Sanofi (SNY - Free Report) and its subsidiary Genzyme recently announced that their oral candidate for relapsing forms of multiple sclerosis (RMS), Aubagio (teriflunomide), has received US Food and Drug Administration (FDA) approval. The FDA approved Aubagio as a once-daily treatment for patients with RMS. Aubagio is currently under regulatory review in the EU.
FDA approval came in on encouraging data from a pivotal phase III study (TEMSO) in patients with RMS. The TEMSO phase III study evaluated Aubagio in two dosage strengths, 7mg and 14mg. Patients in both 7mg and 14mg Aubagio dosage arms demonstrated a 31% reduction in annualized relapse rate compared to placebo. Additionally, the company presented positive results from the phase III TOWER trial, which was conducted on 1,169 patients with RMS.
However, we note that in the TENERE trial, reported in December 2011, Aubagio failed to show statistical superiority over Pfizer/Merck KGaA’s (PFE - Free Report) / Rebif. There are two more studies in progress, namely TOPIC and TERACLES.
Competition in the oral multiple sclerosis market will be intense and Aubagio needs to demonstrate superior efficacy and tolerability to gain share. Novartis’ (NVS - Free Report) 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 - Free Report) BG-12, which is currently under regulatory review in the US and EU.
Another RMS candidate, Lemtrada (alemtuzumab), in Sanofi’s portfolio, suffered a setback last month when the FDA issued a refuse-to-file letter in relation to its marketing application. Though the FDA has not asked for any additional studies, Sanofi will have to rework on the presentation of the data. Sanofi plans to work with the FDA and resubmit the marketing application as early as possible.
A marketing application for Lemtrada for RMS was also filed with the European Medicines Agency (EMA), which has been accepted for regulatory review.
We currently have a Neutral recommendation on Sanofi. The stock carries a Zacks #3 Rank (Hold rating) in the short run.