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Sanofi Pasteur and Statens Serum Institut Team Up Against Tuberculosis

Thursday, February 14, 2008 General News
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LYON, France, February 14 Sanofi pasteur, thevaccines division of the sanofi-aventis Group, announced today that it hassigned a collaborative research and license agreement with the Statens SerumInstitut of Denmark (SSI) for the development and marketing of a new vaccineagainst tuberculosis (TB), a disease that causes the death of two millionpeople, worldwide, each year.
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Under the terms of the agreement, SSI has granted sanofi pasteur alicense to its technology with regard to the use of certain fusion proteinsin the development of a tuberculosis vaccine. The license from SSI includesaccess to the Intercell IC31(R) adjuvant. If the development is successful,sanofi pasteur would manufacture the vaccine commercially.
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SSI TB vaccine candidates are recombinant protein sub-units, includingone currently in a Phase I clinical trial. Results from a previous studyshowed the SSI TB vaccine technology to provide a positive immune response.Sanofi pasteur intends to build on the successes of the SSI vaccine program.

"This agreement is a milestone for sanofi pasteur," said Wayne Pisano,President and Chief Executive Officer of sanofi pasteur, which is alsoworking to develop a vaccine against another one of the biggest globalinfectious disease killers--malaria.

"The current medical arsenal is inadequate for fighting tuberculosis,"Pisano continued. "Improved vaccines are desperately needed if we are tosucceed in controlling this disease. Sanofi pasteur and SSI are joiningforces to develop a vaccine that may have a major impact on global health bypreventing a disease that currently infects one person in the world everysecond."(1)

According to SSI's CEO, Nils Strandberg Pedersen, M.D., this agreement isa very important step in the fight against tuberculosis and for SSI. "SSI isone of the world's leading producers of BCG and has for more than a centuryworked within the field of prevention and control of TB. We are excited toteam up our research with one of the world's largest vaccine manufacturers.The combination of both parties' leading vaccine expertise will really beable to make a difference in the development of a novel TB vaccine for thebenefit of the world's poorest people."

The only TB vaccine (BCG--attenuated Bacille Calmette Guerin) used in theworld today was developed over 80 years ago. A TB vaccine is especiallyimportant in areas of the world where TB is highly prevalent and the chancesof an infant or young child becoming exposed to an infectious case are high.Although BCG is effective in protecting infants against childhood forms ofthe disease, a more effective vaccine is needed for protection of adolescentsand adults against pulmonary tuberculosis.

Professor Paul-Henri Lambert of the Centre of Vaccinology, University ofGeneva, and Chairman of the TBVAC consortium steering committee, agrees thatto effectively control TB, a new or improved vaccine must be developed as analternative to or a complement of BCG. "The development of an improved TBvaccine has been a challenging goal for decades, but significant scientificadvances have been made over the past 15 years that bring us closer than everbefore to achieving this goal," explains Dr. Lambert. "Results obtained withrecombinant protein TB vaccine candidates in pre-clinical studies arepromising, and I am very optimistic about this approach leading to a new TBvaccine."

About Tuberculosis(2)

More than eight million people develop active TB annually, andapproximately two million die from the disease each year. The World HealthOrganization estimates that there are more than 14 million people living withTB. Those with active TB who receive no treatment can infect an average of 10to 15 people annually.

Most TB cases occur in Southeast Asia and Africa. One-third of the numberof new TB cases occurs in Southeast Asia, but the estimated incidence perca
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