6 March 2017
TiGenix Provides Update on Cx601 Marketing Authorization Application procedure in Europe
Leuven (BELGIUM) – 6th March, 2017, 7:00 am CET – TiGenix NV (Euronext Brussels and Nasdaq: TIG), an advanced biopharmaceutical company focused on developing and commercializing novel therapeutics from its proprietary platform of allogeneic stem cells, announces that it has received the Day 180 List of Outstanding Issues (LoOI) from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and expects to receive a Marketing Authorization decision for Cx601 in 2017.
TiGenix announces that it has received the Day 180 LoOI from the Committee for Medicinal Products for Human Use (CHMP) of the EMA and has entered a “clock stop” period as part of the centralized review process related to the Marketing Authorization Application (MAA) for Cx601, which is being developed for the treatment of complex perianal fistula in Crohn’s disease patients. Cx601 has been licensed to Takeda Pharmaceuticals International AG (Takeda) for the exclusive development and commercialization outside the US.
After reviewing the LoOI, TiGenix is confident in its ability to provide detailed and clarifying responses to the CHMP and remains on track to receive a Marketing Authorization (MA) decision for Cx601 in 2017. Receipt of the MA will trigger a milestone payment from Takeda to TiGenix of Euro 15 million. The D180 LoOI is part of the EMA’s official review and approval process.
Crohn’s disease is a chronic inflammatory disease of the gastrointestinal tract, which is thought to affect up to 1.6 million people in Europe. Complex perianal fistulas are a complication for people living with Crohn’s disease and there are limited treatment options. “We remain fully committed, together with our partner Takeda, to bring this much needed alternative treatment to those patients suffering from such a highly debilitating and difficult to treat condition,” concluded Dr. Maria Pascual, Vice President Regulatory Affairs and Corporate Quality of TiGenix.