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First-of-its-Kind Data Show:
Risk to confirmed EDSS progression reduced by 40 percent compared to delayed treatment
Berlin - Bayer Schering Pharma AG, Germany, announced today new data, which
show that immediate initiation of Betaferon® (interferon beta-1b) treatment in
patients with a first event suggestive of multiple sclerosis (MS) can
significantly reduce the risk of permanent neurological impairment as measured
by the Expanded Disability Status Scale (EDSS) by 40 percent over three years
compared to delayed treatment. These findings from the BENEFIT (BEtaferon in
Newly Emerging multiple sclerosis For Initial Treatment) studies* were
presented today at the American Academy of Neurology's 59th Annual Meeting in
Boston, Massachusetts.
"Some patients have already developed significant neurological damage when they
first present with signs of MS, which can lead to accumulated disability later
in life. The BENEFIT results clearly show that immediate treatment with
Betaferon® initiated after the first clinical event can significantly reduce
that damage, which could translate into a greater delay in the time it takes
for patients to suffer from the debilitating consequences of MS," said Dr. Mark
S. Freedman, Professor of Neurology at the University of Ottawa and
investigator of the study. "This is a truly novel finding that has not yet been
demonstrated for any other immunomodulatory MS treatment, and underscores the
urgent need to treat patients early rather than waiting for further signs of MS
to develop. Physicians and patients should consider these unprecedented
findings when making treatment decisions."
"Immediate treatment" refers to treatment initiated after the first clinical
event; "delayed treatment" is initiated after the second clinical event or
after 2 years, whatever comes first.
"We are delighted that the BENEFIT study continues to deliver ground-breaking
results," said Darlene Jody, M.D., President of Bayer HealthCare's Specialized
Therapeutics Global Business Unit. "In the past year, Betaferon® has received
approval around the world for use in patients with the earliest signs of MS. We
intend to submit this novel data for inclusion in our label. Regulatory
approval would further differentiate Betaferon® from other products in the
market place and strengthen our position."
About BENEFIT
BENEFIT is a multi-center trial conducted at 98 sites in 20 countries and
included patients presenting with a single clinical episode suggestive of MS. A
total of 468 patients with a first clinical demyelinating event suggestive of
MS and typical MRI findings were randomized to receive either 250 micrograms of
interferon beta-1b (Betaferon®) every other day or placebo as a subcutaneous
injection in a double blind fashion. The placebo-controlled treatment period
lasted up to 24 months or up to the time when patients were diagnosed with
clinically definite MS. All study participants were then invited to participate
in a follow-up study with Betaferon® to prospectively assess the impact of such
immediate versus delayed treatment with Betaferon® on the long-term course of
the disease for a total observation time of five years.
Results from a prospectively planned analysis of patients three years after the
first event suggestive of MS showed that immediate treatment with Betaferon®
after the first event suggestive of MS reduced the risk for confirmed EDSS
progression by 40 percent over three years compared to delayed treatment. At
three years, patients who initiated Betaferon® treatment immediately were 41
percent less likely to progress to clinically definite MS versus patients who
began treatment later. These results confirm the findings of the
placebo-controlled BENEFIT study.
At the end of three years, 73 percent of patients were on Betaferon® treatment
after the first event suggestive of MS.
About Betaferon® / Betaseron®
Betaferon®, which is marketed in the U.S. and Canada under the trademark
Betaseron®, was the first disease-modifying drug introduced for MS and is a
well-established treatment around the world. In the U.S., Europe and Japan,
Betaferon® has been approved for all relapsing forms of MS. It is able to
reduce the number of MS episodes by one-third, and the frequency of moderate to
severe episodes by as much as 50 percent. Sixteen years' follow up of people
treated with Betaferon® has shown that it is safe and well tolerated.
References
*Mark S. Freedman, et al: Betaseron in Newly Emerging Multiple Sclerosis for
Initial Treatment (BENEFIT): Effects of Immediate vs. Early Onset of Interferon
Beta-1b Treatment, American Academy of Neurology, 59th Annual Meeting
Bayer HealthCare
Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading,
innovative companies in the healthcare and medical products industry and is
based in Leverkusen, Germany. The company combines the global activities of the
Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The
pharmaceuticals business operates under the name Bayer Schering Pharma and as
Bayer HealthCare Pharmaceuticals in the US and Canada. Bayer HealthCare's aim
is to discover and manufacture products that will improve human and animal
health worldwide.
Bayer Schering Pharma
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company.
Its research and business activities are focused on the following areas:
Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized
Therapeutics and Women's Healthcare. With innovative products, Bayer Schering
Pharma aims for leading positions in specialized markets worldwide. Using new
ideas, Bayer Schering Pharma aims to make a contribution to medical progress
and strives to improve the quality of life.
