GENEVA, Switzerland and ROCKLAND, MA., May 27 /PRNewswire-FirstCall/ --
    - First and only prefilled device with new liquid formulation developed
to make infertility treatment easier for patients
    Serono, Inc., the US affiliate of Serono (virt-x: SEO and NYSE: SRA),
announced today that the United States Food and Drug Administration (FDA) has
approved a prefilled device that delivers a new liquid formulation of the
most prescribed gonadotropin in the world: Gonal-f(R) RFF Pen (follitropin
alfa injection).
    Gonal-f(R) RFF Pen is the first and only prefilled and ready-to-use
multi-dose FSH (follicle stimulating hormone) in the US. It will be available
in three sizes that deliver either 300 IU, 450 IU or 900 IU of liquid
Gonal-f(R) filled-by-mass, which can be administered in multiple doses.
Developed to make infertility treatment easier, it provides patients with a
new way to administer Gonal-f(R) by simply dialing the correct dose without
the need to mix medication or load cartridges. It was designed specifically
for the treatment of infertility to allow patients to easily and accurately
deliver a precise daily dose of medication.
    "We are proud to be the first company to offer a prefilled and
ready-to-use pen, providing a new option for infertility patients that is
easy and simple to use, " said Bharat Tewarie, MD, Executive Vice President,
Reproductive Health, Serono, Inc. "Serono is the world leader in reproductive
health, and we are again demonstrating our commitment to continually improve
the patient experience. Gonal-f(R) RFF Pen, in addition to our multi-dose and
single-dose vial presentations, gives us the most extensive and complete
portfolio of infertility products to allow for enhanced dosing flexibility
and individualized treatment." Serono expects Gonal-f(R) RFF Pen to be
available in the US in Q3 of this year.
    Gonal-f(R) RFF Pen is indicated for induction of ovulation and pregnancy
in anovuluatory infertile women in whom the cause of infertility is
functional and not due to primary ovarian failure. It is also indicated for
the development of multiple follicles in ovulatory women participating in an
Assisted Reproductive Technology (ART) program.
    Gonal-f(R) is a highly consistent, filled-by-mass recombinant human
follicle stimulating hormone (r-hFSH) prescribed to supplement or replace
naturally occurring FSH, which stimulates the development of follicles in the
ovaries. The Gonal-f(R) prefilled pen was previously approved by the European
Commission, the Swiss and the Australian Regulatory Authorities and launch is
underway.
    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. About 70% of patients who are
treated succeed in having children.
    Additional Information
    Side effects may occur with the use of infertility medications and,
therefore, they 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 treatment. Side
effects in women using Gonal-f(R) RFF Pen for infertility treatment may
include headache, stomach pain, bloating, nausea and injection site bruising.
    About Serono, Inc. and Infertility
    Serono, Inc. is dedicated to providing patient-friendly, innovative
products to help couples build families. It is the only company to offer a
full portfolio of infertility medications for every stage of the reproductive
cycle and recombinant versions of two hormones needed to treat infertility.
    About Serono
    Serono, Inc., located in Rockland, MA, is the US affiliate of Serono, a
global biotechnology leader, headquartered in Geneva, Switzerland. Serono has
seven recombinant products, Rebif(R) (interferon beta-1a), Gonal-f(R)
(follitropin alfa for injection), Luveris(R) (lutropin alfa), Ovidrel
PreFilled Syringe(R)/Ovitrelle(R) (choriogonadotropin alfa injection),
Serostim(R) [somatropin (rDNA origin) for injection], Saizen(R) [somatropin
(rDNA origin) for injection] and Zorbtive(tm) [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. Serono'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.
    http://www.seronousa.com
    http://www.serono.com
    Reuters: SEO.VX / SRA.N
    Bloomberg: SEO VX / SRA US
    Reference:
    * Package inserts for Serono's US marketed products are available at
http://www.seronousa.com or by calling +1-888-275-7376.

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