Navigation Links
Omthera Pharmaceuticals Announces Invitation to Attend Presentation of the Complete Data Sets from its Phase 3 EVOLVE and ESPRIT Clinical Studies
Date:11/2/2012

PRINCETON, N.J., Nov. 2, 2012 /PRNewswire/ -- Omthera Pharmaceuticals, Inc., a privately held specialty pharmaceuticals company, today announced an invitation to attend the presentation of data from its Phase 3 clinical studies.  The presentation will be held on November 5, 2012 at 7:30 a.m. pst in the Bernards Room at the Millennium Biltmore Hotel, 506 South Grand Avenue, Los Angeles. Participants are also invited to attend the presentation via a live webcast available through the "What's New" section at www.Omthera.com.  The webcast will be available for replay following the presentation.

The Phase 3 EVOLVE (EpanoVa fOr Lowering Very High triglyceridEs) trial was a 12 week, multi-center, randomized, double-blind, study of 399 patients, evaluating the efficacy and safety of three doses of Epanova in patients with fasting triglyceride levels of at least 500 mg/dL but less than 2000 mg/dL.  Patients were randomized into four dosing groups: Epanova 2g/day; Epanova 3g/day; Epanova 4g/day; and control (olive oil 4 g/day).  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-C.

The Phase 3 ESPRIT (Epanova combined with a Statin in Patients with HypertRiglycerIdemia to Reduce Non-HDL CholesTerol) trial was a six-week, randomized, double-blind, parallel group study of 647 patients to assess the efficacy and safety of add-on Epanova to statin therapy in patients with persistent hypertriglyceridemia and high risk for cardiovascular disease. Patients were randomized into three dosing groups; Epanova 2g/day; Epanova 4g/day; and control (olive oil 4 g/day).  The primary objective of the study was to evaluate the efficacy of adding Epanova (2g or 4g daily) to statin monotherapy for lowering Non-HDL-C. Secondary objectives are to evaluate the safety of the Epanova and statin combination therapies, and to evaluate the effects of the combination therapies on TG and other lipids and lipoproteins.

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 HypertriglyceridemiaHypertriglyceridemia 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   Omthera Contact: Omthera Media Relations:Christian Schade

Eric GoldmanChief Financial Officer

Vice President Public RelationsOmthera Pharmaceuticals

Rx Communications Group, LLC908-741-6402

917-322-2563CSchade@Omthera.com

egoldman@rxir.com


'/>"/>
SOURCE Omthera Pharmaceuticals, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Omthera Pharmaceuticals Announces Positive Top-Line Results from Phase 3 EVOLVE Study
2. Savient Pharmaceuticals to Hold First Quarter 2012 Financial Results Conference Call on Wednesday, May 9, 2012
3. Auxilium Pharmaceuticals to Present at the Deutsche Bank 37th Annual Healthcare Conference
4. Nouveau Life Pharmaceuticals (HRID) Contracts with U.S. Manufacturer to Produce New Female Supplement
5. BioElectronics Survey Indicates a Five-Fold Superior Pain Relief Compared to OTC Pharmaceuticals
6. Icahn Issues Statement Regarding Amylin Pharmaceuticals
7. Almost 50 Percent of the Glaucoma Patient Population Remains Untreated, Signifying a Vast Market for Glaucoma Pharmaceuticals, Finds Frost & Sullivan
8. Onyx Pharmaceuticals Announces FDA Advisory Committee to Review Carfilzomib for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma
9. Jazz Pharmaceuticals Announces First Quarter 2012 Financial Results Conference Call On May 8, 2012
10. Inovio Pharmaceuticals Granted U.S. Patent Protection for Synthetic Vaccine for Cervical Dysplasia and Cancer
11. Avanir Pharmaceuticals To Present at Three Conferences In May
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/25/2016)... 25, 2016 According to market ... Growth and Demand Forecast to 2022 - Industry Insights ... Others)" published by P&S Market Research, the global insulin ... 2015, and it is expected to grow at a ... insulin pump segment is expected to witness the fastest ...
(Date:5/25/2016)... Digital Health Dialog, LLC dba EngagedMedia ... US Patent and Trademark Office of U.S. Patent ... for electronic opt-­in and processing of discount coupons ... compliance and otherwise. Logo - http://photos.prnewswire.com/prnh/20160524/371583LOGO ... "Our technology allows for individuals to opt­-in to ...
(Date:5/25/2016)... ReportsnReports.com adds "Chronic Cough ... provides an overview on therapeutic pipeline of Chronic ... therapeutics assessment by drug target, mechanism of action ... along with latest updates, and featured news and ... in the therapeutic development for Chronic Cough and ...
Breaking Medicine Technology:
(Date:5/27/2016)... ... May 27, 2016 , ... This campaign aims to provide a path to ... society can control and change. , As nearly 795,000 Americans suffering from a new ... United States. Plus, with an estimated 129,000 of these people dying from stroke, it’s ...
(Date:5/27/2016)... ... May 27, 2016 , ... ... bolstered by inspiring human interest stories, courtesy of leaders in the nursing and ... within the industry, from leading advocates and associations—namely Jones & Bartlett Learning. , ...
(Date:5/26/2016)... (PRWEB) , ... May 26, 2016 , ... Despite last ... meeting, expect Janet Yellen and company to wait until March 2017 for an interest ... University’s J. Mack Robinson College of Business. , “The Federal Open Market Committee (FOMC) ...
(Date:5/26/2016)... ... May 26, 2016 , ... ... outcomes, hosted members and suppliers for its inaugural Member Conference at the Paris ... mission of elevating the operational health of America’s healthcare providers. , The conference ...
(Date:5/26/2016)... ... May 26, 2016 , ... The Woodlands at John ... a new model of care for living and healing, celebrated its grand opening, today. ... in a Real Home provided by Empowered Staff. , “This is an incredibly fulfilling ...
Breaking Medicine News(10 mins):