Sanofi (SNY) and its subsidiary Genzyme recently presented positive data on its oral treatment for relapsing forms of multiple sclerosis (RMS), Aubagio (teriflunomide). The company presented data from the phase III TOWER trial at the 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
The phase III TOWER trial, conducted on RMS 1,169 patients, evaluated Aubagio in two dosage strengths, 7mg and 14mg. Patients in the 14mg dosage Aubagio arm demonstrated a 36.3% reduction in annualized relapse rate compared to placebo. The reduction was statistically significant. Additionally, a 31.5% reduction in the risk of 12-week sustained accumulation of disability was also observed.
Meanwhile, patients in the 7mg dosage Aubagio arm demonstrated a 22.3% reduction in annualized relapse rate compared to placebo. However, the reduction in the risk of 12-week sustained accumulation of disability was not statistically significant.
On September 12, 2012, the US Food and Drug Administration (FDA) approved Aubagio as a once-daily treatment for patients with RMS. Aubagio is currently under regulatory review in the EU with a final decision expected in the first quarter of 2013.
Competition in the oral multiple sclerosis market is intense. Novartis’ (NVS) Gilenya already has a lead in the oral MS market with the product being approved in September 2010. Another major competitor could be Biogen Idec’s (BIIB) BG-12, which is currently under regulatory review in the US and EU.
Our Recommendation
We currently have a Neutral recommendation on Sanofi. 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.
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