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.
Our Take
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.
BIOGEN IDEC INC (
BIIB
): Free Stock Analysis Report
NOVARTIS AG-ADR (
NVS
): Free Stock Analysis Report
PFIZER INC (
PFE
): Free Stock Analysis Report
SANOFI-AVENTIS (
SNY
): Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment
Research