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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, 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
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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-______)
[GRAPHIC OMITTED] [GRAPHIC OMITTED]
Syntonix Serono
Pharmaceuticals
MEDIA RELEASE
FOR IMMEDIATE RELEASE
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SERONO AND SYNTONIX SIGN WORLDWIDE AGREEMENT
TO DEVELOP AND COMMERCIALIZE
AN INHALEABLE INTERFERON-BETA THERAPY FOR MULTIPLE SCLEROSIS
GENEVA, SWITZERLAND AND WALTHAM, MASS. - MARCH 31, 2005 Serono (virt-x: SEO and
NYSE: SRA) and Syntonix Pharmaceuticals Inc. announced today that they have
entered into an agreement under which Serono has licensed worldwide exclusive
rights to Syntonix' Transceptor(TM) and Synfusion(TM) technologies for the
development and commercialization of interferon-beta:Fc products.
Syntonix' technologies may enable the development of an interferon-beta therapy
for multiple sclerosis (MS) that can be administered by inhalation. It has been
demonstrated that certain Fc constructs can facilitate transport of therapeutic
proteins across the lung epithelium through neonatal Fc receptor-mediated
uptake. In in vivo experiments conducted by Syntonix and Serono, a proprietary
interferon-beta:Fc molecule produced by Syntonix exhibited pharmacokinetic and
pharmacodynamic properties that justify further development.
Serono currently markets Rebif(R), a high-dose, high-frequency interferon
beta-1a therapy for relapsing forms of MS, which is administered three times
weekly via subcutaneous injection. Rebif(R) is the leading treatment for MS
outside the US and the fastest growing treatment for MS in the US.
"Serono has a long-term commitment to people living with multiple sclerosis, as
demonstrated by our continual product enhancements and educational support
services, and we are constantly investigating new therapies and improvements to
current options," said Tim Wells, Head of Research of Serono. "We believe that
interferon-beta:Fc represents a promising approach to enable delivery of
interferon beta-1a by inhalation, and has the potential to provide an easier way
to administer therapy in the future."
"Serono's commitment to multiple sclerosis combined with its global leadership
in biotechnology make them an important partner for Syntonix," stated Garen
Bohlin, President and CEO of Syntonix. "We are pleased that our Transceptor(TM)
and SynFusion(TM) technologies have provided Serono with an opportunity to
extend its already highly successful product franchise in the multiple sclerosis
field."
Under the terms of the agreement, Serono will be responsible for all further
development and commercialization of the product. Syntonix will receive an
upfront license fee and will be eligible for development milestones and
royalties upon commercialization. Additional financial terms were not disclosed.
1/3
ABOUT SYNTONIX' SYNFUSION(TM) AND TRANCEPTOR(TM) TECHNOLOGIES
Syntonix' SynFusion technology links the Fc region of an antibody to a drug in a
novel manner, resulting in active receptor-dependent uptake of these drugs.
Specifically, this enables the development of longer-acting protein therapeutics
by facilitating the recirculation of proteins through the FcRn pathway, delaying
catabolism (the natural processes through which the body breaks down proteins)
and extending their circulating half-life.
Syntonix' Transceptor technology uses the FcRn transport pathway to enable the
pulmonary delivery of its novel Fc-fusion drugs. Syntonix' pulmonary drug
formulations work with existing marketed inhaler devices and do not require
changes to Fc fusions that are longer acting injectable drugs.
ABOUT REBIF(R)
Rebif(R) (interferon beta-1a) is a disease-modifying drug used to treat
relapsing forms of multiple sclerosis and is similar to the interferon beta
protein produced by the human body. Interferon helps modulate the body's immune
system, fight disease and reduce inflammation.
Rebif(R) , which was approved in Europe in 1998 and in the US in 2002, is
registered in more than 80 countries worldwide. In the United States, Rebif(R)
is co-marketed by Serono, Inc. and Pfizer Inc. In 2004, Rebif(R) sales amounted
to US$1.1 billion.
Rebif(R) has been proven to reduce MRI lesion activity and area(1), reduce the
frequency of relapses, and delay the progression of disability. Rebif(R) is
available in a 22 mcg and 44 mcg ready-to-use pre-filled syringe and can be
stored at room temperature for up to 30 days if a refrigerator is not available.
Most commonly reported side effects are injection site disorders, flu-like
symptoms, elevation of liver enzymes and blood cell abnormalities. Patients,
especially those with depression, seizure disorders, or liver problems, should
discuss treatment with Rebif(R) with their doctors.
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 may affect 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.
###
Serono forward-looking statements
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 16, 2005. 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.
###
_________________________
(1) The exact relationship between MRI findings and the clinical status of
patients is unknown
2/3
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, including oncology. Currently, there are
approximately 30 ongoing development projects.
In 2004, Serono achieved worldwide revenues of US$2,458.1 million, and a net
income of US$494.2 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 SYNTONIX
Syntonix is developing next generation biopharmaceuticals that enable better
treatment options for patients with devastating chronic diseases such as
hemophilia, anemia and autoimmune disorders. The company applies its core
expertise around a critical biological pathway to enhance important existing
drugs and to discover novel therapeutics. The resulting proteins, peptides and
antibodies are being commercialized through internal development programs and
collaborations with biotechnology and pharmaceutical partners. More information
is available at www.syntnx.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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SYNTONIX
MEDIA RELATIONS: CORPORATE AND INVESTOR RELATIONS:
Kari Lampka Garen Bohlin
MacDougall Biomedical Chief Executive Officer
Communications
Tel: +1 508 647 0209 Tel: +1 781 547 5248
klampka@macbiocom.com http://www.syntnx.com
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3/3
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 31, 2005 By: /s/ Stuart Grant
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Name: Stuart Grant
Title: Chief Financial Officer