Biotechnology firm Can-Fite BioPharma, which specialises in small molecule drugs that address cancer, liver and inflammatory diseases, has signed a license, collaboration and distribution agreement with CMS Medical Venture Investment Limited for the commercialisation of Can-Fite’s Piclidenoson for the treatment of rheumatoid arthritis and psoriasis and Namodenoson for the treatment of advanced liver cancer and NAFLD/NASH in China (including Hong Kong, Macao and Taiwan).
Under the terms of the agreement, CMS Medical is making an upfront payment of US$2mn to Can-Fite and is required to pay to Can-Fite milestone payments of up to US$14mn upon the achievement of certain regulatory milestones and payments of up to US$58.5mn upon the achievement of certain sales milestones. In addition, the agreement provides for double-digit royalty payments on net sales.
CMS Medical is a wholly-owned subsidiary of China Medical System Holdings Limited, a specialty pharmaceutical company based in China, focusing on marketing, promotion and sales of prescription drugs and other medicinal products to therapeutic departments in hospitals. CMS builds up its product portfolio for its target markets by asset acquisition, equity investment, licensing and distribution as well as in-house R&D. CMS is listed on the Hong Kong Stock Exchange with a current market capitalisation of approximately HK$34bn as at 1 August 2018.
According to the agreement, CMS will be responsible for the development of Piclidenoson and Namodenoson to obtain regulatory approval in China and shall be further responsible for obtaining and maintaining regulatory approval in China for the indications described above. Can-Fite may, at the option of CMS, supply finished product to CMS.
“We are very excited to enter into this agreement with CMS, with their broad and professional experience in development, registration and marketing of diverse drugs in the Chinese market and believe that they are the right partner for us to penetrate this big market,” stated Dr. Sari Fishman, VP business development of Can-Fite. “We believe that CMS’s commitment to us is strong validation of our development efforts to date.”
Can-Fite is currently enrolling patients for its Phase III ACRobat trial of Piclidenoson for the treatment of rheumatoid arthritis and plans to shortly initiate patient enrollment for its Phase III Comfort trial of Piclidenoson for the treatment of psoriasis. The rheumatoid arthritis and psoriasis therapeutic market is dominated by biological drugs that are primarily administered via intravenous injection (IV) and have potential side effects. Rheumatoid arthritis and psoriasis are huge unmet need markets, where rheumatoid arthritis is estimated to reach US$35bn in 2020 and psoriasis is forecast to reach US$9bn in 2018.
Phase II studies with Namodenoson for the treatment of advanced liver cancer (hepatocellular carcinoma, Child Pugh B) and NAFLD/NASH are currently ongoing. The last patient for the advanced liver cancer trial was enrolled in August 2017, and treatment of remaining patients is still ongoing.