Takeda Pharmaceutical Co. Ltd. and Pronova BioPharma Announce Top-line Results of the Pivotal Phase 3 Clinical Trial of TAK-085 in Japan for Treatment of Hypertriglyceridemia
Published: May 10, 2011
May 10, 2011, Osaka, Japan and Lysaker, Norway --- Takeda Pharmaceutical Company Limited (Osaka, Japan, "Takeda") and Pronova BioPharma ASA (Lysaker, Norway, "Pronova") today jointly announced the top-line results of a pivotal phase 3 clinical trial of TAK-085 (Compendial name: omega-3 acid ethyl esters 90).
This is a randomized, double-blind, phase 3 clinical trial to evaluate the efficacy and safety of TAK-085 for patients with hypertriglyceridemia, in comparison with an active comparator, EPA (eicosapentaenoic acid) product already approved in Japan.
The trial consists of three arms, with approximately 200 subjects each, of dosage and administration of 2g and 4g of TAK-085 a day respectively, and 1.8g of EPA a day. The trial demonstrated 4g of TAK-085 was statistically superior to 1.8g of EPA, the recommended daily dose, in lowering the percent change from baseline in triglycerides at the end-of-treatment (primary endpoint measured at 12 weeks). Both two grams of TAK-085 and 1.8g of EPA significantly reduced the same primary endpoint. Additionally, this study demonstrated no statistically significant change in LDL cholesterol in any of the three groups. TAK-085 was safe and well tolerated, with the safety profile comparable to EPA.
Takeda will conduct the full-analysis of the results together with Pronova, and is aiming to submit a New Drug Application in Japan within this fiscal year ending March 31, 2012.
Developed by Pronova, this is the Omega 3-derived prescription drug containing EPA-E (highly purified eicosapentaenoic acid ethyl ester) and DHA-E (highly purified docosahexaenoic acid). It is marketed as LovazaTM in the U.S. with the indication of an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (equal to or in excess of 500 mg/dL) hypertriglyceridemia.
Beside the hypertiglyceridemia indication, in certain European countries including Italy, France, Germany, Spain, the UK, it is also marketed for, adjuvant treatment in secondary prevention after myocardial infarction, in addition to other standard therapy (e.g. statins, antiplatelet drugs, betablockers, ACE inhibitors).
In 2005, Takeda and Pronova entered into a License- and Supply Agreement in which Takeda was granted an exclusive development and marketing right of this product in Japan.
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.
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 over 50 countries and the company is in the process of developing several new, patentable lipid derivatives. Additional information is available on www.pronova.com