) and its subsidiary Genzyme recently announced that their oral
candidate for relapsing forms of multiple sclerosis (RMS),
Aubagio (teriflunomide) 14 mg, has received Australian
Therapeutic Goods Administration (TGA) approval. The TGA approved
Aubagio as a once-daily treatment for patients with RMS.
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We note that Australia is the second country where Aubagio
received approval. 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.
The Australian approval came on the basis of data from a pivotal
phase III study (TEMSO) in patients with RMS. In the trial,
Aubagio demonstrated promising efficacy and safety profile.
Competition in the oral multiple sclerosis (MS) market is
) Gilenya already has a lead in the oral MS market with the
product being approved in September 2010. Another major
competitor could be
) BG-12, which is currently under regulatory review in the US and
We are pleased with Sanofi's progress with its pipeline. Over the
last few months, several of Sanofi's pipeline candidates gained
approval including US approval of Aubagio for RMS and US approval
of Zaltrap (aflibercept) as a combination therapy for
treatment-experienced patients suffering from metastatic
colorectal cancer. Recently, the CHMP also recommended the
approval of Zaltrap and diabetes candidate, Lyxumia
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