Data Presented at XVIIIth World Congress of Neurology, Sydney, Australia

    GENEVA, Switzerland, November 9 /PRNewswire-FirstCall/ -- Serono (virt-x:
SEO and NYSE: SRA) Data presented today at the XVIIIth World Congress of
Neurology in Sydney, Australia, show that treatment with Rebif(R) in patients
with multiple sclerosis (MS) does not alter the immune response to influenza
vaccination.
    Immune response to influenza vaccine was prospectively assessed in an
open-label study over a four-week period in a total of 163 patients with MS.
One group of MS patients (n=86) received Rebif(R) (interferon beta-1a) 44 mcg
subcutaneously three times weekly for at least six months before
administration of the flu vaccine and continued their Rebif(R) treatment
after the vaccination. The control group of MS patients (n=77) did not
receive interferon treatment within six months prior to study entry and
during the study. Patients of both groups received a single dose of the same
influenza vaccine. The data from the two groups were similar on the primary
endpoint, defined by the proportion of patients achieving a hemagglutination
inhibition (HI) titer >40 four weeks after vaccination, which indicates the
ability of patients to mount a positive vaccine response. More than 90% of
the patients in both groups (93% in the Rebif(R)-treated patients group and
91% in the group of patients receiving no interferon treatment) were able to
mount an appropriate immune response.
    No new safety concerns regarding the treatment of MS patients with
Rebif(R) were identified. The proportion of patients experiencing a
vaccine-related adverse event was similar for both the Rebif(R)-treated group
and the control group.
    "These results demonstrate that treatment with Rebif(R) does not alter
the immune response to influenza vaccination, and that this vaccination can
be performed safely in MS patients who are treated with Rebif(R)," said Dr.
Paul Lammers, Chief Medical Officer of Serono, Inc. "This news is important
for patients treated with Rebif(R) as vaccination may provide medical
benefits to people with MS by preventing an influenza virus infection, and
also by possibly avoiding MS exacerbations or worsening of neurologic
symptoms due to concurrent viral infection."
    The importance of MS patients avoiding viral infections was previously
outlined by the Immunization Panel of the MS Council for Clinical Practice
Guidelines. The meta-analysis performed by the Panel demonstrated that MS
subjects were at increased risk of MS exacerbation during concurrent viral
infections.
    Rebif(R) is the only approved MS therapy proven in a four-year clinical
study in the following three key measures of treatment effectiveness:
reducing MRI lesion area and activity[1], reducing relapses and delaying the
progression of disability. Rebif(R) is also supported by eight years of
safety and efficacy 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 reduce MRI lesion activity and area[1], reduce the frequency of
relapses, and delay the progression of disability. Rebif(R) is available in a
22 mcg and 44 mcg ready-to-use pre-filled syringe 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.
    The exact relationship of antibody titers to vaccine efficacy was not
studied and is not known in patients receiving Rebif(R).
    About multiple sclerosis
    Multiple sclerosis is a chronic, inflammatory condition of the nervous
system and is the most common, non-traumatic, neurological disease in young
adults. Multiple sclerosis may affect approximately two million people
worldwide. While symptoms can vary, the most common symptoms of multiple
sclerosis include blurred vision, numbness or tingling in the limbs and
problems with strength and coordination. The relapsing forms of multiple
sclerosis are the most common.
    About influenza
    Influenza is caused by a virus that attacks mainly the upper respiratory
tract - the nose, throat and bronchi and rarely also the lungs. The infection
usually lasts for about a week. It is characterized by sudden onset of high
fever, myalgia, headache and severe malaise, non-productive cough, sore
throat, and rhinitis. Most people recover within one to two weeks without
requiring any medical treatment. In the very young, the elderly and people
suffering from medical conditions such as lung diseases, diabetes, cancer,
kidney or heart problems, influenza poses a serious risk. In these people,
the infection may lead to severe complications of underlying diseases,
pneumonia and death.
    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 March 16, 2005. 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. Currently, there are approximately 30 ongoing development projects.
    In 2004, Serono achieved worldwide revenues of US$2,458.1 million, and a
net income of US$494.2 million, making it the third largest biotech company
in the world. Its products are sold in over 90 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).
    [1] The exact relationship between MRI findings and the clinical status
of patients is unknown.

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