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 March, 2004
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).)
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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)(7).)
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(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 IVAX
MEDIA RELEASE
FOR IMMEDIATE RELEASE
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SERONO AND IVAX ANNOUNCE POSITIVE OUTCOME OF
PHARMACOKINETIC TRIALS WITH ORAL CLADRIBINE
CLADRIBINE TARGETED TO BECOME FIRST ORAL THERAPY FOR MULTIPLE SCLEROSIS
GENEVA, SWITZERLAND, AND MIAMI, USA - MARCH 23, 2004 - Serono (virt-x: SEO and
NYSE: SRA) and IVAX Corporation (AMEX: IVX and LSE: IVX.L) announced today
positive results from two clinical trials with a new proprietary oral
formulation of cladribine, a potential new treatment for multiple sclerosis
(MS). The study results showed that the formulation of oral cladribine which
has been developed by Serono and IVAX has met the targets for an orally
administered product, with blood levels of cladribine in the expected
therapeutic range. Efficacy studies of oral cladribine in MS patients are
planned to start late 2004.
Previous Phase II and Phase III clinical trials have demonstrated the positive
effect of injectable cladribine in patients with MS. In these trials,
cladribine caused a dramatic reduction in new lesion development in the brain as
seen on magnetic resonance imaging (MRI) scans. Patients with relapsing
remitting MS receiving cladribine also experienced clinical benefits.
"As the originator of Rebif(R), a current reference treatment for multiple
sclerosis, Serono has a long-term commitment to patients with multiple
sclerosis", said Ernesto Bertarelli, CEO of Serono. "This is a major step in
the development of the first oral disease modifying treatment for multiple
sclerosis."
Dr. Phillip Frost, CEO and Chairman of IVAX commented, "We are very pleased to
report the important progress which has been made with our partner Serono in the
development of cladribine as a novel oral therapy for multiple sclerosis. With
the successful completion of these clinical trials, another of our products
advances in its clinical development."
Cladribine is being developed by Serono and IVAX under a worldwide agreement
signed in October 2002.
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ABOUT CLADRIBINE
Cladribine is a purine nucleoside analogue that disrupts the proliferation of
certain white blood cells, particularly lymphocytes, which are involved in the
pathological process of multiple sclerosis.
ABOUT MULTIPLE SCLEROSIS
Multiple sclerosis is a chronic, inflammatory condition of the nervous system
and is the most common, non-traumatic, neurological disease in young adults.
Multiple sclerosis affects approximately two million people worldwide. While
symptoms can vary, the most common symptoms of multiple sclerosis include
blurred vision, numbness or tingling in the limbs and problems with strength and
coordination. The relapsing forms of multiple sclerosis are the most common.
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FOR SERONO
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 April 17, 2003. 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.
FOR IVAX
This press release contains certain forward-looking statements regarding product
development efforts and product performance and other non-historical facts which
are being are made pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. These statements involve risks and
uncertainties that cannot be predicted or quantified and, consequentially,
actual results may differ materially from those expressed or implied by such
forward-looking statements. Such risks and uncertainties include, among others,
that development efforts for Cladribine may fail, may not achieve the expected
results or effectiveness and/or may not generate data that would support the
approval or marketing of this product for the indications being studied or for
other indications; that IVAX' patents pertaining to this product may be
invalidated or that additional patents may not be issued, and in either case may
not succeed in preventing other products; and that others may develop product
formulations that are superior to IVAX' formulation. In addition to the risk
factors set forth above, IVAX' forward looking statements may also be adversely
affected by general market factors, competitive product development, product
availability, federal and state regulations and legislation, the regulatory
process for new products and indications, manufacturing issues that may arise,
trade buying patterns, patent positions and litigation, among other things. For
further details and discussion of these and other risks and uncertainties, see
IVAX' Annual Report on Form 10-K and other filings with the Securities and
Exchange Commission.
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ABOUT SERONO
Serono is a global biotechnology leader. The Company has seven recombinant
products, Rebif(R), Gonal-F(R), Luveris(R), Ovidrel(R)/Ovitrelle(R),
Serostim(R), Saizen(R) and Zorbtive(TM) (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 approximately 30 ongoing development
projects.
In 2003, Serono achieved worldwide revenues of US$2,018.6 million, and a net
income of US$390.0 million, making it the third largest biotech company in the
world. Its products are sold in over 90 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).
ABOUT IVAX
IVAX is a multinational pharmaceutical company. The company discovers, develops,
manufactures and markets branded and brand-equivalent (generic) drugs and
veterinary products in the U.S. and abroad. Headquartered in Miami, Florida,
IVAX has operations in over 30 countries and its products are sold in more than
80. The company is strategically focused on product diversification and
geographic expansion in key pharmaceutical markets in North America; Western,
Central and Eastern Europe; Latin America; and Asia. IVAX has more than 700
scientists and researchers involved in research and development.
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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IVAX INVESTOR RELATIONS
Tel: +1 305-575-6043
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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)
March 23, 2004 By: /s/ Allan Shaw
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Name: Allan Shaw
Title: Chief Financial Officer