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Celsion in ThermoDox license agreement with Yakult Honsha
January 2009

COLUMBIA, Md.óCelsion Corp. and Tokyo-based Yakult Honsha Co. Ltd. announced last month definitive agreements relating to the commercialization of Celsion's proprietary ThermoDox drug delivery platform for the Japanese market.

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.

"We have worked diligently over the past few months to arrive at this significant agreement with Yakult and we are very pleased to announce its execution," said Michael H. Tardugno, Celsion's president and CEO, in a press release announcing the deal. "This achievement is an example of the commitment of our two companies to a long-term, mutually rewarding relationship. It is also an example of Celsion delivering on its stated goal of licensing ThermoDox to pharmaceutical partners with the expertise and capabilities essential to market success. We view this partnership with Yakult as further validation of the ThermoDox platform and its potential to treat the expanding hepatocellular carcinoma (HCC) population in Japan."

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. The agreement also stipulates 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.

Dr. Kiyoshi Terada, head, pharmaceutical division/senior managing director, of Yakult noted, "The remarkable evidence of clinical activity suggested by ThermoDox in early phase clinical trials provides Yakult with the confidence necessary for the investment required to support marketing approval in Japan. With an annual incidence of over 40,000 HCC patients, if supported by data from the current randomized phase III trial, ThermoDox has the potential to hold great promise for those suffering with this difficult cancer." DDN



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