Bayer AG - Stockholders' Newsletter Third Quarter 2007 - Study results do not support regulatory filing for Betaferon® 500 mcg

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Study results do not support regulatory filing for Betaferon® 500 mcg

Berlin. Bayer Schering Pharma recently announced top-line results from the BEYOND study, a large randomized trial of patients with relapsing-remitting multiple sclerosis (MS) to investigate the efficacy, tolerability and safety of a 500 mcg dose of Betaferon®/Betaseron® (interferon beta-1b) compared to the standard 250 mcg Betaferon® dose and Copaxone® (glatiramer acetate). The overall outcome of the trial did not show a statistically significant superiority of the 500 mcg Betaferon® dose compared to the 250 mcg Betaferon® dose and Copaxone®. The risk for relapses was similar in all three study arms. In this study, there was a very low relapse rate in the entire study population, unlike in previous trials. The standard 250 mcg dose was shown to be highly effective and well tolerated. Results of the BEYOND study do not support a regulatory filing for the 500 mcg dose of Betaferon® (see also Performance Bayer HealthCare).

The data from the Betaferon® clinical studies, combined with development supporting potential new therapies, demonstrate Bayer Schering Pharma’s long-standing commitment to advancing the treatment of MS patients with new, highly effective and safe therapies.