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, 2002
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 AMGEN
Media Release
FOR IMMEDIATE RELEASE
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SERONO AND AMGEN CLOSE AGREEMENT FOR U.S.
COMMERCIALIZATION OF NOVANTRONE
THOUSAND OAKS, CALIFORNIA, USA AND GENEVA, SWITZERLAND - DECEMBER 18, 2002
Amgen Inc. (NASDAQ:AMGN) and Serono S.A. (virt-x: SEO and NYSE: SRA) announced
today that they have completed their license and commercialization agreement by
which Serono will sell the marketed multiple sclerosis (MS) and chemotherapy
drug Novantrone(R) (mitoxantrone for injection concentrate) in the United
States.
The closing of this deal was completed after the U.S. Federal Trade Commission
granted early termination of the waiting period required by the
Hart-Scott-Rodino Act.
Novantrone is approved by the U.S. Food and Drug Administration (FDA) in the
United States for secondary (chronic) progressive, progressive relapsing and
worsening relapsing-remitting MS, as well as for certain forms of cancer. It is
a topoisomerase II inhibitor which acts by inhibiting DNA replication in
dividing cells.
Novantrone was acquired by Amgen in connection with Amgen's acquisition of
Immunex Corporation in July, 2002. The drug was approved by the FDA for MS
indications in October, 2000, and has also been approved for certain oncology
indications since 1987.
Full prescribing information for Novantrone can be obtained by visiting
www.novantrone.com.
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Amgen is a global biotechnology company that discovers, develops, manufactures
and markets important human therapeutics based on advances in cellular and
molecular biology. Serono is a global biotechnology leader with six recombinant
products on the market, Gonal-F(R), Luveris(R), Ovidrel(R)/Ovitrelle(R),
Rebif(R), Serostim(R) and Saizen(R). (Luveris(R) is not approved in the USA).
-more-
This news release contains forward-looking statements that involve significant
risks and uncertainties, including those discussed below and more fully
described in the Securities and Exchange Commission reports filed by Amgen,
including its most recent Form 10-Q. Amgen conducts research in the
biotechnology/pharmaceutical field where movement from concept to product is
uncertain; consequently, there can be no guarantee that any particular product
candidate will be successful and become a commercial product. Furthermore,
Amgen's research, testing, pricing, marketing and other operations are subject
to extensive regulation by domestic and foreign government regulatory
authorities. In addition, sales of Amgen's products are affected by
reimbursement policies imposed by third party payors, including governments,
private insurance plans and managed care providers. These government regulations
and reimbursement policies may affect the development, usage and pricing of
Amgen's products. In addition, while Amgen routinely obtains patents for its
products and technology, the protection offered by Amgen's patents and patent
applications may be challenged, invalidated or circumvented by its competitors.
Because forward-looking statements involve risks and uncertainties, actual
results may differ materially from current results expected by Amgen. Amgen is
providing this information as of December 18, 2002 and expressly disclaims any
duty to update information contained in this press release.
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.
CONTACT:
Amgen Inc.
Jeff Richardson, 805.447.3227 (media)
Cary Rosansky, 805.447.4634 (investors)
www.amgen.com
Serono International S.A.
USA: 781.681.23 40 (media)
Europe: 41-22-739 36 00 (media)
41-22-739 36 01 (investor relations)
www.serono.com
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EDITOR'S NOTE: An electronic version of this news release may be accessed via
our web site at www.amgen.com. Visit the Corporate Center and click on Amgen
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News. Journalists and media representative may sign up to receive all news
releases electronically at the time of announcement by filling out a short form
in the Amgen News section of the site.
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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)
December 19, 2002 By: /s/ Jacques Theurillat
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Name: Jacques Theurillat
Title: Deputy Chief Executive Officer