Sanofi SA’s dengue vaccine has succeeded in reaching its primary clinical endpoint in a Phase-III study; stock up 1.17% during early hours of trading
French Pharmaceutical Company Sanofi SA (ADR) (SNY) revealed today that its vaccine for the dengue virus had reached its primary end point in a Phase-III efficacy study. The trial included 10,000 volunteers from Asia, a region where the disease is widespread. Latin America is another region with a high incidence of the disease.
If the remaining trials of the vaccine meet set requirements, Sanofi could well become the first pharmaceutical to come out with a vaccine to combat a virus that affects around 100 million people each year, according to the World Health Organization (WHO).
The virus spreads via mosquitos, especially those that can breed in clean water. It causes high fever along with severe joint pain in affected individuals, and is especially dangerous for children since it is accompanied by immensely painful and sometimes fatal symptoms.
Results from the study showed a 56% reduction in the virus in patients administered Sanofi’s treatment – a significant improvement compared to safety profiles from prior studies.
Sanofi has been developing the vaccine for the past 20 years. The current study attracted over 40,000 volunteers for all three phases of the study. Phase-III of the study was conducted in several countries and included children aged two to 14 years. It began in 2011 and continued till 2013.
Volunteers for the study were divided into two groups. Those administered the vaccine received three injections over a six-month period, while a placebo group was given dosages also spanning a six-month period. To study the success of the vaccine, the company looked at the number of symptomatic virologically-confirmed dengue cases caused by any serotype
The vaccine, if successfully commercialized, has the potential to become a blockbuster drug, given the number of patients that are diagnosed with the virus each year. This makes it Sanofi’s most prized pipeline product. The company has been facing generic competition for its other vaccines, and its consolidated sales have declined 5.7% year-over-year.
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