Throughout the European Union, Multiple Sclerosis Patients Can Now Benefit
        From Rebif(R) as Soon as Their Diagnosis of MS is Confirmed

    GENEVA, Switzerland, July 10 /PRNewswire-FirstCall/ -- Serono
(virt-x:SEO and NYSE: SRA) announced today that the European Commission has
approved an update of the Summary of Product Characteristics (SmPC) of
Rebif(R) (interferon beta-1a), in order to align it with current medical
practice. Throughout the European Union, Rebif(R) can now be prescribed
after the diagnosis of multiple sclerosis (MS) has been confirmed based on
one attack and subsequent positive magnetic resonance imaging (MRI) scans.
    The 'therapeutic indication' section of the SmPC of Rebif(R) now takes
into account the McDonald criteria, which are the current reference
criteria for the diagnosis of MS. The SmPC of Rebif(R) was previously based
on the Poser criteria, which were in use at the time of Rebif(R) approval
in the European Union in 1998, and Rebif(R) was consequently indicated for
MS patients who had experienced at least two attacks. Compared with the
Poser criteria, the McDonald criteria utilize MRI evidence as an
alternative to a second attack, and allow the same patients to be diagnosed
with more sensitivity and specificity. Current understanding of the disease
supports that it is critical to initiate treatment as soon as the diagnosis
of MS is established to ensure the best possible outcome for the patients.
    "We are delighted with the European Commission decision," said Roberto
Gradnik, Senior Executive Vice President Europe at Serono. "MS has an
initial stage when clinical manifestations are not pronounced but
irreversible neurological damage is taking place. This neurological damage
determines the relative risk of progression of the disease. People with MS
living in Europe will be able to benefit from the proven efficacy of
Rebif(R) as soon as MS is diagnosed, when it is needed most."
    Rebif(R) is proven effective on the following three key measures of
treatment effectiveness: MRI lesion area and activity, relapse rates, and
disability progression. The safety and efficacy of Rebif(R) are supported
by eight-year follow-up data and 12 years of patient experience from around
the world.
    The European Commission decision means that the updated SmPC of
Rebif(R) is valid immediately in all 25 member states of the European
Union. In most other regions of the world, the therapeutic indication of
Rebif(R) already takes into account the McDonald criteria.
    About Rebif(R)
    Rebif(R) (interferon beta-1a) is a disease-modifying drug used to treat
relapsing forms of multiple sclerosis and is similar to the interferon beta
protein produced by the human body. Interferon helps modulate the body's
immune system, fight disease and reduce inflammation.
    Rebif(R), which was approved in Europe in 1998 and in the US in 2002,
is registered in more than 80 countries worldwide. In the United States,
Rebif(R) is co-marketed by Serono, Inc. and Pfizer Inc. Rebif(R) has been
proven to delay the progression of disability, reduce the frequency of
relapses and reduce MRI lesion activity and area[1]. Rebif(R) is available
in a 22 mcg and 44 mcg ready-to-use pre-filled syringe and a titration
pack, and can be stored at room temperature for up to 30 days if a
refrigerator is not available.
    Most commonly reported side effects are injection site disorders,
flu-like symptoms, elevation of liver enzymes and blood cell abnormalities.
Patients, especially those with depression, seizure disorders, or liver
problems, should discuss treatment with Rebif(R) with their doctors.
    About Serono Neurology
    In addition to Rebif(R), Serono also offers a second therapy within its
US portfolio of multiple sclerosis (MS) therapies: Novantrone(R)
(mitoxantrone for injection concentrate) for worsening forms of MS. Full
prescribing information for these products can be obtained by contacting
Serono or visiting the Serono website. Additional therapy options are
currently under development at Serono, including cladribine tablets,
currently in Phase III studies and potentially the first oral therapy for
treatment of MS, as well as osteopontin, an MMP-12 inhibitor, a JNK
inhibitor and interferon beta:Fc, in early-stage development for MS. Serono
also is taking a leading role in developing an understanding of the role of
genetics in MS, with a whole genome scan currently underway. To-date, 80
genes associated with MS have been identified, based on a 40% scan. The
project is due to be completed in 2006 and will improve understanding of
the causes of MS and the appropriate therapeutic targets for the disease.
    About multiple sclerosis
    Multiple sclerosis (MS) is a chronic, inflammatory condition of the
nervous system and is the most common, non-traumatic, neurological disease
in young adults. MS may affect approximately two million people worldwide.
While symptoms can vary, the most common symptoms of MS include blurred
vision, numbness or tingling in the limbs and problems with strength and
coordination. The relapsing forms of MS are the most common.
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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 February 28, 2006. 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
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ability to sell our products. Serono has no responsibility to update the
forward-looking statements contained in this press release to reflect
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    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 and autoimmune diseases. Currently, there are
more than 25 on-going development projects.
    In 2005, Serono, whose products are sold in over 90 countries, achieved
worldwide revenues of US$2,586.4 million. Reported net loss in 2005 was
US$106.1 million, reflecting a charge of US$725 million taken relating to
the settlement of the US Attorney's Office investigation of Serostim.
Excluding this charge as well as other non-recurring items, adjusted net
income grew 28.4% to US$565.3 million in 2005. 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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    [1] The exact relationship between MRI findings and the clinical status
of patients is unknown.

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