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, 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).)
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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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[GRAPHIC OMITTED]
Serono
Media Release
FOR IMMEDIATE RELEASE
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SERONO RECEIVES FDA APPROVAL FOR NEW PRESENTATIONS OF GONAL-F(R) TO TREAT
INFERTILITY
NEW PRESENTATIONS ALLOW FOR MAXIMUM DOSING FLEXIBILITY AND EASE OF USE
ROCKLAND, MA, MARCH 29, 2003 - SERONO (VIRT-X: SEO AND NYSE: SRA) -Serono,
Inc., the US affiliate of Serono, announced today that the US Food and Drug
Administration (FDA) has approved new presentations of Gonal-f(R) (follitropin
alfa for injection) including a 450 IU multi-dose vial and a 75 IU mono-dose
vial. Serono is the leader in reproductive health, and Gonal-f(R) is the most
prescribed gonadotropin in the world.
The new presentations of Gonal-f(R) expand Serono's portfolio of infertility
treatments to allow for maximum dosing flexibility and ease of use. "We are
very pleased with the approval of the new presentations of Gonal-f(R)," said
Bharat Tewarie, MD, Executive Vice President, Reproductive Health, Serono, Inc.
"We believe these products will provide our customers with the optimal
flexibility they require to tailor treatment to individual patient needs and all
treatment protocols."
The new 450 IU multi-dose vial will be available in addition to the currently
marketed multi-dose presentation, while the new 75 IU mono-dose vial will
replace the current ampules. Gonal-f(R) is indicated for induction of ovulation
and pregnancy as part of hormonal treatment for infertility and development of
multiple follicles as part of an assisted reproductive technology program.
Serono expects the new Gonal-f(R) presentations to be introduced in the US in
Q2.
Gonal-f(R) is a highly consistent recombinant human follicle stimulating hormone
(r-hFSH) prescribed to supplement or replace naturally occurring FSH, which
stimulates the development of follicles in the ovaries. It is the only FSH
available in multi-dose and mono-dose vials for maximum dosing flexibility and
individualized treatment.
Infertility is defined as the inability to achieve pregnancy after one year of
regular, unprotected intercourse (six months if the woman is over 35). It
affects about 6.1 million Americans, which represents about 10 percent of
couples in their childbearing years. About 70% of patients who are treated
succeed in having children.
- more -
ADDITIONAL INFORMATION
Side effects may occur with the use of infertility drugs and, therefore, they
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
Gonal-f(R) treatment. Side effects in women using Gonal-f(R) for ovulation
induction may include headache, ovarian cysts and nausea.
ABOUT SERONO, INC. AND INFERTILITY
Serono, Inc. is dedicated to providing patient-friendly, innovative products to
help couples build families. It is the only company to offer a full portfolio
of fertility drugs for every stage of the reproductive cycle and recombinant
versions of two hormones needed to treat infertility.
ABOUT SERONO
Serono, Inc., located in Rockland, MA, is the US affiliate of Serono, a global
biotechnology leader, headquartered in Geneva, Switzerland. Serono has seven
recombinant products, Rebif(R) (interferon beta-1a), Gonal-F(R) (follitropin
alfa for injection), Luveris(R) (lutropin alfa), Ovidrel(R)/Ovitrelle(R)
(choriogonadotropin alfa injection), Serostim(R) [somatropin (rDNA origin) for
injection], Saizen(R) [somatropin (rDNA origin) for injection] and Zorbtive(TM)
[somatropin (rDNA origin) for injection]. (Luveris(R) is not approved in the
USA.)(1) 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 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.
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(1) 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: 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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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
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 29, 2004 By: /s/ Allan Shaw
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Name: Allan Shaw
Title: Chief Financial Officer