Sanofi Pasteur's AH1N1 Vaccine HUMENZA

Sanofi Pasteur’s A(H1N1) Vaccine HUMENZA®* Recommended by European Medicines Agency

Lyon, France - February 19, 2010 - Sanofi Pasteur, the vaccines division of sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced today that its adjuvanted A(H1N1) monovalent influenza vaccine, Humenza®, has received a positive opinion from Europe’s Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA).
 
The CHMP is recommending the marketing authorization of Humenza® vaccine in European Union countries for the active immunization of persons 6 months of age and older against influenza disease caused by the pandemic A(H1N1) 2009 virus.

The positive opinion granted today to Humenza® vaccine through the European centralized marketing authorization application process was based on a review of results from clinical trials on Sanofi Pasteur’s A(H1N1) AF03-adjuvanted influenza vaccine candidate. These trials--conducted in healthy children (6 months to 17 years of age), adults and the elderly--evaluated the safety of Humenza® vaccine and its ability to elicit a sero-protective immune response to the A(H1N1) pandemic strain now circulating.
 
Humenza® vaccine’s safety profile is satisfactory in all age-groups in the studies and similar to that of adjuvanted pandemic influenza vaccines already licensed. In all age-groups--children 6 months to 17 years of age, adults and the elderly--immune response measurements showed that a single dose of Humenza® influenza A(H1N1) monovalent vaccine induced a high antibody response 21 days post-vaccination that meets the three EMA immunological criteria and is considered sero-protective.

As the world leader in research, development and manufacturing of influenza vaccines,
Sanofi Pasteur is committed to a three-pronged public-health mission: to produce and deliver the southern hemisphere seasonal influenza vaccine, to produce the northern hemisphere seasonal influenza vaccine for later in 2010 and to work with the world’s health authorities to safeguard human health during the current pandemic and to prepare for any future threats. Sanofi Pasteur is working diligently on all fronts.