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The initiation of Phase I was announced on Sept 25, 2006. This project ispart of a contract awarded in 2005 by the U.S. Department of Health and HumanServices (HHS) aimed at accelerating the development of a new cell culture-based influenza vaccine. Phase II trials involving healthy adult volunteers inthe U.S. will focus further on the safety profile and immunogenicity of thecell-based vaccine.
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This vaccine was developed using the PER.C6(R) cell line, licensed fromDutch biotechnology company, Crucell N.V. PER.C6 Cell technology offers SanofiPasteur a promising and reliable production method for seasonal and pandemicinfluenza vaccines in addition to traditional, proven egg-based production.The production scale potential of the PER.C6 cell line has been demonstratedin a successful bioreactor run of 20,000 liters, suggesting robustness ofPER.C6 technology and further showing that this may be a suitable cell linefor large-scale manufacturing of its influenza vaccine. This scale-up processwas achieved under a subcontracting agreement between Sanofi Pasteur and LonzaBiologics plc (Lonza Group).
As the world leader in the research, development and manufacture ofinfluenza vaccines, Sanofi Pasteur is actively involved in other projects inthe 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 toperson, primarily when an infected individual coughs or sneezes. According tothe World Health Organization (WHO), 5-15% of the population is affected withupper respiratory tract infections in annual influenza epidemics.Hospitalization and deaths mainly occur in high-risk groups (elderly, peoplewith chronic conditions/illness). Although difficult to assess, these annualepidemics are thought to result in between three and five million cases ofsevere illness and between 300 000 and 500 000 deaths every year around theworld(1). Most deaths currently associated with influenza in industrializedcountries occur among the elderly over 65 years of age.
About Lonza Group
Lonza Biologics plc, is a biotechnology contract manufacturer andbiologics service provider, which is a business sector of the Lonza Group, achemical and biotechnology company driven by the life sciences. Lonza isheadquartered in Basel, Switzerland, and is listed on the SWX Swiss Exchange.In 2006, Lonza had sales of CHF 2.91 billion. Further information can be foundat www.lonza.com.
About Crucell
Crucell N.V. is a Dutch biotechnology company (Euronext, Nasdaq: CRXL;Swiss Exchange: CRX) focused on research, development and worldwide marketingof vaccines and antibodies that prevent and treat infectious diseases.Crucell's vaccines are sold in public and private markets worldwide. Thecompany licenses its PER.C6(R) production technology and other technologies tothe biopharmaceutical industry. Crucell is headquartered in Leiden (TheNetherlands) and employs over a 1000 people. For more information, pleasevisit www.crucell.com.
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers,develops and distributes therapeutic solutions to improve the lives ofeveryone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York(NYSE: SNY).
Sanofi Pasteur, the vaccines division of sanofi-aventis Group, providedmore than a billion doses of vaccine in 2006, making it possible to immunizemore than 500 million people across the globe. A world leader in the vaccineindustry, Sanofi Pasteur offers the broadest range of vaccines protectingagainst 20 infectious diseases. The Company
