PharmaCell, a Netherlands-based CMO, agreed to buy TiGenix’ cell therapy production facility. In 2012 the facility passed cGMP inspection by the Dutch authorities and obtained approval from the European Medicines Agency for the production of ChondroCelect®, the company’s commercial cell therapy product for cartilage repair in the knee. ChondroCelect will continue to be manufactured at the facility as before under a long-term CMO agreement with PharmaCell, which intends to produce other commercial and investigational cell therapy and regenerative medicine products at the site.
Last October PharmaCell inked a deal with Dendreon for the European commercial production Provenge® (autologous peripheral blood mononuclear cells activated with PAP-GM-CSF or sipuleucel-T) dispersion for infusion. The product had previously been given marketing approval in the European Union for the treatment of asymptomatic or minimally symptomatic metastatic (nonvisceral) castrate-resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated. In the United States, Provenge was approved in 2010 and is produced by Dendreon in its own manufacturing facilities.