Sanofi’s ( SNY - Analyst Report ) vaccines division, Sanofi Pasteur recently announced that the European Medicines Agency (EMA) has given a positive opinion on its vaccine Hexaxim ((DTaP-IPV-Hib-HepB vaccine). The positive opinion was issued by the EMA as part of a procedure to evaluate products for marketing outside EU. This was the first time the EMA issued a positive scientific opinion to a vaccine under the procedure.

The EMA issued the positive opinion for approving the fully liquid Hexaxim vaccine for the protecting infants against six diseases caused by Haemophilus influenzae type b, namely: diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis and invasive infections.

Hexaxim, by targeting six diseases at the same time, reduces the number of vaccinations required by infants thereby facilitating better comfort and compliance.

The EMA’s positive opinion was based on safety and efficacy data from trials involving approximately 4,000 infants across Argentina, Peru, Mexico, South Africa, and Thailand. Hexaxim demonstrated impressive immune response against all the six targeted diseases in the phase III studies. Additionally, the vaccine was found to be safe.

Sanofi possesses one of the world’s leading vaccine operations, with total vaccines sales of €617 million in the first quarter of 2012. The company’s portfolio includes pediatric vaccines, influenza vaccines, adult and adolescent booster vaccines, meningitis vaccines, and travel and endemic vaccines. Sanofi also has a strong position in both seasonal and pre-pandemic influenza vaccines.

Our Recommendation

We are pleased with the company’s efforts to develop its pipeline. We expect Sanofi to continue to contain operating costs in order to increase earnings in the face of weakening sales of some of its key drugs. We also expect the company to pursue bolt on acquisitions.

We currently have a Neutral recommendation on Sanofi. The stock carries a Zacks #3 Rank (Hold rating) in the short run.