UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
OF THE SECURITIES EXCHANGE ACT OF 1934
September 13, 2005
Commission File Number 0-21392
AMARIN CORPORATION PLC
(Translation of registrant's name into English)
7 Curzon Street
London W1J 5HG
England
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F:
Form 20-F [X] Form 40-F [ ]
Indicate by check mark whether by furnishing the information contained
in this Form, the registrant is also thereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes [ ] No [X]
Attachment:
Material Events
(a) Amarin Corporation receives special protocol assessment from FDA for Phase
III clinical trials for Miraxion.
This report on Form 6-K is hereby incorporated by reference
in (a) the registration statement on Form F-3 (Registration No.
333-104748) of Amarin Corporation plc and in the prospectus
contained therein, (b) the registration statement on Form F-3
(Registration No. 333-13200) of Amarin Corporation plc and in the
prospectus contained therein, (c) the registration statement on
Form F-3 (Registration No. 333-12642) of Amarin Corporation plc and
in the prospectus contained therein, (d) the registration statement
on Form F-3 (Registration No. 333-121431) of Amarin Corporation plc and
in the prospectus contained therein and (e) the registration statement
on Form F-3 (Registration No. 333-121760) of Amarin Corporation plc and
in the prospectus contained therein, and this report on Form 6-K
shall be deemed a part of each such registration statement from the
date on which this report is filed, to the extent not superseded by
documents or reports subsequently filed or furnished by Amarin
Corporation plc under the Securities Act of 1933 or the Securities
Exchange Act of 1934.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
AMARIN CORPORATION PLC
By: /s/ Jonathan S. Lamb
Name: Jonathan S. Lamb
Title: General Counsel & Company Secretary
Date: September 13, 2005
EXHIBIT INDEX
Index to Exhibits
Exhibit Item Sequentially Numbered Page
(a) Material event description 4
AMARIN RECEIVES SPECIAL PROTOCOL ASSESSMENT FROM FDA FOR TWO PIVOTAL
PHASE III CLINICAL TRIALS FOR MIRAXION IN HUNTINGTON'S DISEASE
LONDON, United Kingdom, 12th September, 2005 -- 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).
Contact:
Amarin Corporation plc +44 (0) 207 907 2442
Rick Stewart Chief Executive Officer
Alan Cooke Chief Financial Officer
investor.relations@amarincorp.com
Powerscourt +44 (0) 207 236 5615
Rory Godson/Victoria Brough
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.