Pronova BioPharma ASA (Pronova), a global leader in research, development and manufacture of lipid therapies derived from nature, and Takeda Pharmaceutical Company Limited (Takeda) have introduced Lotriga granular capsule 2g (omega-3-acid ethyl esters 90) in Japan for the treatment of hyperlipidemia.

Lotriga, 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 60 countries including the US and Europe. In 2005, Takeda and Pronova entered into a license and supply agreement in which Takeda was granted an exclusive development and marketing right to this product in Japan. Lotriga will be the first prescription medicine in Japan that contains both EPA-E and DHA-E.

In the phase III clinical trial conducted in Japan upon submission, the efficacy and safety of Lotriga for Japanese patients with hypertriglyceridemia (baseline triglyceride level, 150 to 750 mg/dL) have been evaluated in comparison with an active comparator EPA (eicosapentaenoic acid, 0.6g thrice daily, recommended daily dose) product. The trial demonstrated that 2g (once daily) of Lotriga was equal, and 4g (2g twice daily) of Lotriga was statistically superior to the EPA, in the percent change of triglycerides from the baseline. Lotriga was safe and well tolerated, with a safety profile comparable to the EPA.

Morten Jurs, CEO of Pronova, said, “We believe Lotriga provides a new treatment option for hyperlipidemia patients in Japan and we are therefore very pleased that Takeda has launched Lotriga in the Japanese market. The launch marks an important milestone in our geographical expansion strategy and will substantially increase our reach to the patients facing cardiovascular risks that can gain benefits from this triglyceride reducing treatment.”

Masato Iwasaki, director and senior vice president, Pharmaceutical Marketing Division of Takeda, said, “With the launch of Lotriga, we now have a well-rounded product portfolio in the field of lifestyle diseases such as diabetes, hypertension and hyperlipidemia. As these diseases are often concurrent in same patients, we expect that we can contribute further to their health by providing the treatment regimen in accordance with the individual pathologic conditions.”

Predicted sale of Lotriga in fiscal 2012 is several hundred million yens and has been included in the latest financial outlook for fiscal 2012, which was disclosed on October 31, 2012.

Usually, for adults, 2g of Omega-3-acid ethyl esters is orally administered immediately after meals once a day. In the case of high triglyceride level, the dose can be increased 2g twice a day.