Sanofi (SNY) recently announced encouraging top-line data from a trial evaluating Fluzone high-dose vaccine for the prevention of influenza in people aged 65 years and older. The company plans to submit full data from the study to the U.S. Food and Drug Administration (FDA) for modification of the Fluzone High-Dose vaccine label to include the promising data in early 2014.
In the large scale, multi center, efficacy trial, it was found that Fluzone high-dose vaccine was 24.2% more effective in prevention of influenza in people aged 65 years or older than Fluzone vaccine (at the standard dose). The trial met the primary objective.
We remind investors that, in Jun 2013, the FDA had cleared Sanofi’s quadrivalent formulation of Fluzone. The four-strain influenza vaccine is approved for treating children above six months in addition to adolescents and adults.
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 #4 (Sell). We are concerned about generic erosion confronting most of Sanofi’s key drugs. Additionally, recent pipeline failures (oncology candidate iniparib and anticoagulant otamixaban) have put immense pressure on Sanofi’s pipeline.
At present, companies like Actelion Ltd. (ALIOF), Biogen Idec (BIIB) and Gilead Sciences, Inc. (GILD) look well-positioned with all three being Zacks Rank #1 (Strong Buy) stocks.
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