Amarin Informed by FDA of October 16th Advisory Committee Date in Connection With Supplemental New Drug Application (sNDA) for

Amarin Informed by FDA of October 16th Advisory Committee Date in Connection
With Supplemental New Drug Application (sNDA) for Vascepa(R) in the Treatment
of Patients With High Triglycerides (>200 mg/dL and

Submission for Indication Studied in the ANCHOR Phase 3 Clinical Trial Under
Special Protocol Assessment Agreement With FDA

BEDMINSTER, N.J. and DUBLIN, Ireland, June 19, 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 it was informed yesterday by the U.S. Food and
Drug Administration (FDA) that the FDA will convene an advisory committee on
October 16, 2013 in connection with the FDA's review of the Supplemental New
Drug Application (sNDA) seeking approval for the use of Vascepa® (icosapent
ethyl) capsules as an adjunct to diet in the treatment of adult patients with
high triglycerides (TG ≥200 mg/dL and <500 mg/dL) with mixed dyslipidemia. The
FDA has previously assigned a Prescription Drug User Fee Act (PDUFA) date of
December 20, 2013 for completion of its review of the sNDA.The FDA will
consider the recommendation of the advisory committee, but the final decision
regarding the approval of the sNDA will be made by the FDA.

"ANCHOR clinical trial results demonstrated the important role EPA-only
omega-3 can play in helping adult patients with high triglycerides and mixed
dyslipidemia," said Christie M. Ballantyne, M.D., Baylor College of Medicine
and the Methodist DeBakey Heart and Vascular Center, Houston, Texas, and
principal investigator of the ANCHOR trial. "In the ANCHOR trial, Vascepa
lowered high triglyceride levels and showed robust reductions in a broad range
of other lipid parameters on top of optimized statin therapy compared to
placebo. Importantly, these beneficial effects were seen with a safety and
tolerability profile comparable to placebo."

Vascepa was approved in 2012 as an adjunct to diet to reduce triglyceride
levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia, based
on the results of Amarin's MARINE clinical trial.The safety data from both
the MARINE and ANCHOR clinical trials were reviewed by the FDA as part of the
approval of Vascepa in the MARINE indication and are reflected in the approved
product labeling for Vascepa.As is customary practice at FDA, yesterday's
notification from the FDA is the only communication confirming the need for
such a meeting.The FDA advisory committee topics and questions to the
committee are anticipated to be made public by the FDA on its website in the
week preceding the meeting, consistent with FDA procedure.

"For key first-in-class indications, an FDA advisory committee meeting is
expected, and this public forum will be an important opportunity to discuss
the ANCHOR data, which demonstrated Vascepa's unique potential as an adjunct
to diet in the treatment of adult patients with high triglycerides (TG 200-499
mg/dL) and mixed dyslipidemia," said Eliot A. Brinton, MD, FAHA, FNLA,
Director of Atherometabolic Research, Utah Foundation for Biomedical Research,
and President, American Board of Clinical Lipidology. "Currently, many of
these patients are receiving another prescription omega-3 which is not
indicated for this disorder.Having instead an omega-3 product which lowers
LDL-cholesterol in addition to triglycerides, has tolerability comparable to
placebo, and is FDA-approved for use on top of statin therapy would be a
welcome addition to the physician's armamentarium for comprehensive lipid

"With the support of the Amarin team, including our outside consultants, such
as Christie and Eliot, we look forward to the advisory panel and working with
the FDA to obtain regulatory approval of Vascepa for ANCHOR this year," said
Joseph Zakrzewski, Chairman and Chief Executive Officer of Amarin. 

Currently, Amarin only markets Vascepa for the MARINE indication, for which it
was approved in 2012, and which includes approximately 4 million patients in
the United States.The proposed ANCHOR indication would expand the Vascepa
patient population to include adult patients on statin therapy with
triglyceride levels ranging from 200 to 499 mg/dL (and mixed
dyslipidemia).Amarin estimates that one in five, or nearly 40 million, U.S.
adults have triglyceride levels in this range.Amarin began selling Vascepa on
January 28, 2013. Amarin believes that many of the same clinicians who have
prescribed Vascepa for its currently approved indication will prescribe
Vascepa for the much broader indication, based on the ANCHOR study now under
formal FDA review, if approved.

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^(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 For more information about Amarin visit

About Vascepa®(icosapent ethyl) capsules

Vascepa®(icosapent ethyl) capsules, known in scientific literature as AMR101,
is a highly pure-EPAomega-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)
  *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
  *The most common reported adverse reaction (incidence > 2% and greater than
    placebo) was arthralgia (2.3% for Vascepa, 1.0% for placebo).


Forward-looking statements

This press release contains forward-looking statements, including statements
about whether the FDA will hold an advisory committee meeting in connection
with its review of Amarin's pending Supplemental New Drug Application, the
expected timing and outcome of the FDA's review of such regulatory submission,
including the timing and outcome of the proposed advisory committee meeting,
the efficacy and safety ofAmarin'sproduct candidates, market opportunities
for Vascepa, the potential for clinicians to prescribe Vascepa to expanded
patient populations in the future, and the clinical importance of Vascepa.
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 administrative
decisions and the bases for such decisions, research and development, clinical
trials and related regulatory reviews and approvals, and uncertainties
associated with the commercial uptake and market expansion of new
pharmaceutical products. 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.

Vascepa has been approved for use by the FDA as an adjunct to diet to lower
triglyceride levels in adult patients with severe (≥500 mg/dL)
hypertriglyceridemia.Vascepa is under various stages of development for
potential use in other indications that have not been approved by the
FDA.Nothing in this press release should be construed as marketing the use of
Vascepa in any indication that has not been approved by the FDA.

CONTACT: Amarin contact information:
         Joseph Bruno
         Investor Relations and Corporate Communications
         Amarin Corporation
         In U.S.: +1 (908) 719-1315

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