BEDMINSTER, N.J. and DUBLIN, Ireland, Feb. 7, 2012 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a late-stage biopharmaceutical company with a focus on cardiovascular disease today announced that John F. Thero, Amarin's President, is scheduled to present at the Leerink Swann 2012 Global Healthcare Conference on Thursday, February 16, 2012, at 11:30 a.m. ET. This conference will be held at the Waldorf Astoria Hotel in New York City. A live audio webcast of the presentation will be available at:
http://wsw.com/webcast/leerink23/amrn/
About Amarin
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 favorable, statistically significant, top-line results from both of its two pivotal Phase 3 clinical trials of AMR101, 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 filed a New Drug Application (NDA) with the FDA seeking marketing approval of AMR101 in the treatment of patients with very high triglyceride levels (the MARINE indication), and the FDA assigned Prescription Drug User Fee Act (PDUFA) action date of July 26, 2012 for the completion of its review. Amarin plans to separately seek FDA approval for the use of AMR101 in the treatment of high triglyceride levels with mixed dyslipidemia (the ANCHOR indication) if the FDA approves the MARINE indication and after Amarin's REDUCE-IT cardiovascular outcomes trial of AMR101 is substantially underway. In December 2011, patient dosing commenced in the REDUCE-IT trial, which is also being conducted under an SPA agreement with the FDA. Amarin seeks to have at least half of the patients required for the REDUCE-IT study enrolled before the end of 2012. Amarin also has next-generation lipid candidates under evaluation for preclinical development.
Forward Looking Statements
This press release contains forward-looking statements, including statements about Amarin's plans to seek FDA approval for the company's product candidates, the timing of enrolling and completing a planned cardiovascular outcomes study, and the potential populations and indications for which the company's product candidates may be approved by the FDA. 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; the risk that SPAs are not a guarantee that FDA will approve a product candidate; the risk that the FDA may not grant new chemical entity regulatory exclusivity to AMR101 even if FDA marketing approval is obtained; the risk that historical clinical trial enrolment and randomization rates and results 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. 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.