Bayer Schering Pharma AG says that top-line results from the BEYOND study, a large randomized trial of patients with relapsing-remitting multiple sclerosis, did not show statistically significant superiority for a 500mcg dose of Betaferon (interferon beta-1b) compared to a regimen of 250mcg Betaferon and Copaxone (glatiramer acetate).
The risk for relapses, which was the primary endpoint of the trial, was similar in all three study arms. The trial showed a very low relapse rate in the entire study population, unlike in previous trials, Bayer Schering noted.
According to the firm, results of the BEYOND study do not support the regulatory filing for the 500mcg dose of Betaferon. Consequently, the intangible assets from the BEYOND project, capitalized in the course of Bayer's acquisition of Schering (Marketletters passim), will be depreciated. Therefore, an impairment of 152.0 million euros ($219.2 million) will be recognized in the firm's third-quarter financial report.
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