GENEVA, Switzerland and ROCKLAND, Massachusetts, January 24
/PRNewswire-FirstCall/ -- Serono Inc., the US affiliate of global
biotechnology leader Serono (virt-x: SEO and NYSE: SRA), announced today that
it has completed enrollment in its second multi-center, phase III trial of
Serostim(R) (somatropin [rDNA origin] for injection) in the treatment of
HIV-Associated Adipose Redistribution Syndrome (HARS).
    The primary goal of this randomized, double-blind, placebo-controlled
trial is to assess whether Serostim(R) induction therapy significantly
reduces the marked abnormal accumulation of visceral adipose tissue
(intra-abdominal fat) and fat maldistribution which characterize HARS, and
whether low-dose maintenance therapy prevents the abnormalities from
returning during a continued course of therapy.
    "We are pleased to have reached this major milestone for this very
important study," said James Sapirstein, Executive Vice President of
Metabolic Endocrinology at Serono, Inc. "An unmet need clearly exists in this
patient population. Serono is committed to ensuring rapid completion of the
trial and a US registration submission for Serostim as a treatment for this
orphan indication."
    "More than 300 patients were enrolled in the study in only six months.
The dedication of the clinical investigators, all study site personnel and
our in-house study team coupled with the need and enthusiasm for this project
in the HIV community led to speedy enrollment of this study," said Paul
Lammers, Chief Medical Officer at Serono, Inc. "The results of this pivotal
Phase III clinical trial are eagerly awaited."
    About HARS
    HIV-associated adipose redistribution syndrome or HARS is a subset of HIV
lipodystrophy. HIV-associated lipodystrophy is characterized by a variety of
metabolic disturbances and body shape abnormalities that may present
individually or in combination. Patients with HARS experience abnormal,
pathological accumulation of adipose tissue, which may be present with or
without fat depletion and/or metabolic abnormalities. In general, HARS
patients accumulate excess visceral adipose tissue in the abdomen or may
develop a fat pad on the upper back commonly known as a "buffalo hump."
    About Serostim(R)
    Serostim(R) [somatropin (rDNAorigin) for injection] is the only growth
hormone approved by the US Food and Drug Administration for the treatment of
HIV wasting or cachexia. The recommended dose is 0.1 mg/kg daily (6 mg/day
for patients > 55 kg). Serostim(R) 0.1 mg/kg every other day should be
considered as a starting dose in patients thought to be at risk of certain
adverse effects, e.g., glucose intolerance.
    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. Serostim(R) must be used in conjunction with antiretroviral
therapy. Full prescribing information for Serostim(R), including important
safety information, is available at http://www.serostim.com.
    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).
    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.serono.com   Reuters: SEO.VX / SRA.N
                            Bloomberg: SEO VX / SRA US

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