September 3, 2014
By Jessica Wilson, BioSpace.com Breaking News Staff
Sanofi SA , the Paris-based pharmaceutical company, has announced that the company’s dengue-fever vaccine—the first of its kind in the world—achieved its clinical endpoint in a Phase III efficacy study conducted in five countries, involving more than 20,000 people.
Results include a 60.8% reduction of dengue disease cases in patients aged 9-16 years against all four dengue strains—a significant finding because an earlier trial had indicated efficacy against only three strains. In addition, the study showed an 80.3 percent reduction “in the risk of hospitalization due to dengue.” The study also indicates that the vaccine is most effective in people who have had prior exposure to dengue.
Sanofi has spent more than 1.3 billion Euros ($1.7 billion) and 20 years on this journey. “For the first time ever, after 20 years of research and industrial commitment, dengue is set to become a vaccine-preventable disease,” said Olivier Charmeil, president of the French drugmaker’s Sanofi Pasteur vaccine unit.
Chairman of the Partnership for Dengue Control and professor at Duke-NUS Graduate Medical School, Singapore, Duane Gubler emphasized the landmark status of the study: “These new positive phase III results from Latin America are very encouraging because they are consistent with the results reported in July in the Asian phase III trial. Together, the results of these trials suggest that for the first time, a vaccine solution that can help control dengue, is on the horizon.”
The study was conducted in in Brazil, Colombia, Mexico, Honduras and Puerto Rico. The company will publish the results in a peer-reviewed journal and will present the results at the American Society of Tropical Medicine and Hygiene‘s annual meeting at the beginning of November.
Dengue fever, the fastest growing tropical disease, currently affects at least 100 million people, according to the World Health Organization, although many doctors believe that because the disease is often misdiagnosed, the actual number of people affected could be three times that estimate. Though most people survive the excruciatingly painful disease, nicknamed “breakbone fever” because of that pain, more than 20,000 people do die from the disease, with children the most affected population. Dengue fever can cause flu-like symptoms, as well as bleeding gums, vomiting and severe abdominal pain.
While the company has not commented on pricing or sales estimates, Peter Verdult, an analyst at Citigroup Inc. estimated that the vaccine could net 918 million euros ($1.2 billion) in “peak sales” by 2025. Such numbers would be a significant boon to Sanofi Pasteur, which had sales of 3.7 billion euros in 2013.
Guillaume Leroy, head of Sanofi’s dengue vaccine project, indicated that the company would file for regulatory approval in 2015, focusing first on the countries that hosted the trials.
In July, Chris Viehbacher, CEO of Sanofi, said that Mexico, Brazil and Colombia could be the first to market the vaccine, which will be produced in a plant outside Lyon in the Rhône-Alpes region of France beginning in early 2015 and could be ready for commercialization in the latter half of 2015.
Sanofi is not the only contender in the race to develop a cure for dengue. GlaxoSmithKline plc (GSK), Japan-based Takeda Pharmaceutical Co Ltd (TKPYY), as well as Merck & Co. (MRK) are also developing their own versions of vaccines to treat or prevent the spread of dengue virus.
