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SNY's Vaxigrip Filing Accepted in EU

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Sanofi (SNY) recently announced that a decentralized marketing authorization application (MAA) for its quadrivalent flu vaccine, Vaxigrip, has been accepted for review in the EU.

The Vaxigrip quadrivalent formulation contains two strains of influenza A and two strains of influenza B, thus providing it with an edge over the currently available trivalent Vaxigrip version. Vaxigrip trivalent contains two strains of influenza A and one strain of influenza B.

We note that Sanofi’s influenza vaccine portfolio also includes Fluzone. Sanofi is looking to get the quadrivalent formulation of Fluzone approved in the US. To achieve this objective, the company submitted a Supplemental Biologics License Application (sBLA) with the US Food and Drug Administration (:FDA) last year. A final decision from the FDA is expected in the second quarter of 2013.

We note that in the US, AstraZeneca’s (AZN) FluMist Quadrivalent and GlaxoSmithKline (GSK) Fluarix already approved.

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 like what we see in the vaccine pipeline and expect a significant ramp in vaccine sales over the next several years. Sanofi has beefed up its Chinese presence with a new vaccine manufacturing facility in Shenzhen.

Sanofi carries a Zacks Rank #4 (Sell) in the short run. Right now, Allergan Inc. (AGN) looks more attractive in the pharma space with a Zacks Rank #2 (Buy).

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