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."
This application is part of an expanding patent portfolio for Amarin with 17 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.
About Amarin
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. For more information about Vascepa visit www.vascepa.com. For more information about Amarin visit www.amarincorp.com.
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Forward-looking statements
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, and the future status of pending patent applications. 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 trials and related regulatory 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.