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: May 14, 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 settlement of patent litigation with
Ivax Corporation
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report is filed, to the extent not superseded by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: May 14, 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 SETTLEMENT OF
PATENT LITIGATION WITH IVAX CORPORATION
Ivax to sublicense patent rights in return for royalty payments
LONDON, United Kingdom, May 14, 2003 -- Amarin Corporation
plc (NASDAQ: AMRN) (Amarin) announced today that it has entered
into a settlement of patent litigation with Ivax Corporation
(AMEX: IVX). The litigation concerns two U.S. patents licensed to
Amarin by Eli Lilly and Company (NYSE: LLY) upon Amarin's
acquisition from Elan Corporation (NYSE: ELN) of the exclusive
U.S. license rights to Permax (r) (pergolide mesylate) tablets.
In return for a sublicense under those patents, Amarin will
receive royalty payments from Ivax's sale of any pergolide
products, as described below.
"We are very pleased to resolve this litigation on terms
which acknowledge the value of our licensed patents," commented
Rick Stewart, Amarin's chief executive officer. "Settling this
litigation will allow us to focus our resources and efforts on
progressing our pipeline products, Zelapar ( tm )(selegiline
orally disintegrating tablets) and LAX-101 (ethyl
eicosapentaenoate)," he added.
Under the terms of the settlement, Amarin and Lilly will
grant to Ivax a non-exclusive sublicense in the U.S. under the two
patents at issue, beginning September 2, 2003, and continuing for
the remaining life of the patents. In return, Ivax will make
royalty payments to Amarin, to be shared between Amarin and Lilly,
from the first six months' gross profit (net sales less cost of
goods sold) from sales of any Ivax pergolide product under its
Abbreviated New Drug Application (ANDA) for pergolide products,
once approved by FDA. The patent litigation was initiated by Elan
in 2001 upon the filing by Ivax of its ANDA, and was assumed by
Amarin as a part of its acquisition of the U.S. license rights
from Elan. Under the Hatch-Waxman law regarding patent rights and
approval of generic drugs, Elan's commencement of the patent suit
resulted in an automatic stay of approval of Ivax's ANDA by the
Food and Drug Administration (FDA) until September 2003. Ivax has
announced that its ANDA has received tentative approval by the
FDA.
Pergolide is the active pharmaceutical ingredient in Permax,
indicated as adjunctive treatment for Parkinson's disease. An
ANDA for pergolide products has previously been filed by Teva
Pharmaceuticals (Nasdaq: TVA) and approved by FDA. Teva's
product was commercially launched in January of this year. Amarin
is not aware of any other ANDA for pergolide filed with FDA.
Amarin Corporation plc is a specialty pharmaceutical company
focused on neurology. The Company plans to become a leader in
this therapeutic category by providing innovative products and
solutions that address significant unmet medical needs. Amarin
has eleven pharmaceutical products on the U.S. market along with a
development pipeline that includes two late-stage candidates:
Zelapar ( tm ) (selegiline orally disintegrating tablets), for
Parkinson's disease, and LAX-101, a proprietary compound for
Huntington's Disease.
For press release and other Company 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, risks
associated with 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
2002 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.