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Omthera Pharmaceuticals, Inc. Presents Data From Analysis of EVOLVE Trial Showing That Epanova Lowers ApoC-III, a Key Predictor of Cardiovascular Risk


11/9/2012 11:39:04 AM

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 reductions in TG of 26% (p=0.003) in the 2g cohort and 31% (p<0.001) among patients in the 4g cohort, compared to 4% for olive oil. There was also statistically significant reduction in Non-HDL-C in all dose groups, with decreases in Non-HDL-C of approximately 8% (p<0.05) in the 2g cohort and 10% (p<0.01) in the 4g cohort. Non-HDL-C is widely viewed as the most accurate predictor of cardiovascular disease. Reductions in ApoC-III were associated with the expected increase in HDL-C with an increase conversion of VLDL to LDL leading to an increase in LDL-C. There was also an increase in LDL particle size. Independent studies suggest that Omega-3 fatty acid formulations containing DHA alone, decrease TG and VLDL-C levels and increase LDL-C levels in patients with severe hypertriglyceridemia and that those containing EPA alone, lower triglycerides (TG) to a similar extent as EPA and DHA, but also fail to lower ApoC-III.

Commenting on these results, Dr. Davidson noted, "ApoC-III represents a key link between hypertriglyceridemia and the probability of coronary events. We are therefore highly encouraged by the data from this analysis of the EVOLVE trial, which shows the unique effects of Omega-3 products containing both EPA+DHA, like Epanova, on this important marker of cardiovascular risk. These findings highlight the importance of incorporating both EPA and DHA in patient therapy to provide comprehensive risk management for those with hypertriglyceridemia."

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 Omega3 products currently available. Triglyceride, as well as Non-HDL-C lowering with Epanova was recently observed in the Company's 1,000 patient, global Phase 3 program, consisting of its EVOLVE (EpanoVa fOr Lowering Very High triglyceridEs) and ESPRIT (Epanova combined with a Statin in Patients with HypertRiglycerIdemia to Reduce Non-HDL CholesTerol) clinical trials. In all studies performed to date, Epanova has also 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 approximately 40 million of those diagnosed with hypertriglyceridemia (triglycerides greater than 200mg/dL) and an estimated 4 million with very high triglyceride levels (triglycerides 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 pharmaceutical 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. Omthera holds worldwide rights to Epanova under a license from Chrysalis Pharma AG, a privately held Swiss company that is the owner of the product. For more information, please visit www.omthera.com

Contact:
Christian Schade
Chief Financial Officer
Omthera Pharmaceuticals
908-741-6402
CSchade@Omthera.com

SOURCE Omthera Pharmaceuticals, Inc.


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