Takeda advances dengue vaccine into Phase III on heels of Zika R&D plunge

An article by FiercePharma
September 7, 2016

Taking the next step toward challenging Sanofi’s first-to-market Dengvaxia, on Wednesday, Takeda kicked off a global Phase III trial of its dengue vaccine, TAK-003. The announcement comes just days after the company pushed into another mosquito-borne disease, Zika, through a $312 million R&D deal with the U.S. government.

Takeda vaccinated the first subject in a dengue study that’ll include more than 20,000 participants aged 4 to 16 in endemic nations in Latin America and Asia. It’s a “critical milestone” in efforts to bring the candidate--a live-attenuated tetravalent dengue vaccine--to market, Takeda vaccines head Rajeev Venkayya said in a statement.

With the study, Takeda is embarking on a new effort to take its vaccines business global, the Financial Times reported. Analysts have estimated dengue vaccines could be a $1 billion market or more per year, but Sanofi's Dengvaxia launch has faltered and another potential rival is already in Phase III testing in Brazil. It's unclear whether the market would be big enough for all three vaccines.

TAK-003 will be administered in two doses 90 days apart as part of the double-blind, placebo-controlled trial. Investigators will look at vaccine efficacy in all four dengue serotypes “regardless of age and whether the individual has previously been exposed to the virus,” Takeda said in a statement.

That last point could prove to be important, as a new study this week demonstrated that Dengvaxia can lead to more serious dengue infections if it’s used in areas where the disease isn't common. Dengue infections tend to be more serious the second time around, researchers said this week.


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