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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 23, 2002
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 plc announces acceptance for filing of
new drug application for Zelapar ( tm ) by the US 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report is filed, to the extent not superseded by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: May 23, 2002
Index to
Exhibits
Exhibit Item Sequentially Numbered Page
(a) Material Event description- 4
Amarin Corporation plc announces
acceptance for filing of
new drug application for
Zelapar ( tm ) by the US FDA
Exhibit
(a)
Contacts:
Rick Stewart
Chief Executive Officer
Amarin Corporation plc
Phone: +44 (0) 20 7907 2440
Email: rick.stewart@amarincorp.com
Mike Coffee
President & Chief Operating Officer
Amarin Corporation plc
Phone: + (1) 415 389 4755
Email: mike.coffee@amarinpharma.com
AMARIN CORPORATION ANNOUNCES ACCEPTANCE FOR FILING OF
NEW DRUG APPLICATION FOR ZELAPAR ( tm ) BY US FDA
London, United Kingdom, May 23, 2002 -- Amarin
Corporation plc (NASDAQ: AMRN) today announced the acceptance for
filing and substantive review of a New Drug Application (NDA) for
Zelapar ( tm )(selegiline HCl orally dissolving tablets) by the
U.S. Food and Drug Administration (FDA). The filing was made by
Elan Pharmaceuticals, Inc. (Elan), current holder of exclusive
license rights to market and distribute Zelapar in the U.S. As
previously announced, Amarin has an exclusive option to obtain the
U.S. rights to Zelapar from Elan. Upon approval and exercise of
the option, Zelapar will be marketed by Amarin Pharmaceuticals,
Inc., the pharmaceutical development and marketing subsidiary of
Amarin Corporation, plc.
Zelapar, a novel and proprietary formulation of
selegiline, an MAO-B inhibitor, is an oral tablet using the
patented Zydis( r ) fast-dissolving technology of RP Scherer
Corporation, Elan's licensor. Zelapar is being developed as
adjunct treatment to levodopa for the symptoms of Parkinson's
disease. Selegiline, the active ingredient in Zelapar, is
approved for that indication in conventional tablet form. The
Zelapar tablet dissolves in seconds and is absorbed in the tissues
of the mouth, without swallowing or the need for liquids.
"We believe that the convenience of Zelapar for
Parkinson's patients, many of whom have trouble swallowing,
combined with other unique advantages of the formulation, will
make Zelapar an important new treatment option in addition to
currently available therapies for Parkinson's," commented Rick
Stewart, Amarin's chief executive officer. "Now that the NDA has
been accepted for filing, we look forward to completion of the
substantive review process by the FDA, and working toward approval
of the NDA," he added. "On approval, Zelapar will complement our
currently marketed Parkinson's disease product, Permax( r )
(pergolide mesylate tablets), progressing Amarin toward its goal
of becoming a leader in the treatment of movement disorders," said
Rick Stewart. Permax is a dopamine agonist indicated as adjunct
treatment for the treatment of Parkinson's disease.
The U.S. rights to Zelapar are currently licensed to
Elan by R P Scherer Corporation, a unit of Cardinal Health. Elan
will pay all research and development costs, including the costs
of pursuing the NDA to approval. Amarin's option is exercisable
at any time up to and for a period of time after any FDA approval
of the NDA for Zelapar. An initial payment of $10 million would be
made by Amarin upon the closing of the exercise of the option.
The agreement provides for two additional milestone payments
aggregating $27.5 million, contingent on achieving certain revenue
levels, with a final milestone of $15 million payable eight years
from exercise of the option. The final payment is subject to
certain extension rights, and is also subject to certain
reductions based on prior payments made. Amarin would also make
royalty payments based on net sales of Zelapar in the U.S. If
exercised, consummation of the option would be subject to
customary closing conditions, including approval under the Hart-
Scott-Rodino Antitrust Improvements Act.
Amarin Corporation plc is a specialty pharmaceutical
company focused on neurology and pain management. The Company
plans to become a leader in these therapeutic categories by
providing innovative products and solutions that address
significant unmet medical needs. 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 commercialisation, 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.