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 October, 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).) ______
(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
PARATEK
PHARMACEUTICALS
MEDIA RELEASE
FOR IMMEDIATE RELEASE
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SERONO AND PARATEK PHARMACEUTICALS IN PARTNERSHIP
TO DEVELOP A NOVEL ORAL TREATMENT FOR MULTIPLE SCLEROSIS
GENEVA, SWITZERLAND AND BOSTON, USA - OCTOBER 27, 2004 -
Serono (virt-x: SEO and NYSE: SRA) and Paratek Pharmaceuticals, Inc. announced
today that they have entered into an agreement to discover, develop and
commercialize an orally-available disease modifying treatment for multiple
sclerosis (MS).
During the initial phase of their collaboration, Paratek and Serono will seek to
identify for clinical development novel tetracycline derivatives from a library
of non-antibiotic lead compounds discovered by Paratek chemists. Orally
administered minocycline (an antibiotic tetracycline) was reported in a recently
published clinical study to have a therapeutic benefit in the treatment of
patients with relapsing-remitting MS(1). The favorable safety profile of the
tetracycline class is well documented, with a more than 30-year track record in
the marketplace. Serono will be responsible for the worldwide development and
commercialization of compounds arising from the collaboration. No orally
administered disease-modifying drug is currently approved for the treatment of
MS.
"This partnership with Paratek reflects our long-term commitment to patients
with multiple sclerosis", said Tim Wells, Head of Research of Serono.
"Non-antibiotic tetracycline-derived compounds represent a promising approach
for the development of orally available treatments for multiple sclerosis. We
are very pleased to be working with Paratek, which has considerable expertise in
this area and has already identified a number of very promising compounds."
"Serono's commitment to multiple sclerosis and their extensive research
expertise in the fields of neurology, immunology and inflammation were very
attractive to Paratek. This collaboration validates the use of our proprietary
tetracycline chemistry expertise to create improved novel compounds specifically
targeting promising new uses," said Thomas J. Bigger, President and CEO of
Paratek Pharmaceuticals.
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(1) Metz LM et al. Minocycline reduces gadolinium-enhancing magnetic resonance
imaging lesions in multiple sclerosis. Annals of Neurology 2004; 55(5):756
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Under the terms of the agreement, Paratek will receive an initial cash payment,
a loan convertible into Paratek stock, research funding and potential milestone
payments related to development progress and regulatory milestones. In addition
to upfront consideration, Paratek would receive USD 38 million in milestone
payments from Serono for the first product to be successfully developed and
registered in MS. Additional drugs and indications developed would result in
further payments to Paratek. Paratek will receive undisclosed royalties on
product sales should a product reach the market.
Preclinical data on three non-antibacterial tetracycline derivatives covered by
this agreement will be presented today at Neuroscience 2004, the Society for
Neuroscience's 34th Annual Meeting in San Diego.
ABOUT MULTIPLE SCLEROSIS
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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.
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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 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.
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ABOUT SERONO
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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 PARATEK PHARMACEUTICALS
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PARATEK PHARMACEUTICALS, INC. is engaged in the discovery and commercialization
of new therapeutics that treat serious and life-threatening diseases, with a
particular focus on the growing worldwide problem of antibiotic resistance.
Paratek's lead programs are advancing novel compounds that can circumvent or
block bacterial resistance, as well as drugs that can prevent infection by
interfering with Multiple Adaptational Response (MAR) mechanisms in bacteria.
Out of these efforts, Paratek has discovered a new class of antibiotics, the
aminomethylcyclines that target the need for new and potent antibacterials to
overcome the problem of rapidly growing bacterial resistance. The Company's
lead antibiotic clinical candidate, BAY 73-7388, the first product from this
class, is being developed in a collaborative partnership with Bayer HealthCare
AG for the treatment of serious infections.
Outside the antibacterial therapeutic area, Paratek has also established an
internal effort to exploit its novel families of compounds and their unique
mechanism of action in selected anti-inflammatory and neurodegenerative
conditions. Paratek has an active chemical synthesis effort to produce novel
and diverse small molecules, with the goal of developing non-antibacterial
products with improved activity in serious diseases based upon a growing body of
clinical and basic research supporting this approach.
Paratek is privately held and headquartered in Boston, Massachusetts, USA. For
more information, visit Paratek's website at www.paratekpharm.com.
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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
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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PARATEK PHARMACEUTICALS, INC, BOSTON, MA
INVESTOR RELATIONS: MEDIA RELATIONS:
Kate Boxmeyer Justin Jackson
Tel. +1 617.275.0040 x238 Tel. +1 212.213.0006
E-mail: kboxmeyer@paratekpharm.com E-mail: jjackson@burnsmc.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)
October 27, 2004 By: /s/ Francois Naef
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Name: Francois Naef
Title: Secretary