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: February 3, 2003
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 further progress on Lax-101 Clinical
Development for 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report is filed, to the extent not superseded by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: February 3, 2003
Index to
Exhibits
Exhibit Item Sequentially Numbered Page
(a) Material Event description- 4
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: mile.coffee@amarincorp.com
AMARIN CORPORATION ANNOUNCES FURTHER PROGRESS
ON LAX-101 CLINICAL DEVELOPMENT FOR HUNTINGTON'S DISEASE
-- Conference Call to Provide Company Update --
LONDON, United Kingdom, February 3, 2003 -- Amarin Corporation plc
(NASDAQ: AMRN) (Amarin) and its partner, Laxdale Ltd announced today
their intention to conduct an additional Phase III study to support a
New Drug Application (NDA) for LAX-101. This was determined after a
meeting with the Food and Drug Administration (FDA) on January 29, 2003.
LAX-101 is a novel and proprietary product being developed for treatment
of the symptoms of Huntington's Disease (HD). LAX-101 has been granted
Fast Track designation by the FDA and has received Orphan Drug
designation in the U.S. and Europe.
Rick Stewart, Amarin's chief executive officer stated, "The
decision to conduct a second Phase III study is consistent with the
approval process of new drug products for neurological diseases, and
reflects the fact that statistical significance was not achieved in the
"intent to treat" patient population in the first Phase III study. We
were encouraged by the results of our previously announced Phase III
trial and look forward to finalizing our protocol with the FDA for our
second Phase III trial."
Amarin announced on October 28, 2002 preliminary data from a Phase
III study conducted in a multi-center, double-blind, randomized,
placebo-controlled study of LAX-101, which enrolled 135 patients with
HD. The primary endpoint in that 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. While trends favored LAX-101 over placebo,
statistical significance was not reached, when measured in the intent-
to-treat population (all patients entering the study, including those
who dropped out or did not comply with the protocol). Significant
results were achieved in the subset of patients evaluated (those
completing the study in compliance with protocol requirements). The
study also produced trends in favor of LAX-101 in several secondary
endpoints. LAX-101 was found to be well tolerated by patients
throughout the study. The incidence and types of adverse events
reported were similar in the placebo and drug groups.
"As previously noted, the results of the initial Phase III trial,
while not statistically significant in the intent to treat group, were
invaluable in demonstrating benefit in certain patients with
Huntington's Disease in the per protocol group, and providing
information which will allow us to design a further Phase III clinical
study with Laxdale in support of the submission of an NDA. We look
forward to partnering with Laxdale to pursue further development as soon
as possible," Mr. Stewart added.
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.
Conference Call Information
Amarin management will hold a conference call at 11:15 a.m. EST
today, Monday, February 3, 2003. To access the call, dial 888-881-4892
for domestic and 416-640-4127 for international. An audio replay will be
available for seven days; domestic callers dial 877-289-8525 and
international callers dial 416-640-1917. The passcode for the replay is
236321.
About Amarin
Amarin Corporation, plc (Nasdaq: AMRN) is a specialty
pharmaceutical company focused on neurology and pain management. Amarin
has multiple pharmaceutical products on the US market along with a
development pipeline that includes two late-stage candidates: Zelapar (
tm ) (selegiline orally dissolving products) for Parkinson's disease and
LAX-101, a proprietary compound for Huntington's Disease.
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 commercialisation, 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 on Form 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.