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Immediate Treatment of Early MS Patients with Betaferon,Significantly Delayed Permanent Disability

-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
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