Under the agreement, Yakult will pay Celsion licensing fees to acquire the rights to ThermoDox for the Japanese market. An amount of $2.5 million will be paid immediately, followed by an $18 million payment that is conditioned upon the approval of ThermoDox for the treatment of primary liver cancer by the Japanese Ministry of Health, Labor and Welfare. Additional milestone payments are tied to the achievement of certain levels of sales and the approval of other indications.
In addition to the milestone payments, Yakult will pay Celsion a significant double-digit and escalating royalty rate on the sale of ThermoDox in Japan. Celsion will also be the exclusive supplier of ThermoDox to Yakult.
Yakult is required to complete all development and clinical requirements in Japan and apply for marketing approval for the use of ThermoDox in the treatment of primary liver cancer and other indications in Japan. The terms also stipulate that Yakult will pay for all up-front clinical and preclinical development costs associated with Japanese registration. The data from the studies in Japan can be used to support Celsion’s obligations, if any, in other geographies as well.
Michael Tardugno, president and CEO of Celsion, said: We view this partnership with Yakult as further validation of the ThermoDox platform and its potential to treat the expanding hepatocellular carcinoma population in Japan.