Takeda's Dengue Vaccine Is Effective in Late-Stage Study

(Bloomberg) -- Takeda Pharmaceutical Co.’s experimental dengue vaccine hit its main goal in a late-stage study, showing it’s effective in preventing the mosquito-borne virus that afflicts roughly 400 million people a year.

The vaccine prevented all four strains of dengue virus from causing the potentially lethal illness, also known as break-bone fever, the Japanese drugmaker said in a statement Tuesday. While studies so far haven’t raised significant safety concerns, a review of the data will continue, Takeda said.

The findings provide a boost to Takeda’s ambition to tackle the disease, which kills about 20,000 people annually, and avoid setbacks that rival Sanofi encountered after spending more than two decades and 1.5 billion euros ($1.7 billion) getting the world’s first dengue vaccine to the market. The Japanese company said it’s moving ahead with development and commercial manufacturing in preparation for a potential global launch, declining to predict when that may occur.

The virus is “a growing problem, probably due in part to climate change and also due to urbanization and the widespread presence of the mosquitoes that transmit dengue,” Rajeev Venkayya, president of Takeda’s global vaccines unit, said in an interview. “We’re seeing dengue crop up in all kinds of new places.”

Sanofi’s Dengvaxia received a blow in 2017 when an analysis found that people who had never suffered from dengue before getting the shot had a greater risk of developing severe disease if they were later infected. The French pharmaceutical company was forced to cut the value of its stockpiles, and analysts slashed their sales estimates.

“There’s no question there has been a lot of attention to safety,” Venkayya said. “The vaccine that we’re developing will receive extra scrutiny, and we would expect that. That could translate in some places to regulatory review times that are a little bit longer.”

Once it’s approved in some countries, health authorities may recommend pilot-scale roll-outs of the vaccine before a larger introduction, he said.

The Takeda trial is taking place in countries including Brazil, Colombia, Panama, Nicaragua, the Philippines, and Sri Lanka, where severe dengue is a significant cause of illness and death among children. Details will be published in a review, and additional results are due later this year, the company said.

Takeda shares fell as much as 1.1 percent in early Tokyo trading on Wednesday.

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