BEDMINSTER, N.J., and DUBLIN, Ireland, May 22, 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 13/417,899 titled "Pharmaceutical Compositions Comprising EPA and a Cardiovascular Agent and Methods of Using the Same." 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 specifically those results seen in patients on statin therapy.
The claims in this allowed application cover a method to reduce triglycerides in subjects having a triglyceride level of 500mg/dl to 1500mg/dl who are also receiving statin therapy (whether in fixed or non-fixed dose formulation) using an amount of Vascepa effective to reduce triglycerides without substantially increasing low density lipoprotein cholesterol (LDL-C).
"Through our findings from conversations with thought leaders and other clinicians during the launch of Vascepa, we've confirmed that many patients on therapies intended for lowering triglycerides are also on statins. The claims in this allowed application cover the administration of a pharmaceutical composition comprised of EPA in conjunction with a stain, using either a fixed or non-fixed dose, to lower triglycerides without increasing LDL-C, otherwise known as bad-cholesterol," stated Joseph Zakrzewski, Chairman and Chief Executive Officer of Amarin.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. This application is part of an expanding patent portfolio for Amarin with 23 patent applications now either issued or allowed with the USPTO and over 30 additional applications pending in the United States. Amarin is also pursuing patent applications related to Vascepa in multiple jurisdictions outside the United States, including the application for Amarin's MARINE method of use patent in Europe for which Amarin has announced receipt of an Intention to Grant letter.