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 February, 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).) ______
(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
Media Release
FOR IMMEDIATE RELEASE
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EUROPEAN COMMISSION APPROVES GONAL-F(R) FILLED-BY-MASS
PREFILLED PEN
THE MOST CONSISTENT FSH IS NOW AVAILABLE IN AN ACCURATE AND
EASY-TO-USE PRE-FILLED PEN
GENEVA, SWITZERLAND - FEBRUARY 25, 2004 - Serono (virt-x: SEO and NYSE: SRA)
announced today that the European Commission has approved its GONAL-f(R)
Filled-by-Mass solution for injection in a pre-filled pen, which delivers the
company's market-leading recombinant human follicle-stimulating hormone.
"As the worldwide leader in infertility treatment, Serono is committed to
developing innovative products," said Ernesto Bertarelli, Chief Executive
Officer of Serono. "The GONAL-f(R)(FbM) Prefilled Pen delivers the most
consistent FSH in the only ready-to-use pre-filled pen available on the market."
To make infertility treatment easier and more accurate for patients, the new
GONAL-f(R) (FbM) Prefilled Pen is specifically designed for infertility
treatment and will be available in 3 multidose presentations; 300 IU/0.5 ml (22
mcg/0.5 ml), 450 IU/0.75 ml (33 mcg/0.75 ml) and 900 IU/1.5 ml (66 mcg/1.5 ml).
"This is the first ready-to-use pen that enables us to combine the efficacy of
the most consistent FSH with the flexibility to individualize the dosing in
ovulation induction and Assisted Reproductive Techniques for each patient," said
Professor Christoph Keck, M.D., from the Department of Obstetrics and Gynecology
of the University of Freiburg, Germany. "Having GONAL-f(R) (FbM) in a
pre-filled, ready-to-use pen will make the administration easier for the
patients, and help them to ensure that they have injected the right dose."
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The GONAL-f(R) (FbM) Prefilled Pen will continue to carry the same indications
as the currently marketed product for a) anovulation in women who have been
unresponsive to treatment with clomiphene citrate, b) stimulation of
multifollicular development in patients undergoing superovulation for assisted
reproductive technologies, c) in association with a luteinising hormone (LH)
preparation for the stimulation of follicular development in women with severe
LH and FSH deficiency and d) for stimulation of spermatogenesis in men who have
congenital or acquired hypogonadotrophic hypogonadism.
Serono expects the GONAL-f(R)(FbM) Prefilled Pen to be introduced in Europe
during the first half of this year.
ADDITIONAL PRODUCT INFORMATION
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GONAL-f(R) Filled-by-Mass (follitropin alpha) is a recombinant human
follicle-stimulating hormone, which is equivalent in its structure to the
naturally occurring human FSH in the body. GONAL-f(R)(FbM) is used in clinical
practice to treat infertile women and men with low or lacking naturally
occurring FSH. It is the world's leading treatment for male and female
infertility and is registered in more than 80 countries around the world.
Infertility is defined as the inability of a couple to achieve pregnancy after
one year of regular, unprotected intercourse (six months if the woman is over
35). It affects about 10 million Europeans, representing about 10 percent of
couples in their childbearing years. Infertility is just as likely to be related
to male factors as female factors, which each account for about a third of
infertility problems. The remaining third are either a combination of male and
female factors or are unexplained.
SERONO AND INFERTILITY TREATMENT
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Serono, the world leader in reproductive health, is dedicated to providing
patient-friendly, innovative products to help couples build families. Serono is
the only company to offer a full portfolio of fertility drugs for every stage of
the reproductive cycle and recombinant versions of the three hormones needed to
treat infertility: GONAL-f(R) FbM (follitropin alfa), to stimulate the ovaries
and produce eggs; Luveris(R) (lutropin alfa), to stimulate follicular
development in women who are profoundly LH deficient; Cetrotide(R) (cetrorelix
acetate) to prevent a premature ovulation; Ovitrelle(R) (choriogonadotropin
alfa), to help follicles mature and release eggs; and Crinone(R) (progesterone
gel), to help establish and maintain a pregnancy.
For more information on infertility visit www.fertility.com and for Serono's
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marketed fertility products visit www.serono.com (1).
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(1) These websites are not intended for US residents. US residents should
consult the Serono Inc. fertility website at www.seronofertility.com or
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www.seronousa.com.
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ABOUT SERONO
Serono is a global biotechnology leader. The Company has seven recombinant
products, Rebif(R), Gonal-f(R), Luveris(R), Ovidrel(R)/Ovitrelle(R),
Serostim(R), Saizen(R) and Zorbtive (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. The Company's research
programs are focused on growing these businesses and on establishing new
therapeutic areas. Currently, there are over 30 projects in development.
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 April 17, 2003. 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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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,
USA:
INVESTOR RELATIONS:
Tel. +1 781 681 2552
Fax: +1 781 681 2912
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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)
February 25, 2004 By: /s/ Allan Shaw
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Name: Allan Shaw
Title: Chief Financial Officer