In the CARE-MS I trial, 2 annual cycles of alemtuzumab treatment resulted in a 55 percent reduction in relapse rate compared to Rebif® over the two years of the study (p<0.0001), hence satisfying the first primary endpoint, and therefore meeting the predefined protocol criteria for declaring the study a success. Statistical significance was not achieved for the second primary endpoint, time to six month sustained accumulation of disability, as compared to Rebif®. At the two year time point, 8 percent of alemtuzumab treated patients had a sustained increase in their Expanded Disability Status Scale (EDSS) score (or worsening) as compared to 11 percent of those who received Rebif® (Hazard Ratio=0.70, p=0.22).
CARE-MS I, the trial described above, was in first-line RRMS. A companion phase-3 study called CARE-MS II in second-line RRMS is expected to report results in 4Q11.
Lemtrada (a/k/a Campath) is the drug that created the difference of opinion with respect to valuation in SNY’s acquisition of GENZ that was resolved via contingent-value rights (#msg-59975091). The contingent-value rights trade on Nasdaq under the ticker GCVRZ; it will be interesting to see how this security trades today.
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