Full Press Release Details
BEDMINSTER, N.J. and DUBLIN, Ireland, Nov. 15, 2011 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a late-stage biopharmaceutical company with a focus on cardiovascular disease, today announced the presentation of data from Amarin's Phase 3 clinical trial, the MARINE study, in which patients with very high trigylcerides ( 500 mg/dl) treated with 4 grams per day of AMR101 experienced a significant reduction in median placebo-adjusted lipoprotein particle concentrations of total low-density lipoprotein (LDL) and small LDL. The data were presented by Harold Bays, M.D., Medical Director of Louisville Metabolic and Atherosclerosis Research and principal investigator of the MARINE trial, at the American Heart Association's Scientific Sessions in Orlando, Fla.
When looking at lipoprotein particle concentrations and sizes as measured with nuclear magnetic resonance spectroscopy, AMR101 4 grams per day, compared with placebo, significantly reduced median total LDL particle count by 16.3% (P=0.0006), which is an important factor in atherogenesis. This is consistent with, and directly linked to, Amarin's previously reported statistically significant reduction in apolipoprotein B (apo-B) of 8.5% compared to placebo at the 4 grams dose. LDL particle count and apo-B are important risk markers for the prediction of cardiovascular events. Small LDL particle count was reduced by 25.6% (P<0.0001) compared with placebo, which is a common risk factor for cardiovascular events in patients with diabetes. AMR101 2 grams per day, compared with placebo, significantly reduced median small LDL particle count by 12.8% (P <0.05) and reduced median total LDL particle count by 1.1% (NS). Amarin previously reported a non statistically significant reduction in apolipoprotein B (apo-B) of 2.6% compared to placebo at the 2 grams dose. LDL particle size did not change significantly for the 2 or 4 grams doses.
"Increased apo-B and LDL particle concentration may increase cardiovascular disease risk," said Dr. Bays. "In the previously reported results of the MARINE trial, we observed that AMR101 significantly reduced triglycerides and apo-B, without increasing LDL cholesterol, as compared to placebo, in a most challenging patient population having triglyceride levels 500 mg/dL. In this follow-up analysis of the MARINE trial, AMR101 reduced both total and small LDL particle concentration, which is not only consistent with its known effects in decreasing apo-B and lack of LDL-cholesterol raising in patients with very high triglyceride levels, but also is suggestive of another potentially favorable lipid effect."
The MARINE trial, the largest study ever conducted with omega-3 fatty acids in treating patients with very high triglycerides (>500 mg/dL), was a Phase 3, multicenter, placebo-controlled, randomized, double-blind, 12-week study. The study enrolled 229 hypertriglyceridemia patients for treatment with AMR101 4 gram/day, 2 gram/day or placebo. As reported in November 2010, the primary endpoint of the MARINE study was achieved with statistically significant reductions in triglycerides compared to placebo of 33% (P<0.0001) for the 4 gram and 20% (P=0.0051) for the 2 gram doses, respectively. The median baseline triglyceride levels were 703 mg/dl, 680 mg/dl, and 657 mg/dl for the patient group treated with placebo, 4 grams of AMR101, and 2 grams of AMR101, respectively.
AMR101 is a prescription-grade omega-3 fatty acid, comprising not less than 96% ultra pure EPA (icosapent ethyl), that Amarin is developing 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). Triglycerides are fats in the blood. 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. AMR101 demonstrated a safety profile comparable to placebo in two completed Phase 3 clinical trials.
Amarin Corporation plc is a late-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). Amarin 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 in November 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 in April 2011. Both 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. In September 2011, Amarin submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of AMR101 for treatment of the patient population studied in the MARINE trial. Amarin plans to separately seek approval for the population studied in the ANCHOR trial after its REDUCE-IT cardiovascular outcomes trial is substantially underway. In August 2011, an SPA agreement with the FDA was reached for the REDUCE-IT cardiovascular outcomes study. The Company seeks to have this study substantially underway before the end of 2012.
This press release contains forward-looking statements, including statements about the efficacy, safety and therapeutic benefits of the Company's product candidates, clinical trial results, statements about the clinical importance of certain biomarkers and the impact of AMR101 on such biomarkers and statements regarding residual cardiovascular risk. 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 and the planned cardiovascular outcomes study; uncertainties associated generally with research and development, clinical trials and related regulatory approvals; risks associated with qualifying new contract manufacturers prior to commercial launch; 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 enrollment and randomization rates may not be predictive of future results; risks associated with our intellectual property including the risk that our patent applications may not issue; 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. The Company'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.