PRINCETON, N.J., Jan. 9, 2012 /PRNewswire/ -- Omthera Pharmaceuticals, Inc., a privately held specialty pharmaceuticals company, today announced positive data from a pharmacokinetic study comparing 2 week bioavailability of Epanova™ to Lovaza®. In the 52 subject clinical study, after 14 days of dosing on a low fat diet, plasma EPA and DHA levels were 5.8 fold higher in subjects dosed with Epanova compared to those dosed with Lovaza. Additionally, Epanova increased steady state plasma levels of EPA plus DHA by 448%, compared to 90% for Lovaza.
Commenting on the results, Dr. Michael Davidson, Co-Founder and Chief Medical Officer of Omthera, stated, "We are extremely pleased with these results which confirm the superior bioavailability of Epanova over the leading prescription Omega-3 in the steady state. There is a clear dose response for triglyceride lowering with Omega-3 fatty acids and this data further supports our view that Epanova may well become the new best in class prescription product for addressing the rapidly growing unmet clinical need for the management of hypertriglyceridemia."
John J. P. Kastelein, M.D., Ph.D., Professor of Medicine and Chairman of the Department of Vascular Medicine at the Academic Medical Center (AMC) of the University of Amsterdam, and a member of Omthera's Scientific Advisory Board, noted, "Hypertriglyceridemia and its associated increase in cardiovascular risk has become an epidemic across the world. Prescription Omega-3's, due to their safety and proven efficacy, are ideally suited to provide the clinical solution to this growing problem. The new Epanova data showing marked improvement in long term bioavailability of EPA and DHA is stunning, and enhances my opinion that this will translate into improved triglyceride lowering effects."
President and CEO, Jerry Wisler, will provide an overview of these results during Omthera's corporate presentation at the 30th Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Tuesday, January 10, 2012 at 8:30 am PT.
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 profile.
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, 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. In November, 2011, the Company completed the enrollment of a pivotal Phase III clinical trial for its lead product candidate, Epanova™, an Omega-3 fatty acid compound in development as a triglyceride-lowering adjunct therapy to diet in patients with very high triglycerides (greater than or equal to 500 mg/dL); preliminary data from this study in expected in April, 2012. In August 2011, Omthera initiated a Phase III trial for Epanova in 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. For more information, please visit www.omthera.com
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