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Omthera Pharmaceuticals, Inc. Initiates Phase III ESPRIT Trial of Add-on Epanova™ to Statin Therapy in Patients with Hypertriglyceridemia
Date:8/15/2011

in combination therapies, and to evaluate the effects of the combination therapies on other lipids and lipoproteins.  The trial is expected to enroll 642 subjects and will be conducted at approximately 100 sites in the U.S.  

Principal investigator for the ESPRIT study, Dr. Stephen Nicholls, Assistant Professor of Molecular Medicine and the Cardiovascular Director of the Cleveland Clinic Coordinating Center for Clinical Research and a consultant for Omthera Pharmaceuticals, noted, "Millions of Americans treated with statins, are still at risk for cardiovascular events.  Non-HDL-C is an important target of drug therapy for patients on a statin with TG between 200 and 500 mg/dL.  The results of this trial, if positive, could further support the use of omega-3 free fatty acids as a treatment for these patients."

Dr. Michael Davidson, Chief Medical Officer and co-Founder of Omthera, stated, "The development of Epanova, which has the potential to become the best in class omega-3 fatty acid, is well underway.  Data generated earlier this year demonstrated that Epanova has superior bioavailability compared to the market leader, Lovaza®, and our EVOLVE trial, intended to support our planned NDA filing, has been actively enrolling subjects.  Today, with the initiation of the ESPRIT trial, we have now taken a further step to potentially expand the indication to include patients with persistent hypertriglyceridemia and high risk for cardiovascular disease, who are on statin therapy, for which there are currently no approved prescription omega-3 drugs."

About Epanova™Epanova is a patent protected, novel, ultra-pure mixture of the free fatty acid forms of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Omthera has developed a substantial body of data on Epanova, which points to an improved and more predictable bioavailability as compared to the ethyl ester form found in prescription Omega 3 product
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SOURCE Omthera Pharmaceuticals, Inc.
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