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Omthera Pharmaceuticals Announces Positive Top-Line Results from Phase 3 EVOLVE Study
Date:4/26/2012

he complete data set at an upcoming scientific meeting."

Dr. Michael Davidson, Co-Founder and Chief Medical Officer of Omthera, stated, "In addition to the triglyceride lowering benefit, we were pleased to observe from these top-line results a meaningful decrease of 8% in non-HDL-cholesterol in both the 2 and 4 gram dose groups.  We believe these data will be important for Epanova in light of the growing reliance of the medical community (Journal of the American Medical Association, March 28, 2012 – Vol 307, No 12) on non-HDL-cholesterol as the more accurate arbiter of the risk for cardiovascular disease, especially in patients with hypertriglyceridemia. We have recently completed enrollment and randomization in ESPRIT, our 647 patient statin combination study.   The primary objective of ESPRIT is to evaluate the efficacy of adding Epanova (2 gram or 4 gram daily) to statin monotherapy for lowering non-HDL-cholesterol.  We look forward to the results from this study, expected in July 2012, to further validate the progression of Epanova as a best-in-class therapy for the treatment of patients with mixed dyslipidemia."

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 products currently available.  Triglyceride lowering with Epanova was previously observed in two large, placebo-controlled, randomized, double-blind, Phase III studies involving 748 Crohn's disease patients with normal triglyceride levels for ≥52 weeks, approximately 400 of which were treated with Epanova for remission of disease. In all studies performed to date, Epanova has demonstrated a very good safety and tolerability pr
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SOURCE Omthera Pharmaceuticals, Inc.
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