Takeda’s dengue vaccine surpasses Sanofi’s in P2 trial

Sanofi spent more than $1.5 billion and two decades to develop the first ever vaccine for dengue fever, only a few years after approval, however, it looks like it could be beaten, in terms of efficacy, by Takeda’s vaccine candidate.

In Phase 2 trials, Takeda’s vaccine improved overall reduction of dengue disease cases by 71.1%, which compares favourably to Sanofi’s Dengvaxia’s results of 60.8%.

The trial showed that 21 individuals (1.3%) of the 1,596 children and adolescents vaccinated with TAK-003 were found to have contracted dengue, which compared favourably the nine (4.5%) of 198 individuals receiving a placebo.

Beyond this, Takeda’s TAK-003 was able to achieve a sustained antibody response against all four serotypes of the virus – Sanofi managed protection against all four types, but with differing levels of efficacy.

Takeda is currently running a Phase 3 efficacy trial where it will hope to be able to prove that its vaccine can surpass Sanofi across all four serotypes.

"We are seeing an acceptable safety profile and sustained antibody responses out to 18 months in this trial. These data are an important step in the development of our dengue vaccine candidate," said Derek Wallace, Global Dengue Program Lead at Takeda. "The reduced incidence of dengue in children and adolescents receiving TAK-003 is encouraging, however data from our ongoing Phase 3 efficacy trial, TIDES, are required to confirm these findings."

Takeda released that data from this larger trial would be expected by late 2018.

The one issue that Takeda could face, if approved, are sales; Sanofi expected its own breakthrough vaccine to become a blockbuster seller but managed only $64 million in sales in 2016. It is still expected to reach approximately $400 million in sales per year, by 2022, but that could change if Takeda enters the market in 2019.

The delay in bringing the product to market for Sanofi and hiccups in important local markets, such as in the Phillipines, could explain away some of the issues in sales. Takeda will be hoping it can learn from such lessons to snatch a share of the market after launch.