PETACH TIKVA, Israel—Can-Fite BioPharma Ltd. announced today that it has signed a License, Collaboration and Distribution Agreement with CMS Medical Venture Investment Limited for the commercialization 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 $2,000,000 to Can-Fite and is required to pay to Can-Fite milestone payments of up to $14,000,000 upon the achievement of certain regulatory milestones and payments of up to $58,500,000 upon the achievement of certain sales milestones. In addition, the agreement provides for double-digit royalty payments on net sales.

 

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.

 

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 and have potential side effects. Rheumatoid arthritis and psoriasis are huge unmet need markets, where rheumatoid arthritis is estimated to reach $35B in 2020 and psoriasis is forecast to reach $9B 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. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe, and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers, including colon, prostate, and melanoma.

 

“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.”