Drugmakers often crank up production ahead of approvals so they will be ready to push the drugs into the supply chain as soon after the regulatory thumbs up as possible. But given the complexity of manufacturing the 4-in-1 dengue vaccine, Sanofi ($SNY) has already started producing the experimental drug in preparation for its expected launch in 2015.
"This is a very high-tech production since the vaccine is a 4-in-1 and should protect against the four types of dengue virus that circulate worldwide," a spokesman said Monday.
The highly anticipated vaccine and potential blockbuster is being manufactured at a plant in Neuville-sur-Saone, France. Fill and pack will be done at another Sanofi Pasteur plant. The company has invested €300 million ($391 million) in the new facility, which is dedicated to the vaccine. "One of the reasons we chose the Neuville site is the fact that it is close to our Marcy l'Etoile site where our European R&D center is located," the spokesman explained.
About 150 people currently work at the new facility, which will have be able to produce 100 million doses a year at full capacity.
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.
- read the Reuters story
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