Serostim(R) granted accelerated approval in 1996 as treatment for AIDS
  patients with wasting or cachexia, a serious and life threatening disease

  Confirmatory multi-center, placebo-controlled study substantiates previous
  findings of increased lean body mass and improvement in physical endurance


    ROCKLAND, Mass., Aug. 29 /PRNewswire/ -- Serono, Inc. announced today that
the US Food and Drug Administration (FDA) has granted full approval for
Serostim(R) [somatropin (rDNA origin) for injection] which is indicated for
the treatment of HIV patients with wasting or cachexia to increase lean body
mass and body weight, and improve physical endurance. (1)
    Serostim(R) received accelerated approval in 1996, a special regulatory
status granted by the FDA for approval of a drug that is used to treat
patients with serious or life-threatening illnesses, and provides meaningful
therapeutic benefit over any existing treatments.  Under the terms of the
accelerated approval, Serono conducted a multi-center, confirmatory placebo-
controlled study with Serostim(R).  Data from this trial substantiate previous
study findings of increased lean body mass and improvement in physical
endurance with Serostim(R).  In addition, patients in this study perceived an
improvement in their wasting symptoms with Serostim(R) treatment.
    "We are very pleased that the FDA has granted full approval for
Serostim(R)," said James Sapirstein, Executive Vice President, Metabolic
Endocrinology, Serono, Inc. "Wasting continues to be a major concern in the
management of HIV and AIDS treatment, even with the benefits of highly active
antiretroviral therapy.  Serostim(R) makes an important and positive
difference in the physical endurance of people experiencing HIV wasting."
    HIV-associated wasting is a chronically debilitating and potentially life-
threatening condition.  It is a metabolic disorder that causes the body to use
vital muscle and organ tissue, which is critical for survival, for energy
instead of primarily using the body's stored fat.  Loss of lean body mass,
which consists of muscle tissue, important body organ tissue and blood cells,
can lead to increased risk of opportunistic infections, illness, and extreme
fatigue and can profoundly diminish a person's quality of life.  Serostim(R)
was granted orphan drug designation by the FDA in 1991 for this condition.

    Clinical Study of Serostim in AIDS Wasting
    The full approval of Serostim(R) is based upon a randomized, double-blind,
dose-ranging study that confirmed the clinical efficacy of Serostim(R) in the
treatment of HIV wasting.  The study treated 757 patients with HIV-associated
wasting at US, European and other international trial sites.  Participants
were treated with placebo, Serostim(R) on alternate days (0.1 mg/kg) or
Serostim(R) on a daily basis (0.1mg/kg).
    The result on the study's primary endpoint of cycle work output was
statistically significant for the Serostim(R) daily dose group as compared to
the placebo group (p<0.0001). Positive results were also seen for the
secondary endpoint of change in lean body mass for the Serostim(R) daily dose
group as compared to the Serostim(R) alternate day group (p=0.017) and as
compared to the placebo group (p<0.0001).  In addition, patient perception of
the impact of treatment on their wasting symptoms was positive with both doses
of Serostim(R).
    All study participants completing the 12-week placebo-controlled phase of
the trial (n=646) continued treatment into an extension phase; 548 of these
patients completed an additional 12 weeks of active treatment.  In these
patients, positive results in cycle work output and lean body mass either
improved further or were maintained with continued treatment with Serostim(R).

    Additional Product Information
    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.
    Serostim(R) is generally well tolerated.  The most common adverse events
associated with Serostim(R) therapy are mild to moderate muscle and joint pain
and swelling/edema, 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. The Company has six recombinant products on the
worldwide market, Gonal-F(R) (follitropin alfa for injection), Luveris(R)
(lutropin alfa), Ovidrel(R)/Ovitrelle(R) (choriogonadotropin alfa for
injection), Rebif(R) (interferon beta-1a), Serostim(R) [somatropin (rDNA
origin) for injection] and Saizen(R) [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 over 30 projects in development.
    Serono was awarded the International James D. Watson 2003 Helix Award from
the Biotechnology Industry Organization (BIO) in recognition of the Company's
outstanding leadership and highest standards of scientific and product
achievement.
    In 2002, Serono achieved worldwide revenues of $1.546 billion, and a net
income of $321 million, making it the third largest biotech company in the
world. The Company operates in 45 countries, and its products are sold in over
100 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
     http://www.seronousa.com

     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) Concomitant antiretroviral therapy is necessary.

    (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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