Taiho Pharmaceutical Co., Ltd. and Servier, an independent French research-based pharmaceutical company, have entered into an exclusive license agreement for the development and commercialization of TAS-102 (trifluridine and tipiracil hydrochloride) in Europe and other countries.

Taiho Pharmaceutical Co., Ltd. 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 Pharmaceutical Co., Ltd. for use in the treatment of refractory metastatic colorectal cancer (mCRC).

Under this agreement, Taiho Pharmaceutical Co., Ltd. will receive a total of US$ 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.

‘‘We are very pleased to enter into this agreement for TAS-102 with Servier who has a strong presence around the world especially in Europe as a research-based pharmaceutical company and has made a long term commitment to oncology,’’ said Masayuki Kobayashi, President and Representative Director of Taiho Pharmaceutical Co., Ltd. ‘‘Taiho and Servier will work vigorously in close cooperation to accelerate development and commercialization of TAS-102 and make it available to patients globally.’’

‘‘This partnership with Taiho will hopefully allow us to rapidly bring a new therapeutic option to patients suffering from refractory metastatic colorectal cancer in Europe and other countries, ’’ said Olivier Laureau, president of Servier. ‘‘We respect and value Taiho’s well-known expertise in the development of oral cancer drugs and hence this collaboration will contribute to develop Servier’s capabilities in oncology. Such a landmark agreement confirms Servier’s strong ambition in oncology and our willingness to bring to cancer patients new therapeutic solutions through Servier’s extensive portfolio of innovative treatments currently in clinical development. This is in line with our commitment to therapeutic progress for the benefit of patients.”

Taiho Pharmaceutical Co., Ltd. and Servier anticipate that TAS-102, as a new treatment option, will make an even greater contribution to cancer patients in Europe and other countries through their partnership.

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.

There are no definitive data on the number of patients who are refractory to standard metastatic colorectal cancer treatments; however, colorectal cancer is one of the most common cancers in the European Unioni and the third most common cancer worldwide. In 2013, a study published in the European Journal of Cancer revealed that an estimated 447,000 patients (242,000 men and 205,000 women) were diagnosed with and 215,000 patients died of colorectal cancer in Europe in 2012.i In addition, the American Cancer Society estimated that 136,830 patients (71,830 men and 65,000 women) were diagnosed with and 50,310 patients died of cancer of the colon and rectum in the United States in 2014.