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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

BEDMINSTER, N.J., Aug. 15, 2011 /PRNewswire/ -- Omthera Pharmaceuticals, Inc., a privately-held emerging specialty pharmaceuticals company, announced today that the first patient has been enrolled in its ESPRIT (Epanova combined with a Statin in Patients with HypertRiglycerIdemia to Reduce Non-HDL CholesTerol) Phase III clinical trial of Epanova™, in patients with hypertriglyceridemia (TG level greater than or equal to 200 and < 500 mg/dL) despite treatment with a statin. The trial has been granted a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration.

Epanova, a novel formulation of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), is Omthera's lead compound, currently in development as a prescription omega-3 free fatty acid for the treatment of patients with very high triglycerides (greater than or equal to 500 mg/dL).  The Company's Pivotal Phase III EVOLVE (EpanoVa fOr Lowering Very high triglyceridEs) trial for this indication, which received SPA approval in November 2010, is ongoing, and will form the basis for filing a new Drug Application ("NDA") with the U.S. Food & Drug Administration.  The results of the ESPRIT trial are not required for regulatory approval, but rather, if positive, would serve to expand the use of Epanova to a larger patient population.

The Phase III ESPRIT trial will be a six-week, randomized, double-blind, placebo-controlled, parallel group study to assess the efficacy and safety of add-on Epanova to statin therapy in patients with persistent hypertriglyceridemia despite statin therapy and who remain at high risk for cardiovascular disease.  The primary objective is to evaluate the efficacy of adding Epanova (2g or 4g daily) to statin monotherapy for lowering Non-HDL cholesterol ("Non-HDL-C"). Secondary objectives are to evaluate the safety of the Epanova and stat
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SOURCE Omthera Pharmaceuticals, Inc.
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