Sanofi's ( SNY">SNY ) subsidiary,Genzyme , recently announced disappointing top-line results of its phase III candidate,Aubagio (teriflunomide ). Results were presented from the phase IIITENERE trial, which was conducted on 324 patients with relapsing forms of multiple sclerosis (RMS ).
Aubagio failed to show statistical superiority over Pfizer/MerckKGaA's ( PFE">PFE / MKGAF">MKGAF )Rebif . Results showed that 48.6% and 37.8% of patients receiving7mg and14mg ofAubagio respectively achieved the primary endpoint as compared to 42.3% of patients receivingRebif , over a two-year period.
However, both doses ofAubagio were found to be safe and well tolerated.Sanofi plans to present detailed data from the phase IIITENERE trial at an upcoming medical meeting.
TENERE is the second completed study evaluating the efficacy ofAubagio inRMS patients. In October 2010,Sanofi had announced positive results onAubagio from a pivotal phase III study (TEMSO ) in patients withRMS . There are three more studies in progress, namely TOWER, TOPIC andTERACLES which makes the program one of the largest and broadest amongst any oral multiple sclerosis agent under development.
Competition in the oral MS market will be intense andAubagio needs to demonstrate superior efficacy and tolerability to gain share. Novartis' ( NVS">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">BIIB ) BG-12, which has shown encouraging data so far.
In such a scenario and given theTENERE data,Aubagio , if approved, will most likely generate modest sales.Aubagio is currently under regulatory review in the US with the EU filing slated for the first quarter of 2012. We currently have a Neutral recommendation onSanofi . The stock carries aZacks #3 Rank (Hold rating) in the short run.
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