First Trial Assessing Therapeutic Benefit of Two Different Dosage Regimens
    of Disease Modifying Therapy in People With First Clinical Symptoms
                       Suggesting Multiple Sclerosis

    GENEVA, Switzerland, December 12 /PRNewswire-FirstCall/ -- Serono
(virt-x: SEO and NYSE: SRA) announced today the initiation of a Phase III
clinical trial to evaluate the effect of two dosage regimens of the new
formulation of Rebif(R) (interferon beta-1a 44 mcg, three times a week or
once a week) on the time to conversion to multiple sclerosis (MS) in people
with first clinical symptoms suggestive of the disease. The trial, called
the REFLEX study (REbif FLEXible dosing in early MS), will involve 480
patients considered at risk of developing MS because of a recently
experienced isolated demyelinating event and of typical magnetic resonance
imaging (MRI) brain scans.
    "It has been demonstrated that early treatment with interferon-beta can
reduce the risk of developing multiple sclerosis. Optimizing the impact of
such treatment on development of irreversible neurological damage and
ascertainment of long term outcomes is still subject of active experimental
and clinical research", said Professor Ludwig Kappos, from the Department
of Neurology, University Hospital Basel, Switzerland, and a member of the
Steering Committee of the REFLEX study. "The REFLEX study will determine
the respective therapeutic benefit of two different dosage regimens of the
new formulation of Rebif(R) for people at risk of developing multiple
sclerosis."
    The REFLEX study is a randomized, double-blind, placebo-controlled,
multicenter trial. Study participants will receive either the new
formulation of Rebif(R) 44 mcg three times a week (160 patients), or the
new formulation of Rebif(R) 44 mcg once a week (160 patients), or placebo
(160 patients) as a subcutaneous injection for a period of 24 months,
unless they suffer from a second attack leading to a diagnosis of
clinically definite MS. In this case, patients will be offered open label
treatment with the new formulation of Rebif(R) 44 mcg three times a week.
The primary endpoint of the study is time to conversion to MS, according to
the McDonald criteria. Other endpoints will include assessments of MRI
brain scans, clinical relapses and disability progression.
    The REFLEX study will also evaluate the effect of the new formulation
of Rebif(R) on cognitive function as measured by the Paced Auditory Serial
Addition Test (PASAT)[1]. Cognitive dysfunction can occur early in MS and
impact memory, ability to process information and learning. A sub-study
will assess retinal nerve fiber thickness (a marker of axonal loss) by
means of optical coherence tomography (OCT). This sub-study will be
conducted in selected centers, equipped with this leading edge technology.
In addition, the REFLEX study will aim at identifying genetic/genomic
profiles associated with disease and treatment outcomes.
    The new formulation of Rebif(R) has been developed by an innovative
approach, using state-of-the-art technologies. It is under regulatory
review by the European Medicines Agency, the US Food and Drug
Administration and other healthcare authorities, and is not currently
approved.
    About Rebif(R)
    Rebif(R) (interferon beta-1a) is a disease-modifying drug used to treat
relapsing forms of multiple sclerosis (MS) 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[2]. Rebif(R) is not
approved for treatment of chronic progressive MS. 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 and multiple sclerosis
    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 therapeutic options are
currently under development at Serono, including oral cladribine, currently
in Phase III studies and potentially the first oral therapy for treatment
of MS, as well as several products in early stage development including:
osteopontin, an MMP-12 inhibitor, a JNK inhibitor and interferon beta:Fc.
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.
    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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    Forward-looking statements
    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
products as a result of competition or other factors, our ability to obtain
reimbursement coverage for our products, the outcome of any government
investigations and litigation. Serono is providing this information as of
the date of this press release, and 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 and autoimmune diseases.
    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).
    For more information, please contact
    Corporate Media
    Relations:
    Tel: +41-22-414-36-00
    Fax: +41-22-414-30-85
    http://www.serono.com

    Media Relations, USA:
    Tel: +1-781-681-2340
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    http://www.seronousa.com

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    Relations:
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    Fax: +41-22-414-30-22
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    [1] The PASAT is a measure of cognitive function that assesses auditory
information processing speed (the ability to attend to orally presented
information, process the information in memory, and then formulate a
response in a timely fashion) and flexibility, as well as calculation
ability.
    [2] The exact correlation between MRI findings and the current or
future clinical status of patients, including disability progression, is
unknown.

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