Takeda acquires Inviragen for up to $250 million

Company gains promising vaccine candidates against dengue and hand, foot and mouth disease

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FORT COLLINS, Colo.—Takeda Pharmaceutical Co. Ltd. and itswholly owned subsidiary, Takeda America Holdings Inc., have entered into adefinitive agreement to acquire Inviragen Inc., for an upfront payment of $35million and future payments of up to $215 million linked to the progress ofclinical development and achievement of key commercial milestones.
 
 
Headquartered in Fort Collins, Colo., with facilities inMadison, Wis., and Singapore, Inviragen is a privately held biopharmaceuticalcompany specializing in research and development of innovative vaccines forinfectious diseases.
 
 
"We were looking for a partner for our dengue and hand, footand mouth disease (HFMD) vaccines," says Inviragen CEO Dr. Dan Stinchcomb."We've got good data under our belt in terms of safety and immune response, soefficacy and manufacturability come next."
 
 
The company's lead candidate, DENVax, is a four-strainrecombinant viral vaccine for the prevention of dengue infection. Anadministration schedule of two doses of DENVax over 90 days is currently beingevaluated in Phase II clinical trials. In addition to DENVax, Inviragen'svaccine candidate to protect against HFMD caused by enterovirus 71 (EV71) hascompleted Phase I clinical testing. Inviragen has also developed a recombinantvaccine candidate to protect against chikungunya, currently in preclinicaldevelopment.
 
 
"The acquisition of Inviragen supports Takeda's overallresearch and development programs, long-term growth strategy and commitment toimprove health through innovation and new technology," says Dr. TadatakaYamada, Takeda's chief medical and scientific officer and member of the Takedaboard of directors. "Coming less than a year after the acquisition of LigoCytewith the world's leading norovirus vaccine candidate, this illustrates Takeda'scommitment to its global vaccine business and global public health."
 
 
Dengue is the most important mosquito-borne viral illness inthe world, and is one of four World Health Organization future vaccinepriorities. It is estimated that about 400 million people worldwide areinfected by the dengue virus each year, of which nearly 100 million developclinical illness. Approximately 500,000 people are hospitalized and 20,000,mostly children, die from severe complications such as hemorrhagic fever.Currently there are only symptomatic treatments available for dengue and denguehemorrhagic fever, and the only means of prevention is through mosquitocontrol. The number of reported symptomatic dengue infections has increased30-fold in the past 50 years, and the global footprint of dengue is expanding.
 
 
HFMD epidemics occur annually throughout the Asia Pacificregion, with millions of cases reported yearly since 2010. Chikungunya, whichis a mosquito-transmitted virus, has produced epidemics in Africa, India, Asiaand Europe. There are no specific treatments or cures for dengue, HFMD orchikungunya.
 
"It can be difficult to find investors for markets outsidethe U.S. and EU," Dan Stinchcomb notes, "but we were fortunate to close seriesA financing in 2009, with EDBI, Charter Life Sciences, Venture Investors andPhillip Private Equity Ph.D."
 
 
To preserve continuity and build upon Inviragen's success,Takeda will integrate the Inviragen team into Takeda's Vaccine BusinessDivision. Inviragen's wholly owned subsidiary in Singapore, Inviragen Pte.Ltd., will enhance Takeda's core vaccine R&D capabilities. The impact ofthe acquisition on Inviragen's people and operations will be worked out overtime, Stinchcomb says. Pending the satisfaction of customary closingconditions, the deal is expected to close in the next few weeks.
 
 
"Approximately 3.6 billion people—half the world'spopulation—live in dengue endemic countries, which tend to be low-to-middleincome places," Stinchcomb states. "The public health market is low cost, butprivate markets in many countries exist and provide needed income for vaccinemanufacturers. Finally there is the tourist market. So there are three tiers thatsupport efforts to bring these life-saving vaccines to those who need themmost."


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