Amarin Announces FDA Review Division Response to ANCHOR SPA Agreement Reinstatement Request
January 21 2014 - 1:00AM
Conference Call Set for 8:00
a.m. ET today
Amarin Plans Appeal to FDA Office
Level, No FDA sNDA Action Expected During Appeal
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) has notified Amarin in connection
with Amarin's request for reconsideration of DMEP's October 2013
decision to rescind the ANCHOR clinical trial Special Protocol
Assessment (SPA) agreement that DMEP "does not plan to re-instate
the ANCHOR SPA agreement."
In its communication to Amarin, DMEP stated that information
submitted by Amarin supports testing the hypothesis that Vascepa®
(icosapent ethyl) 4 grams/day versus placebo reduces major adverse
cardiovascular events in statin-treated subjects with residually
high triglyceride levels, as is being studied in the Vascepa
REDUCE-IT cardiovascular outcomes study. However, DMEP
reiterated its position expressed at the October 2013 Vascepa
advisory committee meeting that currently available data from
studies of other therapies do not support use of drug-induced
reductions in serum triglycerides as a basis for approval of an
indication that DMEP views as ostensibly and impliedly an
indication to reduce the risk of cardiovascular disease.
Prior to being able to appeal DMEP's October 2013 decision to
rescind the ANCHOR SPA agreement, FDA protocol requires that DMEP
first be given a formal opportunity for reconsideration. With that
step now completed, Amarin plans to appeal the DMEP decision to the
FDA Director of the Office of Drug Evaluation II (ODE-II), the next
level under FDA dispute resolution guidance. Based on information
available to Amarin, Amarin does not expect a determination on the
pending ANCHOR supplemental new drug application (sNDA) while
Amarin prepares its appeal or while this appeal is pending. Amarin
also plans to continue its efforts toward a positive determination
on the pending ANCHOR sNDA.
As previously stated, Amarin recognizes the significant
challenge it faces in its efforts to reinstate the ANCHOR SPA
agreement and obtain approval of the ANCHOR sNDA. 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. There also can be no
assurance that the FDA will not communicate the results of its
review of the ANCHOR sNDA prior to the timing expected.
Vascepa remains FDA approved for use as an adjunct to diet to
reduce triglyceride levels in adult patients with severe (≥500
mg/dL) hypertriglyceridemia.
Conference call today
Members of the Amarin management team will host a webcast and
conference call to provide a company update and discuss the recent
FDA action today at 8:00 a.m. ET.
The conference call can be heard live via the investor relations
section of the company's website at www.amarincorp.com, or via
telephone by dialing 877-407-9124 within the United States or
201-689-8584 from outside the United States. A replay of the call
will be made available for a period of two weeks following the
conference call. To hear a replay of the call, dial 877-660-6853
(inside the United States) or 201-612-7415 (outside the United
States). A replay of the call will also be available through the
company's website shortly after the call. For both dial-in numbers
please use conference ID 13574872.
About Vascepa® (icosapent ethyl)
capsules
Vascepa® (icosapent ethyl) capsules, known in scientific
literature as AMR101, is a highly pure-EPA omega-3
prescription product in a 1 gram capsule.
Indications and Usage
- Vascepa (icosapent ethyl) is indicated as an adjunct to diet to
reduce triglyceride (TG) levels in adult patients with severe (≥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.
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.
Forward-looking statement
This press release contains forward-looking statements,
including statements about Amarin's plan to appeal the ANCHOR SPA
agreement rescission and Amarin's expectation about the timing of
FDA response to Amarin's pending ANCHOR sNDA. 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: the risk that
Amarin's interpretation of the applicable legal standards and
scientific information related to the ANCHOR SPA agreement
rescission may not be determinative or adjudicated in Amarin's
favor or at all; uncertainties associated generally with research
and development, clinical trials and related regulatory decisions;
the risk that FDA will follow the recommendation of the advisory
committee against ANCHOR sNDA approval; the risk that the FDA may
communicate the results of its review of the ANCHOR sNDA prior to
the timing expected. A further list and description the risks and
uncertainties 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 this forward-looking statement, which speaks 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
Investor Relations and Corporate Communications
Amarin Corporation
In U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com
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