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 November, 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).) ______
(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 AMGEN
MEDIA RELEASE
FOR IMMEDIATE RELEASE
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SERONO AND AMGEN SIGN LICENSE AGREEMENT
FOR MULTIPLE SCLEROSIS PRODUCT
THOUSAND OAKS, CALIFORNIA, USA AND GENEVA, SWITZERLAND - NOVEMBER 13, 2002 -
Amgen Inc. (NASDAQ:AMGN) and Serono S.A. (virt-x: SEO and NYSE: SRA). Amgen and
Serono announced today that they have signed a license and commercialization
agreement by which Serono will sell the marketed drug Novantrone (mitoxantrone
for injection concentrate) in the United States. Novantrone is approved by the
FDA in the United States for secondary progressive, progressive relapsing and
worsening relapsing-remitting multiple sclerosis, as well as for certain forms
of cancer in the United States. The terms were undisclosed.
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 had US sales of $71 million last year. It 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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Closing of the transaction is subject to review and clearance by U.S. regulatory
authorities.
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 , Luveris , Ovidrel /Ovitrelle , Rebif ,
Serostim and Saizen (somatropin). (Luveris is not approved in the USA).
This news release contains forward-looking statements that involve significant
risks and uncertainties, including the possibility that the license transaction
will not close or that the companies may be required to modify aspects of the
transaction to achieve regulatory approval, and other 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, our research, testing, pricing, marketing and other
operations are subject to extensive regulation by domestic and foreign
government regulatory authorities. In addition, sales of our 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 our products.
In addition, while we routinely obtain patents for our products and technology,
the protection offered by our patents and patent applications may be challenged,
invalidated or circumvented by our 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 November 13, 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, Inc.
USA: 781.681.2122 (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
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.
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)
November 13, 2002 By: /s/ Jacques Theurillat
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Name: Jacques Theurillat
Title: Deputy Chief Executive Officer