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 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 ADVISORY COMMITTEE ISSUES FAVORABLE RECOMMENDATION FOR EFFICACY OF
LUVERIS(R) IN FOLLICULAR DEVELOPMENT
ROCKLAND, MA, SEPTEMBER 30, 2003 - Serono, Inc. announced today that the
Reproductive Health Drugs Advisory Committee of the U.S. Food and Drug
Administration (FDA) issued a favorable recommendation for Luveris(R) in
Serono's proposed indication of follicular development. Luveris(R) (lutropin
alfa for injection) administered with follitropin alfa for injection, is
proposed for the indication of stimulation of follicular development in
infertile hypogonadotropic hypogonadal (HH) women with profound luteinizing
hormone deficiency (LH < 1.2 IU/L). HH is a rare endocrine deficiency affecting
between 2,800 and 5,600 women in the US and can range from mild to severe.
The FDA had previously recommended that Serono study an endpoint of ovulation
rates, an endpoint frequently used for products in ovulation induction.
However, the Committee agreed that in this rare patient population the endpoint
of follicular development was appropriate.
"We are very pleased with the recommendation of the Advisory Committee
supporting the efficacy of Luveris(R) for follicular development in this rare
patient population and will continue to work closely with the FDA as it
finalizes its review of this important new treatment," said Paul Lammers, MD,
Chief Medical Officer, Serono, Inc. "Serono's development of Luveris(R) is part
of our ongoing commitment to reproductive health and our leadership role in this
area. Luveris(R) is the third of three recombinant fertility hormones developed
exclusively by Serono."
Luveris(R) is a recombinant form of luteinizing hormone (LH), a naturally
occurring fertility hormone. It is the first and only drug product to contain
LH exclusively that can address the unmet medical need for fertility treatment
by profoundly LH deficient women. Women whose opportunities for pregnancy are
limited by profound LH deficiency have no available treatment approved
specifically for their condition. These women lack the ability to produce the
hormones needed for full development of follicles in the ovaries, ovulation, and
growth of the lining of the uterus sufficient to support implantation of a
fertilized egg and early pregnancy.
The Advisory Committee's recommendation was based on a review of the clinical
development program conducted in patients with this rare condition, including a
phase III confirmatory, double-blind, placebo-controlled, randomized trial. In
this trial, patients were treated with either Luveris(R) or placebo,
co-administered with Serono's recombinant follicle stimulating hormone (r-hFSH),
Gonal-f(R) (follitropin alfa for injection). In the Luveris(R) and Gonal-f(R)
treatment group, 17 patients (65.4%) achieved the primary endpoint of follicular
development compared to two patients (15.4%) in the placebo and Gonal-f(R)
group. The four-fold difference between the two groups was both clinically
meaningful and statistically significant (p=0.006).
In these studies, Luveris(R) was well tolerated with reported adverse events
similar to those of other currently approved recombinant gonadotropin products.
The Advisory Committee recommendation is considered by the FDA in making its
decision regarding Luveris(R), which is expected before the end of this year.
Luveris(R) received an Orphan Drug Designation from the FDA and is currently
approved for the treatment of women with profound LH deficiency in 46 countries
worldwide, including countries of the European Union such as France, Germany and
the United Kingdom.
SERONO AND INFERTILITY TREATMENT
Serono, the global leader in infertility, 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.) 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 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
www.seronousa.com
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SERONO S.A.
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
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)
October 1, 2003 By: /s/ Allan Shaw
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Name: Allan Shaw
Title: Chief Financial Officer