Takeda set to develop Zika virus vaccine with US funding of up to US$312 mn

September 2, 2016

In response to the growing number of cases of the Zika virus infection in more than 60 countries and territories all over the world, including the US, Japanese drugmaker Takeda Pharmaceutical Co. is the latest to join the list of companies developing vaccines against the Zika virus.

The company has recently announced that its Vaccine Business Unit has been selected by the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the US Department of Health and Human Services.

Takeda will be receiving an initial fund of US$19.8 million over the next 18 months to cover the vaccine development through Phase 1 pre-clinical research and manufacturing in preparation for early human trials, with potential funding of up to US$312 million if ASPR/BARDA exercises all options to take the vaccine through Phase 3 trials and filing of the Biologics License Application (BLA) in the US.

The World Health Organization (WHO) has declared the Zika outbreak to be a Public Health Emergency of International Concern on February 1, 2016. On February 8, 2016, the US Centers for Disease Control and Prevention (CDC) elevated its Zika response efforts to its highest response level, Level 1.

There is no vaccine or medicine for Zika, and infection during pregnancy can cause a serious birth defect called microcephaly and other severe fetal brain defects.Many people infected with Zika will have no symptoms or mild symptoms that last several days to a week.

Dr. Rajeev Venkayya, Corporate Officer and President of the Global Vaccine Business Unit at Takeda said: “This Zika vaccine program joins our work in dengue, norovirus, our partnership with the Japanese Government on pandemic influenza, and the recently announced partnership with the Bill & Melinda Gates Foundation to help eradicate polio. These efforts to develop a vaccine against the Zika virus reinforce Takeda’s commitment to the health of people everywhere, including the most vulnerable populations that are threatened by Zika.”

Takeda is also in discussions with the Cabinet Secretariat of the Prime Minister Office regarding potential participation of the Japanese government and the country’s health agencies in this collaboration.

Takeda will develop an inactivated, adjuvanted, whole Zika virus vaccine and manufacturing of the vaccine will occur at Takeda’s facilities in Hikari, Japan.

In recent weeks, US authorities determined that local mosquitoes were transmitting Zika in an area of south Florida, while the US territory of Puerto Rico has experienced a widespread outbreak.

More recently, Singapore identified a local outbreak with recent reports confirming that health authorities in the city-state have already detected 151 people with the Zika virus infection. Their first locally-transmitted Zika virus infection was reported August 27.

The Singapore government said earlier that half of the 115 cases reported previously were foreigners, mainly from China, India and Bangladesh, and most had already recovered. Many of them are believed to be among the hundreds of thousands of migrant workers in Singapore’s construction and marine industries.

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