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Sanofi Pasteur Initiates Phase II Trial of Cell Culture-Based Seasonal Influenza Vaccine
Date:11/7/2007

SWIFTWATER, Pa., and LYON, France, Nov. 7 /PRNewswire-FirstCall/ -- Sanofi Pasteur, the vaccines division of sanofi-aventis Group, announced today that it has initiated Phase II testing of its cell culture-based seasonal influenza vaccine in the U.S.

The initiation of Phase I was announced on Sept 25, 2006. This project is part of a contract awarded in 2005 by the U.S. Department of Health and Human Services (HHS) aimed at accelerating the development of a new cell culture- based influenza vaccine. Phase II trials involving healthy adult volunteers in the U.S. will focus further on the safety profile and immunogenicity of the cell-based vaccine.

This vaccine was developed using the PER.C6(R) cell line, licensed from Dutch biotechnology company, Crucell N.V. PER.C6 Cell technology offers Sanofi Pasteur a promising and reliable production method for seasonal and pandemic influenza vaccines in addition to traditional, proven egg-based production. The production scale potential of the PER.C6 cell line has been demonstrated in a successful bioreactor run of 20,000 liters, suggesting robustness of PER.C6 technology and further showing that this may be a suitable cell line for large-scale manufacturing of its influenza vaccine. This scale-up process was achieved under a subcontracting agreement between Sanofi Pasteur and Lonza Biologics plc (Lonza Group).

As the world leader in the research, development and manufacture of influenza vaccines, Sanofi Pasteur is actively involved in other projects in the U.S. and Europe with the goal of developing new influenza vaccines.

Seasonal Influenza Overview

Influenza is a highly infectious virus that spreads easily from person to person, primarily when an infected individual coughs or sneezes. According to the World Health Organization (WHO), 5-15% of the population is affected with upper respiratory tract infections in annual influenza epidemics. Hospitalization and deaths mainly occur in high-ris
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