AMR101 Phase 3 Study Data in Patients With Diabetes Mellitus (Type 2) to be Presented at the American Diabetes Association's 72nd Scientific Sessions
BEDMINSTER, N.J., and DUBLIN, Ireland, June 4, 2012 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN), a late-stage biopharmaceutical company focused on cardiovascular disease, today announced that data from the AMR101 pivotal Phase 3 ANCHOR study will be presented in a poster at the American Diabetes Association's (ADA) 72nd Scientific Sessions at the Pennsylvania Convention Center in Philadelphia, Pennsylvania on June 9, 2012.
The poster, titled "Effects of AMR101 on Lipid and Inflammatory Parameters in Patients with Diabetes Mellitus-2 (Type 2) and Residual Elevated Triglycerides (200-500 mg/dL) on Statin Therapy at LDL-C Goal: The ANCHOR Study," will present an analysis of the effect on lipid and inflammatory parameters in patients with diabetes from Amarin's Phase 3 ANCHOR study. The ANCHOR study, a multicenter, placebo-controlled, randomized, double-blind, 12-week study, investigated AMR101 as a treatment for patients with high triglycerides (e200 and <500 mg/dL) who were also on statin therapy for elevated low-density lipoprotein cholesterol. Of 702 total patients, 514 (73%) had diabetes mellitus-2.
This poster will be presented by Eliot A. Brinton M.D., FAHA, FNLA, Director of Atherometabolic Research, Utah Foundation for Biomedical Research, and President, Utah Lipid Center, in Salt Lake City. Dr. Brinton has served as President of the Pacific Lipid Association, is a founding board member of the National Lipid Association, and is Vice President of the American Board of Clinical Lipidology.
AMR101 (icosapent ethyl) is a patented, ultra pure omega-3 fatty acid, comprising not less than 96% EPA (icosapent ethyl), that Amarin is developing as a treatment for patients with very high triglyceride levels (e500 mg/dL), and for patients with high triglyceride levels (e200 and <500mg/dL) who are also on statin therapy for elevated low-density lipoprotein cholesterol, or LDL-C, levels (which we refer to as mixed dyslipidemia). The efficacy and safety of AMR101 were studied in two Phase 3 clinical trials, the MARINE trial, which studied patients with very high triglyceride levels, and the ANCHOR trial, which studied patients with high triglyceride levels who were also on statin therapy for elevated LDL-C levels. These two Phase 3 clinical trials showed favorable results in triglyceride reduction compared to placebo in the studied patient populations. Reduction in triglyceride levels was achieved without a statistically significant increase in LDL-C levels, and in the 4 gram AMR101 ANCHOR results, with a statistically significant decrease in LDL-C levels. These trials also showed favorable results, particularly with the 4 gram dose of AMR101, in other important lipid and inflammation biomarkers, including Apo-B, non-HDL-C, Total-Cholesterol, VLDL-C, Lp-PLA2, and hs-CRP. In these trials, AMR101 exhibited a safety profile comparable to placebo. In December 2011, Amarin commenced patient dosing in a cardiovascular outcomes study of AMR101, titled REDUCE-IT (Reduction of Cardiovascular Events with EPA Intervention Trial), that is designed to evaluate the efficacy of AMR101 in reducing major cardiovascular events in a high risk patient population on statin therapy.
Amarin Corporation plc is a late-stage biopharmaceutical company with expertise in lipid science focused on the treatment of cardiovascular disease. Amarin has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for the use of its lead product candidate, AMR101, in the treatment of patients with very high triglyceride levels (the population studied in Amarin's MARINE trial), and the FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of July 26, 2012. Amarin plans to separately seek approval for use of AMR101 in the treatment of patients with high triglyceride levels who are also on statin therapy for elevated LDL-C levels, the population studied in the ANCHOR trial, if the FDA approves the MARINE indication and after the REDUCE-IT cardiovascular outcomes trial is substantially underway. Each of the MARINE, ANCHOR and REDUCE-IT studies is the subject of a Special Protocol Assessment (SPA) agreement with the FDA.
This press release contains forward-looking statements, including statements about the efficacy, safety and therapeutic benefits of Amarin's product candidates, clinical trial results, including statements about the clinical importance of certain biomarkers and the impact of AMR101 on such biomarkers. 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 include the following: uncertainties associated generally with research and development, clinical trials and related regulatory approvals; the risk that SPAs are not a guarantee that FDA will approve a product candidate upon submission; the risk that FDA may not complete its review of the NDA by the PDUFA goal date and the risk that historical clinical trial enrollment and randomization rates may not be predictive of future results. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin 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. Amarin 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.
Amarin's product candidates are in various stages of development and are not available for sale or use outside of approved clinical trials. Nothing in this press release should be construed as marketing the use of such product candidates.
CONTACT: Investor contact information: Stephen D. Schultz Senior Director, Investor Relations and Corporate Communications Amarin Corporation In U.S.: +1 (860) 572-4979 x292 firstname.lastname@example.org Lee M. Stern The Trout Group In U.S.: +1 (646) 378-2922 email@example.com Media Contact Information: David Schull or Martina Schwarzkopf, Ph.D. Russo Partners In U.S.: +1 (212) 845-4271 or +1 (212) 845-4292 (office) +1 (347) 591-8785 (mobile) firstname.lastname@example.org email@example.comSource: Amarin Corporation plc 2012 GlobeNewswire, Inc.