BEDMINSTER, N.J., and DUBLIN, Ireland, Feb. 7, 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 Notice of Allowance for U.S. Patent Application Serial Number 13/614,146. This application includes claims intended to protect the Vascepa ® (icosapent ethyl) indication approved by the U.S. Food and Drug Administration (FDA) based on Amarin's MARINE clinical trial results.
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. After issuance, Amarin plans to list this patent in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book.
The claims in this allowed application cover a method of use relating to Vascepa's MARINE indication. Specifically, the allowed independent claim covers use of icosapent ethyl, or EPA, including Vascepa, in lowering triglycerides through the daily administration of about 2500 mg to about 5000 mg of EPA, independent of DHA content, present in one or more capsules, effective to lower triglycerides in the subject by at least 25% without increasing LDL-C by more than 5%."The claims in this allowed application cover the specified method of administration of a pharmaceutical composition comprising EPA over a broad range of daily EPA doses and amounts of EPA per capsule—including, for example, a daily dosing regimen of 4 capsules with about 625 mg to about 1.25 grams of EPA per capsule," stated Joseph Zakrzewski, Chairman and Chief Executive Officer of Amarin. "The issuance of this Notice of Allowance represents yet another significant step toward Amarin's goal of protecting the commercial potential of Vascepa to beyond 2030 through patent protection, regulatory exclusivity, trade secrets and by taking advantage of manufacturing barriers to entry."