Amarin Announces Notification of Patent Allowance for U.S. Application 13/623,450 Related to Vascepa(R) and FDA Approved MARINE Indication
Strengthens Positioning of Vascepa for Exclusivity Into 2030
BEDMINSTER, N.J., and DUBLIN, Ireland, Dec. 13, 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
13/623,450. This application includes claims intended to protect the Vascepa(R) (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 highly pure icosapent ethyl, or EPA, including Vascepa, in lowering triglycerides regardless of the drug's effect on LDL-C levels.
"This allowance is significant in that it would broaden our currently issued MARINE method of use claims to cover the use of Vascepa (and other highly pure EPA formulations) without regard to LDL-C levels," 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."
This application is part of an expanding patent portfolio for Amarin with 11 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.
The 13/623,450 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.
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(R) (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
In U.S.: +1 (908) 719-1315