The three background statins used in the ANCHOR trial, simvastatin, atorvastatin or rosuvastatin, represent approximately 80% of statins currently used. The most common trade names for these drugs are Zocor®, Lipitor® and Crestor®, respectively.
AMR101 is a prescription-grade omega-3 fatty acid, comprising not less than 96% ultra pure icosapent ethyl (ethyl-EPA), 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. Significant scientific and clinical evidence support the efficacy and safety of ethyl-EPA in reducing triglyceride levels.
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, as reported above. The Company is planning to file an NDA for AMR101 before the end of Q3, 2011. The Company is evaluating which data, in addition to safety data, from the ANCHOR trial to include in this NDA. If the ANCHOR results are added to the NDA, the NDA would seek approval for the indication studied in the MARINE trial with the ANCHOR results either as a separate indication for use or referenced in the label as data supporting the safe use of AMR101 in the treatment of high triglyceride levels in statin-treated patients who have mixed dyslipidemia. In order to obtain a separate indication for AMR101 based on the ANCHOR trial results, the FDA requires that we have a clinical outcomes study substantially underway at the time of the NDA filing. The Company is in the late stages of designing this outcomes study. The results of an outcomes study are not required for FDA approval of the broader indication and an outcomes study is not required for the indication being studied in the MARINE trial. The MARINE and ANCHOR trials were conducted under separate 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 success of clinical trial results the timing of and content of regulatory filings, the likelihood of approval, the potential label of any approved drug, competitive market positioning and the commercial opportunity for AMR101, including the number of patients that could potentially benefit from AMR101, and the timing of data publication. 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; uncertainties relating to the further analysis of 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. 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.
Investor Contact Information:
Stephen D. Schultz
Investor Relations and Corporate CommunicationsAmarin CorporationIn U.S.: +1 (860) 572-4979 x292
Lee M. Stern
The Trout GroupIn U.S.: +1 (646) 378-2922
Media Contact Information:
, Ph.D.Russo PartnersIn U.S.: +1 (212) 845-4271 or +1 (212) 845-4292 (office)+1 (347) 591-8785 (mobile)
SOURCE Amarin Corporation plc