It's no easy feat to take an experimental vaccine into a massive, 20,000-patient Phase III study in Asia and Latin America, but that's just what Takeda did this fall with its dengue shot. To get there, however, the company’s vax unit had to stoke up a global growth spurt.
The shot had already been through nine Phase I and Phase II trials, and in each study at the early stages, the vaccine was “consistently well tolerated, with good immune responses against all four dengue serotypes, importantly regardless of baseline dengue exposure,” Global Dengue Program Medical Director Derek Wallace told FiercePharma.
Then, it was time for Phase III, where the stakes are higher. It's expensive to run a trial in nine countries and many thousands of patients, and the company had to make a concerted effort to bolster its vaccines group, which didn't have the worldwide spread—or depth—Takeda needed.
“As an organization, we have a history of vaccine sales in Japan,” Wallace said. “But in order to be a vaccine company with a global global footprint, we’ve needed to build a team with significant experience in vaccine development and manufacturing. This Phase III demonstrates that we have that."
“It’s certainly not something we take lightly. To be at this stage, we are very proud of that.”
Competing with Dengvaxia
If approved, TAK-003 would challenge Sanofi’s Dengvaxia, which took 20 years to develop and, since its December 2015 launch, has hit some speed bumps. In three quarters this year, the vaccine has brought in €50 million in sales; execs have said the shot will likely miss previous estimates of €200 million for 2016, partly because of political and economic turmoil in Latin America.
Still, the opportunity for sales is solid. Analysts have said the dengue vaccine market could be worth $1 billion per year or more.
For its part, Takeda has been working on the TAK-003 dengue shot since 2010, Wallace said, to a point where it’s “confident” in the vaccine’s formulation and schedule. The new trial, in children aged 4 to 16, will finish enrolling early next year, and Takeda should have an “understanding of efficacy profile toward the end of 2018,” Wallace said.
Dubbed TIDES, the study will be conducted in Thailand, the Philippines, Vietnam, Sri Lanka, the Dominican Republic, Panama, Nicaragua, Colombia and Brazil.
If Takeda is able to gain approval with TAK-003, the fact that the vaccine can provide a benefit regardless of previous exposure could prove to be one strength, given a recent data analysis showing otherwise for Dengvaxia in some instances. It’s administered in two doses 90 days apart.
In Takeda’s broader vaccine ambitions, dengue fits alongside programs in Zika, Chikungunya, Enterovirus 71, norovirus and polio. Just days before the company entered the Phase III dengue trial, Takeda signed on with the U.S. government in a $312 million Zika R&D deal, joining the likes of Sanofi and GlaxoSmithKline to partner with federal agencies against the global epidemic.