New data presented at a recent medical meeting on HIV and infectious diseases

    Rockland, Mass., Feb. 12 /PRNewswire-FirstCall/ -- Serono, Inc., the US
affiliate of Serono (virt-x: SEO and NYSE: SRA), announced new clinical data
on Serostim(R) [somatropin (rDNA origin) for injection] as a potential
maintenance therapy to sustain reductions in excess visceral fat accumulation
in patients with HIV-associated adipose redistribution syndrome (HARS) who had
previously received Serostim(R)(1) induction therapy.  The data was recently
presented at a medical meeting on HIV and infectious diseases.  HARS is a
debilitating medical condition experienced by people being treated for HIV and
for which there is currently no medical treatment.  The visceral adipose
tissue accumulation seen in HARS may be associated with an adverse risk
profile.
    "Based on its efficacy and safety profile, a low dose of Serostim(R)
merits additional investigation as a maintenance therapy for HIV patients with
HARS," said study lead investigator, Donald P. Kotler, M.D., St. Luke's
Roosevelt Hospital, New York.
    A prospective, multi-center, randomized, dose-finding extension trial
evaluated the safety and efficacy of Serostim(R) maintenance therapy,
administered at a dose of 1 or 2 mg daily, to sustain reductions in excess
trunk fat in patients with HARS following treatment with Serostim(R) at a
higher dose.  Laboratory measurements of potential metabolic conditions
occurring with HARS, such as lipid profiles, were also included.
    Serono has previously reported positive findings of Serostim(R) for the
Treatment of Adipose Redistribution Syndrome (STARS) study, a double-blind,
placebo-controlled study, designed to evaluate Serostim(R) as a potential HARS
therapy.  The study results showed that Serostim(R) 4mg administered daily for
12 weeks decreased visceral adipose tissue and trunk fat as compared to
placebo (p<0.001).  A significant decline in total and non-HDL cholesterol as
compared to placebo was also observed (p<0.005).
    The present trial was an extension of the STARS study.  The maintenance
phase involved 142 HIV positive patients with HARS and demonstrated
significant reductions (p<0.01) in trunk fat, non-HDL cholesterol and total
cholesterol from the trial baseline to week 60 in patients taking either 1 mg
or 2 mg of Serostim(R) as a maintenance therapy.
    "Serono is committed to continuing research aimed at resolving metabolic
complications associated with HIV, including HARS," commented Paul Lammers,
MD, MSc, Chief Medical Officer, Serono, Inc.
    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, i.e., glucose intolerance.
    In patients with HIV-associated wasting, Serostim(R) has a generally
manageable side effect profile.  The most common adverse events associated
with Serostim(R) therapy are mild to moderate muscle and joint pain and
swelling, which occur in a dose-related manner and often subside with
continued treatment or dose reduction.  Cases of new onset impaired glucose
intolerance, new onset Type 2 diabetes mellitus and exacerbation of
preexisting diabetes mellitus have been reported in patients receiving
Serostim(R).  Some patients develop diabetic ketacidosis and diabetic coma.
In some patients, therapy with Serostim(R) necessitated initiation or
adjustment of anti-diabetic treatment.  Patients with a history of
hyperglycemia or other risk factors for glucose intolerance should be
monitored closely during treatment with Serostim(R).  Transient increases in
glucose levels occur early in treatment and should be monitored.
    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, Inc., located in Rockland, MA, is the US affiliate of Serono, a
global biotechnology leader, headquartered in Geneva, Switzerland. The Company
has seven recombinant products, Rebif(R) (interferon beta-1a), Gonal-F(R)
(follitropin alfa for injection), Luveris(R) (lutropin alfa),
Ovidrel(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.)(2) In addition to being the world
leader in reproductive health, Serono has strong market positions in
neurology, metabolism and growth. 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 April 17, 2003.  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.

    For more information, please contact:

     Serono, Inc., Rockland, MA
     Media Relations:   Investor Relations:
     Tel. 781 681 2340   Tel.  781 681 2552
     Fax:  781 681 2935  Fax:  781 681 2912

     Serono in Geneva, Switzerland:
     Media Relations:      Investor Relations:
     Tel: 22-739 36 00     Tel: 22-739 36 01

     Fax: 22-739 30 85     Fax: 22-739 30 22
     http://www.serono.com
     Reuters: SEOZ.VX / SRA.N
     Bloomberg: SEO VX / SRA US


    (1) Serostim(r) is currently not approved for the treatment of HARS.
    (2) 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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