After more than 20 years of development, Sanofi ($SNY) finally has some Phase III data for its dengue vaccine, and it's data the French company likes. The first of two Phase III studies hit its primary clinical endpoint, the company said Monday, which should push it closer toward making the candidate--and its blockbuster aspirations--a reality.
|Sanofi Pasteur CEO Olivier Charmeil--Courtesy of Sanofi|
In a trial involving more than 10,000 children in Southeast Asia, the shot reduced the incidence of dengue by 56%, with initial safety data matching the jab's good track record in previous studies. Results from the other Phase III study, which includes more than 20,000 volunteers throughout Central and South America, will complement this data come Q3 of this year, the company said.
As Sanofi Pasteur CEO Olivier Charmeil noted in a statement, the success is the result of more than two decades of work in the field, including collaborations with investigators, volunteers, authorities, scientific experts and international organizations. The drugmaker has some recent stumbles in the rearview mirror, with a September 2012 study showing just 30% overall efficacy against dengue fever type 2, one of four virus types the vaccine is meant to ward off.
But if the positive results continue to roll in, the payoff will be worth the company's efforts. The often deadly tropical virus, which affects up to 100 million people per year, currently lacks a vaccine to help defend against it. And if Sanofi gets to market first, analysts see $1.4 billion a year in peak sales in the vaccine's future.
"This is the first time ever a dengue vaccine successfully completed a Phase III efficacy study," Dr. Rozario Capeding, the principal investigator at the Philippines' Research Institute for Tropical Medicine, said in a statement. "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."
- read the release (PDF)