BEDMINSTER, N.J. and DUBLIN, Ireland, Jan. 23, 2013 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that the United States Patent and Trademark Office (USPTO) has published notification of a Notice of Allowance for Amarin's U.S. Patent Application Serial Number 12/815,569 titled "Compositions and Methods for Lowering Triglycerides Without Raising LDL-C Levels in a Subject on Concomitant Statin Therapy." This application includes claims intended to protect the proposed Vascepa ® (icosapent ethyl) indication based on Amarin's Phase 3 ANCHOR clinical trial results. Amarin is on track to file a Supplemental New Drug Application for the Vascepa ANCHOR indication with the U.S. Food and Drug Administration (FDA) by the end of February 2013, and expects an FDA action date on the application before the end of 2013.
A Notice of Allowance is issued after the USPTO makes a determination that a patent can be granted from an application. The issued patent would have a term that expires no earlier than in 2030. Amarin plans to list this patent in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book, after issuance of the patent and the anticipated approval of Vascepa in the ANCHOR indication.
The claims in this allowed application cover a method of use relating to Vascepa's ANCHOR indication. Specifically, the allowed independent claim covers use of icosapent ethyl, or EPA, including Vascepa, in lowering triglycerides through the daily administration of about 4 capsules, each containing about 900 mg to about 1000 mg of EPA, regardless of EPA purity with not more than about 3% docosahexaenoic acid."We are very pleased to announce this Notice of Allowance, the first from many pending patent applications with the USPTO expected to cover our planned ANCHOR indication for Vascepa," stated Joseph Zakrzewski, Chairman and CEO of Amarin. "The claims cover a significant range of EPA dosage strengths administered to patients on any statin product. This allowance is based upon showings that important clinical results for Vascepa in Amarin's ANCHOR trial were surprising and unexpected, key factors considered by the USPTO in granting a patent."