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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EUROPEAN COMMISSION APPROVES SERONO'S OVITRELLE(R) SOLUTION FOR INJECTION IN A
PRE-FILLED SYRINGE FOR TREATMENT OF INFERTILITY
OVITRELLE(R) - THE WORLD'S ONLY RECOMBINANT, FILLED-BY-MASS AND CONSISTENT HCG
IS NOW AVAILABLE IN A READY-TO-USE PRE-FILLED SYRINGE THAT WILL ALLOW PATIENTS
TO ADMINISTER HCG WITH ONE SIMPLE STEP
GENEVA, SWITZERLAND, OCTOBER 30, 2003 - Serono S.A. (virt-x: SEO and NYSE: SRA),
announced today that the European Commission has approved its new pre-filled
syringe for Ovitrelle(R) (choriogonadotropin alfa).
Designed to make infertility treatment easier for patients, the new Ovitrelle(R)
Solution for Injection is designed so that patients can administer their r-hCG
in one single step. Unlike other hCG treatments, the Ovitrelle(R) Solution for
Injection 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, Ovitrelle(R) triggers
ovulation in women being treated for infertility.
"hCG administration is a single, once only injection and therefore getting it
right is essential to the success of the cycle," said Professor Matts Wikland
M.D, PhD of the Fertility Center at Carlanderska Hospital, Gothenburg, Sweden.
"Having Ovitrelle(R) as a liquid in a ready to use pre-filled syringe will make
the process significantly easier for patients and help to ensure that they do
not incorrectly reconstitute or administer this crucial injection."
The new pre-filled syringe for Ovitrelle(R) will continue to carry the same
indication as the currently marketed product for triggering ovulation and
luteinization in women undergoing infertility treatment.
"We are extremely pleased that the European Commission has approved the
Ovitrelle(R) Solution for Injection in a pre-filled syringe," said Hans
Christian Rohde, Corporate Vice President, Reproductive Health, Serono. "We are
constantly striving to introduce the most consistent products and to deliver
them in the most accurate devices to help to increase the treatment efficiency
in assisted cycles."
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Serono expects Ovitrelle(R) Solution for Injection in a pre-filled syringe to be
available in December, replacing the currently available powder form of
Ovitrelle(R).
ADDITIONAL PRODUCT INFORMATION
Ovitrelle(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.
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
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 for injection
filled-by-mass), 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; Ovitrelle(R) (choriogonadotropin alfa for injection),
to help follicles mature and release eggs; and Crinone(R) (progesterone gel), to
help establish and maintain a pregnancy.
For more information on infertility and full prescribing information for
Serono's marketed fertility products visit www.serono.com.
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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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ABOUT SERONO
Serono is a global biotechnology leader. The Company has six recombinant
products on the market, Gonal-f(R), Luveris(R), Ovidrel(R)/Ovitrelle(R),
Rebif(R), Serostim(R) and Saizen(R) (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.
Serono was awarded the International James D. Watson Helix 2003 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 US$ 1.538 billion, and a net
income of US$321 million, making it the third largest biotech company in the
world. The Company operates in 44 countries, and its products are sold in 94
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).
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
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Bloomberg: SEO VX / SRA
US
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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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 30, 2003 By: /s/ Allan Shaw
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Name: Allan Shaw
Title: Chief Financial Officer