Data From Amarin's AMR101 Phase 3 MARINE Trial to be Presented at the European Society of Cardiology (ESC) Congress 2011
Additional Data Documenting Positive Phase 3 Trial Results and the Biological Significance of AMR101, a Pure EPA, to be Presented in Paris
BEDMINSTER, N.J., and DUBLIN, Ireland, Aug. 25, 2011 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today announced that data from the pivotal Phase 3 MARINE trial investigating AMR101 as a treatment for very high triglycerides (≥500 mg/dL)will be presented at the European Society of Cardiology (ESC) Congress 2011 at the Parc des Expositions, in Paris from Aug. 27 to 31, 2011.
Harold Bays, M.D., Medical Director, Louisville Metabolic and Atherosclerosis Research Center, and principal investigator of the MARINE study, will give the oral presentation entitled "AMR101, a pure-EPA omega-3 fatty acid, lowers triglycerides in patients with very high triglycerides without raising LDL-C: the MARINE Study" during the session titled "Moving to a better selection of target populations: any progress?" in conference room Brussels (Zone D) on Monday, Aug. 29, at 11 a.m. CEST. As reported in November 2010, the MARINE study met its primary endpoint - the percent change in triglyceride (TG) levels from baseline to week 12 - for both the 4 gram and 2 gram per day dose groups of AMR101.Additionally, the MARINE study demonstrated no statistically significant increase in LDL-cholesterol and a safety profile similar to placebo.
A poster featuring data from the MARINE trial will also be presented at the ESC Congress 2011. The abstract entitled "Effects of AMR101, a Pure EPA Omega-3 Fatty Acid, on the Fatty Acid Profile in Plasma and Red Blood Cells in Patients With Very High Triglycerides (Results From the MARINE Trial)" will be presented by Rene Braeckman, Ph.D., Vice President and Head of Development Operations for Amarin. The poster session will be held in Poster Zone C on Monday, Aug. 29, from 2 to 6 p.m. CEST.
The MARINE trial was sponsored by Amarin.
AMR101 is a prescription-grade omega-3 fatty acid, comprising not less than 96% ultra pure icosapent ethyl (ethyl-EPA), that Amarin is developing as a potentially best-in-class prescription medicine for the treatment of patients with very high triglyceride levels (≥500 mg/dL). AMR101 is also being evaluated as a potentially first-in-class therapy for patients with high triglyceride levels (≥200 and <500mg/dL) who are also on statin therapy for elevated LDL-cholesterol levels. Significant scientific and clinical evidence support the efficacy and safety of ethyl-EPA in reducing triglyceride levels.
Amarin Corporation plc is a clinical-stage biopharmaceutical company with expertise in lipid science focused on the treatment of cardiovascular disease. The Company's lead product candidate is AMR101 (icosapent ethyl). The Company reported positive, statistically significant top-line results for both of its two pivotal Phase 3 clinical trials, the MARINE trial (investigation of AMR101 as a treatment for patients with very high triglycerides [>500 mg/dL]), as reported on November 29, 2010 and the ANCHOR trial (investigation of AMR101 for the treatment of patients on statin therapy with high triglycerides [>200 and <500mg/dL] with mixed dyslipidemia), as reported on April 18, 2011. Both the MARINE and the ANCHOR trials were conducted under Special Protocol Assessment (SPA) agreements with the U.S. Food and Drug Administration (FDA). Amarin also has next-generation lipid candidates under evaluation for preclinical development.
This press release contains forward-looking statements, including statements about presentation and publication of clinical trial results. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. A list and description of these risks, uncertainties and other matters can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
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