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 May, 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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SERONO
Media Release
FOR IMMEDIATE RELEASE
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NEW ADVANCE FOR INFERTILE COUPLES
SERONO'S INNOVATIVE GONAL-F(R) (FBM) PREFILLED PEN IS PHYSICIANS',
NURSES' AND PATIENTS' PREFERRED CHOICE IN FERTILITY TREATMENT
GENEVA, SWITZERLAND, MAY 3, 2004 - Serono (virt-x: SEO and NYSE: SRA) announced
today that the new GONAL-f(R) Filled-by-Mass (FbM) Prefilled Pen is considered
as the preferred choice for fertility treatment following an expert meeting held
this weekend in Lisbon, Portugal, on the initial experience of physicians,
nurses and patients with the innovative pre-filled pen.
The GONAL-f(R) (FbM) Prefilled Pen has recently been approved by the European
Commission, the Swiss and the Australian Authority. Through its combination of
an accurate and easy-to-use delivery device - the Prefilled Pen - with
GONAL-f(R) (FbM), the most consistent follicle-stimulating hormone available, it
represents a significant advance for physicians, nurses and patients in
fertility treatment. Infertility is defined as the inability of a couple to
achieve pregnancy after one year of regular, unprotected intercourse and it
affects according to WHO around 60 - 80 million people worldwide.
In a phase IIIb study that compared the GONAL-f(R) (FbM) Prefilled Pen with
another pen available on the market, twice as many of the treated patients
preferred the GONAL-f(R) (FbM) Prefilled pen, as it required less time for
training, less time to prepare their daily injections and also gives patients
more confidence that they have injected the right dose of FSH. "The GONAL-f(R)
(FbM) Prefilled Pen ensures an accurate dosing and correct administration, as it
is ready-to-use and easy for patients to inject themselves, making the treatment
more acceptable for them", said Professor Dr. Christoph Keck from the Department
of Obstetrics and Gynecology of the University of Freiburg, Germany. (1)
In Australia, the country with most experience to date with the GONAL-f(R) (FbM)
Prefilled Pen, nurses reported a significant reduction in the time to train
patients, and it also reduced patient confusion. "My nurses have told me how
much less time they have to spend with patients and that fewer mistakes are
being made due to incorrect dosing, as patients do not have to reconstitute the
medication or to load a cartridge", explained Dr. Ric Porter, director from IVF
Australia's Northshore Unit in Chatswood.
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1) Serono Data on File, Phase IIIb study, University of Freiburg, Germany.
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The GONAL-f (FbM)(R) Prefilled Pen is specifically designed for fertility
treatment and is available in three multidose strengths, allowing individualized
dosing in Ovulation Induction and Assisted Reproductive Techniques. Delivering
the most consistent recombinant FSH - GONAL-f(R) (Filled-by-Mass) - it results
in a greater and more predictable control over ovarian stimulation (2) and
increases treatment efficiency in terms of a reduction of the number of
stimulation days (3) (4), and the number of cancelled cycles (3).
ADDITIONAL PRODUCT INFORMATION
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GONAL-f(R) Filled-by-Mass (follitropin alfa) 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 the latest
advance which takes advantage of a standardized, highly consistent manufacturing
process to ensure batch-to-batch and vial-to-vial consistency in dosage,
resulting in the most consistent FSH and therefore in optimal control over
treatment cycles. GONAL-f(R) 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
90 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 FERTILITY 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.
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2) Hugues et al.; Improvement in consistency of response to ovarian stimulation
with recombinant human follicle hormone resulting from a new method for
calibrating the therapeutic preparation, RBM online, December 2002, Vol. 6, No.
2, pp 185 - 190
3) Tredway et al.; Improvement of clinical profile with GONAL-f
Filled-by-Mass in ovulation induction, 7th Congress of the Latin American
Federation of the Sterility and Fertility Societies (FLASEF), Montevideo,
Uruguay, November 2002.
4) Balasch et al.; Outcome from consecutive assisted reproduction cycles in
patients treated with recombinant follitropin alfa filled-by-bioassay and those
treated with recombinant follitropin alfa filled-by-mass, RBM online, April
2004, Vol. 8, No. 4.
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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(TM) (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 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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FOR MORE INFORMATION, PLEASE CONTACT:
CORPORATE MEDIA RELATIONS: CORPORATE 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: SEO.VX / SRA.N
--------------------- Bloomberg: SEO VX / SRA US
INVESTOR RELATIONS, USA:
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)
May 3, 2004 By: /s/ Francois Naef
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Name: Francois Naef
Title: Secretary