Sanofi's struggling dengue vaccine could face competition from India/U.S. alliance

India's External Affairs Minister, Sushma Swaraj, talked up vaccine development plans with U.S. Secretary of State John Kerry at a press conference in New Delhi.

India and the U.S. are crafting plans to work together on developing vaccines for dengue fever and other diseases that pose a major public health threat. 

During a visit to India this week, U.S. Secretary of State John Kerry confirmed that talks are underway for public-private partnerships that would work on vaccines for dengue, as well as tuberculosis and respiratory syncytial virus (RSV).

Secretary Kerry particularly highlighted the dengue fever project at a press conference with Indian External Affairs Minister Sushma Swaraj, pointing to the unnecessary loss of life caused by the mosquito-borne disease. More than 15,000 dengue cases have already been reported in India this year, a significant uptick from the usual count.

It will likely be some time before the dengue initiative delivers a commercial candidate. Nevertheless, the news adds to pressure facing Sanofi's recently-launched dengue fever vaccine Dengvaxia, which is not meeting sales targets despite being the only product of its type on the market.

Sanofi reported sales of just €20 million in the first half of the year--and only €1 million in the second quarter. That's a low return given the $1.5 billion the company spent on developing Dengvaxia.

It can take time for vaccine sales to ramp up; green lights for inclusion in public immunization programs often come months after regulatory approval. Still, Sanofi had expected €200 million in Dengvaxia sales for 2016. It recently said it'll miss that target and blamed the miss on political upheavals in Latin America.

The vaccine has yet to be approved in any Asian markets other than the Philippines, which has allocated $73.5 million to launch a public vaccination campaign in one million schoolchildren.

Sanofi's hopes of a swift approval in India were dashed, however, when an expert committee refused to clear Dengvaxia without clinical trials in the local population.

The French pharma is trailed in dengue by Japan's Takeda, whose DENVax could begin to steal market share by 2020, analysts say. An NIH candidate is also in Phase III testing in Brazil.

Meanwhile, India has already chalked up some successes in the indigenous development of vaccines for serious public health issues. Last year it launched a home-grown rotavirus vaccine called Rotavac--developed by Bharat Biotech--as a cheaper alternative to Merck's ($MRK) RotaTeq and GlaxoSmithKline's ($GSK) Rotarix.

The new U.S.-India vaccine project will be carried out under the long-established Indo-U.S. Vaccine Action Program, which was involved in the development of Rotavac.

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