Takeda Pharmaceuticals has announced plans to invest more than €100m to build a new manufacturing plant for its dengue vaccine candidate in Singen, Germany.
The tetravalent dengue vaccine candidate TAK-003 is based on a live-attenuated dengue serotype 2 virus (DENV-2), which provides the genetic ‘backbone’ for all four vaccine viruses.
Takeda vaccinated the first subject in the Tetravalent Immunisation against Dengue Efficacy Study (TIDES) on 7 September this year.
The study is currently enrolling about 20,000 healthy children aged between four and 16 years living in dengue-endemic countries within Latin America and Asia.
It is a Phase II, double-blind, randomised, placebo-controlled trial of the company’s live-attenuated tetravalent dengue vaccine candidate.
The assessment is aimed at protecting subjects against symptomatic dengue fever caused by any of the four dengue virus serotypes.
Vaccine safety and immunogenicity are also evaluated as part of the study, with two doses of the vaccine candidate or placebo administered 90 days apart.
Takeda Pharmaceuticals global manufacturing and supply officer Dr Thomas Wozniewski said: “This manufacturing plant investment reinforces Takeda’s strong support for our global vaccine strategy in general, and dengue in particular.
“The new plant will provide millions of people with access to a medicine that addresses a huge unmet medical need. It underlines our commitment to improve the lives of people worldwide.”
Initial construction activities of the plant are set to begin immediately, with the facility expected to be ready for production in 2019.