Successful Completion of Trial Meets Pre-Specified Primary and Major
Secondary Endpoints

    GENEVA, Switzerland and ROCKLAND, Massachusetts, January 9
/PRNewswire-FirstCall/ -- Serono (virt-x: SEO NYSE: SRA) announced today the
completion of its pivotal Phase III double-blind, placebo-controlled trial of
Serono's recombinant human growth hormone in the treatment of HIV-associated
Adipose Redistribution Syndrome (HARS), which met all pre-specified primary
and major secondary endpoints. Serono plans to submit the file to the FDA in
the first half of 2006 and expects that the data will be presented at
upcoming scientific meetings.
    More than 300 patients enrolled in the trial to determine if daily
administration of r-hGH as treatment for the abnormal fat accumulation and
distribution associated with HARS reduces Visceral Adipose Tissue (VAT) more
effectively than placebo.
    In the first phase of the study, patients were randomly assigned to
receive either r-hGH 4 mg daily, or placebo. Growth hormone was administered
for 12 weeks and all patients were measured by CT scan to determine changes
in VAT from baseline. In the second placebo-controlled phase of the study,
r-hGH was administered as 2 mg on alternate days for 24 weeks to assess the
ability of a maintenance regimen to sustain improvements in VAT.
    "The completion of this important research study of r-hGH in HARS is a
strategic milestone for Serono and may lead to an important advance for
patients living with this condition, that not only affects their health but
also their quality of life," said Dr. Paul Lammers, Chief Medical Officer at
Serono, Inc. "The rapid enrollment in the study demonstrates the need for
treatment for this rare medical syndrome. We anticipate filing a supplemental
New Drug Application (sNDA) in the first half of 2006."
    About HARS
    HIV-associated adipose redistribution syndrome or HARS is characterized
by fat maldistribution in HIV-infected patients. Patients with HARS
experience abnormal, pathological accumulation of adipose tissue in the
trunk, primarily in the form of visceral adipose tissue located deep within
the abdomen, underneath the abdominal muscle wall. This fat accumulation may
be present with or without fat depletion (lipoatrophy) and/or metabolic
abnormalities.
    Recombinant human growth hormone is not approved by the FDA for the
treatment of HARS.
    About Recombinant Human Growth Hormone
    Recombinant Human Growth Hormone (r-hGH) is human growth hormone produced
by recombinant DNA technology. Serono's r-hGH products are indicated for the
treatment of pediatric growth hormone deficiency, adult growth hormone
deficiency, HIV wasting or cachexia and for the treatment of short bowel
syndrome.
    Growth hormone should be used with caution in patients with insulin
resistance, glucose intolerance, diabetes, and in women who are pregnant or
nursing. The most commonly reported adverse events include mild
injection-site reactions, moderate muscle and joint pain, and edema/swelling.
Patients with a history of hyperglycemia or other risk factors for glucose
intolerance or pancreatitis should be monitored closely. Use of growth
hormone is contraindicated in treatment of patients in intensive care units
due to complications following open-heart surgery or abdominal surgery,
multiple accidental trauma or acute respiratory failure; patients with active
neoplasia; and patients with known hypersensitivity to growth hormone.
    Full prescribing information for Serono's approved indications, including
important safety information, is available at http://www.seronousa.com.
    Background material
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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 16, 2005. 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, including
oncology. Currently, there are approximately 30 ongoing development projects.
    In 2004, Serono achieved worldwide revenues of US$2,458.1 million, and a
net income of US$494.2 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).
    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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