SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUERS PURSUANT TO RULE
13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT
OF 1934
Dated: October 28, 2002
Commission file number 0-21392
AMARIN CORPORATION PLC
(Exact name of Registrant as Specified in its Charter)
ENGLAND
(Jurisdiction of Incorporation or
organization of Issuer)
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.
[X] Form 20-F [ ] Form 40-F
Indicate by check mark whether the registrant by
furnishing the information contained in this Form is
also thereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the
Securities Exchange Act of 1934.
[ ] Yes [X] No
Attachment:
Material Events
(a) Amarin Corporation announces encouraging preliminary results of LAX-101
pivotal study in Huntington's Disease.
This report on Form 6-K is hereby incorporated
by reference in the registration statement on Form F-3
(Registration Statement No. 333-12642) of Amarin
Corporation plc and in the prospectus contained therein,
and in the Registration Statement on Form F-3
(Registration No. 333-13200) 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report is filed, to the extent not superseded by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.
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/Richard A B Stewart
Richard A B Stewart
Chief Executive Officer
Date: October 28, 2002
Index to
Exhibits
Exhibit Item Sequentially Numbered Page
(a) Material Event description- 4
Amarin Corporation announces encouraging
preliminary results of LAX-101 pivotal
study in Huntington's Disease
Exhibit
(a)
Contacts:
Rick Stewart
Chief Executive Officer
Amarin Corporation plc
Phone: +44 (0) 207 907 2440
Email: rick.stewart@amarincorp.com
Mike Coffee
President & Chief Operating Officer
Amarin Corporation plc
Phone: 415-389-4755
Email: mike.coffee@amarinpharma.com
AMARIN CORPORATION ANNOUNCES ENCOURAGING PRELIMINARY
RESULTS OF LAX-101 PIVOTAL STUDY IN HUNTINGTON'S DISEASE
LONDON, United Kingdom, October 28, 2002 -- Amarin Corporation plc (NASDAQ:
AMRN) (Amarin) announced today the preliminary results of a Phase III study of
LAX-101, an investigational, novel and proprietary product being developed for
treating patients with Huntington's disease (HD).
The primary variable in the trial was the change over a one-year period in the
Total Motor Score 4 (TMS-4) subscale of the Unified Huntington's Disease Rating
Scale (UHDRS), the standard rating scale for trials in this disease.
Preliminary results indicate that evaluable patients taking LAX-101 (the per
protocol group) reached statistical significance when compared to placebo,
using one of the analytical methods specified in the protocol. In addition, a
majority of assessments representing the secondary endpoints, including total
UHDRS score improvement, showed trends in favor of LAX-101 but did not reach
statistical significance.
In the intent-to-treat group (all patients entering the study, including those
who dropped out or did not comply with the protocol), preliminary results
indicate that measurement of the TMS-4 primary variable did not reach
significance, though trends toward improvement were observed and favored LAX-
101. LAX-101 was found to be well tolerated by patients throughout the trial.
The incidence and types of adverse events reported were similar in the placebo
and drug groups.
The results are from a multi-center, double-blind, randomized, placebo-
controlled study of LAX-101, which enrolled 135 patients with HD at six sites,
located in the United States, Canada, U.K. and Australia. These results are
also consistent with findings in Phase II studies previously reported by Amarin
in January 2002.
Rick Stewart, chief executive officer of Amarin, stated, "We are encouraged by
the results of this trial and look forward to working closely with our partner
Laxdale Ltd., who is in discussions with the U.S. Food and Drug Administration
(FDA) in relation to the findings."
LAX-101 has been granted Fast Track designation by FDA as well as having
received Orphan Drug designation in the U.S. and in Europe. Amarin licensed
the U.S. marketing rights from U.K.-based Laxdale Ltd.
Huntington's disease is an autosomal-dominant genetic disease that has been
diagnosed in approximately 30,000 patients in the U.S. The gene for HD causes
the formation of abnormal proteins due to multiple repeats in a segment of the
DNA of affected patients. In the U.S. it is estimated that in addition to the
approximately 30,000 patients with a clinical diagnosis of HD, there are an
additional number of individuals with the HD gene who are pre-symptomatic, who
will eventually develop the disease. Because HD generally strikes patients
during their peak earning potential years (30-50 years old) and because
patients with end-stage disease require continuous nursing care, often in
institutions, the annual cost to the U.S. economy for HD has been estimated to
be as high as $2.5 billion.
Amarin Corporation, plc is a specialty pharmaceutical company focused on
neurology and pain management. The company plans to become a leader in these
therapeutic categories by providing innovative products and solutions that
address significant unmet medical needs.
Statements in this press release that are not historical facts are forward-
looking statements that involve risks and uncertainties which may cause the
Company's actual results in future periods to be materially different from any
performance suggested herein. Such risks and uncertainties include, without
limitation, risks associated with the inherent uncertainty of pharmaceutical
research, product development, regulatory approval and commercialization, the
impact of competitive products and patents, as well as other risks and
uncertainties detailed from time to time in periodic reports. For more
information, please refer to Amarin Corporation's Annual Report
for 2001 or 20-F and its Form 6-Ks as filed with the U.S. Securities
and Exchange Commission. The Company assumes no obligation to update
these statements.