Servier to pay $130m for Taiho's mCRC drug in Europe

Servier is to pay Taiho Pharmaceutical $130m in an upfront payment and European approval milestone for commercialization rights to TAS-102 (an oral combination of trifluridine and tipiracil hydrochloride) in Europe and other countries. The product is under review by the US FDA and the EMA for use in the treatment of refractory metastatic colorectal cancer (mCRC). If approved, it will face a competitive market. Taiho has retained commercialization rights in the US, Canada, Mexico and Japan/Asia and the rights to manufacture and supply the product. In addition to $130m, Taiho could receive additional regulatory and sales milestones and royalties. The companies will also collaborate on the further global development of TAS-102, sharing effort and cost on an equal basis. The regulatory filings were supported by data from the Phase III RECOURSE trial. The product was approved in Japan in 2014. If approved, Taiho's product will face competition from many well-established products including 5-fluorouracil and oxaliplatin, as well as Bayer's Stivarga (regorafenib). Servier will be hoping the fractionally better OS data for TAS-102 compared with Stivarga will help to differentiate the product.