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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

s 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 greater than or equal to 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 profile.

About Hypertriglyceridemia Hypertriglyceridemia refers to a condition in which patients have high blood levels of triglycerides and is associated with increased risk of heart disease. It is one component of a range of lipid disorders collectively referred to as dyslipidemia. The overall dyslipidemia population in the U.S. is believed to be in excess of 100 million, with over 27 million of those diagnosed with hypertriglyceridemia (TGs greater than 200mg/dL) and an estimated 5 million with very high triglyceride levels (TGs greater than 500mg/dL). Very high triglycerides are associated with an increased risk of pancreatitis. Regulatory approval for the treatment of very high triglycerides is based on a significant reduction in the serum triglyceride levels.

About Special Protocol Assessments (SPA)A Special Protocol Assessment (SPA) is a binding written agreement between the sponsor and the FDA indicating that the sponsor's proposed trial protocol design, clinical endpoints and statistical analyses are acceptable to support regulatory approval. Final marketing approval depends on efficacy results, adverse event profiles and an evaluation of the benefit/risk of a treatment as demonstrated in the trial.  For further information regarding the SPA process, please visit FDA's website, www.fda.gov.

About Omthera Pharmaceuticals, Inc.Founded in 2008, Omthera Pharmaceuticals, Inc. is a privately held, emerging specialty pharmaceuticals company focusing its
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SOURCE Omthera Pharmaceuticals, Inc.
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