Amarin Announces Notification of Patent Allowance for U.S. Application 13/282,145 Related to Vascepa(TM) and FDA Approved MARINE Indication Positions Vascepa for Exclusivity Into 2030
September 04, 2012
BEDMINSTER, N.J. and DUBLIN, Ireland, Sept. 4, 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 a Notice of Allowance for U.S. Patent Application Serial Number 13/282,145, titled "Method of Treating Hypertriglyceridemia." The 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. 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 term that expires no earlier than in 2030. After issuance, Amarin plans to list the patent in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book.
Investors can find information on Amarin's patents and pending applications in the United States on the Patent Application Information Retrieval, or PAIR, system maintained by the USPTO at http://portal.uspto.gov/external/portal/pair.
"This Notice of Allowance is based upon showings that the clinical results for Vascepa in Amarin's MARINE trial were surprising and unexpected, key factors considered by the USPTO in granting a patent," stated Joseph Zakrzewski, Chairman and CEO of Amarin. "Amarin's goal is to protect 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 issuance of this Notice of Allowance is a significant step toward achieving this goal."
This application is part of an expanding patent portfolio for Amarin with seven patent applications now either issued, allowed or in advanced stages of prosecution with the USPTO and over 25 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.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. VascepaTM (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=13817Forward-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.
Amarin disclaims any liability for inaccurate information on the USPTO's PAIR system.
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