Spain has licensed TiGenix NV's expanded Madrid plant paving the way for a potential European launch of Cx601, its cell therapy forthe Crohn's disease complications. Belgium-based TiGenix announced it received the Spanish Medicines Agency (AEMPS) license this week, explaining the Madrid plant will provide capacity for production of its portfolio of cell therapies including the candidate cell therapy Cx601. Chief technical officer Wilfried Dalemans said: 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. Cx601 has been accepted for review by the European Medicines Agency (EMA) and Swissmedic, which began reviewing TiGenix dossier in June. At the time the firm told us Takeda will take over responsibility for making the cell therapy from 2021 but did not provide additional details. Manufacturing expansion Cx601 is made from stem cells taken from donor adipose tissue. It is being developed for the treatment of complex perianal fistulas in patients with Crohns disease patients who do not otherwise respond to standard therapies. The therapy is madein a 2-dimensional cell culture. TiGenix expanded the Madrid facility with support from Japanese drug firm Takeda, which licensed rights … Continue reading
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