Updated on 16 June 2015
Japan's Taiho Pharmaceutical Co. Ltd. and France's Servier have entered into an exclusive license agreement on June 12, 2015 for the development and commercialization of TAS-102 (nonproprietary names: trifluridine and tipiracil hydrochloride) in Europe and other countries.
Taiho retains the right to develop and commercialize TAS-102 in the United States, Canada, Mexico and Japan/Asia and to manufacture and supply the product.
TAS-102 is an oral combination anticancer drug initially developed by Taiho for use in the treatment of refractory metastatic colorectal cancer (mCRC).
Under this agreement, Taiho will receive a total of $130 million in an upfront payment and for MAA approval in the EU. In addition, Taiho will receive further regulatory and sales event milestone payments and royalties based on net sales. Taiho and Servier will also collaborate on the further global development of TAS-102 sharing effort and cost on an equal basis.
TAS-102 is currently under review by Health Authorities in Europe and the United States and in 2014 was approved for marketing in Japan. In the United States, Taiho Oncology Inc., a subsidiary of Taiho Pharmaceutical Co. Ltd., will market TAS-102.
TAS-102 is an oral combination anticancer drug of trifluridine (FTD) and tipiracil hydrochloride (TPI). FTD is an antineoplastic nucleoside analog, which is incorporated directly into DNA, thereby interfering with the function of DNA. The blood concentration of FTD is maintained via TPI, which is an inhibitor of the FTD-degrading enzyme, thymidine phosphorylase. TAS-102 is commercially available in Japan and is under regulatory review in the United States of America and the European Union for the treatment of refractory metastatic colorectal cancer.