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: July 13, 2004
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 DEFINITIVE AGREEMENT TO
ACQUIRE LAXDALE LTD.
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extent not superseded by documents or reports subsequently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.
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: July 13, 2004
Index to
Exhibits
Exhibit Item Sequentially Numbered Page
(a) Material Event description- 4
Exhibit (a)
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
AMARIN CORPORATION ANNOUNCES DEFINITIVE AGREEMENT
TO ACQUIRE LAXDALE LTD.
Combined Company to Lead in Development and Commercialization of
Neuroscience Compounds
LONDON, United Kingdom, July 12, 2004 - Amarin Corporation plc
(NASDAQ: AMRN) today announced that it has signed a definitive
agreement to acquire Laxdale Limited, a privately owned, neuroscience
development company based in Stirling, Scotland. Laxdale's
development pipeline includes programs in Huntington's disease,
treatment unresponsive depression and other neurological disorders.
Amarin previously licensed the U.S. rights to Miraxion TM (formerly
referred to as LAX-101) for Huntington's disease in November 2000.
The purchase price comprises an initial consideration of 3.5 million
Amarin American Depositary Shares. Other success related milestones
payable on product approvals are as follows:
- On receipt of a marketing approval for Miraxion in Huntington's
disease in the U.S. and Europe, a stock or cash payment of 7.5
million pound sterling for each approval
- On receipt of a marketing approval for any other indication
or product using Laxdale intellectual property, a stock or cash
payment of 5 million pound sterling for each of the first two marketing
approvals.
The transaction is contingent upon Amarin shareholder approval,
completion by Amarin of a $15 million financing and other customary
conditions. Amarin has agreed a loan facility of up to 950,000 pound
sterling to Laxdale. This loan facility is secured by a floating charge
against Laxdale's assets.
In conjunction with the acquisition of Laxdale, Amarin will execute
cross-licensing agreements with Scarista Limited at closing providing
Amarin with rights to specified intellectual property covering
North America, the E.U. and Japan for the payment of 500,000 pound sterling.
Rick Stewart, chief executive officer of Amarin Corporation,
commented, "Our long-term collaboration with Laxdale on the
development of Miraxion for Huntington's disease has given Amarin
a great appreciation of the scientific capabilities, competencies
and depth of the development pipeline in central nervous system
diseases at Laxdale. We have been particularly encouraged by
additional clinical data analysis from the initial pivotal clinical
trial in Huntington's disease which identified a sub-group
of Huntington's disease patients which responded positively
to Miraxion."
Sherri Clarkson, managing director of Laxdale, commented, "Laxdale
enjoys a proud reputation for scientific excellence in central
nervous system disorders. A combination with Amarin, our U.S. marketing
partner, makes tremendous strategic sense to progress the Phase III
development program for Miraxion."
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
- A development pipeline beyond Miraxion consisting of additional
neuroscience programs at earlier stages of development.
Development Pipeline
Amarin's late-stage development pipeline will consist of the following key
programs:
Program Indication Development Status
Miraxion Huntingdon's disease Filed (EMEA)
(E.U.)
Miraxion Huntingdon's disease Phase III studies to commence
(U.S.) early next year
Miraxion Treatment unresponsive Phase II to commence next year
Depression (to be partnered)
Miraxion for Huntington's Disease - Recent Progress
Miraxion has been granted Fast Track designation by FDA as well as
having received Orphan Drug designation both in the U.S. and in
Europe. Laxdale recently met with the Food and Drug Administration
(FDA) regarding the clinical trial protocol for Miraxion in additional
Phase III clinical studies in Huntington's disease. As a result of
those discussions with the FDA, revisions have been made to the protocol
to include two six-month studies totaling approximately 400 patients.
It is anticipated that the studies will start early next year subject
to finalization of the protocol. Miraxion was submitted for regulatory
approval in Europe in June 2003 based on the initial Pivotal
clinical data.
The initial Pivotal clinical trial in 135 Huntington's disease patients
did not achieve statistical significance in the "Intent to Treat"
group of patients primarily due to a high number of patients who did
not comply with the protocol. However, in those patients that complied
with the protocol ("per protocol"), a trend to statistical significance
was observed.
Recent additional analysis of the clinical data from the initial
study also identified a sub-set of Huntington's patients (with a
specific gene variant) that responded to Miraxion with statistical
significance at 6 months and at 12 months. The per protocol analysis
and the additional clinical data in this patient sub-group provides
Amarin with valuable information with which to design our planned
Phase III studies.
Huntington's Disease is an autosomal-dominant genetic disease that
has been diagnosed in approximately 30,000 patients in the U.S.
with a similar number in Europe. Additionally, over 200,000
persons are genetically "at risk" of developing the disease in
the U.S. alone. Huntington's disease is a neurodegenerative
disease characterized by movement disorder, dementia and
psychiatric disturbance. Onset of symptoms is typically between
40-45 years of age with a typical life expectancy from diagnosis
of 15-25 years. Huntington's disease is believed to be caused
by a genetic mutation of the cytosine, adenosine and guanine
(CAG) polymorphic trinucleotide repeat. 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.
Miraxion for Treatment Unresponsive Depression
Two 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
these 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 the encouraging clinical trial results in treatment
unresponsive depression, Amarin intend to further evaluate the
clinical benefits of Miraxion in this indication and will seek a
development and marketing partner to accelerate the program.
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.
Miraxion is being developed as an adjunctive therapy to treat those
who do not respond to current treatments.
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 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 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.