LONDON, September 12 /PRNewswire-FirstCall/ -- Amarin Corporation plc
(NASDAQ: AMRN) today announced that it has reached an agreement with the U.S.
Food and Drug Administration (FDA) under the Special Protocol Assessment
(SPA) procedure for the design of two pivotal Phase III clinical trials of
Miraxion(TM) (ultra-pure ethyl-EPA) in Huntington's disease. The Special
Protocol Assessment (SPA) is a process under which the FDA provides
evaluation and guidance on clinical trial protocols for Phase III trials.
    Rick Stewart, Chief Executive Officer of Amarin, commented; "Reaching
agreement with the FDA on the trial designs is a positive development for
Amarin. This is a major milestone for the company and we look forward to
immediate enrollment in the U.S. trial."
    The U.S. and European trials will be multi-centre, randomized, double
blind, placebo -controlled studies of Miraxion at 43 sites in the U.S. and up
to 28 sites in Europe. The trials are expected to involve a total of up to
540 Huntington's disease patients with approximately 300 in the U.S. Phase
III trial and approximately 240 in the European Phase III trial over a 6
month period. Patients in the U.S. trial will participate in a further
6-month extension period.
    The Huntington Study Group (H.S.G.), based at the University of
Rochester, will conduct the U.S. clinical trial on behalf of Amarin. The
H.S.G. is a non-profit group of physicians and other health care providers
from medical centers in the U.S., Canada, Europe and Australia, experienced
in the care of Huntington's disease patients and dedicated to clinical
research of Huntington's disease. The European clinical trial will be
conducted in collaboration with EURO-HD and ICON, a leading contract research
organization (CRO). EURO-HD is a non-profit group of physicians and other
healthcare professionals dedicated to the research and care of Huntington's
disease patients.
    The primary endpoint of the trials will be to determine whether Miraxion
taken 2 grams per day (1gram twice daily) results in clinically and
statistically significant changes in the Total Motor Score-4 subscale of the
Unified Huntington's Disease Rating Scale (UHDRS).
    About Amarin Corporation
    Amarin Corporation plc is a neuroscience company focused on the
development and commercialization of novel drugs for the treatment of central
nervous system disorders. Miraxion, Amarin's lead development compound, is in
phase III development for Huntington's disease and in phase II development
for depressive disorders.
    For press releases and other corporate information, visit our website at
http://www.amarincorp.com.
    DISCLOSURE NOTICE: The information contained in this document is as of
12th September, 2005. Amarin assumes no obligation to update any
forward-looking statements contained in this document as a result of new
information or future events or developments.
    This document contains forward-looking statements about Amarin's
financial condition, results of operations, business prospects and products
in research that involve substantial risks and uncertainties. You can
identify these statements by the fact that they use words such as "will",
"anticipate", "estimate", "project", "intend", "plan", "believe" and other
words and terms of similar meaning in connection with any discussion of
future operating or financial performance or events. Among the factors that
could cause actual results to differ materially from those described or
projected herein are the following: the success of Amarin's research and
development activities; decisions by regulatory authorities regarding whether
and when to approve Amarin's drug applications, as well as their decisions
regarding labelling and other matters that could affect the commercial
potential of Amarin's products; the speed with which regulatory
authorizations, pricing approvals and product launches may be achieved; the
success with which developed products may be commercialized; competitive
developments affective Amarin's products under development; the effect of
possible domestic and foreign legislation or regulatory action affecting,
among other things, pharmaceutical pricing and reimbursement, including under
Medicaid and Medicare in the United States, and involuntary approval of
prescription medicines for over-the-counter use; Amarin's ability to protect
its patents and other intellectual property; claims and concerns that may
arise regarding the safety or efficacy of Amarin's product candidates;
governmental laws and regulations affecting Amarin's operations, including
those affecting taxation; Amarin's ability to maintain sufficient cash and
other liquid resources to meet its operating requirements; general changes in
U.K. and U.S. generally accepted accounting principles; growth in costs and
expenses; and the impact of acquisitions, divestitures and other unusual
items, including Amarin's ability to integrate its acquisition of Amarin
Neuroscience Limited. A further list and description of these risks,
uncertainties and other matters can be found in Amarin's Annual Report on
Form 20-F for the fiscal year ended December 31, 2004, and in its Reports of
Foreign Issuer on Form 6-K filed with the SEC.

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