Leuven (BELGIUM) - February 23, 2016, 07:00h CET - TiGenix NV (Euronext Brussels: TIG), an advanced biopharmaceutical company focused on developing and commercialising novel therapeutics from its proprietary platforms of allogeneic expanded stem cells, announced today that it has successfully obtained the license for commercial production of Cx601, TiGenix’s product for the treatment of complex perianal fistulas in Crohn’s disease patients. The issuance of the manufacturing license from the Spanish Medicines Agency (AEMPS) represents a relevant achievement in bringing Cx601 closer to commercial launch.
“We are very pleased with this approval which confirms our state-of-the-art GMP manufacturing capabilities in the stem cell field” said Wilfried Dalemans, Chief Technical Officer. “The commercial GMP license in addition to the current GMP license for clinical manufacturing is a clear recognition of our proven capabilities in the field and sets the stage for gearing-up the manufacturing of Cx601 commercial lots, making TiGenix a leading reference in the development of cell therapy medicinal products once more”.
Following the successful completion of its Phase III ADMIRE-CD clinical trial in August, the approval marks a new milestone in TiGenix’s mission to bring Cx601 to European patients suffering from complex perianal fistulas, a complication of Crohn’s disease for which there is currently no effective treatment.
“This timely and successful achievement fulfils one of the final requirements for our plan to file a Marketing Approval Application for Cx601 at the European Medicines Agency (EMA) in the coming weeks,” said Maria Pascual, VP Regulatory Affairs. “In this way our plan remains in line with the expectation to make Cx601 available to European patients in the second half of 2017".
