After entering into a license and supply agreement, Pronova granted Takeda exclusive development, marketing and distribution rights 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 EPA and DHA.
TAK-085 has already been approved and is commercially available in the U.S. (marketed as Lovaza), for the treatment of adult patients with high triglyceride levels—as well as 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 (e.g., statins, antiplatelet drugs, betablockers, ACE inhibitors) and adult patients with high triglyceride levels.
"The initiation of phase 3 trial for TAK-085 in Japan is an important milestone for our company," said Morten Jurs, CEO of Pronova. "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."
"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," said Nancy Joseph-Ridge, MD, general manager, Pharmaceutical Development Division of Takeda.