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 May, 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-______)
SERONO NOVIMMUNE
Media Release
FOR IMMEDIATE RELEASE
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SERONO AND NOVIMMUNE TO COLLABORATE IN DEVELOPMENT
OF TWO NOVEL TREATMENTS FOR AUTOIMMUNE DISEASES
GENEVA, SWITZERLAND - MAY 17, 2005 - Serono (virt-x: SEO and NYSE: SRA) and
NovImmune (private) have signed an exclusive agreement under which NovImmune has
granted Serono exclusive worldwide rights to develop and commercialize two of
NovImmune's fully human monoclonal antibodies, NI-0401 and NI-0501, which may
have therapeutic potential in a broad range of autoimmune diseases:
- NI-0401 targets the CD3 antigen, a key regulator in the activation of
T-cells. The proliferation of activated T-cells is a hallmark of many
autoimmune diseases, including insulin-dependent diabetes, Crohn's disease,
multiple sclerosis and rheumatoid arthritis, and of organ transplant
rejection.
- NI-0501 targets interferon-gamma, a key cytokine involved in the regulation
of immune and inflammatory responses. Interferon-gamma is
overexpressed in autoimmune diseases such as systemic lupus erythematosus,
Crohn's disease and several forms of vasculitis.
NI-0401 and NI-0501 are currently in preclinical development. NI-0401 is
expected to enter clinical trials later this year.
Under the terms of the agreement, NovImmune is responsible for the development
of the two products until the completion of Phase IIa clinical trials, after
which Serono will take over further development. Serono will pay a license fee
of $5 million for the two products, make a CHF 7.5 million equity investment in
NovImmune, and lend NovImmune up to CHF 7.5 million, convertible into shares of
NovImmune on certain conditions or repayable with accrued interest at maturity.
Based on the successful development and initial registration of the products,
NovImmune may receive up to $ 105 million in future milestone payments. In
addition, NovImmune may receive further milestone payments based on approval of
the products for additional indications, and will also be entitled to receive
undisclosed royalties based on eventual net sales of the products.
"NovImmune is proud of this alliance as it represents a recognition of the
quality and clinical relevance of these products. Our products can profit from
Serono's expertise in development and marketing across multiple indications to
maximize their full potential" declared Jack Barbut, NovImmune's CEO. "More
specifically, NI-0401, which should enter the clinic later this year, addresses
a basic mechanism of the immune response and could be efficacious in treating
numerous different immune related diseases."
"NovImmune has used state-of-the-art technologies to design antibodies with very
distinctive properties," said Tim Wells, Head of Research at Serono. "We expect
that NI-0401 and NI-0501 will have significant advantages over precedent
molecules and that those advantages will translate into greater therapeutic
potential for the treatment of chronic autoimmune disorders."
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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 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, the outcome of government
investigations and litigation 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
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 NOVIMMUNE
NovImmune is a Geneva-based product development company focusing on immune
mechanisms in order to clinically impact Immune Related Diseases, Inflammation
and Organ transplantation. NovImmune develops fully human monoclonal antibodies,
based on its direct access to both the transgenic mouse lines and antibody
display technology. NovImmune has a strategic partnership for GMP production
with Lonza Biologics. In addition, NovImmune is developing a new class of
immunosuppressors and anti-inflammatory agents as low molecular weight
inhibitors of MHC Class II expression, directed against highly specific and
totally validated protein targets. NovImmune's first product NI-0401 is expected
to enter clinical trials in Q4 2005.
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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NOVIMMUNE SA
:
Tel: +41 22 839 41 01
Fax: +41 22 839 41 02
http://www.novimmune.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)
May 17, 2005 By: /s/ Stuart Grant
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Name: Stuart Grant
Title: Chief Financial Officer