Amarin Announces FDA Award of Three-Year Exclusivity for Vascepa(R) (icosapent ethyl) Capsules
22 February 2014 - 8:01AM
Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company
focused on the commercialization and development of therapeutics to
improve cardiovascular health, announced today that the U.S. Food
and Drug Administration (FDA) has awarded three years of marketing
exclusivity to Vascepa® (icosapent ethyl) capsules in connection
with the July 26, 2012 approval of Vascepa pursuant to the
Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic
Act. Such exclusivity extends through July 25, 2015 and is expected
to be supplemented by a 30-month stay under the Hatch-Waxman
Amendments that would be triggered after patent infringement
litigation initiated by Amarin following valid notice to Amarin of
the acceptance of an application to the FDA seeking approval of a
generic version of Vascepa. FDA marketing exclusivity is separate
from, and in addition to, patent protection, trade secrets and
manufacturing barriers to entry which also help protect Vascepa
against generic competition.
"Amarin is reviewing the FDA's reasoning for granting Vascepa
three-year, rather than five-year, exclusivity, and evaluating
whether to challenge the decision," stated John Thero, President
and Chief Executive Officer of Amarin. "Over the past year, Amarin
has significantly bolstered its patent position for Vascepa thereby
decreasing the relative value of FDA marketing exclusivity in
protecting Vascepa. Amarin now has 40 issued and allowed U.S.
patents that provide the primary means to protect the exclusivity
of Vascepa to 2030. These patents, all but two of which expire in
2030, are anticipated to protect the exclusivity of Vascepa well
beyond the FDA marketing exclusivity period and to augment the
protection afforded by Amarin's trade secrets and existing
manufacturing barriers to entry."
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 and is available by prescription. For
more information about Vascepa visit www.vascepa.com. For more
information
about Amarin visit www.amarincorp.com.
Forward-looking statements
This press release contains forward-looking statements,
including statements about whether Amarin will challenge the FDA
exclusivity grant for Vascepa in favor of five-year, NCE
exclusivity, whether FDA regulatory exclusivity, patents, trade
secrets and manufacturing barriers to entry would be sufficient to
protect Vascepa against competition. 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 maintaining trade secrets
and manufacturing barriers to entry. 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.
Availability of other information about
Amarin
Investors and others should note that we communicate with our
investors and the public using our company website
(www.amarincorp.com), our investor relations website
(http://www.amarincorp.com/investor-splash.html), including but not
limited to investor presentations and investor
FAQs, Securities and Exchange Commission filings, press
releases, public conference calls and webcasts. The information
that we post on these channels and websites could be deemed to be
material information. As a result, we encourage investors, the
media, and others interested in Amarin to review the information
that we post on these channels, including our investor relations
website, on a regular basis. This list of channels may be updated
from time to time on our investor relations website and may include
social media channels. The contents of our website or these
channels, or any other website that may be accessed from our
website or these channels, shall not be deemed incorporated by
reference in any filing under the Securities Act of 1933.
CONTACT: Amarin contact information:
Joseph Bruno
Director, Investor Relations and
Corporate Communications
Amarin Corporation plc
In U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com
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