Navigation Links
Omthera Pharmaceuticals Announces Positive Top-Line Results from Phase 3 EVOLVE Study

PRINCETON, N.J., April 26, 2012 /PRNewswire/ -- Omthera Pharmaceuticals, Inc., a privately held specialty pharmaceuticals company, today announced positive top-line data from its EVOLVE (EpanoVa fOr Lowering Very High triglyceridEs) clinical study for Epanova™, the Company's lead compound for the treatment of patients with very high triglycerides.  The Phase 3 clinical trial randomized 399 subjects with triglyceride levels of 500-2000 mg/dl to 2, 3, or 4 grams of Epanova, or 4 grams of olive oil for a total of 12 weeks of treatment. The primary endpoint of the trial was the percentage change in triglyceride level from baseline to week 12, and the secondary endpoint was the reduction in non-HDL-cholesterol.  The top-line results demonstrated highly statistically significant reduction of triglycerides in all dose groups, with median decreases in triglycerides from baseline to end of treatment of approximately 26% in the 2 gram cohort and 31% for those subjects on the 4 gram dose.  Furthermore, Epanova appeared safe and well tolerated, with discontinuation rates due to adverse events, primarily gastrointestinal, ranging from 5% to 7% across all dosing groups.

Commenting on the results, Jerry Wisler, Chief Executive Officer and Co-Founder of Omthera, stated, "We are pleased by the comprehensive lipid benefits shown by Epanova in the EVOLVE study - especially at the 2 gram dose, which demonstrated triglyceride lowering comparable to that of 4 gram doses of other prescription omega-3 products.  This comparable efficacy of Epanova at a significantly lower dose supports the prior demonstration of improved bioavailability of this free fatty acid formulation versus the ethyl ester form found in other prescription Omega 3 products.  The preliminary data also showed dose-dependent increases in plasma EPA and DHA levels with Epanova.  We look forward to completing a comprehensive analysis of the study and aim to present the complete data set at an upcoming scientific meeting."

Dr. Michael Davidson, Co-Founder and Chief Medical Officer of Omthera, stated, "In addition to the triglyceride lowering benefit, we were pleased to observe from these top-line results a meaningful decrease of 8% in non-HDL-cholesterol in both the 2 and 4 gram dose groups.  We believe these data will be important for Epanova in light of the growing reliance of the medical community (Journal of the American Medical Association, March 28, 2012 – Vol 307, No 12) on non-HDL-cholesterol as the more accurate arbiter of the risk for cardiovascular disease, especially in patients with hypertriglyceridemia. We have recently completed enrollment and randomization in ESPRIT, our 647 patient statin combination study.   The primary objective of ESPRIT is to evaluate the efficacy of adding Epanova (2 gram or 4 gram daily) to statin monotherapy for lowering non-HDL-cholesterol.  We look forward to the results from this study, expected in July 2012, to further validate the progression of Epanova as a best-in-class therapy for the treatment of patients with mixed dyslipidemia."

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 ≥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 approximately 35 million of those diagnosed with hypertriglyceridemia (triglycerides greater than 200mg/dL) and an estimated 5 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

Omthera Contact:

Christian Schade

Chief Financial Officer

Omthera Pharmaceuticals


Omthera Media Relations:

Eric Goldman

Vice President Public Relations

Rx Communications Group, LLC


SOURCE Omthera Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Omthera Pharmaceuticals, Inc. to Present at Leerink Swann 2012 Global Healthcare Conference and Citi 2012 Global Healthcare Conference
2. Omthera Pharmaceuticals Announces Positive Long Term Bioavailability Data Comparing Epanova™ to Lovaza®
3. Omthera Pharmaceuticals, Inc. to Present at the 30th Annual J.P. Morgan Healthcare Conference
4. Omthera Pharmaceuticals, Inc. to Present at the 23rd Annual Piper Jaffray Health Care Conference
5. Timothy J. Maines Joins Omthera Pharmaceuticals as Vice President of Quality
6. Omthera Pharmaceuticals, Inc. to Present at the Rodman and Renshaw 13th Annual Healthcare Conference
7. Omthera Pharmaceuticals, Inc. Initiates Phase III ESPRIT Trial of Add-on Epanova™ to Statin Therapy in Patients with Hypertriglyceridemia
8. Christian S. Schade to Join Omthera Pharmaceuticals as Executive Vice President and Chief Financial Officer
9. Drs. Ben Machielse Joins Omthera Pharmaceuticals, Inc. as Chief Operating Officer
10. Omthera Pharmaceuticals, Inc. to Present at the 2011 Wells Fargo Securities Healthcare Conference
11. Omthera Pharmaceuticals, Inc. to Present at the BIO Windhover/Pharmaceutical Strategic Outlook 2011 Conference
Post Your Comments:
(Date:11/26/2015)... DUBLIN , November 26, 2015 ... has announced the addition of the  ... in the European Cell Surface Marker ... Emerging Opportunities"  report to their offering.  ... announced the addition of the  "2016 ...
(Date:11/25/2015)...  Amgen (NASDAQ: AMGN ) today announced the ... the United States (U.S.) Food and ... to Humira ® (adalimumab). Amgen believes this submission ... FDA and represents Amgen,s first BLA submission using the ... M.D., executive vice president of Research and Development at ...
(Date:11/25/2015)... 25, 2015 AAIPharma Services Corp./Cambridge Major ... at least $15.8  Million to expand its laboratories ... . The expansion will provide additional office ... growing demands of the pharmaceutical and biotechnology markets. ... will provide up to 40,000 square feet of ...
Breaking Medicine Technology:
(Date:11/28/2015)... ... ... EST until 11:59 p.m. EST, customers will be racing the clock to ... or more to free gifts with purchases, there will be a new sale available on ... skin care and cosmetic needs, customers will save on already discounted prices. , Top brands ...
(Date:11/27/2015)... (PRWEB) , ... November 27, 2015 , ... According to ... are not changing the way that they are handling security in light of the ... and security presence in an attempt to stop an attack from reaching U.S. soil. ...
(Date:11/27/2015)... ... November 27, 2015 , ... Lizzie’s Lice Pickers just announced ... offering customers 10% off of their purchase of lice treatment product. In addition, customers ... According to a company spokesperson. “Finding lice is a sure way to ruin the ...
(Date:11/27/2015)... ... November 27, 2015 , ... Intellitec Solutions announced today ... Group (MSDSLUG). Recognized as Microsoft’s official group for end users of Dynamics SL ... users, partners, industry experts and representatives. Intellitec Solutions’ membership status demonstrates their ongoing ...
(Date:11/27/2015)... ... 2015 , ... The men and women on this list ... the country. They have overseen financial turnarounds, shown commitment to their community through ... as a whole through their advocacy and professional efforts. , Becker's Hospital Review ...
Breaking Medicine News(10 mins):