Drug Development, Vaccines

Stepping out as a global player, a restructured Takeda enrolls 20,000-plus in new dengue PhIII in a showdown with Sanofi

Christophe Weber, president and chief executive officer of Takeda Pharmaceutical Co., speaks during the 18th Nikkei Global Management Forum in Tokyo, Japan  (CREDIT: Tomohiro Ohsumi/Bloomberg via Getty Images)


Last summer, when Takeda set out to restructure its global R&D operations, CEO Christophe Weber zeroed in on four key areas: cancer, GI, CNS diseases and vaccines. Part of that commitment to vaccines included a makeover into a global player. And today the biopharma company took a big step forward in that direction with the completion of enrollment of more than 20,000 kids into a pivotal Phase III test of a new dengue vaccine.

This is the largest clinical vaccine trial that Takeda has ever done. And it enrolled children and adolescents in Latin America as well as Asia to see how their vaccine — TAK-003 — can protect populations from the dengue virus. The randomized population will get two doses of either the vaccine or a placebo at day 1 and day 90. And it’s investing more than 100 million euros in a new vaccine plant to manufacture a global supply.

Takeda has already completed a slate of nine Phase I and Phase II trials for this vaccine, capturing evidence of safety and efficacy. Initial results from the Phase III TIDES study will start to roll in next year.

Sanofi will be watching closely. The pharma giant — an effective partner with Regeneron saddled with an unproductive French R&D group — spent more than $1.5 billion over 20 long years to develop Dengvaxia, the first approved vaccine for dengue. But it’s imperfect at best and initial sales last year were a disappointment. Still, analysts have estimated that the market for this drug could break a billion dollars a year.

Unless Takeda gets in its way.

Over the past year Takeda has been tearing up its old R&D structure and putting in a new organization the centers heavily on hubs in Boston and Japan.

Takeda has more vaccines in the clinic as well. It’s pursuing BARDA-funded studies on a Zika vaccine as well as a polio effort backed by the Bill & Melinda Gates Foundation. Now Weber’s promise of remaking Takeda into a global operator will be put to the test.


The best place to read Endpoints News? In your inbox.

Full-text daily reports for those who discover, develop, and market drugs. Join 19,000+ biopharma pros who read Endpoints News by email every day.

Free Subscription

BioNJ CEO Summit 2017