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Omthera Pharmaceuticals Presents Data From Analysis Of EVOLVE Trial Showing That Epanova Lowers ApoC-III, A Key Predictor of Cardiovascular Risk
Date:11/9/2012

PRINCETON, N.J., Nov. 9, 2012 /PRNewswire/ -- Omthera Pharmaceuticals, Inc., a privately held specialty pharmaceuticals company, today announced that Chief Medical Officer, Dr. Michael H. Davidson, recently presented data from the Company's Phase 3 EVOLVE (EpanoVa fOr Lowering Very High triglyceridEs) trial at the Scientific Sessions of the American Heart Association (AHA) in Los Angeles, CA. Dr. Davidson's presentation specifically focused on the effects of Epanova, Omthera's lead, Omega-3 free fatty acid compound for the treatment of patients with hypertriglyceridemia (very high triglycerides), on apolipoprotein C-III (ApoC-III), one of the tertiary endpoints of the EVOLVE study.  Epanova is a patent protected, novel, ultra-pure mixture of the free fatty acid forms of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). ApoC-III, a protein component of very low density lipoprotein (VLDL), is an independent predictor of recurrent coronary events and is found to be elevated in patients suffering from very high triglycerides.  

ApoC-III inhibits lipoprotein lipase activity and hepatic uptake of triglyceride-rich lipoproteins, thereby reducing the conversion of VLDL to LDL and enhancing the formation of more atherogenic small, dense LDL.   Various clinical trials indicate that elevated levels of ApoC-III are an independent risk predictor for coronary heart disease. Lower levels of ApoC-III are associated with lower rates of coronary heart disease, making ApoC-III an important and novel therapeutic target. 

Omthera's EVOLVE trial evaluated 399 patients in four dosing groups: Epanova 2g/day, Epanova 3g/day, Epanova 4g/day and control (olive oil 4g/day).  An analysis of these patients showed statistically significant reductions in ApoC-III of 11% (p=0.022) in the 2g cohort and 14% (p<0.001) in the 4g cohort, compared to olive oil (2%).  

The analysis also showed statistically significant red
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SOURCE Omthera Pharmaceuticals, Inc.
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