Sanofi's ($SNY) dengue vaccine is not yet approved, and a trial of the med last year failed to hit its efficacy goal. Still, the French drugmaker is believed to have the lead candidate in the race for the badly needed vaccine and is making it known that it has started up production so it can have the potential blockbuster ready to go, assuming it gets approval in the next two years.
"Production time is rather long, it takes two years to produce this vaccine," Reuters said Anthony Quin told reporters as a way of explaining why it is starting now. Quin heads Sanofi Pasteur's manufacturing site in Neuville-sur-Saone, France, a facility in which the French drugmaker has invested €300 million ($391 million) in preparation for getting a drug to market.
A vaccine for dengue is a huge prize for patients--and the company that develops it. Reuters, citing World Health Organization (WHO) figures, said dengue is the world's fastest-spreading tropical disease and is believed to pose the potential for pandemic. But the condition is caused by four virus strains that a vaccine will have to address. It is believed effective vaccines will be quickly adopted and turn in $1 billion in sales.
But efficacy is key, and Sanofi last year had to report that results of a 4,000-patient study in Thailand turned in only 30.2% efficacy, not the expected 70%. The candidate did not protect against one of the four strains. The study could have paved the way to regulatory approval, but now the drugmaker has to wait for the data from two Phase III trials with 31,000 people enrolled in Asia and Latin America.
And Sanofi is not the only drugmaker chasing this prize. In May, Japan's Takeda bought its way into the sector with the acquisition of Inviragen for $35 million up front and potentially $215 million more in milestone payments. The Colorado company has a vaccine that has shown promising results, leading Takeda and analysts to believe it could be hot on the heels of Sanofi's drug.
To make sure it keeps the lead, Sanofi is cranking up production at its new facility in anticipation of a 2015 launch.The plant will be able to produce 100 million doses a year when in full production, and Sanofi is making every effort to be the first to need to do that.
- read the Reuters story
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