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 January, 2005
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 ____
(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_
(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 TO INITIATE PHASE III CLINICAL TRIAL
OF MYLINAX(R) IN MULTIPLE SCLEROSIS
MYLINAX(R) TARGETED TO BECOME FIRST ORAL THERAPY FOR MULTIPLE SCLEROSIS
GENEVA, SWITZERLAND, AND MIAMI, USA - JANUARY 11, 2005 -
Serono (virt-x: SEO and NYSE: SRA) and IVAX Corporation (AMEX: IVX and LSE:
IVX.L) announced today that they will initiate a Phase III study with Mylinax(R)
(a proprietary oral formulation of cladribine) in the first quarter of 2005.
This multi-center, multi-national study is designed to assess the effectiveness
of Mylinax(R) in patients with relapsing forms of multiple sclerosis. Endpoints
will include assessments of clinical relapses, disability progression and MRI
(magnetic resonance imaging) brain scans. It will be a two-year, double-blind,
placebo-controlled study involving over 1,200 patients.
"As a leader in multiple sclerosis, we are committed to providing new treatment
options that can further improve the quality of the lives of people with
multiple sclerosis," said Ernesto Bertarelli, CEO of Serono. "With the
initiation of the Phase III program of Mylinax(R), we are getting closer to
realizing our objective to bring the first oral disease-modifying treatment to
people with multiple sclerosis."
"We are very pleased to have reached this important milestone in the development
of Mylinax(R) as a novel therapy for multiple sclerosis," said Dr. Phillip
Frost, Chairman and CEO of IVAX Corporation. "The initiation of this Phase III
study supports our belief in Mylinax(R) and our choice of Serono as a partner
that could help maximize its potential."
Previous clinical trials using a parenteral formulation demonstrated positive
effects of cladribine administered via injection in patients with multiple
sclerosis. In these trials, reduction in new lesion development in the brain as
seen on MRI scans and clinical benefits were observed.
Mylinax(R) 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 interferes with the behavior and
the proliferation of certain white blood cells, particularly lymphocytes, which
are involved in the pathological process of multiple sclerosis. Through its
differentiated mechanism of action, Mylinax(R) may offer an alternative option
to patients with 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.
###
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 March 25, 2004. 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 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, consequently, actual
results may differ materially from those expressed or implied by such
forward-looking statements. Such risks and uncertainties include, among others,
that indications from previous clinical trials may not be indicative of future
results; that others may develop product formulations that are superior to IVAX'
formulations, that Phase III clinical trials for Mylinax(R) may not be commenced
or completed on a timely basis or at all, may fail, may not achieve the expected
results or effectiveness and/or may not generate data that would support the
continued development, approval or marketing of this product for the indications
being studied or other indications; and that Mylinax(R) may not become the first
oral therapy for multiple sclerosis. 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 eight biotechnology
products, Rebif(R), Gonal-F(R), Luveris(R), Ovidrel(R)/Ovitrelle(R),
Serostim(R), Saizen(R), Zorbtive(TM) and Raptiva(R). In addition to being the
world leader in reproductive health, Serono has strong market positions in
neurology, metabolism and growth and has recently entered the psoriasis area.
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 Corporation, headquartered in Miami, Florida, discovers, develops,
manufactures, and markets branded and brand equivalent (generic) pharmaceuticals
and veterinary products in the U.S. and internationally.
In 2003, IVAX had worldwide net revenues of $1.4 billion and net income of $121
million. During the first nine months of 2004, IVAX' worldwide net revenues have
been $1.33 billion and net income, $135 million. IVAX has direct operations in
over 36 countries and its products are sold in more than 80. IVAX is listed on
the American, London and Warsaw stock exchanges.
Copies of this and other news releases may be obtained free of charge from IVAX'
website at www.ivax.com.
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FOR MORE INFORMATION, PLEASE CONTACT:
SERONO
CORPORATE MEDIA RELATIONS: CORPORATE 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: SEO.VX / SRA.N
--------------------- Bloomberg: SEO VX / SRA US
MEDIA RELATIONS, USA: INVESTOR RELATIONS, USA:
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 CORPORATION
David Malina
Director/Investor Relations & Corporate Communications
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)
January 11, 2005 By: /s/ Stuart Grant
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Name: Stuart Grant
Title: Chief Financial Officer