Amarin Announces Enrollment of the REDUCE-IT Cardiovascular Outcomes Study Surpasses 6,000 Patients

Amarin Announces Enrollment of the REDUCE-IT Cardiovascular Outcomes Study
Surpasses 6,000 Patients

Study Evaluating the Effectiveness of Vascepa(R) in Reducing Major
Cardiovascular Events in a High-Risk Patient Population

BEDMINSTER, N.J., and DUBLIN, Ireland, Sept. 25, 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 the number of patients enrolled in
the company's REDUCE-IT cardiovascular outcomes study of Vascepa^® (icosapent
ethyl) capsules has surpassed 6,000.

The REDUCE-IT (Reduction of Cardiovascular Events with EPA - Intervention
Trial) study is a multinational, prospective, randomized,double-blind,
placebo-controlled, parallel-group study taking place at over 400 clinical
sites in 11 countries to evaluate the effectiveness and safety of Vascepa^®
(icosapent ethyl) capsules, as an adjunct to optimized statin therapy, in
reducing the incidence of first major cardiovascular events ina patient
population at high risk for such events.The control arm of the study consists
of patients on optimized statin therapy plus placebo. The active arm of the
study consists of patients on optimized statin therapy plus Vascepa 4g/day.
The high-risk patient population in REDUCE-IT has both a mean and median
baseline triglyceride (TG) level over 200 mg/dL, a level substantially above
those from recently conducted outcomes trials of other prescription lipid
modifying therapies. Furthermore, Amarin has taken steps to ensure that the
final baseline TG levels remain above 200 mg/dL.In addition, all patients
enrolled in the study have either documented cardiovascular disease (CVD) or
are at high-risk for CVD.

The REDUCE-IT study is being conducted under Amarin's previously announced
Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug
Administration (FDA).An SPA agreement is an agreement with the FDA that the
Phase 3 trial protocol design, clinical endpoints, and planned statistical
analyses are acceptable to support regulatory approval. An SPA agreement is
generally considered binding upon the FDA unless public health concerns
unrecognized at the time of protocol assessment are evident.

"Reaching the 6,000 patient mark in the REDUCE-IT trial represents significant
progress toward full enrollment and another significant highlight for Amarin
in 2013," said Joseph Zakrzewski, Amarin's Chairman and CEO."The results of
REDUCE-IT may enable us to seek additional indications for Vascepa including
cardiovascular risk reduction, which would represent a patient population
estimated to be almost twice that of the combined indications studied in the
MARINE and ANCHOR trials or approximately 70 million adults in the United
States alone."

About Vascepa^®(icosapent ethyl) capsules

Vascepa^®(icosapent ethyl) capsules, known in scientific literature as
AMR101, is a patented, pure-EPAomega-3 prescription product in a 1 gram

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).


Vascepa is under various stages of development for potential use in
indications that have not been approved by the FDA, such as the potential
indications that are under development in the REDUCE-IT trial. 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 For more information about Amarin visit

Forward-looking statements

This press release contains forward-looking statements, including statements
about, Amarin's ability to seek additional indications based on the results of
the study and the size of the potential patient population represented by such
potential indication, clinical trial results, the utility of an SPA agreement
and the likelihood of regulatory submissions and approvals. 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
uncertainties associated generally with the rate and continued success with
patient enrollment, continued study execution, reliance on third parties
conducting the study, the rate of cardiovascular events contemplated within
the study design, and risks associated generally with research and
development, clinical trials, related regulatory submissions and approvals and
estimation of patient populations. 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 (, our investor
relations website (, including
but not limited to investor presentations and investor FAQs,Securities and
Exchange Commissionfilings, 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
         Amarin Corporation
         In U.S.: +1 (908) 719-1315

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