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
August 24, 2004
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 announces results of gene variant data analysis
from initial Miraxion(TM) Phase III clinical trial
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 and
(c) the registration statement on Form F-3 (Registration No. 333-12642)
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superseded by documents or reports subsequently filed or furnished by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/ Alan Cooke
Name: Alan Cooke
Title: Chief Financial Officer
Date: August 24, 2004
Index to Exhibits
Exhibit Item Sequentially Numbered Page
(a) Material event description 4
Contact:
Rick Stewart
Chief Executive Officer
Amarin Corporation plc
Phone: +44 (0) 207 907 2442
investor.relations@amarincorp.com
Alan Cooke
Chief Financial Officer
Amarin Corporation plc
Phone: +44 (0) 207 907 2442
investor.relations@amarincorp.com
AMARIN CORPORATION ANNOUNCES RESULTS OF GENE
VARIANT DATA ANALYSIS FROM INITIAL MIRAXION(TM)
PHASE III CLINICAL TRIAL
Analysis identifies characteristics of Huntington's disease patients
responsive to Miraxion(TM)
LONDON, United Kingdom, August 24, 2004 - Amarin Corporation plc
(NASDAQSC: AMRN) today announced the results of a gene variant data
analysis from the initial Phase III clinical trial for Miraxion(TM)
(formerly referred to as LAX-101) in Huntington's disease. The
analysis identifies a group of patients with a specific gene variant
that experienced a significant response to Miraxion(TM). The initial
twelve month, phase III multi-center, double blind, randomized placebo
controlled study of Miraxion(TM) was conducted in 2002 by Laxdale
Limited ("Laxdale") with 135 enrolled patients with Huntington's disease
at six centers in the United States, Canada, the United Kingdom and
Australia. The primary endpoint in the initial 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.
The additional data analysis identifies a group of participants in the
initial study for whom Miraxion(TM) showed a significant clinical
benefit. Huntington's disease is believed to be caused by a genetic
mutation of the cytosine, adenosine and guanine (CAG) polymorphic
trinucleotide repeat. It is believed that there is a direct link between
CAG repeat length and age of onset, disease progression and clinical
symptoms of Huntington's disease. CAG repeat length can be measured
via a genetic blood test.
Efficacy of Miraxion(TM)
The possibility that treatment efficacy of Miraxion(TM) could be related to
the number of CAG repeats was proposed as part of the pre-specified analysis
and exploratory analysis was conducted after completion of the trial to
examine this influence. A strong correlation between the CAG repeat number
and the change in TMS-4 score was revealed in those patients taking
Miraxion(TM). In order to explore this effect further, patients were split
into two groups based around the median number of CAG repeats, which was
identified as 45. Those patients that took Miraxion(TM) and had a CAG
repeat length of less than 45 comprised the responsive group. This effect
was consistent across all centers. In total, 67 of the 135 patients in the
initial phase III study had this specific gene variant. It is estimated
that patients with a CAG repeat length of less than 45 represent over 65%
of all Huntington's disease patients.
The group of patients with a CAG repeat length of less than 45 in the intent
to treat group receiving Miraxion(TM) showed a statistically significant
improvement over those patients receiving placebo (p=0.029, n=67). In the
group of patients with a CAG repeat length of less than 45 who observed the
clinical trial protocol (per protocol patients) receiving Miraxion(TM)
showed a 22.7% improvement in TMS-4 score versus patients receiving placebo
who showed a 5.7% deterioration at the end of the twelve month study
(p=0.006, n=44). This improvement was observed over a 6-month period and
maintained for a further 6 months. In the 12-month open label continuation
phase of the trial, this improvement continued to be maintained. At the end
of the open-label phase all patients who had taken part in the trial were
offered compassionate supply. More than 3 years after the commencement of
this trial, 101 of the 135 patients enrolled in the trial continue to be
supplied Miraxion(TM).
Rick Stewart, Chief Executive Officer of Amarin commented, "This data
analysis, showing significant clinical benefit to specific patients taking
Miraxion(TM), will be an important component in the design of the planned
phase III clinical trials. It will allow us to more accurately target
patients with this specific gene variant, particularly relating to age of
onset of the disease. Improvement and stability are particularly beneficial
if initiated at an early stage in this devastating disease. This could
significantly extend a patient's professional activities, maintain a good
quality of life, and potentially defer the onset of the later stages of the
disease."
Planned Phase III Trials
Amarin intends to commence two phase III clinical trials totaling over 400
Huntington's disease patients in early 2005, subject to consummation of
Amarin's proposed acquisition of Laxdale and the completion of an equity
fund raising.
Miraxion(TM) has been granted Fast Track designation for Huntington's disease
by the United States Food and Drug Administration and received Orphan Drug
designation both in the U.S. and in Europe. Miraxion(TM) is also in clinical
development for depression.
Huntington's Disease
Huntington's disease is a genetic neurodegenerative disease characterized
by movement disorder, dementia and psychiatric disturbance. It has been
diagnosed in approximately 30,000 patients in the U.S. with a similar number
in Europe. Additionally, over 200,000 persons in the U.S. alone are
genetically "at risk" to developing the disease. Onset of symptoms is
typically between 30-50 years of age with a typical life expectancy from
diagnosis of 10-25 years. Patients with late stage disease require continuous
nursing care, often in nursing homes, with an estimated annual cost to the
U.S. economy of up to $2.5 billion. Presently, there is no effective
treatment or cure for HD.
About Amarin Corporation
Amarin Corporation is a neuroscience company focused on the development and
commercialisation of novel drugs for the treatment of neurological disorders
affecting the central nervous system.
For press releases and other corporate information, visit our website at
http://www.amarincorp.com.
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, the uncertainty of entering into and consummating a
definitive agreement on terms acceptable to the parties, the inherent
uncertainty of pharmaceutical research, product development 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
2003 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 information
on its expectations.