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Amarin Announces Submission of Supplemental New Drug Application (sNDA) for Vascepa(R) for the Treatment of Patients With High



Amarin Announces Submission of Supplemental New Drug Application (sNDA) for
Vascepa(R) for the Treatment of Patients With High Triglycerides With Mixed
Dyslipidemia

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

BEDMINSTER, N.J. and DUBLIN, Ireland, Feb. 26, 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 has submitted a Supplemental New Drug
Application (sNDA) with the U.S. Food and Drug Administration (FDA) seeking
approval for the marketing and sale of Vascepa^(R) (icosapent ethyl) capsules
for use 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. Amarin
expects to hear within 74 days from the FDA whether the sNDA submission has
been accepted for review (inclusive of the standard 60-day review and the
standard 14-day communication periods).

"This submission marks another significant milestone achieved for Amarin. Data
from our pivotal Phase 3 placebo-controlled ANCHOR study showed that Vascepa
is unique in that it significantly lowered both triglycerides and
LDL-cholesterol on top of optimized statin therapy and exhibited a safety and
tolerability profile similar to placebo, unlike the clinical results of other
triglyceride-lowering therapies," said Joseph S. Zakrzewski, Chairman and
Chief Executive Officer of Amarin. "The submission of this sNDA for Vascepa
follows the FDA approval and recent launch of Vascepa for use as an adjunct to
diet to lower triglyceride levels in adult patients with severe (TG ≥500
mg/dL) hypertriglyceridemia. If approved for the ANCHOR indication, Vascepa
will be the only approved prescription omega 3 therapy for cardiovascular
health management in this patient population (TG ≥200 mg/dL and <500 mg/dL
with mixed dyslipidemia) and will represent the next generation of lipid
management for potentially millions of patients."

It is estimated that one in five, or nearly 40 million U.S. adults, have
triglyceride levels greater than 200 mg/dL. In the United States alone, it is
estimated that 75 million adults have triglyceride levels greater than 150
mg/dL (population studied in the ongoing Vascepa REDUCE-IT cardiovascular
outcomes study), including 4 million people with severe hypertriglyceridemia
(Vascepa approved indication) and 36 million people with high triglyceride
levels (the triglyceride range studied in the ANCHOR trial). Clinical
treatment guidelines include recommendations for triglyceride reductions in
adults with triglyceride levels greater than 200 mg/dL^1 and it is believed
that each group represents a potential multi-billion dollar market
opportunity. In the top seven world markets it is estimated that the number of
people with elevated triglyceride levels is at least two times that of the
United States alone.

^1Executive Summary of the Third Report of the National Cholesterol Education
Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High
Blood Cholesterol in Adults (Adult Treatment Panel III). JAMA. May 16,
2001;285(19):2486-97

About Vascepa® (icosapent ethyl) capsules

Vascepa® (icosapent ethyl) capsules, known in scientific literature as AMR101,
is a patented, 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.

FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM

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
www.vascepa.com. For more information about Amarin visit www.amarincorp.com.

The Amarin Corporation plc logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=13817

Forward-looking statements

This press release contains forward-looking statements, including statements
about regulatory submissions and the timing and potential for FDA acceptance,
review and approval of such submissions, the efficacy and safety of Amarin's
product candidates and market opportunities for Vascepa 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 research and development, clinical trials and related regulatory reviews
and approvals, including whether Amarin has, in the FDA's view, reached
substantial enrollment in its REDUCE-IT outcomes study of Vascepa, a
prerequisite to the FDA's acceptance of the sNDA for the ANCHOR indication. 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: Stephen Schultz or Joseph Bruno
         Investor Relations and Corporate Communications
         Amarin Corporation
         In U.S.: +1 (908) 719-1315
         investor.relations@amarincorp.com

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