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Omthera Pharmaceuticals, Inc. Announces Initiation of the ECLIPSE Trial: Epanova Compared to Lovaza In a Pharmacokinetic Single-dose Evaluation

08/11/2010

BEDMINSTER, N.J., Nov. 8, 2010 - Omthera Pharmaceuticals, Inc., a privately-held emerging specialty pharmaceuticals company, today announced the initiation of a randomized, open-label, four-way cross-over pharmacokinetics study to evaluate the bioavailability of Epanova™, Omthera's lead compound for the treatment of very high triglycerides, in comparison to Lovaza®, the leading prescription Omega-3.  Epanova is an Omega-3 fatty acid compound containing a novel formulation of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). The primary objective of the four-week study, called ECLIPSE (Epanova Compared to Lovaza In a Pharmacokinetic Single-dose Evaluation), is to compare the bioavailability of EPA from Epanova and Lovaza in either a low or high fat diet setting. 

The study will include 50 subjects.  In the four cross-over periods, all subjects will be given a single 4-gram dose of either Epanova or Lovaza with low and high fat meals.  Data is expected from this study in the first quarter of 2011.

"Several studies have compared the absorption of Omega-3 fatty acids in the ethyl ester and free fatty acid forms and found that the free fatty acid form has up to four times greater bioavailability. Given that Epanova is a free fatty acid form of EPA and DHA, whereas Lovaza is an ethyl ester EPA and DHA product, Epanova may offer distinct advantages in the marketplace," said Dr. Michael Davidson, Chief Medical Officer of Omthera Pharmaceuticals.  "Further, free fatty acid Omega-3s are well absorbed when given with a low fat meal and may therefore have clinical relevance in patients with hypertriglyceridemia who should be maintained on a low fat diet."

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 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 Omthera Pharmaceuticals, Inc.
Founded in 2008, Omthera Pharmaceuticals, Inc. is a privately-held, emerging specialty pharmaceuticals company focusing its efforts on the clinical development of new therapies for dyslipidemia.  Led by a team of experts with exceptional experience in developing new therapies for lipid disorders, Omthera is dedicated to developing innovative therapies for the millions of patients who have elevated triglyceride levels and increased risk of cardiovascular disease.  The lead product candidate is Epanova, an Omega 3 fatty acid compound preparing to enter Phase III clinical development as a triglyceride-lowering adjunct therapy to diet in patients with very high triglycerides (greater than or equal to 500 mg/dL).  Future planned clinical trials for Epanova include patients with high triglycerides (greater than or equal to 200 mg/dL and less than or equal to 500 mg/dL) currently on statin therapy.  Omthera holds worldwide rights to Epanova.