Needle-Free Delivery Option Exclusive to Saizen(R) Available for Patients

    GENEVA, Switzerland and ROCKLAND, Massachusetts, January 10
/PRNewswire-FirstCall/ -- Serono Inc., the US affiliate of Serono (virt-x:
SEO and NYSE: SRA), announced today the availability of Saizen(R) [somatropin
(rDNA origin) for injection] for use in the treatment of patients with adult
growth hormone deficiency (AGHD), following its FDA approval.
    "This new indication for Saizen(R) represents the evolution of our growth
hormone portfolio and further demonstrates our commitment to the metabolic
franchise," said James Sapirstein, executive vice president of Metabolic
Endocrinology at Serono, Inc. "Patients with AGHD who are treated with
Saizen(R) therapy can use our easy-to-use drug delivery devices such as
cool.click(R), a needle-free device that is preferred by pediatric patients
and is now available for use by adults taking Saizen(R)."
    Adult Growth Hormone Deficiency (AGHD) can be effectively treated with
Saizen(R). With the U.S. approval, patients who were growth hormone deficient
during childhood and have growth hormone deficiency as an adult, may continue
to use Saizen(R). In addition, adult patients who have adult onset growth
hormone deficiency either alone, or associated with multiple hormone
deficiencies, now have access to Saizen(R) and its line of devices.
    Saizen(R) can be administered using a needle-free device, cool.click(R),
the only FDA approved needle-free device for the administration of growth
hormone. It can also be administered with a recently launched autoinjector
pen device, one.click(R), or by traditional needle and syringe. Serono's
portfolio of innovative devices gives patients the choice they want in growth
hormone delivery.
    Patients can learn more about Saizen(R) and Serono's growth hormone
delivery devices by talking with their physician, or by calling Serono
Connections for Growth(R) toll-free at 1-800-582-7989. The full prescribing
information for Saizen(R) can be found online at http://www.seronousa.com.
    About Adult Growth Hormone Deficiency (AGHD)
    Growth hormone deficiency can be a significant problem for adults even
though they no longer get taller. AGHD is recognized as a specific clinical
syndrome with numerous physiological consequences, with effects on:
    - Changes in body composition, including central obesity;
    - Lipids in the blood;
    - Muscle strength;
    - Bone composition;
    - Exercise capacity and energy;
    - Cardiovascular risk; and
    - Psychological well-being (social isolation and depression).
    There are also studies indicating that patients with AGHD have an
increased risk of mortality from cardiovascular disease, possibly
attributable to their growth hormone (GH) deficiency.
    GH deficiency in adults can result from a pituitary or peri-pituitary
tumor or as a direct result of the surgery/radiation used to manage these
conditions. Less commonly, GH deficiency in adults arises from a deficiency
acquired in childhood.
    About Saizen(R)
    Saizen(R) [somatropin (rDNA origin) for injection] is a human growth
hormone produced by recombinant DNA technology. The recommended dose for
adults at the start of therapy is .005 mg/kg daily. The dosage may be
increased to not more than .01 mg/kg daily after four weeks depending upon
the patient's tolerance of treatment.
    Saizen(R) is indicated for the long-term treatment of children with
growth failure due to inadequate secretion of endogenous growth hormone. It
is indicated for replacement of endogenous growth hormone in adults with
growth hormone deficiency that meets the criteria of adult onset or childhood
onset.
    In patients with AGHD, the most common adverse events with associated
growth hormone therapy are joint and muscle pain, edema, carpal tunnel
syndrome, and tingling.
    Growth hormone should be used with caution in patients with insulin
resistance, glucose intolerance, diabetes, hypothyroidism, intracranial
hypertension, and in women who are pregnant or nursing. GH should not be used
in patients with Prader-Willi syndrome who are severely obese or have severe
respiratory impairment; in the presence of active neoplasia; and in patients
with proliferative or preproliferative diabetic retinopathy; or in patients
hospitalized with acute critical illnesses.
    Full prescribing information for Saizen(R), including important safety
information, is available at http://www.seronousa.com.
    About Serono Connections for Growth(R)
    Connections for Growth(R) provides reimbursement support and educational
materials for practitioners and families. They offer educational materials,
reconstitution and dosage information, reimbursement support, access to
cool.click(R) supplies, and contact information for local nurses in the
Serono Nurse Network.
    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.
    About Serono
    Serono is a global biotechnology leader. The Company has eight
biotechnology products, Rebif(R), Gonal-F(R), Luveris(R), Ovidrel(R)
/Ovitrelle(R), Serostim(R), Saizen(R), Zorbtive(TM) and Raptiva(R). 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).
    http://www.serono.com

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