Sanofi’s (SNY) subsidiary, Genzyme, recently announced that it has filed marketing applications for Lemtrada (alemtuzumab) for the treatment of relapsing multiple sclerosis (RMS) in both the EU and the US. The company has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) and a marketing authorization application (MAA) to the European Medicines Agency (EMA).
Lemtrada demonstrated efficacy and safety in two phase III trials, which were completed in 2011. In the first study, CARE-MS I, Lemtrada met the first primary endpoint. Results showed that treatment with two annual cycles of Lemtrada resulted in a 55% reduction in relapse rate compared to Pfizer/Merck KGaA’s (PFE/MKGAF) Rebif over the two-year span of the study. However, Lemtrada failed to achieve statistical significance for the second primary endpoint. Results showed that 8% of patients treated with Lemtrada had a sustained increase in their Expanded Disability Status Scale (EDSS) score (or worsening) compared to 11% of the patients on Rebif.
In the second study, CARE-MS II, Lemtrada met both the primary endpoints. Results showed that treatment with Lemtrada resulted in a 49% reduction in relapse rate compared to Rebif, over a two-year period. Additionally, Lemtrada showed a 42% reduction in the risk of sustained accumulation (worsening) of disability.
Lemtrada is being developed in collaboration with Bayer HealthCare (BAYRY).
Sanofi’s pipeline also includes Aubagio (teriflunomide), another RMS drug. Aubagio is under regulatory review in both the US and the EU. Earlier this month, the company reported positive top-line results from a last-stage trial of Aubagio.
We are pleased with the company’s efforts to develop its pipeline. We expect Sanofi to continue to contain operating costs in order to increase earnings in the face of weakening sales of some of its biggest products. We also expect the company to pursue bolt on acquisitions.
We currently have a Neutral recommendation on Sanofi. The stock carries a Zacks #3 Rank (Hold rating) in the short run.
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