BEDMINSTER, N.J., and DUBLIN, Ireland, Sept. 26, 2011 – Amarin Corporation plc (NASDAQ: AMRN), 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 (>500 mg/dL), high triglycerides (>200 and <500 mg/dL) and borderline high triglycerides (>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 (>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 (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.