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The World's First, Large-Scale Dengue Vaccine Efficacy Study Successfully Achieved Its Primary Clinical Endpoint

 
  • First available data demonstrated a 56% reduction of dengue disease cases in a study of more than 10,000 volunteers from Asia  
  • Initial safety data are consistent with the good safety profile observed in previous studies

               LYON, France, April 28, 2014 (GLOBE NEWSWIRE) -- Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), today announced that the first of two pivotal Phase III efficacy studies with its dengue vaccine candidate has achieved its primary clinical endpoint. The efficacy study showed a significant reduction of 56% of dengue disease cases. Initial safety data are consistent with the good safety profile observed in previous studies. Full analysis of the data will be undertaken in the coming weeks and reviewed by external experts prior to disclosure at an upcoming international scientific congress and publication in a peer-reviewed journal later this year.

Dengue is a threat to nearly half the world's population 1, 2 and is a pressing public health priority in many countries in Asia and Latin America where epidemics occur. The annual incidence rate of 4.7% observed in the control group demonstrates the very high burden of disease in Asia.   "This achievement is the result of more than 20 years of work in the field of dengue, collaborating with investigators, volunteers, authorities, scientific experts and international organizations," said Olivier Charmeil, President and CEO of Sanofi Pasteur . "Developing a dengue vaccine for the benefit of children and their parents is at the heart of our mission. Our goal is to make dengue the next vaccine-preventable disease and to support the WHO's ambition to reduce dengue mortality by 50% and morbidity by 25% by 2020."

"This is the first time ever a dengue vaccine successfully completed a Phase III efficacy study," said Dr. Capeding, principal investigator, Research Institute for Tropical Medicine, the Philippines . "These significant clinical results, associated with the good safety profile of the vaccine, bring real hope to more than 100 million people affected each year by dengue, a disease without any specific treatment today."  

The results of this first, large-scale efficacy study will be further complemented by results in Q3 2014 from a second, large-scale study currently conducted in Latin America, including more than 20,000 volunteers from Brazil, Colombia, Honduras, Mexico and Puerto Rico.

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