BEDMINSTER, N.J., and DUBLIN, Ireland, July 24, 2012 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a late-stage biopharmaceutical company focused on cardiovascular disease, announced today that the results of its pivotal ANCHOR Phase 3 clinical trial are now available electronically through The American Journal of Cardiology and are scheduled for print publication in the October 2012 issue.
The publication, titled "Efficacy and Safety of Eicosapentaenoic Acid Ethyl Ester (AMR101) Therapy in Statin-Treated Patients With Persistent High Triglycerides (from the ANCHOR study)," describes the previously reported results of the Phase 3 ANCHOR clinical trial of Amarin's product candidate AMR101, in which all primary and secondary endpoints were achieved.
The ANCHOR trial, a multicenter, placebo-controlled, randomized, double-blind, 12-week 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 at LDL-C (low-density lipoprotein cholesterol) goal who were at high risk of cardiovascular disease. The trial was conducted under a Special Protocol Assessment (SPA) agreement with the FDA. The trial's primary endpoint was defined as the percentage change in triglyceride levels from baseline compared to placebo after twelve weeks of treatment.
"The ANCHOR trial results exemplify why AMR101 has the potential to become an important lipid-lowering therapy. Not only did AMR101 demonstrate statistically significant decreases in triglyceride levels, but it did so with a statistically significant decrease in LDL-C beyond the decrease from optimized statin therapy at the 4 gram dose and showed non-inferiority at the 2 gram dose," stated Christie M. Ballantyne, M.D., Baylor College of Medicine and the Methodist DeBakey Heart and Vascular Center, Houston, Texas, and principal investigator of the ANCHOR trial. "In addition to reductions in triglycerides and LDL-C reductions, AMR101 also demonstrated statistically significant reductions in non-HDL-C, Apo-B, Lp-PLA2 and VLDL-C, all important lipid biomarkers. The favorable ANCHOR trial results provide a strong rationale for conducting Amarin's REDUCE-IT trial, the cardiovascular outcomes study of AMR101, which is currently recruiting patients at high risk for cardiovascular events."
About AMR101
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 (≥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, an investigational drug, 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.
About Amarin
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, timing of publication, 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 or grant new chemical entity regulatory exclusivity to AMR101; the risk that historical clinical trial enrollment and randomization rates may not be predictive of future results and related cost may increase beyond expectations; and the risk that publications of scientific data may not accept proposals to publish AMR101 data. 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 promoting the use of such product candidates.