Data Presented at 22nd ECTRIMS Congress in Madrid

    MADRID, Spain, September 28 /PRNewswire-FirstCall/ -- Serono (virt-x:
SEO and NYSE: SRA) announced today data from an ongoing two-year (96 weeks)
Phase IIIb trial show that the new formulation of Rebif(R) (interferon
beta-1a) 44 mcg subcutaneously (sc) three times weekly (tiw) for the
treatment of relapsing forms of multiple sclerosis (MS) offers substantial
improvement in tolerability and reduction in antibody formation observed at
one year (48 weeks), compared with historical data from patients.
Historical data for the currently available formulation of Rebif(R) is the
EVIDENCE study. These data are presented today at a satellite symposium at
the 22nd Congress of the European Committee for Treatment and Research in
Multiple Sclerosis (ECTRIMS) in Madrid, Spain.
    "These results are promising news for patients with multiple
sclerosis," said Prof Per Soelberg Sorensen, from the Danish MS Research
Center, Copenhagen University Hospital, Rigshospitalet and an investigator
of the trial. "If approved the new formulation of Rebif(R) potentially
represents an improvement in the treatment of patients with multiple
sclerosis."
    The incidence of injection site reactions with the new formulation of
Rebif(R) at 48 weeks was nearly three-fold less than in the EVIDENCE study
(29.6% versus 83.8%). Injection site reactions are one of the reasons why
some patients discontinue MS treatment. Treatment enhancements resulting in
a decrease of injection site reactions are usually associated with improved
compliance and adherence to treatment.
    The primary endpoint of the study is the proportion of neutralizing
antibody positive patients at the last assessment. At 48 weeks, the data
showed that 13.9% of patients treated with the new formulation of Rebif(R)
were neutralizing antibody positive. In the EVIDENCE study at 48 weeks,
24.4% of the patients were positive. Persistent neutralizing antibodies
were detected in 2.5% of the patients treated with the new formulation of
Rebif(R) at 48 weeks. In the EVIDENCE study at 48 weeks, the rate of
persistent neutralizing antibodies observed was 14.3%.
    "The new formulation of Rebif(R) has been developed by an innovative
approach, using state-of-the-art technologies, with a major focus on the
molecule's structural and functional integrity," said Franck Latrille,
Senior Executive Vice President Global Product Development at Serono.
"Based on the improvements in tolerability and immunogenicity, the new
formulation of Rebif(R) could lead to an improved benefit-to-risk profile."
    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 Rebiject II
auto-injector to facilitate injections; a 29 gauge-5 bevel needle
pre-filled syringe, the thinnest needle in a ready-to-use pre-filled
syringe for the treatment of MS; and a titration pack designed to make
starting on Rebif(R) therapy easier and more convenient. The new
formulation of Rebif(R) is currently under regulatory review by the
European Medicines Agency, the US Food and Drug Administration and other
healthcare authorities.
    The results presented today are the 48-week results from a 96-week,
Phase IIIb, multicenter, single-arm, open-label study evaluating the safety
and immunogenicity of the new formulation of Rebif(R) 44 mcg sc tiw in 260
patients with relapsing forms of MS. The primary objective of the study was
to compare the antigenicity of new formulation Rebif to historical data.
    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 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.
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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    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).
    [1] The exact relationship between MRI findings and the clinical status
of patients is unknown.

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