Amarin Corporation plc, a late-stage biopharmaceutical company focused on the development of therapeutics to improve cardiovascular health, has received notice of intention to grant letter for European Patent Application Number EP2395991, titled "Use of Eicosapentaenoic Acid Ethyl Ester for Treating Hypertriglyceridemia" from European Patent Office. This patent application is intended to protect the exclusivity of Amarin's drug candidate, AMR101, for use in an indication that Amarin may seek through the European Medicines Agency (EMA).
"This European intention to grant letter further substantiates that the findings from Amarin's MARINE clinical trial were unexpected and follows the recent issuance of a pharmaceutical composition patent in the United States (US Patent No. 8,188,146) covering EPA with no DHA in a capsule and Notice of Allowance for US Patent Application Serial Number 12/769,885 titled "Highly Stable EPA in a Capsule," stated Joseph Zakrzewski, chairman and CEO of Amarin. "This patent application is part of Amarin's expanding patent portfolio intended to cover AMR101. Amarin is currently prosecuting greater than 25 pending US patent applications and multiple other patent applications outside the United States with the goal of protecting the commercial potential of AMR101 to 2030 and beyond."
AMR101 (icosapent ethyl) is a patented, ultra pure omega-3 fatty acid, comprising not less than 96% EPA (icosapent ethyl), that Amarin is developing as a treatment for patients with very high triglyceride levels (=500 mg/dL), and for patients with high triglyceride levels (=200 and < 500mg/dL) who are also on statin therapy for elevated low-density lipoprotein cholesterol, or LDL-C, levels (which we refer to as mixed dyslipidemia). The efficacy and safety of AMR101 were studied in two phase III clinical trials, the MARINE trial, which studied patients with very high triglyceride levels, and the ANCHOR trial, which studied patients with high triglyceride levels who were also on statin therapy for elevated LDL-C levels. These two phase III clinical trials showed favourable results in triglyceride reduction compared to placebo in the studied patient populations. Reduction in triglyceride levels was achieved without a statistically significant increase in LDL-C levels, and in the 4 gram AMR101 ANCHOR results, with a statistically significant decrease in LDL-C levels. These trials also showed favourable results, particularly with the 4 gram dose of AMR101, in other important lipid and inflammation biomarkers, including Apo-B, non-HDL-C, Total-Cholesterol, VLDL-C, Lp-PLA2, and hs-CRP. In these trials, AMR101 exhibited a safety profile comparable to placebo. In December 2011, Amarin commenced patient dosing in a cardiovascular outcomes study of AMR101, titled REDUCE-IT (Reduction of Cardiovascular Events with EPA — Intervention Trial), that is designed to evaluate the efficacy of AMR101 in reducing major cardiovascular events in a high risk patient population on statin therapy.