Sanofi Reveals Cerdelga Data, FDA OK’s Quadracel Vaccine

Sanofi’s SNY subsidiary, Genzyme, announced the publication of data from a phase III study (ENCORE) on Cerdelga in The Lancet.

The randomized, open-label, non-inferiority phase III study was conducted to evaluate whether patients suffering from Gaucher disease type I who have been stabilized after receiving 3 or more years of enzyme replacement therapy (ERT) infusions would continue to remain stable after switching to Cerdelga. In the study, patients were given either oral Cerdelga or ERT with Cerezyme (Sanofi’s Gaucher disease drug) over a period of 12 months.

Results revealed that 85% of patients on Cerdelga and 94% of patients on Cerezyme maintained stability in spleen volume, hemoglobin level, liver volume and platelet count after 12 weeks of treatment, thereby meeting the primary efficacy endpoint of the study.

We remind investors that Cerdelga is already approved both in the U.S. (Aug 2014) and EU (Jan 2015) for the first-line oral therapy in certain adult patients (who are CYP2D6 poor metabolizers, intermediate metabolizers or extensive metabolizers) suffering from Gaucher disease type I.

Sanofi Gains FDA Nod for Immunization Vaccine Quadracel

In a separate press release, Sanofi’s vaccines division, Sanofi Pasteur, announced that the FDA has approved Quadracel (diphtheria and tetanus toxoids and acellular pertussis absorbed and inactivated poliovirus; DTaP-IPV) for active immunization against diphtheria, tetanus, pertussis and poliomyelitis in children aged 4-6 years.

We note that Sanofi’s Human Vaccines (Vaccines) segment generated revenues of €3.97 billion in 2014. The company’s portfolio includes pediatric vaccines, influenza vaccines, adult and adolescent booster vaccines, meningitis vaccines, and travel and endemic vaccines. The company intends to launch five vaccines by 2020. We expect a significant ramp in vaccine sales over the next several years.

Sanofi carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector include Acorda Therapeutics, Inc. ACOR, Cytokinetics, Inc. CYTK and Novo Nordisk NVO. While Acorda and Cytokinetics are Zacks Rank #1 (Strong Buy) stocks, Novo Nordisk holds a Zacks Rank #2 (Buy).

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