Sanofi-Aventis (SNY) recently reported mixed data on its phase III multiple sclerosis candidate, Lemtrada (alemtuzumab). Results were presented from the phase III CARE-MS I study, which was conducted in patients with relapsing-remitting multiple sclerosis (RRMS).
Alemtuzumab met the first primary endpoint of the randomized phase III study. Results showed that treatment with two annual cycles of alemtuzumab resulted in a 55% reduction in relapse rate compared to Rebif over the two years of the study. However, alemtuzumab failed to achieve statistical significance for the second primary endpoint – time to six month sustained accumulation of disability, compared to Rebif. Results showed that 8% of patients treated with alemtuzumab had a sustained increase in their Expanded Disability Status Scale (EDSS) score (or worsening) compared to 11% of the patients on Rebif.
Alemtuzumab is being developed in collaboration with Bayer HealthCare (BAYRY). The candidate is currently in another phase III study – CARE-MS II – which is evaluating alemtuzumab against Rebif in relapsing-remitting multiple sclerosis patients who have relapsed while on treatment. Sanofi expects to present top-line data from this study in the fourth quarter of 2011.
Sanofi is looking to file for US and EU approval of alemtuzumab early next year. The candidate, which became a part of Sanofi’s pipeline following its acquisition of Genzyme, enjoys fast track status from the US Food and Drug Administration (FDA).
Neutral on Sanofi
We currently have a Neutral recommendation on Sanofi, which carries a Zacks #3 Rank (short-term “Hold” rating). The company recently completed its acquisition of biotech company Genzyme Corporation. This acquisition will boost Sanofi’s revenues as well as its pipeline.
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