BEDMINSTER, N.J., and DUBLIN, Ireland, Nov. 26, 2012 (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 13/610,247. This application includes claims intended to protect the Vascepa® (icosapent ethyl) indication approved in July 2012 by the U.S. Food and Drug Administration (FDA) based on Amarin's MARINE clinical trial results.
The '247 application is a continuation of Amarin's U.S. Patent Number 8,293,728 (formerly, the '153 application) and broadens the '728 claims by covering the use of Vascepa with and without other lipid lowering agents, such as statins. The '247 application claims gauge drug effects against a subject's own baseline and, alternatively, on a patient population basis. On November 19, 2012, Amarin announced notification of a Notice of Allowance for U.S. Patent Application Serial Number 13/608,775 which is also a continuation of the '728 application and also broadens the '728 claims by covering the use of Vascepa with and without other lipid lowering agents, but gauges Vascepa effects against placebo control.
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.
"This Notice of Allowance builds on the recent allowance for U.S. Patent Application Serial Number 13/608,775, both of which cover the use of Vascepa with or without the use of lipid altering agents, such as statins. This is significant in that it broadens our currently issued MARINE method of use claims," stated Joseph Zakrzewski, Chairman and CEO 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 and trade secrets and by taking advantage of manufacturing barriers to entry."
The 13/610,247 Notice of Allowance has not yet been posted on the USPTO public PAIR website. Amarin has posted this Notice of Allowance and related claims in the Press Release section of its corporate website.
This application is part of an expanding patent portfolio for Amarin with 10 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. For more information about Vascepa visit www.vascepa.com. For more information about Amarin visit www.amarincorp.com.
The Amarin Corporation plc logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=13817
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.
CONTACT: Stephen D. Schultz Investor Relations and Corporate Communications Amarin Corporation In U.S.: +1 (908) 719-1315 firstname.lastname@example.org
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