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Large Study Shows that Presence of Neutralizing Antibodies Did Not,Predict Clinical Response to Betaseron Treatment

WAYNE, N.J., April 02, 2007 /PRNewswire/ -- Berlex, Inc., a U.S. affiliate of Bayer Schering Pharma AG, Germany, announced today the results of a retrospective study demonstrating that the presence of neutralizing antibodies (NAbs) that can develop in response to Betaseron(R) (interferon beta-1b) therapy did not predict clinical response in patients with multiple sclerosis (MS).(1) The study looked at data from over 6,600 patients across three continents. It is the largest dataset ever analyzed on the relevance of NAbs to interferon beta therapy. The results were published in the March issue of The Journal of International Medical Research.

"This study confirms that NAbs, which develop in response to Betaseron therapy, tend to disappear over time and provides important evidence that the presence of NAbs in these patient populations was not associated with a poor clinical response to treatment." said Dr. Douglas Goodin, lead author of the article and Professor of Neurology, University of California, San Francisco. "While it is unclear how these findings might apply to other beta interferon therapies, these data underscore the fact that decisions regarding Betaseron treatment should be based on the clinical circumstances of the individual patient and not solely on the basis of their NAb status."

NAbs are antibodies that may attach themselves to an injected protein drug, such as beta interferon therapy, thereby potentially inhibiting its biological activity. All immunomodulating therapies for MS may cause the development of NAbs in a varying portion of patients, but there is controversy in the medical community about the role NAbs may or may not play in a patient's response to therapy.

"This study reinforces expert recommendations that treatment decisions should be based on a patient's overall response to therapy and not on the actual or potential presence of neutralizing antibiodies," said Da
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