Sanofi's Fluzone Quadrivalent Gets FDA Nod

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Sanofi (SNY) recently announced that the US Food and Drug Administration (:FDA) has cleared its quadrivalent formulation of Fluzone. The four-strain influenza vaccine has been approved for treating children above six months in addition to adolescents and adults.

Sanofi expects Fluzone Quadrivalent to be available in the US for the influenza season 2013-2014. The intramuscular vaccine will be available in pre-filled syringes and single-dose vials.

We remind investors that AstraZeneca’s (AZN) intranasal influenza vaccine FluMist Quadrivalent and GlaxoSmithKline’s (GSK) intramuscular vaccine Fluarix Quadrivalent are already approved in the US. While, FluMist Quadrivalent can be used in people in the age group of 2 – 49 years, Fluarix Quadrivalent is recommended for adults and children aged 3 years and above.

We believe Fluzone Quadrivalent targeting children above six months will give Sanofi an edge over other vaccines and help the company to capture market share.

We note that Sanofi possesses one of the world’s leading vaccine operations, with total sales of €697 million in the first quarter of 2013, up 15.9% from the year ago quarter. 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 carries a Zacks Rank #3 (Hold). We remain concerned about the generic erosion confronting most of Sanofi’s key drugs including Plavix, Avapro, Lovenox, Taxotere, Eloxatin and Xatral. The genericization of Avapro and Plavix is expected to negatively impact Sanofi’s business net income by around €800 million in the first half of 2013.

Sanofi is looking to combat headwinds by containing operating costs. Additionally, new product launches should make significant revenue contributions in the upcoming quarters.

Companies that currently look attractive include Novo Nordisk (NVO), carrying a Zacks Rank #2 (Buy).

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