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, 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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CLINICAL STUDY SHOWS NEED FOR FEWER INJECTIONS TO PREVENT PREMATURE OVULATION
DURING THE TREATMENT OF INFERTILITY
First head-to-head clinical study of GnRH antagonists in the treatment of
infertility
PHILADELPHIA, PA, OCTOBER 19, 2004 - SERONO (VIRT-X SEO AND NYSE: SRA) - In the
first clinical trial to directly compare gonadotropin releasing hormone (GnRH)
antagonists, patients using Cetrotide(R) (cetrorelix acetate for injection)
required fewer injections compared to patients using Ganirelix Acetate (formerly
known as Antagon(TM) Injection) to prevent premature ovulation during
infertility treatment. The data were presented today at the 60th Annual Meeting
of the of the American Society for Reproductive Medicine (ASRM) by John G.
Wilcox, MD, FCOG, Assistant Clinical Professor in the Department of Obstetrics
and Gynecology at the University of Southern California School of Medicine and
Managing Partner of Huntington Reproductive Center in Pasadena, CA.
"This study shows that hormonal surges can be inhibited with a single injection
for the majority of patients until follicles are large enough for oocyte
retrieval and subsequent fertilization," said Dr. Wilcox. "Cetrotide(R) offers
patients a similar safety profile as well as similar efficacy compared to
Ganirelix Acetate, but Cetrotide(R) has the added benefit of significantly fewer
injections."
Most of the patients who used Cetrotide(R) (66.7%) required one injection while
most of the patients who used Ganirelix Acetate (62.5%) required four or more
injections to achieve the same endpoint.
"Cetrotide(R) is an important part of Serono's full portfolio of
patient-friendly products designed to make infertility treatment easier," said
Bharat Tewarie, MD, MBA, Executive Vice President, Reproductive Health, Serono,
Inc. "The ease-of-use it offers demonstrates our commitment to improving the
patient experience."
Gonadotropin releasing hormone (GnRH) antagonists are used in the treatment of
infertility to prevent the spontaneous release of LH (luteinizing hormone), a
hormonal event that impacts the development of eggs. They work by directly
blocking the trigger effect of GnRH to stop a possible LH surge before it
begins, allowing eggs to reach the level of development needed for
fertilization.
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. The majority of patients who complete
treatment ultimately succeed in having a child.
ABOUT THE STUDY
The prospective, open-label, randomized, comparative study was conducted at 16
medical centers in the United States and included 185 infertile patients
undergoing ART procedures. A single subcutaneous injection of Cetrotide(R) 3 mg
or a daily subcutaneous injection of Ganirelix Acetate 250 mcg was administered
in a flexible protocol to prevent premature LH surge when the lead follicle was
> 14 mm. Daily Cetrotide(R) 0.25 mg was administered if the criteria for
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recombinant human chorionic gonadotropin (hCG) administration were not met four
days after receiving Cetrotide(R) 3 mg. Most women receiving Cetrotide(R)
(66.7%) received only a single dose. Of the remaining patients, 89.8% needed
only one additional dose. The overall pregnancy rate for the Cetrotide arm was
51.7% (45/87), and the overall pregnancy rate for the Ganirelix Acetate arm was
48.9% (43/88), with no statistically significant difference between treatment
groups. These results, presented at ASRM, represent a final analysis of data.
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. Mild and short lasting injection reactions like reddening,
itching and swelling at the injection sites have occurred in women using
Cetrotode(R). Nausea and headache have also been reported.
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 PreFilled
Syringe(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:
MEDIA RELATIONS, USA: INVESTOR RELATIONS, USA
Dana Jessup Susan Ince
Tel: +1 781 681 2443 Tel: +1 781 681 2552
Fax: +1 781 681 2937 Fax: +1 781 681 2912
www.seronousa.com
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CORPORATE MEDIA RELATIONS: CORPORATE INVESTOR RELATIONS:
Tel: +41 22 739 3600 Tel: +41 22 739 3601
Fax: +41 22 739 3085 Fax: +41 22 739 3022
www.serono.com Reuters: SEO.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)
October 19, 2004 By: /s/ Francois Naef
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Name: Francois Naef
Title: Secretary