Servier licenses TAS-102 (trifluridine and tipiracil hydrochloride) from Taiho for Europe and other countries-Taiho

Taiho Pharmaceutical Co., Ltd. and Servier Laboratories announced that they 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 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 a colorectal cancer.

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.

Comment: If approved in the EU and US, TAS 102 will face competition from many well-established products including 5-fluorouracil and oxaliplatin, as well as Bayer's Stivarga (regorafenib).