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 March, 2003
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 (OSI) PHARMACEUTICALS
Media Release
FOR IMMEDIATE RELEASE
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SERONO AND OSI PHARMACEUTICALS ANNOUNCE AGREEMENT FOR OSI TO MARKET
NOVANTRONE(R) IN ONCOLOGY
GENEVA, SWITZERLAND AND MELVILLE, NEW YORK- MARCH 12, 2003 -- Serono S.A.
(virt-x: SEO and NYSE: SRA) and OSI Pharmaceuticals, Inc. (NASDAQ: OSIP)
announced today that they have entered into an agreement by which OSI will
market and promote the drug Novantrone(R) (mitoxantrone concentrate for
injection) for the approved oncology indications in the United States. In
consideration for these exclusive rights, OSI will pay Serono initial fees
totaling $55 million plus maintenance fees in return for commissions on net
sales in oncology. To support Novantrone(R), OSI intends to build commercial
operations which will include a sales force and an associated marketing and
sales management infrastructure.
Novantrone(R) is approved by the U.S. Food and Drug Administration for the
treatment of acute nonlymphocytic leukemia (ANLL), which includes myelogenous,
promyelocytic, monocytic and erythroid acute leukemias, and the relief of pain
associated with advanced hormone-refractory prostate cancer (HRPC). The drug is
also approved for certain advanced forms of multiple sclerosis (MS). Serono will
continue to be responsible for the marketing of the multiple sclerosis
indication for Novantrone(R) and book all U.S. sales in all indications. Total
sales of Novantrone(R) in 2002, were approximately $80 million. Serono acquired
from Amgen the U.S. rights to Novantrone(R) for both MS and oncology in December
2002.
"Gaining access to a high-quality, marketed oncology product to both build a
revenue base and allow us to seed a commercial organization has been a key
corporate goal over the last two years," stated Colin Goddard, Ph.D., Chief
Executive Officer of OSI Pharmaceuticals. "We see Novantrone(R) as a well
established therapeutic product in oncology of about the right size that became
available at the right time and have moved aggressively to secure this
opportunity. We believe our new relationship with Serono represents a win-win
for both parties. Further, we believe this deal, coupled with our recently
announced intention to acquire Cell Pathways' pro-apoptotic pipeline and the
marketed oncology-care product Gelclair(TM), represent major steps forward in
continuing to build a high quality oncology organization."
"We have found an excellent partner in OSI, who have a significant commitment to
developing a commercial presence in the field of oncology," said Ernesto
Bertarelli, Serono's Chief Executive Officer. "This agreement enables Serono to
focus on Novatrone(R) in our specialist area of multiple sclerosis, while
ensuring that the product continues to be well supported in its oncology
indications."
Novantrone(R) (mitoxantrone for injection concentrate) is a synthetic
antineoplastic anthracenedione used intravenously as an anti-cancer agent. The
product was approved by the FDA in 1987 for ANLL and in 1996 for the relief of
pain associated with HRPC. It was registered for MS indications in October 2000.
It is a DNA-reactive agent that intercalates into DNA through hydrogen bonding,
causing crosslinks and strand breaks. Novantrone(R) also interferes with RNA and
is a potent inhibitor of topoisomerase II, an enzyme responsible for uncoiling
and repairing damaged DNA.
ABOUT SERONO
Serono is a global biotechnology leader. The Company has six recombinant
products on the market, Rebif(R), Gonal-F(R), Luveris(R), Ovidrel(R)/
Ovitrelle(R), Serostim(R) and Saizen(R) (Luveris(R) is not approved in the USA).
In addition to being the world leader in reproductive health, Serono has strong
market positions in neurology, metabolism and growth. Serono's research programs
are focused on growing these businesses and on establishing new therapeutic
areas. Currently, there are over 30 projects in development.
In 2002, Serono achieved worldwide revenues of US $1.546 billion, and a net
income of US $321 million, making it the third largest biotech company in the
world. Serono operates in 45 countries, and its products are sold in over 100
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 OSI
OSI Pharmaceuticals, Inc. is a leading biotechnology company focused on the
discovery, development and commercialization of high-quality, next-generation
oncology products that both extend and improve the quality-of-life for cancer
patients worldwide. OSI has a balanced pipeline of oncology drug candidates that
includes both next-generation cytotoxic agents and novel mechanism-based,
gene-targeted therapeutics. OSI's most advanced drug candidate, Tarceva(TM)
(erlotinib HCl), a small-molecule inhibitor of the EGFR gene, is currently in
Phase III clinical trials for lung and pancreatic cancers.
This news release contains forward-looking statements. These statements are
subject to known and unknown risks and uncertainties that may cause actual
future experience and results to differ materially from the statements made.
Factors that might cause such a difference include, among others, the impact of
acquisitions and divestitures on the synergies of OSI's programs, the success of
research and development activities and of pre-clinical development thereof, the
completion of clinical trials, the FDA review process and other governmental
regulation, pharmaceutical collaborators' ability to successfully develop and
commercialize drug candidates, competition from other pharmaceutical companies,
product pricing and third party reimbursement, and other factors described in
OSI Pharmaceuticals' filings with the Securities and Exchange Commission.
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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 May 21 2002. 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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-more-
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 Fax: +41-22-739 30 22
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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Contact: OSI Pharmaceuticals, Inc. Burns McClellan (representing OSI)
Kathy Galante Jonathan Nuggent (investors)
Director Kathy Jones, Ph.D. (media)
Investor & Public Relations (212) 213-0006
(631) 962-2000
-end-
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 12, 2003 By: /s/ Allan Shaw
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Name: Allan Shaw
Title: Chief Financial Officer