BEDMINSTER, N.J. and DUBLIN, Ireland, Nov. 3, 2011 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a clinical-stage biopharmaceutical company focused on cardiovascular disease, has scheduled a conference call with members of senior management to discuss the Company's financial results and business initiatives for its fiscal third quarter on Tuesday, November 8, 2011, at 8:00 a.m. ET. To participate in the call, please dial (877) 407-0778 within the U.S. or (201) 689-8565 from outside the U.S. A replay of the call will be made available for a period of two weeks following the conference call. To hear a replay of the call dial (877) 660-6853 (inside the
U.S.) or (201) 612-7415 (outside the U.S.). A replay of the call will also be available via the Company's website shortly after the call. For both dial-in numbers please use account number 286 and conference ID 382190. The conference call can also be heard live via the investor relations section of the Company's website at http://investor.amarincorp.com/.
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). 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 of the Company's product candidates, likelihood of success of clinical trial, the timing of initiating, enrolling and completing a planned cardiovascular outcomes study, and the potential market positioning and market potential for AMR101. 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 enrolment and randomization rates may not be predictive of future results; risks associated with our intellectual property including the risk that our recently filed 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.
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. SternThe 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
+1 (212) 845-4292 (office)
Source: Amarin Corporation plc
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