Takeda Pharmaceutical said it will receive up to $312 million from the Biomedical Advanced Research and Development Authority (BARDA) toward developing a Zika virus vaccine.

Takeda will receive $19.8 million in initial funding to cover the vaccine development through Phase I, with potential funding of up to $312 million if BARDA exercises all options to take the vaccine through Phase III trials and a BLA filing with the FDA.

Under its agreement with BARDA, Takeda will develop an inactivated, adjuvanted, whole Zika virus vaccine. The first stage of work will include developing and producing the investigational vaccine, completing preclinical studies, submitting an IND application to the FDA, and carrying out a Phase I clinical trial.

The vaccine will be manufactured at Takeda’s facilities in Hikari, Japan.

Takeda said it also is in talks with BARDA and the Cabinet Secretariat of the Prime Minister Office regarding potential participation of Japanese health agencies in the Zika collaboration, citing commitments by the Japanese government and Prime Minister Shinzo Abe to infectious disease preparedness.

Rajeev Venkayya, M.D., corporate officer and president of Takeda’s global vaccine business unit, said in a statement the BARDA collaboration follows the company’s work in dengue, norovirus, and a partnership with the Japanese government on pandemic influenza.

In May, Takeda announced it had received a $38 million grant from the Bill & Melinda Gates Foundation toward a partnership to develop, license, and supply at least 50 million doses per year of Sabin-strain inactivated poliovirus vaccine (sIPV) to more than 70 developing countries.








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