Amarin Announces FDA Review Division Response on ANCHOR SPA
Agreement Reinstatement Request Will Be Delayed
BEDMINSTER, N.J., and DUBLIN, Ireland, Jan. 15, 2014 (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 Division of
Metabolism and Endocrinology Products (DMEP) within the U.S. Food and
Drug Administration (FDA) notified the company today that a
determination on Amarin's request for reconsideration of DMEP's October
2013 decision to rescind the ANCHOR clinical trial Special Protocol
Assessment (SPA) agreement will be delayed. FDA previously notified the
company that it planned to convey its decision to Amarin no later than
January 15, 2014. In today's communication, DMEP provided no definitive
date for its planned response. Based on dialogue with DMEP, Amarin does
not expect the delay to be for a significant period of time.
There can be no assurance that Amarin will be successful in its effort
to reinstate the ANCHOR SPA agreement or obtain a label expansion
reflecting the ANCHOR clinical trial data.
Vascepa is FDA approved for use as an adjunct to diet to reduce
triglyceride levels in adult patients with severe ( greater than or
equal to 500 mg/dL) hypertriglyceridemia. The ANCHOR Supplemental New
Drug Application (sNDA) seeks approval of Vascepa for use as an adjunct
to diet and exercise for adult patients on statin therapy with mixed
dyslipidemia (one or more lipid disorder) and triglyceride levels
between 200 and 499 mg/dL.
About Vascepa(R) (icosapent ethyl) capsules
Vascepa(R) (icosapent ethyl) capsules, known in scientific literature
as AMR101, is a highly pure-EPA omega-3 prescription product in a 1
Indications and Usage
-- Vascepa (icosapent ethyl) is indicated as an adjunct to diet to reduce
triglyceride (TG) levels in adult patients with severe ( greater than or
equal to 500 mg/dL) hypertriglyceridemia.
-- The effect of Vascepa on the risk for pancreatitis and cardiovascular
mortality and morbidity in patients with severe hypertriglyceridemia has
not been determined.
Important Safety Information for Vascepa
-- Vascepa is contraindicated in patients with known hypersensitivity
(e.g., anaphylactic reaction) to Vascepa or any of its components and
should be used with caution in patients with known hypersensitivity to
fish and/or shellfish.
-- The most common reported adverse reaction (incidence > 2% and greater
than placebo) was arthralgia (2.3% for Vascepa, 1.0% for placebo).
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.
Vascepa is under various stages of development for potential use in
indications that have not been approved by the FDA. Nothing in this
press release should be construed as promoting the use of Vascepa in
any indication that has not been approved by the FDA.
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.
This press release contains forward-looking statements, including
statements about anticipated FDA review of the ANCHOR SPA rescission
decision and the timing of such review. 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: uncertainties associated generally with regulatory review
and approvals; the risk that SPA agreements with the FDA are not a
guarantee that FDA will approve a product candidate; the risk
associated with the FDA's rescinding of the ANCHOR SPA agreement; the
risk that FDA will follow the recommendation of the advisory committee
against ANCHOR sNDA approval; the risk that the FDA may not complete
its review of the ANCHOR SPA reinstatement in the timing expected; and
the risk that Amarin's interpretation of the applicable legal standards
and scientific information related to the SPA agreement rescission may
not be determinative or adjudicated in Amarin's favor or at all. 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: Joseph Bruno
Investor Relations and Corporate Communications
In U.S.: +1 (908) 719-1315