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 19, 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 Zelapar ( tm ) receives approvable letter
from FDA.
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report is filed, to the extent not superseded by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 18, 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 ZELAPAR ( tm ) RECEIVES APPROVABLE
LETTER FROM FDA
London, United Kingdom, February 18, 2003-- Amarin
Corporation plc (NASDAQ: AMRN) announced today that Zelapar( tm )
(selegiline HCl orally disintegrating tablets) has received an
approvable letter from the U.S. Food and Drug Administration (FDA)
for a New Drug Application (NDA) filed by a subsidiary of Elan
Corporation plc (NYSE: ELN). The FDA accepted the NDA for filing
in April 2002.
"We look forward to the remaining requirements of the FDA
being expeditiously fulfilled," commented Rick Stewart, Amarin's
Chief Executive. "Upon exercise of our option, Zelapar will
complement our currently marketed Parkinson's disease product,
Permax ( r ) (pergolide mesylate) tablets, progressing Amarin toward
its stated goal of becoming a leader in the treatment of movement
disorders."
Amarin has the exclusive option to acquire the U.S. rights to
Zelapar from Elan. Zelapar, a novel and proprietary formulation of
selegiline, is an MAO-B inhibitor that addresses the dopamine
deficiency, which characterizes Parkinson's disease. Zelapar is an
oral tablet using the patented Zydis ( r ) fast-dissolving
technology of RP Scherer Corporation, a unit of Cardinal Health,
Elan's licensor. Zelapar is being developed as an adjunct
treatment to levodopa for the symptoms of Parkinson's disease.
Selegiline, the active ingredient in Zelapar, is approved for this
indication in a conventional tablet form. The Zelapar tablet
dissolves in seconds and is absorbed in the tissues of the mouth.
There is no need to swallow or use liquid in conjunction with this
dosage.
Amarin will hold a conference call to discuss its 2002 annual
earnings report later this month, and will provide specific
details for the call in a forthcoming release. The approval and
launch of a generic to Permax, Amarin's dopamine agonist for the
treatment of Parkinson's disease, has resulted in a requirement to
review the intangible asset value of Permax. It is expected that a
substantial non-cash, exceptional charge will be taken. The final
amount will be provided in Amarin's full year 2002 earnings
report, to be released later this month.
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 (selegiline HCl orally disintegrating tablets)
for Parkinson's disease and LAX-101, a proprietary compound for
Huntington's Disease. For press releases and other Company
information, visit our websites at http://www.amarincorp.com and
http://www.amarinpharma.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 report,
including but not limited to the filing or approval of the NDA for
Zelapar. 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 information on its
expectations.