U.S. government in $300M-plus Zika vaccine R&D deal with Takeda

The U.S. government’s public health emergency department BARDA could pay out more than $300 million to Japanese pharma Takeda to develop a new vaccine against the Zika virus as new figures suggest billions are now at risk of the disease.

Under the deal, BARDA will pay out $19.8 million to cover the costs of vaccine development through Phase I, but could also stump up $312 million should things go well. Should this happen, the Authority will fund the research through Phase III along with a filing of a BLA in the U.S. for the vax.

Takeda, which has a history of vaccine development and works on dengue, norovirus and polio programs, said under the deal and with the cash boost it will develop an inactivated, adjuvanted, whole Zika virus vaccine. Manufacturing of the vaccine will occur at Takeda’s facilities in Hikari, Japan.

Early stages will be focused on finishing up preclinical studies, an IND to the FDA and starting a Phase I test. There are currently no treatments or vaccines marketed for the virus and much of the public health effort is now aimed at preaching safe sex practices to those in affected areas to reduce the risk of sexual transmission of the disease, as it can remain in the blood for around a week after infection.

As well as BARDA, Takeda said it was also looking to the Japanese government for help in this collab, saying in a statement that it was in: “Discussions with the Cabinet Secretariat of the Prime Minister Office regarding potential participation of Japanese health agencies in this collaboration.”

Dr. Rajeev Venkayya, president of the Global Vaccine Business Unit at Takeda, said: “Working with BARDA, Takeda is deploying its world-class expertise and capabilities in vaccine development for emerging infectious diseases, and our outstanding team and manufacturing facilities in Hikari, Japan.

“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.”

The Zika virus is spread by mosquito bites has been linked to thousands of babies being born with underdeveloped brains, a condition known as microcephaly. The WHO declared Zika a Public Health Emergency of International Concern at the start of the year.

In the latest set of figures released by the U.S. government, around 50 cases of locally transmitted Zika infections have been reported in Florida, with most people having no symptoms or mild illness.

It is much more widespread in the U.S. territory of Puerto Rico and across the countries of South America, as well as Asia and Africa--with 65 countries now believed to have cases of transmission of the virus.

This week, the researchers writing in The Lancet Infectious Diseases said that more than 2 billion people could be at risk from Zika virus outbreaks in parts of Africa and Asia with those living in India, Indonesia and Nigeria the most vulnerable to transmission.

A number of companies are already starting work on their own forms of a Zika vaccine, with GlaxoSmithKline ($GSK), Sanofi ($SNY) India’s Bharat Biotech and Inovio Pharmaceuticals ($INO) the bigger names to have signed up.

Merck ($MRK), Johnson & Johnson ($JNJ) and Pfizer ($PFE) are according to press reports weighing up their options as to whether to get involved, given the likely lack of ROI they would get from research costs. This is likely why programs, like BARDA’s are having to use a carrot approach to pay toward development.

The National Institutes of Health (NIH) a month ago also launched a clinical trial of its Zika vaccine candidate.