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.
Amarin Corporation plc is a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health. Amarin's product development program leverages its extensive experience in lipid science and the potential therapeutic benefits of polyunsaturated fatty acids. Vascepa® (icosapent ethyl), Amarin's first FDA approved product, is a patented, ultra pure omega-3 fatty acid product comprising not less than 96% EPA and available by prescription. For more information about Vascepa visit www.vascepa.com. For more information about Amarin visit www.amarincorp.com.
This press release contains forward-looking statements, including statements about whether the subject patent would be issued and adequately protect Vascepa against competition, the expiration date of the pending patent, Amarin's plan to list the patent, when issued, in FDA's Orange Book, Amarin's plan to protect the commercial potential of Vascepa, the future status of pending patent applications, planned regulatory submissions and expected action dates. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include the following: events that could interfere with the issuance of a patent, or once issued, the continued validity or enforceability of a patent; Amarin's ability generally to maintain adequate patent protection and successfully enforce patent claims against third parties; commercializing Vascepa without violating the intellectual property rights of others; and uncertainties associated generally with research and development, clinical trial enrollment in Amarin's REDUCE-IT trial and related regulatory submissions, action dates and approvals. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including its most recent Quarterly Report on Form 10-Q. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Amarin undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
CONTACT: Joseph Bruno Investor Relations and Corporate Communications Amarin Corporation In U.S.: +1 (908) 719-1315 firstname.lastname@example.org
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