MYSTIC, Conn. and DUBLIN, April 5, 2011 /PRNewswire/ -- Amarin Corporation plc (Nasdaq: AMRN), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today announced that data from the MARINE trial, a pivotal Phase 3 study investigating AMR101 as a treatment for very high triglycerides (≥500 mg/dL), will be presented at the National Lipid Association (NLA) 2011 Annual Scientific Sessions at the Sheraton New York Hotel and Towers in New York City
on May 19-22, 2011.
The MARINE trial results will be presented in an abstract titled "AMR101, a Pure-EPA Omega-3 Fatty Acid, Lowers Triglycerides in Patients With Very High Triglycerides Without Raising LDL-C: the MARINE Study" by Harold Bays, M.D., Medical Director, Louisville Metabolic and Atherosclerosis Research Center, and principal investigator of the study. As reported in November 2010, the MARINE study met its primary endpoint of percent change in triglyceride (TG) levels from baseline to week 12, for both the 4 gram and 2 gram dose groups of AMR101. Additionally, the MARINE study demonstrated no statistically significant increase in LDL cholesterol and a safety profile similar to placebo.
Two additional EPA-related abstracts will also be presented at the NLA annual meeting. The abstract titled "Effects of Eicosapentaenoic Acid and Docosahexaenoic Acid on Low-Density Lipoprotein Cholesterol: A Critical Review" will be presented by Terry Jacobson, M.D. from Emory University, Atlanta, GA. The other abstract is titled "Comparative Lipid Antioxidant Effects of Omega-3 Fatty Acids in Combination with HMG-CoA Reductase Inhibitors" and will be presented by Preston Mason, Ph.D. from Elucida Research, Beverly, MA and Harvard Medical School. All three of the studies were sponsored by Amarin.
Following the presentation of MARINE results at the above forum in May, Amarin, together with clinical investigators from the MARINE study, plans to publish additional data from the MARINE trial, including data related to statistically significant reductions in several important lipid and inflammatory markers such as Apo B, Lp-PLA2, VLDL-C, LDL particle number, and total cholesterol.
About the Authors
Harold Bays, M.D.
Harold Bays, M.D., FACP, FACE is Medical Director and President of Louisville Metabolic and Atherosclerosis Research Center (L-MARC). Dr. Bays received his medical degree, completed his Internship and Residency in Internal Medicine, and received his fellowship in endocrinology and metabolism all at the University of Louisville School of Medicine. He is board certified in both internal medicine and endocrinology and metabolism. Dr. Bays has served as a Principal Investigator for over 400 clinical trials, including studies of all currently marketed lipid-altering drug treatments, as well as studies of investigational drugs for obesity, diabetes mellitus, hypertension, osteoporosis, osteoarthritis, and other metabolic disorders. He has written, or has been a contributing author
to over 100 scientific manuscripts and book chapters, and been an author of ~100 scientific abstracts.
Terry Jacobson, M.D.
Dr. Jacobson is Director, Office of Health Promotion and Disease Prevention, Professor of Medicine, Emory University. He is a Member of the Board of Trustees of the National Lipid Association (NLA), and President-Elect of the Southeast Lipid Association (SELA). Dr. Jacobson has authored or coauthored over 150 peer-reviewed articles on coronary heart disease (CHD) risk modification, cost-effectiveness, lipid drug safety, and the dietary and pharmacologic treatment of hyperlipidemia.
Preston Mason, Ph.D.
R. Preston Mason, MBA, PhD, is a faculty member of the Department of Medicine, Division of Cardiology, at the Harvard Medical School-affiliated Brigham and Women's Hospital in Boston, Massachusetts. He is also President and founder of Elucida Research LLC, a private biotechnology firm in Beverly, Massachusetts. Dr. Mason completed his graduate studies in cell biology and biophysics at the University of Connecticut School of Medicine (M.D./Ph.D. predoctoral fellowship). After a 1-year postdoctoral fellowship funded by the American
Heart Association, he joined the faculty at the University of Connecticut School of Medicine in 1991. Dr. Mason's research interests include the biophysics of cell membrane and lipoprotein metabolism, molecular pharmacology, calcium transport mechanisms, and vascular cell membrane alterations during atherogenesis. A frequent lecturer at national and international meetings and academic seminars, Dr. Mason has written or co-authored more than 100 articles, book chapters, and abstracts.
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). On November 29, 2010, the Company reported positive, statistically significant top-line results from the MARINE trial, the first of its Phase 3 clinical trials of AMR101. In the MARINE trial, AMR101 was investigated as a treatment for very high triglycerides (>500 mg/dL). The MARINE and 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.
Investor Contact Information:
Stephen D. Schultz
Investor Relations and Corporate Communications
In U.S.: +1 (860) 572-4979 x292
Lee M. Stern
The Trout Group
In U.S.: +1 (646) 378-2922
Media Contact Information:
David Schull or Martina Schwarzkopf, Ph.D.
In U.S.: +1 (212) 845-4271 or +1 (212) 845-4292 (office)
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SOURCE Amarin Corporation plc