TiGenix has obtained a licence for the commercial production of expanded adipose-derived stem cells (eASCs) at its expanded manufacturing facility in Madrid, Spain, following an inspection by the Spanish Medicines Agency (AEMPS).
This licence will provide the company with production capacity for the potential European commercial roll out of Cx601, which is an investigational stem cell therapy for the treatment of complex perianal fistulas in patients with Crohn’s disease. Additionally, this expanded facility offers the company the opportunity to manufacture other pipeline products.
“We are very pleased with this approval for our expanded facility, which confirms our state-of-the-art GMP manufacturing capabilities in the stem cell field,” said Wilfried Dalemans, Chief Technical Officer at TiGenix. “We have now significantly increased our manufacturing capacity, a key step in the preparation for commercialization of Cx601 in Europe and in the further development of our pipeline.”
The company has submitted a marketing authorisation (MA) application for Cx601 to the European Medicines Agency (EMA) and a decision is anticipated this year. Should it be approved it will enable marketing of the product in all 28 EU member states as well as Norway, Iceland and Lichenstein. Cx601 has been licensed to Takeda for exclusive development and commercialization outside of the US.