Osaka, Japan-based Takeda Pharmaceutical Co. Ltd. is gaining access to several key vaccine candidates targeted against major infectious diseases in the developing world such as dengue and hand, foot and mouth disease (HFMD), through its acquisition of Inviragen Inc., of Fort Collins, Colo.

Takeda will pay $35 million up front and up to $215 million contingent on various clinical and commercial milestones. The transaction will be conducted through Takeda's wholly owned subsidiary Takeda America Holdings Inc.

With additional facilities in Madison, Wis., and Singapore, Inviragen is focused on developing vaccines to protect against infectious diseases worldwide.

"Initially, Inviragen was looking for a partner that was capable of conducting later-stage development of its vaccine candidates," Dan Stinchcomb, co-founder and CEO, told BioWorld Today.

Takeda launched a global vaccine business division in January 2012 to build upon the 60 years' experience that the company had in manufacturing and supplying vaccines in Japan.

"Our product candidates hit the bull's eye of their own product strategy in the sense that they were addressing unmet medical needs in emerging economies and could truly have an impact on global public health," added Stinchcomb.

In October last year Takeda's Vaccine Business Division, headquartered in Deerfield, Ill., added virus-like particle platform (VLP) technology through the acquisition of LigoCyte Pharmaceuticals Inc. for an upfront payment of $60 million, with future contingent consideration based on the progress of development projects. LigoCyte's lead product, the norovirus vaccine has been shown to confer protection in an initial human challenge trial. (See BioWorld Today, Oct. 8, 2012.)

Inviragen's vaccine to protect against dengue fever is in Phase II clinical testing. Also in the pipeline is a vaccine candidate to protect against hand, foot and mouth disease caused by enterovirus 71 (EV71), which has completed Phase I clinical testing. Vaccines to protect against chikungunya and Japanese encephalitis are also in development.

In February, it started the second stage of an ongoing Phase II study testing DENVax, its four-strain recombinant viral vaccine for the prevention of dengue infection, following review and recommendation by the data safety monitoring board. The study is enrolling individuals in Puerto Rico, Colombia, Singapore and Thailand. The first stage administered DENVax or placebo to individuals in multiple age groups. The second stage will test DENVax for safety and immunogenicity in about 200 additional children, ages 18 months to 11 years. (See BioWorld Today, Feb. 28, 2013.)

The number of reported symptomatic dengue infections has increased 30-fold in the past 50 years, and the global footprint of dengue is expanding. HFMD epidemics occur annually throughout the Asia Pacific region, with millions of cases reported since 2010.

Beyond a significant expansion of its vaccine pipeline, Takeda believes that this current acquisition will enhance core vaccine R&D capabilities with Inviragen's vaccine development center in Singapore, in one of the regions where the vaccines under development will have the greatest impact.

Takeda is planning to integrate the Inviragen team, which currently numbers 51 employees at its various locations, into Takeda's Vaccine Business Division, Stinchcomb said.

Pending the satisfaction of customary closing conditions, the deal is expected to close within the next few weeks.