Phase 3 ANCHOR and MARINE Trial Data to be Presented in November at the American Heart Association's Scientific Sessions
MYSTIC, Conn. and DUBLIN, Ireland, Aug. 4, 2011 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today announced that data from each of its two pivotal Phase 3 studies, the ANCHOR trial and the MARINE trial, will be presented at the American Heart Association's Scientific Sessions 2011 in Orlando, Fla. The presentation of the ANCHOR trial results will be the first presentation of data from this trial at a scientific session. The presentation of MARINE trial results will include data that has not been previously presented.
The ANCHOR trial results will be presented in an abstract by Christie M. Ballantyne, M.D., Methodist DeBakey Heart and Vascular Center, Houston, and principal investigator of the ANCHOR trial. This abstract is scheduled to be presented in an oral session on Wednesday, November 16, 2011 at 10:00 am ET. The presentation will be part of a scientific session titled "Novel Lipid Modifying Therapies and Other Atheropreventive Treatments."
The additional MARINE data will be presented in an abstract titled "Effects of AMR101, a Pure Ethyl Eicosapentaenoic Acid Omega-3 Fatty Acid, on Lipoprotein Particle Concentration and Size in Patients with Very High Triglycerides (the MARINE Study) by Harold Bays, M.D., Medical Director, Louisville Metabolic and Atherosclerosis Research Center, and principal investigator of the study. This abstract is scheduled to be orally presented on Tuesday, November 15, 2011 at 4:45 pm ET. The presentation will be part of a scientific session titled "New Frontiers in Lipid Management."
Following the presentation of ANCHOR results at the above forum in November, Amarin, together with clinical investigators from the ANCHOR study, plans to publish additional data from the ANCHOR trial. Results of the MARINE study will be published in the September issue of The American Journal of Cardiology. A separate oral presentation of MARINE trial results is also scheduled to be presented on August 29, 2011 at 11:45 am CEST at the annual meeting of the European Society of Cardiology in Paris.
AMR101 is a prescription-grade omega-3 fatty acid, comprising not less than 96% ultra pure EPA (icosapent ethyl), 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) 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). 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 without increasing LDL-C. AMR101 demonstrated a safety profile
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). The Company 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 on November 29, 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 on April 18, 2011. Both the MARINE and the 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 the efficacy and safety of the Company's product candidates and the timing of data publication and presentation. 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; uncertainties associated generally with research and development, clinical trials and related regulatory approvals; 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 enrolment and randomization rates may not be predictive of future results;
uncertainties relating to the timing of data collection and analysis for the ANCHOR and MARINE trials; 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 as filed with the SEC. 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.
CONTACT: Investor Contact Information:
Stephen D. Schultz
Senior Director Investor Relations
and Corporate Communications
In U.S.: +1 (860) 572-4979 Ext.292
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)
Source: Amarin Corporation plc
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