Sanofi’s (SNY) subsidiary, Genzyme, recently announced interim data on its multiple sclerosis (MS) candidate, Lemtrada (alemtuzumab), from the first year of an extension study. Lemtrada is currently under regulatory review in both the US and the EU for the treatment of MS. Sanofi expects a final decision on Lemtrada by both the European Medicines Agency (:EMA) and the US Food and Drug Administration (:FDA) by the end of this year.
The extension study enrolled patients from two pivotal 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 the 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 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 the 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
The extension study enrolled more than 90% of the MS patients who received Lemtrada in the phase III pivotal studies. The interim results from the first year of the extension study demonstrated that 67% of the patients from CARE-MS I study and 55% patients from CARE-MS II study were relapse-free in the first year.
We are pleased with Sanofi’s efforts to develop its pipeline, which should fetch significant revenue contributions upon approval. We believe that the pipeline at Sanofi must deliver, since many of its drugs are facing generic competition.
Sanofi carries a Zacks Rank #3 (Hold) in the short run. However, other large cap pharma stocks such as Novo Nordisk (NVO) currently look more attractive with a Zacks Rank #2 (Buy).
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