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Serono Submits New Formulation of Rebif(R) for Approval in the United States and in Europe

 Trial Data Show New Formulation of Rebif(R) Offers Substantial Improvement
        in Overall Tolerability and Reduction in Antibody Formation

    GENEVA, Switzerland, and ROCKLAND, Massachusetts, April 4
/PRNewswire-FirstCall/ -- Serono (virt-x:SEO and NYSE: SRA) announced today
the submission of a supplemental Biologics Licence Application (sBLA) to
the US Food and Drug Administration (FDA) and of a variation to the current
Marketing Authorization to the European Medicines Agency (EMEA) for a new
formulation of Rebif(R) (interferon beta-1a) as a treatment of multiple
sclerosis (MS).
    Data from a Phase III clinical trial in patients with relapsing forms
of MS show that the new formulation of Rebif(R) results in a substantial
improvement in overall tolerability, as measured by pre-specified
parameters including injection site reactions, which are an important
factor for patients when choosing an MS therapy. The trial data also show
that the incidence of antibody formation with the new formulation of
Rebif(R) is reduced. Serono expects data on the new formulation of Rebif(R)
to be presented at a major medical conference in the second half of 2006.
    "These results are promising news for patients with multiple
sclerosis," said Prof Per Soelberg S0rensen, from the Danish MS Research
Center, Copenhagen University Hospital, Rigshospitalet and an investigator
of the trial. "While Rebif(R) is well established in the treatment of
relapsing forms of multiple sclerosis, results from this clinical trial
show that the new formulation offers promising improvements which could
translate into additional benefits to the patient."
    "Serono is focused upon providing multiple sclerosis patients with
enhanced therapeutic solutions," said Franck Latrille, Senior Executive
Vice President Global Product Development. "This is supported by innovative
development and manufacturing technology platforms that we have implemented
to deliver world-leading biotech therapies."
    The new formulation of Rebif(R) is the latest of many product
developments from Serono to continually enhance the convenience and
tolerability of Rebif(R). Other enhancements have included the new Rebiject
II auto-injector to facilitate injections; a 29 gauge-needle pre-filled
syringe, the thinnest needle in a ready-to-use pre-filled syringe for the
treatment of MS; a titration pack designed to make starting on Rebif(R)
therapy easier and more convenient.
    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.
    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 government
investigations and litigation 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.
    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).
    Reuters: SEO.VX / SRA.N
    Bloomberg: SEO VX / SRA US
    [1] The exact relationship between MRI findings and the clinical status
of patients is unknown.


SOURCE Serono International S.A.




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