Pronova BioPharma ASA : Pronova BioPharma ASA : Lotriga® 2g Now Available for a Treatment of Hyperlipidemia in Japan Lysaker, Norway and Osaka, Japan, January 10th, 2013 - Pronova BioPharma ASA ("Pronova") and Takeda Pharmaceutical Company Limited ("Takeda") today announced that Lotriga® granular capsule 2g (generic name: omega-3-acid ethyl esters 90) is now available for the treatment of hyperlipidemia in Japan. 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 U.S. 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 3 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. CEO Morten Jurs of Pronova, remarked that "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, remarked that "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 31st, 2012. <Reference> Japanese Brand Name:Lotriga® 2g Generic Name:omega-3-acid ethyl esters 90 Dosage and Administration: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. Indication:Hyperlipidemia 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 60 countries and the company is in the process of developing several new, patentable lipid derivatives. Additional information is available on www.pronova.com. 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. Media Contacts: Pronova BioPharma ASA Hamed Brodersen, VP Investor Relations and Communications Tel: +47-40-46-81-10 Takeda Pharmaceutical Company Limited Corporate Communications Dept. (PR/IR) Tel: +81-3-3278-2037 This information is subject of the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act. ------------------------------------------------------------------------------ This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients. The owner of this announcement warrants that: (i) the releases contained herein are protected by copyright and other applicable laws; and (ii) they are solely responsible for the content, accuracy and originality of the information contained therein. Source: Pronova BioPharma ASA via Thomson Reuters ONE HUG#1669223
Pronova BioPharma ASA : Pronova BioPharma ASA : Lotriga® 2g Now Available for a Treatment of Hyperlipidemia in Japan
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