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Amarin
Corporation plc
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 12/815,569 titled "Compositions and Methods
for Lowering Triglycerides Without Raising LDL-C Levels in a Subject on
Concomitant Statin Therapy." 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 of February 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 the anticipated approval of
Vascepa in the ANCHOR indication.
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