–EPA therapy demonstrates a wide range of lipid lowering benefits
without the LDL-C increase as seen with omega-3s containing DHA–
-Amarin’s AMR101 contains >96% EPA -
NEW YORK, May 19, 2011 – Amarin Corporation plc (Nasdaq: AMRN), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, announced that three Amarin-sponsored studies on the benefits of pure EPA (icosapent ethyl) will be presented today at the National Lipid Association 2011 Annual Scientific Sessions (NLA) in New York City. The NLA is an association of clinical lipidologists, lipid researchers and allied clinical team members comprising of a total of five regional chapters representing more than 3,500 members from across the United States.
These papers cover the following topics:
• MARINE Phase 3 pivotal trial results in patients with very high triglyceride levels (>500 mg/dL)
• A critical review of the comparative effects of EPA and DHA on low-density lipoprotein cholesterol (LDL-C), and
• The antioxidant effects of omega-3 fatty acids in combination with HMG-CoA reductase inhibitors (atorvastatin)
MARINE Phase 3 Pivotal Trial Results (Abstract 114)
In the MARINE study, the largest study of omega-3 fatty acids in this population, AMR101 (pure EPA) significantly reduced triglycerides at both the 4 and 2 gram per day doses in patients with very high triglycerides (>500 mg/dL). While top-line data for MARINE was reported by the Company in November 2010, the NLA-presented poster provides additional data on efficacy endpoints, patient demographics and safety and tolerability of AMR101. In a separate release, the Company discloses additional details from this poster. The MARINE study results, as summarized in this poster, will be presented by its principal investigator, Harold Bays, M.D., Medical Director of Louisville Metabolic and Atherosclerosis Research Center. This is the first time these MARINE results will be presented at a medical and scientific forum.
Comparative Effects of EPA and DHA on LDL-C (Abstract 106)
This paper will present an evaluation of results from 22 published studies discussing the effects of EPA and DHA on LDL-C. Across all studies (n=22), LDL-C increased from baseline in 75% of DHA−treated groups (by 0.2%−16.0%) compared with 40% of EPA−treated groups (by 0.3%−6.5%). The results also showed that both DHA and EPA monotherapies could lower triglyceride levels. The poster is authored by Terry Jacobson, M.D., director of the Office of Health Promotion and Disease Prevention and Professor of Medicine, Emory University.
EPA as an Inhibitor of Lipid Oxidation (Abstract 107)
The paper will present data that shows EPA is a potent inhibitor of lipid oxidation at both normal and elevated cholesterol levels and that antioxidant activity was enhanced in combination with statins. The ability of EPA to prevent oxidation of lipids was significantly greater than DHA (p<0.001). The oxidative modification of polyunsaturated fatty acids in low-density lipoproteins is causally related to atherogenesis. The poster discussing EPA as an inhibitor of lipid oxidation is authored by Preston Mason, Ph.D., faculty member of the Department of Medicine, Division of Cardiology, at the Harvard Medical School-affiliated Brigham and Women's Hospital.
Commenting on the NLA abstracts, Paresh Soni, MD, PhD, SVP and Head of Development stated, “We are pleased that the MARINE trial results are getting attention in a forum of specialists in the lipidology field and that the papers on comparative effects of EPA/DHA and oxidation inhibition further support the benefits of AMR101, which is >96% EPA.”
AMR101 is a prescription-grade omega-3 fatty acid, comprising not less than 96% ultra pure EPA(icosapent ethyl), 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) and 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 (which we refer to as mixed dyslipidemia). Significant scientific and clinical evidence support the efficacy and safety of ethyl-EPA in reducing triglyceride levels and other important lipid and inflammation biomarkers, including Apo-B, non-HDL-C, Total-Cholesterol, VLDL-C, Lp-PLA2, and hs-CRP without increasing LDL-C. AMR101 demonstrated a safety profile comparable to placebo in both trials.
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 the efficacy, safety and benefits of the Company's product candidates and the timing of data publication. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein are the following: anticipated operating losses and the likely need for additional capital to fund future operations; uncertainties associated generally with research and development, clinical trials and related regulatory approvals; the risk that SPAs are not a guarantee that FDA will accept an NDA or approve a product candidate upon submission; the risk that historical clinical trial enrolment and randomization rates may not be predictive of future results; uncertainties relating to the timing of data collection and analysis for the ANCHOR and MARINE trials; dependence on third-party manufacturers, suppliers and collaborators; significant competition; loss of key personnel; and uncertainties associated with market acceptance and adequacy of reimbursement, technological change and government regulation. A further 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 and its most recent Quarterly Report on Form 10-Q. 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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