Days after Sanofi ($SNY) received its first approval in Mexico for its pioneering dengue fever vaccine, it's said to be in discussions to bring the jab to India following a successful trial on an adult population there.
 |
| Sanofi dengue head Guillaume Leroy |
India's Business Standard reported that the French pharma completed a study of the vaccine, Dengvaxia, on Indian adults in Delhi, Ludhiana, Bengaluru, Pune and Kolkata, with a spokesperson saying that the shot proved "safe and immunogenic in Indian adults with results comparable to clinical studies carried out in Asia."
In two prior Phase III clinical trials, the vaccine protected 66% of people aged 9 and older against all four dengue serotypes and 93% of people against the more deadly severe dengue. It reduced dengue hospitalizations by 80% and protected 82% of people who had previous dengue exposure. It protected 52% of people who hadn't been exposed.
Sanofi received its first blessing, from Mexican regulators, in people aged 9 to 45 on Wednesday, the culmination of 20 years and $1.5 billion in R&D.
That endemic nation is likely to be the first of many countries to incorporate Dengvaxia into efforts against the virus, which last year infected 390 million people worldwide. In fact, Sanofi Pasteur CEO Olivier Charmeil said this summer while describing the prospect that the vaccine's market could potentially reach 3 billion to 4 billion people. In contrast with many past vaccine launches, Sanofi has said that it's "flipping the model" for its Dengvaxia launch, favoring wide access in endemic countries rather than looking first to the U.S. and Europe to recoup development costs. A price for the Mexican market wasn't provided.
 |
| Sanofi's Olivier Charmeil |
According to Sanofi's figures, world healthcare systems spend $9 billion annually on treating dengue, and the Wall Street Journal reports that other prevention techniques such as mosquito nets add an additional $6 billion to $9 billion in global costs. Analysts have predicted the vaccine could bring in more than $1 billion in peak sales; Charmeil said this summer that it is anticipated to be on Sanofi Pasteur's "high end" of profitability.
Takeda is also developing a dengue shot, which analysts have said could be competing for market share by 2020, and the Serum Institute of India could prove to be a competitor in India after it set out for a fast-track approval this fall for its dengue treatment. GlaxoSmithKline ($GSK) and Merck ($MRK) are farther off with their candidates. And just last week, the U.S. Army teamed up with Hawaii Biotech to work toward a candidate that could protect military personnel and international travelers.
- here's the Business Standard story
- and the release on the Mexico approval
- get more from WSJ (sub. req.)