysaker, Norway, “Pronova”) today announced that the advancement of TAK-085 (Compendial name: omega-3 acid ethyl esters 90 (Ph. Eur.)) 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 U.S. (marketed as LovazaTM), for the treatment of the adult patients with high triglyceride levels -and major European countries including Italy, France, Germany, Spain and U.K., for the treatment of adjuvant treatment in secondary prevention after myocardial infarction, in addition to other standard therapy (e.g. statins, antiplatelet drugs, betablockers, ACE inhibitors) and adult patients with high triglyceride levels.

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