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

PRINCETON, N.J., April 26, 2012 /PRNewswire/ -- Omthera Pharmaceuticals, Inc., a privately held specialty pharmaceuticals company, today announced positive top-line data from its EVOLVE (EpanoVa fOr Lowering Very High triglyceridEs) clinical study for Epanova™, the Company's lead compound for the treatment of patients with very high triglycerides.  The Phase 3 clinical trial randomized 399 subjects with triglyceride levels of 500-2000 mg/dl to 2, 3, or 4 grams of Epanova, or 4 grams of olive oil for a total of 12 weeks of treatment. The primary endpoint of the trial was the percentage change in triglyceride level from baseline to week 12, and the secondary endpoint was the reduction in non-HDL-cholesterol.  The top-line results demonstrated highly statistically significant reduction of triglycerides in all dose groups, with median decreases in triglycerides from baseline to end of treatment of approximately 26% in the 2 gram cohort and 31% for those subjects on the 4 gram dose.  Furthermore, Epanova appeared safe and well tolerated, with discontinuation rates due to adverse events, primarily gastrointestinal, ranging from 5% to 7% across all dosing groups.

Commenting on the results, Jerry Wisler, Chief Executive Officer and Co-Founder of Omthera, stated, "We are pleased by the comprehensive lipid benefits shown by Epanova in the EVOLVE study - especially at the 2 gram dose, which demonstrated triglyceride lowering comparable to that of 4 gram doses of other prescription omega-3 products.  This comparable efficacy of Epanova at a significantly lower dose supports the prior demonstration of improved bioavailability of this free fatty acid formulation versus the ethyl ester form found in other prescription Omega 3 products.  The preliminary data also showed dose-dependent increases in plasma EPA and DHA levels with Epanova.  We look forward to completing a comprehensive analysis of the study and aim to present t
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SOURCE Omthera Pharmaceuticals, Inc.
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