Pipeline updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.
Earlier this week, Sanofi’s (SNY) subsidiary, Genzyme, announced positive interim data on its multiple sclerosis (MS) candidate, Lemtrada (alemtuzumab), from the second year of an extension study.
The extension study enrolled more than 90% of the MS patients who received Lemtrada in either of the phase III CARE-MS I and CARE-MS II studies.
The interim results from the second year of the extension study showed that 74% of the patients from CARE-MS I and 66% of patients from CARE-MS II experienced improved or stable disability as measured by the Expanded Disability Status Scale (EDSS), for the additional two years beyond the two-year pivotal MS studies. Moreover, nearly 70% of the patients treated with Lemtrada in the pivotal studies did not receive a third course of treatment in the third and fourth year.
Sanofi presented the data at the European Committee for Research and Treatment in Multiple Sclerosis (ECTRIMS) meeting.
We remind investors that Sanofi’s resubmitted supplemental Biologics License Application (sBLA) for Lemtrada (treatment of relapsing forms of multiple sclerosis) was accepted for review by the FDA in May this year. The company expects a response in the fourth quarter of 2014.
We note that Bayer (BAYRY) has an agreement with Sanofi to co-promote Lemtrada in the U.S. However, Sanofi holds worldwide rights to the development and commercialization of Lemtrada for MS.
Lemtrada is already approved in the EU, Canada and Australia among others. Sanofi has another drug in its MS portfolio – Aubagio.
While we are pleased with Sanofi’s efforts to develop its MS pipeline, we note that once approved, Lemtrada will be entering a market largely dominated by players like Biogen (BIIB).
Sanofi holds a Zacks Rank #4 (Sell). A better-ranked stock in the health care sector is Allergan Inc. (AGN) carrying a Zacks Rank #1 (Strong Buy).
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