Sanofi's Vaccine Gets EU Approval


Sanofi’s (SNY) vaccines division, Sanofi Pasteur, announced that the European Commission (EC) has approved its 6-in-1 pediatric vaccine Hexyon/Hexacima (DTaP-IPV-Hib-HepBvaccine).

The vaccine will be marketed as Hexyon in Western European countries (including France, Germany, and UK among others), while it will be marketed as Hexacima in Eastern European countries.

The 6-in-1 vaccine will prevent diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis and invasive infections caused by haemophilus influenzaetype b in infants.

The approval did not come as a surprise as the European Medicines Agency’s (:EMA) Committee for Medicinal Products for Human Use (CHMP) rendered a positive opinion on Hexyon/Hexacima in Feb 2013.

The approval came on the basis of data from phase III studies, which enrolled approximately 5,000 infants. Hexyon/Hexacima demonstrated encouraging efficacy and safety profile in the trials.

We note that Sanofi possesses one of the world’s leading vaccine operations, with total sales of €3.9 billion in 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.

Sanofi continues to expand its vaccine business. We expect a significant ramp in vaccine sales over the next several years.

Sanofi carries a Zacks Rank #3 (Hold) in the short run. Meanwhile, stocks such as Athersys, Inc. (ATHX), Transcept Pharmaceuticals, Inc. (TSPT) and Osiris Therapeutics, Inc. (OSIR) carry a Zacks Rank #1 (Strong Buy) and are worth considering.

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