Sanofi ( SNY ) recently provided an update on its pipeline. Sanofi boasts of a robust pipeline with 65 new molecular entities and vaccines in clinical development, of which 17 are in phase III development or under regulatory review.
We note that several of Sanofi's candidates will be up for approval in the coming quarters. The French pharma giant expects regulatory decision in the EU on Zaltrap (aflibercept) for second-line metastatic colorectal cancer and Lyxumia (lixisenatide) for type II diabetes in the first quarter of 2013. The US Food and Drug Administration (FDA) is also expected to render a final decision regarding acceptance of Lyxumia's new drug application (NDA) in the first quarter of 2013.
Sanofi expects the FDA to give a final decision on its candidate, Kynamro (mipomersen) for treating patients suffering from homozygous familial hypercholesterolemia, by January 29, 2013.
The company expects an opinion from the Committee for Medicinal Products for Human Use (CHMP) on Aubagio (teriflunomide) for treating patients suffering from relapsing multiple sclerosis (MS) in the first quarter of 2013. The CHMP is expected to issue its opinion regarding the EU approval of another MS candidate in Sanofi's pipeline, Lemtrada (alemtuzumab), in the second quarter of 2013.
Turning to the vaccine pipeline, the FDA is expected to decide on the intramuscular quadrivalent formulation of Fluzone in the second quarter of 2013. Moreover, the CHMP is expected to render its opinion on pediatric hexavalent vaccine in the first quarter of 2013.
Another vaccine for the prevention of primary symptomatic clostridium
difficile infections (CDI) is expected to move into phase III studies in the third quarter of 2013.
Sanofi also expects data from several phase III studies during the course of the year.
Overall, we are pleased with Sanofi's efforts to develop its pipeline, which should make significant revenue contributions upon approval. However, we note that Sanofi's biggest challenge is the generic threat that is faced by several of its products.
We currently have a Neutral recommendation on Sanofi. The stock carries a Zacks Rank #2 (Buy) in the short run.