Yakult Honsha Co., Ltd. (Mr. Sumiya Hori, President) today announced the execution of definitive agreements with Celsion Corporation (NASDAQ: CLSN) relating to the commercialization of Celsion’s proprietary ThermoDox® drug delivery platform for the Japanese market.
Yakult will 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.
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 the milestone 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 achievement of certain levels of sales and the approval of other indications.
In addition to the milestone payments, Yakult will pay Celsion a royalty rate on the sale of ThermoDox® in Japan.
Celsion will be the exclusive supplier of ThermoDox® to Yakult.
ThermoDox® is Celsion's proprietary heat-sensitive liposomal encapsulation of doxorubicin, an approved and frequently used anti-cancer drug used in the treatment of various cancers. Localized heat (at 40-42 degrees Celsius and above) releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited locally in a targeted tumor.
Clinical Development Status
ThermoDox® is currently in a phase 3 clinical trial in the U.S. for liver cancer as well as a phase 2 trial for recurrent chest wall breast cancer. Additionally, Celsion recently obtained regulatory approval to conduct its global study titled “A Phase III, Randomized, Double-Blinded, Dummy-Controlled Study of the Efficacy and Safety of ThermoDox(R) (Thermally Sensitive Liposomal Doxorubicin) in Combination with Radiofrequency Ablation (RFA) Compared to RFA Alone in the Treatment of Non-Resectable Hepatocellular Carcinoma (HCC)” in Hong Kong, Taiwan, Korea, Canada, and Italy, and anticipates that a Clinical Trial Agreement will be obtained in China before the end of 2008.
About Primary Liver Cancer
Primary liver cancer is a type of cancer that begins in the cells of the liver and is not typically detected early, often resulting in a poor patient prognosis. According to the National Cancer Center of Japan, primary liver cancer is the third leading cause of cancer deaths in Japan among adults and more than 40,000 people are diagnosed with the disease annually.
Celsion is dedicated to the development and commercialization of oncology drugs including tumor-targeting treatments using focused heat energy in combination with heat activated drug delivery systems. Celsion has research, license or commercialization agreements with leading institutions such as the National Institutes of Health, Duke University Medical Center, University of Hong Kong, North Shore Hospital-Albert Einstein Medical School.
Comments from Yakult and Celsion
Dr. Kiyoshi Terada, Head, Pharmaceutical Division/Senior Managing Director, Member of the Board noted, “We delighted to have reached an agreement with Celsion for an exclusive license to ThermoDox for Japan. 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. We look forward to our work with Celsion and the potential to expand our partnership to address other cancers for which there is no current standard of care.”
“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. “This achievement is an example of the commitment of our two companies to a long term, mutually rewarding relationship. It is also example of Celsion delivering on its stated goal of licensing ThermoDox® to pharmaceutical partners with the expertise and capability 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.”
Safe Harbor Statement
Celsion wishes to inform readers that forward-looking statements in this release are made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, unforeseen changes in the course of research and development activities and in clinical trials by others; possible acquisitions of other technologies, assets or businesses; risks that negotiations of definitive agreements with letter of intent signatories may not be successful; possible actions by customers, suppliers, competitors, regulatory authorities; and other risks detailed from time to time in the Company's periodic reports filed with the Securities and Exchange Commission.