Amarin Announces NDA Submission for AMR101 for the Treatment of Patients With Very High Triglycerides
BEDMINSTER, N.J. and DUBLIN, Ireland, Sep 26, 2011 (GlobeNewswire via COMTEX) -- Amarin Corporation plc /quotes/zigman/109177 AMRN -1.83% , a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today announced that it has 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 patients with very high triglycerides. The submission is based on the entire data set from the Company's AMR101 development program, including safety and efficacy data from the Phase 3 MARINE and ANCHOR studies.
"This is another significant milestone achieved for Amarin. Data from our two pivotal Phase 3 studies show that, unlike other triglyceride-lowering therapies, AMR101 does not increase LDL-cholesterol and, in certain cases, significantly decreases it," said Joseph S. Zakrzewski, Chairman and Chief Executive Officer of Amarin. "The submission of this NDA moves AMR101 one step closer to commercial launch. If AMR101 is approved, we believe it can play a significant role in cardiovascular health management."
It is estimated that 75 million people in U.S. alone have triglyceride levels greater than 150mg/dL, including 4 million people with very high triglyceride levels (the triglyceride range studied in the MARINE trial) and 36 million people with high triglyceride levels (the triglyceride range studied in the ANCHOR trial). Elevated triglycerides are clinically stratified into three groups: very high triglycerides (greater than or equal to 500 mg/dL), high triglycerides (greater than or equal to 200 and <500 mg/dL) and borderline high triglycerides (greater than or equal to 150 and <200 mg/dL). Clinical treatment guidelines include recommendations for triglyceride reductions in each of these groups and each group represents a multi-billion dollar market opportunity. In the top seven world markets it is estimated that the number of people with elevated triglyceride levels is at least two times that of the U.S. alone.
The treatment of patients with very high triglycerides was studied in the Company's MARINE trial. The treatment of patients with high triglycerides on statin therapy was studied in the Company's ANCHOR trial. Amarin plans to separately seek approval for the treatment of high triglycerides in patients on statin therapy (the population studied in the ANCHOR trial) after its REDUCE-IT cardiovascular outcomes trial is substantially underway, which the Company expects will occur before the end of 2012 (final results of the REDUCE-IT outcomes study are not required for approval of the very high triglyceride indication).
In both the MARINE and ANCHOR trials, AMR101 achieved all primary endpoints and was well tolerated with a safety profile comparable to placebo. Each trial was conducted under a Special Protocol Assessment (SPA) agreement from the FDA. As recently announced, an SPA agreement was also reached for the REDUCE-IT cardiovascular outcomes study.
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 (greater than or equal to 500 mg/dL) and as a potentially first-in-class therapy for patients with high triglyceride levels (greater than or equal to 200 and <500mg/dL) who are also on statin therapy for elevated LDL-cholesterol levels (which we refer to as mixed dyslipidemia). Triglycerides are fats in the blood. 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 comparable to placebo in two complete Phase 3 clinical trials.
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 [ greater than or equal to 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 [ greater than or equal to 200 and <500mg/dL] with mixed dyslipidemia), as reported on April 18, 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.
This press release contains forward-looking statements, including statements about the efficacy, safety and market opportunities of AMR101, the clinical importance of AMR101, regulatory submissions and approvals and the commercial opportunity and competitive positioning 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: the risk that the NDA will not be accepted by FDA for deficiencies in the application or other reasons; the risk that SPAs are not a guarantee that FDA will accept an NDA or approve a product candidate upon submission; 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 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.