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 October, 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 ____
(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-______)
S serono
MEDIA RELEASE
FOR IMMEDIATE RELEASE
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FDA APPROVES SERONO'S LUVERIS(R) FOR CONCOMITANT USE WITH GONAL-F(R)
APPROVAL EXPANDS SERONO'S RECOMBINANT PORTFOLIO IN THE UNITED STATES
GENEVA, SWITZERLAND AND ROCKLAND, MA, OCTOBER 15, 2004 - SERONO (VIRT-X SEO AND
NYSE: SRA) - Serono announced today that the US Food and Drug Administration
(FDA) has approved Luveris(R) (lutropin alfa for injection) for concomitant use
with Gonal-f(R) (follitropin alfa for injection) for stimulation of follicular
development in infertile hypogonadotropic hypogonadal (HH) women with profound
LH deficiency (LH < 1.2 IU/L).
HH is a rare endocrine deficiency. Women with HH are unable to produce the
hormones needed for full development of follicles in the ovaries, ovulation and
growth of the lining of the uterus sufficient to support implantation of a
fertilized egg and early pregnancy.
Luveris(R) is the first and only approved recombinant human form of luteinizing
hormone (LH), a naturally occurring fertility hormone. The Luveris(R) approval
makes Serono the only company to offer three recombinant fertility hormones,
part of its long-term global strategy to develop a 100% recombinant human
gonadotropin portfolio. By the end of this year, Serono will complete a
systematic commercial phase out of its older-generation urinary products, with
the exception of Japan.
"The Luveris(R) approval is a result of Serono's strong dedication to research
and development of products in reproductive health," said Bharat Tewarie, MD,
Executive Vice President, Reproductive Health, Serono, Inc. "We recognized the
additional endocrine needs of this special population of patients and developed
recombinant human LH specifically for them as part of our continued commitment
to advancing infertility treatment." Data on Luveris(R) are being presented at
the 60th Annual Meeting of the American Society for Reproductive Medicine in
Philadelphia later this month. For patients and healthcare providers who would
like additional information on Luveris(R) and other Serono products, a toll-free
educational service called Fertility LifeLines(TM) (1-866-538-7879) is
available.
"Luveris(R), in conjunction with Gonal-f(R), helps individualize treatment for a
special population of infertile patients," said Zev Rosenwaks, MD, Director,
Center for Reproductive Medicine and Infertility at New York Weill Cornell. "It
provides an option for women who specifically do not produce or secrete LH."
Luveris(R) addresses an unmet medical need and has also received Orphan Drug
designation from the FDA Office of Orphan Products Development. It is currently
approved in over 60 countries worldwide, including countries in the European
Union, Asia, Latin America and Australia.
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ADDITIONAL INFORMATION
Side effects may occur with the use of infertility drugs and, therefore, should
only be prescribed by physicians who are thoroughly familiar with infertility
problems and their management. Ovarian hyperstimulation syndrome (OHSS) with or
without vascular and pulmonary complications can occur with the use of
infertility drugs. Reports of multiple births have been associated with
gonadotropin treatments. The most common side effects in women using Luveris(R)
include headache, abdominal pain, nausea, OHSS, breast pain, and ovarian cyst.
Please see full prescribing information for product details.
ABOUT SERONO, INC. AND FERTILITY
Serono, Inc., a subsidiary of Serono S.A., is a leader in fertility health,
dedicated to developing patient-friendly, innovative products that help people
build families. It is the only company to offer a full portfolio of fertility
medications for every stage of the reproductive cycle and recombinant versions
of three hormones used in the treatment of infertility, including the newly
approved Gonal-f(R) RFF Pen (follitropin alfa injection). For more information,
please contact Fertility LifeLines(TM), a toll-free educational service that
offers customized information and support to people with fertility health
concerns, available at 1-866-LETS-TRY (1-866-538-7879).
ABOUT SERONO S.A.
Serono is a global biotechnology leader. The Company has eight biotechnology
products, Rebif(R) (interferon beta-1a), Gonal-f(R) (follitropin alfa for
injection), Luveris(R) (lutropin alfa for injection), Ovidrel(R)/Ovitrelle(R)
(choriogonadotropin alfa injection), Serostim(R) [somatropin (rDNA origin) for
injection], Saizen(R) [somatropin (rDNA origin) for injection], Zorbtive(TM)
[somatropin (rDNA origin) for injection] and Raptiva(R) (efalizumab). 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. Currently, there are
approximately 30 ongoing development projects.
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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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.
Package inserts for Serono's US marketed products are available at
www.seronousa.com or by calling 1-888-275-7376.
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FOR MORE INFORMATION, PLEASE CONTACT:
SERONO, INC., ROCKLAND, MA
MEDIA RELATIONS:
Renee Connolly INVESTOR RELATIONS:
Tel. +1 781 681 2340 Susan Ince
Fax: +1 781 681 2935 Tel. +1 781 681 2552
www.seronousa.com Fax: +1 781 681 2912
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SERONO S.A.
GENEVA, SWITZERLAND:
MEDIA RELATIONS:
Tel. +41-22 739 36 00 INVESTOR RELATIONS:
Fax: +41-22-739 30 85 Tel. +41-22 739 36 01
www.serono.com Fax: +41-22-739 30 22
--------------------- Reuters: SEOZ.VX / SRA.N
Bloomberg: SEO VX / SRA US
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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)
October 15, 2004 By: /s/ Francois Naef
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Name: Francois Naef
Title: Secretary