The United States Patent and Trademark Office (USPTO) has issued Notice of Allowance for Amarin Corporation's US Patent Application Serial Number 12/769,885 titled "Highly Stable EPA in a Capsule."
The issued patent would cover a stable pharmaceutical composition of AMR101 comprising at least 95 per cent EPA and would have a patent term that would expire no earlier than in 2030.
“The issuance of this Notice of Allowance follows the recent issuance of a pharmaceutical composition patent (US Patent No. 8,188,146) covering EPA with no DHA in a capsule,” stated Joseph Zakrzewski, chairman and chief executive officer of Amarin. Joseph further added, “This patent application is part of our expanding patent portfolio for Amarin covering AMR101. Amarin is currently prosecuting greater than 25 pending US patent applications 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 per cent 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 favorable 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.
Amarin Corporation plc is a late-stage biopharmaceutical company with expertise in lipid science focused on the treatment of cardiovascular disease.