SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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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 December, 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- )
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SERONO micromet
Media Release
FOR IMMEDIATE RELEASE
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SERONO AND MICROMET TO COLLABORATE IN DEVELOPMENT AND
COMMERCIALIZATION OF NOVEL ANTI-CANCER DRUG
AGREEMENT FOR MT201, CURRENTLY IN PHASE II CLINICAL TRIALS
GENEVA, SWITZERLAND AND MUNICH, GERMANY - DECEMBER 7, 2004 - Serono (virt-x: SEO
and NYSE: SRA) and Micromet (private) have signed an exclusive collaboration and
license agreement for the development and commercialization of Micromet's fully
human monoclonal antibody MT201 (adecatumumab). MT201 is a pan-carcinoma
monoclonal antibody directed against the epithelial cell adhesion molecule
Ep-CAM. The product is currently being tested in two multicenter phase II
clinical trials for the treatment of prostate and metastatic breast cancer.
Ep-CAM, the target antigen for MT201, is overexpressed with high frequency on
most human carcinomas, suggesting that it may have therapeutic potential in the
treatment of a broad range of cancers, including prostate, breast, colon, lung,
stomach, pancreatic, head & neck, and ovarian cancer.
Under the terms of the agreement, Micromet will be responsible for completing
the ongoing phase II clinical trials, and Serono will take over further
development and commercialization of the product. Effective immediately, Serono
will be responsible for all development costs. Micromet will receive an initial
license fee of US$10 million and additional milestone payments of up to US$138
million if the product is successfully developed and registered worldwide in
three or more indications. In addition, Micromet will receive undisclosed
royalties based on net sales of the product. Under certain terms and conditions,
Micromet may elect to share in the development and commercialization of the
product in the US and EU in exchange for a share of profits.
"With its longstanding history and experience in protein based therapeutics,
Serono is an excellent partner for MT201," commented Christian Itin, CEO of
Micromet. "We are excited to collaborate with Europe's most successful
biotechnology company."
"We are committed to the development of novel targeted therapeutics for cancer,"
said Serono's CEO Ernesto Bertarelli. "MT201 is a promising product with
considerable therapeutic potential in the treatment of solid tumours. With this
important addition to our pipeline, Serono's portfolio of novel anti-cancer
agents is evolving well." Serono is currently evaluating TACI-Ig in two clinical
trials for the treatment of B-cell malignancies.
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MT201 has been specifically designed to selectively eliminate tumour cells while
leaving healthy tissues largely unharmed. Phase I data have demonstrated an
excellent safety profile of MT201, and no MT201 neutralizing antibodies have
been observed so far in man. An investigational new drug application (IND) for
the product was recently cleared by the United States Food and Drug
Administration (FDA) for the initiation of phase II studies in the United
States.
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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.
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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.
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).
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ABOUT MICROMET
Micromet AG, a private Munich-based biotechnology company, puts novel concepts
in immunotherapy to work. Using proprietary technologies, the Company is
building a strong pipeline of innovative drug candidates for the treatment of
cancer, inflammation and autoimmune disease. Two candidates are currently in
clinical trials. The Company has established a powerful drug development
platform based on its BiTE(TM) technology ("Bispecific T cell engagers"), a
unique drug format that leverages the outstanding cytotoxic potential of T
cells, the most powerful 'killer cells' of the human immune system. In addition,
Micromet is exploiting the potential of SCAs (single-chain antibodies) for the
development of novel drug candidates under a multi-year strategic collaboration
with Enzon Inc. Micromet has integrated infrastructure and expertise in all
disciplines of drug design and development. The Company has attracted both
top-tier life science investors and corporate drug development partners such as
MedImmune, Inc., Enzon, Inc., and now Serono.
For further information, please visit the Company's web site at www.micromet.de
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FOR MORE INFORMATION, PLEASE CONTACT:
SERONO IN GENEVA, SWITZERLAND:
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
SERONO, INC., ROCKLAND, MA:
MEDIA RELATIONS, USA: INVESTOR RELATIONS, USA:
Tel: +1 781 681 2486 Tel: +1 781 681 2552
Fax: +1 781 681 2935 Fax: +1 781 681 2912
http://www.seronousa.com
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MICROMET
Media: Evelyn Wolf
Phone: +49 89 895277-220
Email: evelyn.wolf@micromet.de
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Investors: Ines-Regina Buth
Phone: +49 89 895277-221
Email: ines-regina.buth@micromet.de
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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 Swis corporation
(Registrant)
December 7, 2004 By: /s/ Francois Naef
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Name: Francois Naef
Title: Secretary