SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
________
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13A-16 OR 15D-16 OF
THE SECURITIES EXCHANGE ACT OF 1934
For the month of February, 2003
Serono S.A.
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(Registrant's Name)
15 bis, Chemin des Mines
Case Postale 54
CH-1211 Geneva 20
Switzerland
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(Address of Principal Executive Offices)
1-15096
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(Commission File No.)
(Indicate by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.)
Form 20-F X Form 40-F
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(Indicate by check mark if the registrant is submitting the Form 6-K in
paper as permitted by Regulation S-T Rule 101 (b)(1).) ______
(Indicate by check mark if the registrant is submitting the Form 6-K in
paper as permitted by Regulation S-T Rule 101 (b)(7).) ______
(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 No X
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(If "Yes" is marked, indicate below the file number assigned to the
registrant in connection with Rule 12g3-2(b): 82-______)
SERONO
MEDIA RELEASE
FOR IMMEDIATE RELEASE
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SERONO SUBMITS APPLICATION FOR EUROPEAN UNION
APPROVAL OF RAPTIVA(TM) FOR PSORIASIS
GENEVA, SWITZERLAND - FEBRUARY 26, 2003 - SERONO S.A. (VIRT-X: SEO AND NYSE:
SRA) Serono announced today that it has submitted a Marketing Authorization
Application (MAA) to the European Agency for the Evaluation of Medicinal
Products (EMEA) for Raptiva(TM) (efalizumab) for the treatment of adults with
moderate-to-severe psoriasis. The EMEA has confirmed that the application is
valid, and that the regulatory procedure has commenced.
"With the filing of Raptiva in Europe, Serono is one step nearer to entering a
new therapeutic area, " said Ernesto Bertarelli, Serono's Chief Executive
Officer. "The treatment advance represented by Raptiva will address many of the
unmet needs of people with psoriasis."
This submission is based on efficacy and safety studies in more than 2,100
patients with psoriasis. In these clinical trials, Raptiva(TM) showed fast
onset of clinical response - as early as two weeks - and control of plaque
psoriasis over a one year period of treatment.
The company plans to submit the applications for the marketing authorization of
Raptiva(TM) with Canadian, Australian and Swiss authorities by the end of this
quarter.
Serono has the rights to develop and market Raptiva(TM) worldwide outside of the
United States and Japan. Development and marketing rights in the United States
remain with Genentech Inc. (NYSE:DNA) and its U.S. partner XOMA (Nasdaq: XOMA),
who filed a Biologics License Application (BLA) with the FDA in December 2002.
ABOUT RAPTIVA(TM)
Raptiva(TM), a recombinant humanized monoclonal antibody, is designed to inhibit
the adhesion of T-lymphocytes to other cell types by inhibiting the binding of
LFA-1 to ICAM-1. This mechanism of action has a number of effects depending upon
the cell type, which include: (1) inhibition of T-lymphocyte interactions with
tissue-specific cells, (2) inhibition of T-lymphocyte migration, (3) inhibition
of T-lymphocyte activation, proliferation and cytokine release. In the clinical
Phase III studies, Raptiva(TM) was given as a once-a-week subcutaneous
injection. Raptiva(TM) is currently in Phase II trials in Rheumatoid Arthritis
and is being also evaluated for the treatment of Psoriatic Arthritis.
-more-
ABOUT SERONO
Serono is a global biotechnology leader. The Company has six recombinant
products on the market, Gonal-F(R), Luveris(R), Ovidrel(R)/Ovitrelle(R),
Rebif(R), Serostim(R) and Saizen(R) (Luveris(R) is not approved in the USA). In
addition to being the world leader in reproductive health, Serono has strong
market positions in neurology, metabolism and growth. The Company's research
programs are focused on growing these businesses and on establishing new
therapeutic areas. Currently, there are over 30 projects in development.
In 2002, Serono achieved worldwide revenues of US$1.546 billion, and a net
income of US$321 million, making it the third largest biotech company in the
world. The Company operates in 45 countries, and its products are sold in over
100 countries. Bearer shares of Serono S.A., the holding company, are traded on
the virt-x (SEO) and its American Depositary Shares are traded on the New York
Stock Exchange (SRA).
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Some of the statements in this press release are forward looking. Such
statements are inherently subject to known and unknown risks, uncertainties and
other factors that may cause actual results, performance or achievements of
Serono S.A. and affiliates to be materially different from those expected or
anticipated in the forward-looking statements. Forward-looking statements are
based on Serono's current expectations and assumptions, which may be affected by
a number of factors, including those discussed in this press release and more
fully described in Serono's Annual Report on Form 20-F filed with the U.S.
Securities and Exchange Commission on May 21 2002. These factors include any
failure or delay in Serono's ability to develop new products, any failure to
receive anticipated regulatory approvals, any problems in commercializing
current products as a result of competition or other factors, our ability to
obtain reimbursement coverage for our products, and government regulations
limiting our ability to sell our products. Serono has no responsibility to
update the forward-looking statements contained in this press release to reflect
events or circumstances occurring after the date of this press release.
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FOR MORE INFORMATION, PLEASE CONTACT:
SERONO IN GENEVA, SWITZERLAND:
MEDIA RELATIONS: INVESTOR RELATIONS:
Tel: +41-22-739 36 00 Tel: +41-22-739 36 01
Fax: +41-22-739 30 85 Fax: +41-22-739 30 22
http://www.serono.com Reuters: SEOZ.VX / SRA.N
--------------------- Bloomberg: SEO VX / SRA US
SERONO, INC., ROCKLAND, MA
MEDIA RELATIONS: INVESTOR RELATIONS:
Tel. +1 781 681 2340 Tel. +1 781 681 2552
Fax: +1 781 681 2935 Fax: +1 781 681 2912
http://www.seronousa.com
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GENENTECH:
MEDIA CONTACT:
Tara Cooper: +1 (650) 225-5505
INVESTOR CONTACT:
Kathee Littrell: +1 (650) 225-1034
www.gene.com
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SIGNATURES
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.
SERONO S.A.
a Swiss corporation
(Registrant)
February 26, 2003 By: /s/ Allan Shaw
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Name: Allan Shaw
Title: Chief Financial Officer