Approval Expands Serono's Recombinant Portfolio in the United States

    GENEVA, Switzerland and ROCKLAND, Massachusetts, October 15
/PRNewswire-FirstCall/ -- Serono (virt-x SEO and NYSE: SRA) announced today
that the US Food and Drug Administration (FDA) has approved Luveris(R)
(lutropin alfa for injection) for concomitant use with Gonal-f(R)
(follitropin alfa for injection) for stimulation of follicular development in
infertile hypogonadotropic hypogonadal (HH) women with profound LH deficiency
(LH < 1.2 IU/L).
    HH is a rare endocrine deficiency. Women with HH are unable 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.
    Luveris(R) is the first and only approved recombinant human form of
luteinizing hormone (LH), a naturally occurring fertility hormone. The
Luveris(R) approval makes Serono the only company to offer three recombinant
fertility hormones, part of its long-term global strategy to develop a 100%
recombinant human gonadotropin portfolio. By the end of this year, Serono
will complete a systematic commercial phase out of its older-generation
urinary products, with the exception of Japan.
    "The Luveris(R) approval is a result of Serono's strong dedication to
research and development of products in reproductive health," said Bharat
Tewarie, MD, Executive Vice President, Reproductive Health, Serono, Inc. "We
recognized the additional endocrine needs of this special population of
patients and developed recombinant human LH specifically for them as part of
our continued commitment to advancing infertility treatment." Data on
Luveris(R) are being presented at the 60th Annual Meeting of the American
Society for Reproductive Medicine in Philadelphia later this month. For
patients and healthcare providers who would like additional information on
Luveris(R) and other Serono products, a toll-free educational service called
Fertility LifeLines(TM) (+1-866-538-7879) is available.
    "Luveris(R), in conjunction with Gonal-f(R), helps individualize
treatment for a special population of infertile patients," said Zev
Rosenwaks, MD, Director, Center for Reproductive Medicine and Infertility at
New York Weill Cornell. "It provides an option for women who specifically do
not produce or secrete LH."
    Luveris(R) addresses an unmet medical need and has also received Orphan
Drug designation from the FDA Office of Orphan Products Development. It is
currently approved in over 60 countries worldwide, including countries in the
European Union, Asia, Latin America and Australia.
    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. Reports of multiple births have been associated
with gonadotropin treatments. The most common side effects in women using
Luveris(R) include headache, abdominal pain, nausea, OHSS, breast pain, and
ovarian cyst. Please see full prescribing information for product details.
    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(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).
    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
http://www.seronousa.com or by calling +1-888-275-7376.
    http://www.seronousa.com
    http://www.serono.com

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