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: November 12, 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'S PARTNER TANABE SUBMITS DCV MORPHINE ONCE DAILY
FORMULATION TO MHLW IN JAPAN
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report is filed, to the extent not superseded by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: November 12, 2002
Index to
Exhibits
Exhibit Item Sequentially Numbered Page
(a) Material Event description- 4
AMARIN'S PARTNER TANABE SUBMITS
DCV MORPHINE ONCE DAILY
FORMULATION TO MHLW IN JAPAN
Exhibit
(a)
Contacts:
Rick Stewart
Chief Executive Officer
Amarin Corporation plc
Phone: +44 (0) 207 907 2440
Email: rick.stewart@amarincorp.com
AMARIN'S PARTNER TANABE SUBMITS DCV MORPHINE
ONCE DAILY FORMULATION TO MHLW IN JAPAN
First Filing for Amarin's DCV Technology in Japan
Expands Amarin's Presence in Pain Management
LONDON, United Kingdom, November 12, 2002 -- Amarin
Corporation plc (NASDAQ: AMRN) today announced that
Tanabe Seiyaku Co. Ltd., its Japanese partner for the
development of a once daily Morphine Sulphate
formulation, has submitted a New Drug Application
("NDA") dossier for this formulation to the Ministry of
Health, Labor and Welfare ("MHLW") for regulatory
review. This submission follows the successful
conclusion of an extensive clinical program undertaken
by Tanabe in Japan.
The formulation is indicated for the relief of
moderate to severe pain, and was developed by Amarin's
European oral product development facility, Amarin
Development AB, based in Malmo, Sweden. Four dosage
strengths have been developed (20, 30, 60 and 120 mg)
all of which utilise Amarin's patented Diffusion
Controlled Vesicle (DCV) technology for the controlled
release of morphine sulphate over a period of up to 24
hours. As part of the development process, the DCV
technology has been successfully transferred to
Tanabe's Osaka facility; the product will be
manufactured there for commercial sale once approved.
Rick Stewart, chief executive officer of Amarin,
commented, "We are pleased that our long term
relationship and collaboration with Tanabe has again
come to fruition with the filing of this NDA to the
MHLW. DCV Morphine OD is the first product to be filed
in Japan using our proprietary DCV technology, which has
been utilised in five product formulations worldwide.
In addition to our strong franchise in neurology
products, this submission serves as an important step
toward expanding our presence in pain management. We
look forward to the future successful commercialisation
of this product. "
Amarin and Tanabe have a long established relationship
relating to controlled-release products. In the late
1980's Amarin developed for Tanabe a controlled release
formulation of diltiazem, which is sold today through
various licensees in over 30 territories across the
world. To date, over 3 billion of these tablets have
been manufactured and used in the treatment of patients
with cardiovascular disease.
Amarin's DCV system is used for the controlled release
of substances for periods up to 24 hours. The patented
technology consists of a tablet core, incorporating the
active ingredient, surrounded by a water-insoluble
membrane containing minute particles of water-soluble
material. The soluble particles dissolve when the
tablet is ingested, resulting in a macro-porous film
structure through which drug is released at a steady
rate. In addition to Tanabe Seiyaku, principal
licensees for the technology include Pharmacia and
Sanofi-Synthelabo. Over 4 billion tablets incorporating
the DCV technology have been manufactured and used
effectively by patients in more than thirty countries.
Amarin Corporation plc is a specialty pharmaceutical
company focused on pain management and neurology. The
Company plans to become a leader in these therapeutic
categories by providing innovative products and
solutions that address significant unmet medical needs.
Amarin Development AB is a wholly owned subsidiary of
Amarin Corporation plc dedicated the research and
development of advanced controlled release and site
specific technology solutions to create improved outcome
formulations of both new and existing drugs.
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 reports. For
more information, please refer to Amarin Corporation
plc'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.