After the company's largest investment ever in the development of a vaccine, Sanofi Pasteur's dengue vaccine launch is set for this year, and it'll be closely watched as the group introduces the jab in a manner reversed from traditional launches.
Sanofi, which has in the past first launched vaccines in the U.S. and Europe, won't be able to recoup its investment through traditional routes, dengue head Guillaume Leroy told an audience at the World Vaccines Congress on Wednesday. Instead, the company is "flipping the model" to favor wide access.
Sanofi will first look to highly endemic, middle-income countries. And rather than first filing regulatory submissions in the U.S. and Europe, he said that the company is ready to submit in the first half of this year in dengue-stricken nations.
"We are, finally, after 20 years of research and additional commitment, set to make dengue the next vaccine-preventable disease," he said. "We still have a lot of work to do."
Sanofi has spent 20 years and €1.5 billion on the candidate's development, and, in anticipation of the launch, spent €300 million on a manufacturing facility in 2009 in Neuville-sur-Saône, France. Leroy said the manufacturing capacity there is 100 million vaccines annually, expected to start in early 2016.
In November, Sanofi Pasteur reported that its candidate--set to be the first dengue vaccine in the world--showed 95% efficacy against dengue hemorrhagic fever and an 80.3% reduction in the risk of hospitalization. Those data supported an 88.5% cut in hemorrhagic fever and a 88.5% hospitalization reduction the shot put up in a study of 10,275 children across Asia.
Sanofi isn't alone, though, in working on a dengue candidate. In August last year, analysts predicted that Takada's DENVax dengue prospect would be battling for a $330 million market by 2020, with regulatory approval expected late next year. The jab could feature a more convenient dosing schedule and competitive pricing strategy, helping it cut down Sanofi's first-to-market advantage. Competitors Merck and GlaxoSmithKline are further off with their candidates.
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