Amarin’s AMR101 Pivotal Phase 3 MARINE Clinical Trial Completes Patient Enrollment and Randomization
DUBLIN, Ireland and MYSTIC, Conn., Aug. 10 /PRNewswire-FirstCall/ – Amarin Corporation plc (Nasdaq: AMRN), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today announced that its MARINE trial, a Phase 3 clinical trial of AMR101, has completed patient enrollment and randomization into the treatment phase of this trial. The Company indicated that top line results from this trial are expected early in 2011, towards the early part of the range of guidance provided previously.
The MARINE trial is a multi-center, placebo-controlled, randomized, double-blind, 12-week pivotal study to evaluate the efficacy and safety of 2 grams and 4 grams of AMR101 in patients with fasting triglyceride levels greater than or equal to 500 mg/dl. Patients in this trial are characterized as having very high triglyceride levels according to the National Cholesterol Education Program Adult Treatment Panel III treatment guidelines. The primary endpoint in the MARINE trial is the percentage change in triglyceride level from baseline after 12 weeks of treatment. Consistent with the protocol for this trial, the Company expects that the 229 patients randomized in this study will be sufficient to achieve statistical significance. The MARINE study is the largest controlled therapeutic trial ever conducted in this population.
As of the date of this release, over half of the 650 patients currently targeted for the ANCHOR trial, a separate on-going Phase 3 trial for AMR101, have been enrolled and randomized to dosing. Consistent with previous guidance, the Company anticipates completing patient enrolment and randomization for ANCHOR in 2011 and reporting top-line results from the ANCHOR trial in 2011. This trial is designed to evaluate the safety and efficacy of 2 grams and 4 grams of AMR101 in patients with high triglyceride levels (between 200 mg/dl and 500 mg/dl) who are also on statin therapy for elevated LDL cholesterol levels. No prescription omega-3 based drug, such as AMR101, is currently approved in the U.S. for this indication.
Dr. Declan Doogan, Amarin’s Interim CEO, said: “We are extremely pleased that the MARINE study has been able to complete recruitment faster than we initially expected and we very much look forward to reviewing and reporting the results of this trial early in 2011.” He added, “Elevated triglyceride levels are increasingly being recognized and treated as an independent modifiable risk factor for cardiovascular disease in much the same way as elevated LDL cholesterol levels were more than a decade ago. We believe that AMR101 represents an improved treatment alternative for patients with higher than normal triglyceride levels.”
Amarin Corporation plc is a clinical-stage biopharmaceutical company with expertise in lipid science focused the treatment of cardiovascular disease. The Company’s lead product candidate is AMR101 (ethyl icosapentate), which is presently being investigated in two Phase 3 clinical trials, one for the treatment of patients with very high triglyceride levels and the other for the treatment of patients with high triglycerides with mixed dyslipidemia. Both of these Phase 3 trials are being 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. For more information please visit www.amarincorp.com.
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This press release contains forward-looking statements, including statements about the timing of clinical trial results and the potential indications and market opportunity for AMR101 if approved by the U.S. Food and Drug Administration. 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 historical enrolment and randomization rates may not be predictive of future results; 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 20-F. 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.
SOURCE Amarin Corporation plc