Leuven (BELGUIM) - July 5, 2016, 8:00h CEST - TiGenix NV (Euronext Brussels: TIG), an advanced biopharmaceutical company focused on the development and commercialization of novel therapeutics based on its proprietary platforms of allogeneic expanded stem cells, today announced the initiation of the withdrawal of the Marketing Authorization for ChondroCelect® due to commercial reasons. This decision is in line with TiGenix’s strategy to concentrate its resources and capabilities on its allogeneic stem cell platforms, its upcoming Cx601 Phase III US trial and its other clinical stage assets.
Due to the regulatory environment around autologous chondrocyte-based cell therapy products in Europe leading to a difficult competitive landscape for ChondroCelect, together with the lack of reimbursement in key European countries, TiGenix has been prompted to initiate the withdrawal process of the Marketing Authorization for ChondroCelect® for commercial reasons. Consequently, TiGenix has come to an agreement with Sobi for the early termination of their existing commercial relationship and will also terminate its manufacturing agreement with PharmaCell.
“TiGenix continues to be committed to bring novel therapeutics based on our proprietary allogeneic stem cell platforms to patients with high unmet medical need, as was evidenced by the recently announced licensing agreement with Takeda Pharmaceutical for the ex-US rights to commercialize Cx601 for the treatment of perianal fistula in Crohn’s disease,” said Eduardo Bravo, CEO of TiGenix. “To deliver shareholder value we need to focus all our efforts and internal resources on the upcoming Cx601 Phase III US trial while advancing with our other clinical stage assets, namely AlloCSC-01 in acute myocardial infarction and Cx611 in severe sepsis.”
TiGenix will be working with the regulatory agencies on this withdrawal, and is in the process of notifying healthcare professionals and remind them of the availability of therapeutic alternatives for patients with cartilage lesions of the knee.
