Sanofi 's ( SNY ) subsidiary Genzyme (acquired in April 2011) recently announced encouraging data on its phase III candidate, Lemtrada (alemtuzumab). Results were presented from the phase III CARE-MS II trial, which was conducted in 840 patients with relapsing remitting multiple sclerosis (RRMS).
Lemtrada met both the co-primary endpoints of the randomized phase III study. Results showed that treatment with Lemtrada resulted in a 49% reduction in relapse rate compared to Pfizer/Merck KGaA's ( PFE / MKGAF ) Rebif, over a two year period.
Additionally, Lemtrada showed a 42% reduction in the risk of sustained accumulation (worsening) of disability. The side effects observed in the trial were similar to earlier trials of Lemtrada and manageable in nature. A full analysis of the phase III CARE-MS II trial will be presented at an upcoming scientific meeting.
Sanofi is looking to file for US and EU approval of Lemtrada in the first quarter of 2012. 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). Lemtrada is being developed in collaboration with Bayer HealthCare ( BAYRY ).
We currently have a Neutral recommendation on Sanofi. The stock carries a Zacks #4 Rank (Sell rating) in the short run. We expect 2012 earnings to be hit by the loss of US exclusivity on Plavix and Avapro. While new product launches should make significant revenue contributions in the early part of the decade, we expect Sanofi to continue to contain operating costs in order to grow earnings in the face of weakening sales of some of its biggest products. We also expect the company to look to grow revenue through additional partnering deals and acquisitions. The Genzyme acquisition has not only brought in additional revenues, it has also strengthened Sanofi's pipeline.