Sanofi’s (SNY) Aubagio is currently marketed in the U.S. as a once-daily treatment for patients with relapsing forms of multiple sclerosis. Aubagio is also approved in several other regions including the EU, Australia, Argentina, Chile, South Korea, and Mexico. In the second quarter of 2013, Aubagio generated sales of €33 million compared with €20 million in the first quarter of 2013. We believe that Aubagio possesses significant commercialization opportunity.
The company announced positive data from the two-year, double-blind, multi-center TOPIC (n = 618) study evaluating Aubagio. It was found that the use of Aubagio 14mg resulted in a 35% reduction in the risk of a new clinical relapse or MRI lesion as compared to placebo.
Additionally, the increase in total lesion volume was 5% in the Aubagio 14mg arm as compared to 28% in the placebo arm. However, Aubagio 7mg failed to show statistically significant difference from placebo on certain endpoints.
We note that apart from Aubagio, currently available oral multiple sclerosis therapies include Novartis’ (NVS) Gilenya and Biogen Idec’s (BIIB) Tecfidera. Competition in the oral multiple sclerosis market is intense and Aubagio needs to demonstrate superior efficacy and tolerability to gain share.
Sanofi carries a Zacks Rank #4 (Sell). We are concerned about the generic erosion confronting most of Sanofi’s key drugs. Additionally pipeline failures (oncology candidate — iniparib and anticoagulant — otamixaban) have put immense pressure on Sanofi’s pipeline.
Right now, Allergan Inc. (AGN) looks more attractive in the pharma space with a Zacks Rank #2 (Buy).
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