SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
________
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, 2003
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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FDA APPROVES SERONO'S OVIDREL(R) PREFILLED SYRINGE
FOR TREATMENT OF INFERTILITY
OVIDREL(R) PREFILLED SYRINGE IS THE FIRST READY-TO-INJECT LIQUID INFERTILITY
TREATMENT APPROVED BY THE FDA
ROCKLAND, MA, OCTOBER 8, 2003 - Serono, Inc., the US affiliate of Serono S.A.
(virt-x: SEO and NYSE: SRA), announced today that the United States Food and
Drug Administration (FDA) has approved its new pre-filled syringe for Ovidrel(R)
(choriogonadotropin alfa injection), making it the first liquid, ready-to-inject
therapy for infertility treatment in the US.
Designed to make infertility treatment easier for patients, the new Ovidrel(R)
Pre-Filled Syringe is the only liquid infertility treatment approved by the FDA
that patients can administer in one single step. Unlike other infertility
treatments, the Ovidrel(R) PreFilled Syringe does not require patients to mix
medication prior to injection. It is also the only available recombinant version
of human chorionic gonadotropin (hCG), one of three hormones required to treat
infertility. Essentially equivalent in structure to naturally occurring hCG,
Ovidrel(R) triggers ovulation in women being treated for infertility.
"The administration of the hormone medication needed to trigger ovulation is one
of the most crucial steps in the infertility treatment cycle," said Raymond W.
Ke, MD, Associate Professor of Obstetrics and Gynecology at the University of
Tennessee and Director of IVF for Fertility Associates of Memphis, Tennessee.
"Having Ovidrel(R) in a pre-filled syringe will make that step easier for
patients and may alleviate some of the difficulties and stresses associated with
infertility treatment."
The new pre-filled syringe for Ovidrel(R) will continue to carry the same
indication as the currently marketed product for triggering ovulation in women
undergoing infertility treatment.
"We are very pleased that the FDA has approved the Ovidrel(R) PreFilled
Syringe," said Bharat Tewarie, MD, Executive Vice President, Reproductive
Health, Serono, Inc. "We are committed to advancing infertility treatment by
developing safe, effective and patient-friendly products manufactured using
state-of-the-art technology."
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Serono expects Ovidrel(R) PreFilled Syringe to be available in November,
replacing the currently available powder form of Ovidrel(R).
ADDITIONAL PRODUCT INFORMATION
Ovidrel(R) is one of a complete line of widely prescribed Serono infertility
therapies used to promote follicle growth, ovulation and maturation of eggs in
the ovaries of women undergoing assisted reproductive technologies (ART), such
as in vitro fertilization, and to induce ovulation in women with infertility due
to anovulation.
Ovidrel(R) PreFilled Syringe is well tolerated. Side effects may include
injection site bruising, pain or inflammation, tiredness, nausea, headache and
abdominal pain. With all assisted reproduction there is a risk of ovarian
hyperstimulation syndrome, multiple pregnancy or miscarriage.
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 6.1 million Americans, 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
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) (follitropin alfa for injection), to stimulate the
ovaries and produce eggs; Luveris(R) (lutropin alfa for injection), to stimulate
follicular development in women who are profoundly LH deficient; Cetrotide(R)
(cetrorelix acetate for injection) to control hormonal surges; Ovidrel(R)
(choriogonadotropin alfa for injection), to help follicles mature and release
eggs; and Crinone(R) (progesterone gel), to help establish and maintain a
pregnancy. (Luveris(R) is not approved in the US.)
For more information on infertility and full prescribing information for
Serono's US marketed fertility products visit www.seronofertility.com.
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ABOUT SERONO
Serono, Inc., located in Rockland, MA, is the US affiliate of Serono, a global
biotechnology leader. The Company has six recombinant products on the worldwide
market, Gonal-F(R) (follitropin alfa for injection), Luveris(R) (lutropin alfa),
Ovidrel(R)/Ovitrelle(R) (choriogonadotropin alfa for injection), Rebif(R)
(interferon beta-1a), Serostim(R) [somatropin (rDNA origin) for injection] and
Saizen(R) [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. The
Company's research programs are focused on growing
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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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these businesses and on establishing new therapeutic areas. Currently, there are
over 30 projects in development.
Serono was awarded the International James D. Watson 2003 Helix Award from the
Biotechnology Industry Organization (BIO) in recognition of the Company's
outstanding leadership and highest standards of scientific and product
achievement.
In 2002, Serono achieved worldwide revenues of $1.546 billion, and a net income
of $321 million, making it the third largest biotech company in the world. The
Company operates in 45 countries, and its products are sold in over 100
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, 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
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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 8, 2003 By: /s/ Allan Shaw
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Name: Allan Shaw
Title: Chief Financial Officer