Data for Amarin's AMR101 to be Presented at the National Lipid Association 2012 Annual Scientific Sessions
BEDMINSTER, N.J. and DUBLIN, Ireland, May 24, 2012 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a late-stage biopharmaceutical company focused on cardiovascular disease, today announced that additional data from the AMR101 pivotal Phase 3 studies (MARINE and ANCHOR) will be presented along with an encore presentation of the ANCHOR study by Harold E. Bays M.D., Medical Director, Louisville Metabolic and Atherosclerosis Research Center,at the National Lipid Association (NLA) 2012 Annual Scientific Sessions in Scottsdale, Ariz., on May 31- June 3.
The first poster, titled "AMR101, a Pure Ethyl Eicosapentaenoic Acid Omega-3 Fatty Acid and its Effects on Inflammation-Associated End Points from the MARINE and ANCHOR Studies," will present new data on the effects of AMR101 on inflammatory markers in patients from both Phase 3 studies.
The second poster is titled "A Phase 3, Multicenter, Placebo-Controlled, Randomized, Double-Blind, 12-Week Study to Evaluate the Effect of Two Doses of AMR101 on Fasting Serum Triglycerides and Other Lipid Parameters in Statin-Treated Patients with Persistent High Triglycerides (≥200 and < 500 mg/dL): The ANCHOR Study."
The MARINE study, a multicenter, placebo-controlled, randomized, double-blind, 12-week study, investigated AMR101 as a treatment for very high triglycerides (≥ 500 mg/dL) in 229 patients. The ANCHOR study investigated AMR101 as a treatment for high triglycerides (≥200 and < 500mg/dL) in 702 patients with mixed dyslipidemia (two or more lipid disorders) on background statin therapy who were at LDL-C (low-density lipoprotein cholesterol) goal, and who were also at high risk of cardiovascular disease. Despite the benefits of statin therapy, patients in this population have significant residual risk for cardiovascular events. The data from the ANCHOR study were previously presented at the American Heart Association in November 2011.
AMR101 (icosapent ethyl) is an 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 (≥500 mg/dL), and for patients with high triglyceride levels (≥200 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.
Forward looking statements
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
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)
+1 (347) 591-8785 (mobile)
Source: Amarin Corporation plc
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