Cell therapy company confident on answers to EMA

23 December 2016

Belgian biopharma firm TiGenix (Euronext Brussels: TIG) has submitted its responses to the European Medicines Agency's (EMA) day 120 list of questions for Cx601, its lead product candidate being developed for complex perianal fistulas in Crohn's disease.

The questions were issued by the EMA’s Committee for Medicinal Products for Human Use (CHMP) as part of the centralized review process of the marketing authorization application (MAA) of Cx601, which has been licensed to Takeda Pharmaceutical (TYO: 4502) for its exclusive development and commercialization outside the USA.

This deal involved the Japanese drugmaker making an upfront payment of 25 million euros ($26 million) and TiGenix is eligible to receive additional regulatory and sales milestone payments for up to a potential total of 355 million euros and double-digit royalties on net sales by Takeda.

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