Sanofi (SNY - Free Report) 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.
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 intense. 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.
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 (lixisenatide).
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.