Breaking News

EDF Names Jean-Bernard Levy Interim Chairman, CEO
Tweet TWEET

Amarin Announces Notification of Additional U.S. Patent Allowance for U.S. Application 13/272,520 Based on ANCHOR Clinical Trial

Amarin Announces Notification of Additional U.S. Patent Allowance for U.S.
Application 13/272,520 Based on ANCHOR Clinical Trial Results

  Patent Application Related to High (≥200 mg/dL to <500 mg/dL) Triglyceride
                  Patient Population With Mixed Dyslipidemia

BEDMINSTER, N.J. and DUBLIN, Ireland, Feb. 1, 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 13/272,520 titled "Compositions and Methods
for Lowering Triglycerides." This application includes claims intended to
protect the proposed Vascepa^® (icosapent ethyl) indication based on Amarin's
Phase 3 ANCHOR clinical trial results. Amarin is on track to file a
Supplemental New Drug Application for the Vascepa ANCHOR indication with the
U.S. Food and Drug Administration (FDA) by the end ofFebruary 2013, and
expects an FDA action date on the application before the end of 2013.

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 and approval of Vascepa in the
ANCHOR indication.

The claims in thisallowed applicationcover a method of use relating to
Vascepa's ANCHOR indication. Specifically, the allowed independent claims
covers use ofabout 4 grams per day of highly pure icosapent ethyl, or EPA,
including Vascepa, to lower triglycerides and LDL-C. 

"This Notice of Allowance with method of use claims related to our planned
ANCHOR indication for Vascepa follows the recent '569 Notice of Allowance,
also for the ANCHOR indication, and also covers administration of Vascepa to
patients on any statin product," stated Joseph Zakrzewski, Chairman and CEO of
Amarin."This allowance is based upon showings that important clinical results
for Vascepa inAmarin'sANCHOR trial were surprising and unexpected, key
factors considered by the USPTO in granting a patent."

This application is part of an expanding patent portfolio for Amarin with 16
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.

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.

The Amarin Corporation plc logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=13817

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, 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
trials 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.

Amarin'sproduct candidates are in various stages of development and are not
available for sale or use outside of approved clinical trials. Nothing in this
press release should be construed as promoting the use of such product
candidates.

CONTACT: Stephen D. Schultz
         Investor Relations and Corporate Communications
         Amarin Corporation
         In U.S.: +1 (908) 719-1315
         investor.relations@amarincorp.com

company logo
 
Press spacebar to pause and continue. Press esc to stop.