View:
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
October 12, 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 closing of the acquisition of Laxdale Limited.
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date on which this report is filed, to the extent not superseded by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/ RICHARD A.B. STEWART
Name: Richard A.B. Stewart
Title: Chief Executive Officer
Date: October 12, 2004
EXHIBIT INDEX
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
AMARIN CORPORATION CLOSES ACQUISITION OF LAXDALE LTD.
- - Amarin gains access to a late stage CNS pipeline and leading
neuroscience development capability -
LONDON, United Kingdom, October 12, 2004 - Amarin Corporation plc (NASDAQSC:
AMRN) today announced that it has successfully closed the acquisition of Laxdale
Limited, a private neuroscience development company based in Stirling, Scotland.
The acquisition provides Amarin with a significant neuroscience pipeline in
clinical development for central nervous system disorders. The most advanced
candidate, Miraxion(TM), for which Amarin had originally licensed U.S. rights in
November 2000, is in phase III development for Huntington's disease. In
addition, the acquisition provides Amarin with a leading neuroscience
development capability.
As announced on July 12, 2004, the purchase price comprises an initial
consideration of 3.5 million ordinary shares (to be represented as Amarin
American Depositary Shares) and other success related milestones as set
out in the earlier press release.
KEY BENEFITS TO AMARIN
- Improvement in Amarin's share of Miraxion's economics by reducing Amarin's
royalty obligations on U.S. sales from an effective rate of 40% previously to 5%
post acquisition
- E.U. and Japanese rights to Miraxion for Huntington's disease plus existing
licensee relationships for the major European markets and Japan
- North American, E.U. and Japanese rights to Miraxion in all other central
nervous system disorders, including treatment unresponsive depression
- Leading neuroscience development capability which can be further leveraged
through in-licensing and acquiring rights to additional programs, and
- A development pipeline beyond Miraxion consisting of additional
neuroscience programs at earlier stages of development
Rick Stewart, chief executive officer of Amarin Corporation, commented, "The
successful completion of the Laxdale acquisition and the conclusion of the
$12.75 million financing creates a company with an exciting late-stage
development pipeline, a strong balance sheet and a near term opportunity with
Miraxion in phase III clinical trials."
Mr. Stewart continued "Our near term objectives are twofold; firstly to focus
resources on the upcoming phase III clinical trials in Huntington's disease and
secondly to seek a development and marketing partner for Miraxion in treatment
unresponsive depression."
In conjunction with the acquisition of Laxdale, Amarin has paid GBP Sterling
500,000 at closing to execute cross-licensing agreements with Scarista Limited,
providing Amarin with rights to specified intellectual property covering North
America, the E.U. and Japan.
Following the financing and acquisition of Laxdale, Amarin now has approximately
37.6 million ordinary shares in issue.
DEVELOPMENT PIPELINE
Amarin's late-stage development pipeline now consists of the following key
programs:
PROGRAM INDICATION DEVELOPMENT STATUS
Miraxion (E.U.) Huntington's disease Filed (EMEA)
Miraxion (U.S.) Huntington's disease Phase III studies to
commence early next year
Miraxion Treatment- Additional Phase II to
unresponsive commence next year
depression (to be partnered)
LAX-200 Depression, Phase II
products schizophrenia,
Multiple sclerosis
MIRAXION(TM) AND HUNTINGTON'S DISEASE
Miraxion(TM), Amarin's lead late-stage development product, is being developed
for the treatment of Huntington's disease, with phase III trials due to commence
in early 2005. Miraxion for Huntington's disease has been granted Fast Track
designation and received Orphan Drug designation both in the U.S. and in Europe.
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"
of 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 Huntington's disease.
MIRAXION AND TREATEMENT-UNRESPONSIVE DEPRESSION
Clinical depression is one of the most common mental illnesses, affecting more
than 19 million people in the U.S. alone each year. In 2003, U.S. sales of
antidepressants were approximately $12 billion. However, about one third of
patients with depression still fail to respond to standard drugs and another
third show only partial response. Miraxion is being developed as an adjunctive
therapy to treat those who do not respond to current treatments.
Phase II clinical trials have been conducted with Miraxion in treatment-
unresponsive depression that concluded with statistical significance that a
1-gram per day dose of Miraxion was effective in treating depression in
patients who remained depressed, despite receiving standard therapy. The
results of two trials were published in the Archives of General Psychiatry
in October 2002 and the American Journal of Psychiatry in March 2002.
As a result of these encouraging clinical trial results, Amarin intends to
further evaluate the clinical benefits of Miraxion in this indication and
will seek a development and marketing partner to accelerate the program.
CORPORATE STRATEGY
Amarin's goal is to capitalize on its strong reputation and strategic position
in neuroscience and to become a leader in the development and commercialization
of novel drugs which address unmet medical needs.
Amarin will develop its late-stage development pipeline initially focusing on
Huntington's disease and treatment-unresponsive depression, for which a
development partner will be sought. Amarin will seek to directly commercialize
its neurology products in the U.S. and out-license or partner its rights in
Europe and Japan. Amarin will also out-license or partner its pipeline globally
for indications outside neurology.
Amarin also intends to leverage its development capabilities by supplementing
its internal development pipeline through acquiring and/or in-licensing products
for direct marketing by Amarin in its core U.S. market and selected field of
neuroscience.
AMARIN'S SHORT-TERM OBJECTIVES
- To successfully complete Phase III studies with Miraxion in Huntington's
disease by the end of next year
- To commence Phase II or Phase III studies during 2005 with at least two
other products either from Amarin's internal pipeline or from in-licensing
activities
ABOUT AMARIN CORPORATION
Amarin Corporation plc is a neuroscience company focused on the development and
commercialisation of novel drugs for the treatment of central nervous system
disorders. Miraxion is in phase III development for Huntington's disease and is
in phase II development for treatment unresponsive depression.
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 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 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.