On Friday, the European Commission (EC) granted approval of Takeda’s Alofisel – previously known as Cx601 – for the treatment of complex perianal fistulas in adult patients with Crohn's disease, making it the first allogeneic stem cell therapy to receive central marketing authorization (MA) approval in Europe.
While autologous therapies are made using a patient’s own cells within a timely and specialised supply chain, allogeneic – or ‘off-the-shelf’ – cell products can be manufactured more in line with standard biotherapeutics, with consistent pharmaceutical release criteria, over time and from batch to batch.
Alofisel is made in plastic flasks in incubators at a one-litre scale, using stem cells taken from healthy volunteers who have undergone liposuction for cosmetic reasons at a facility in Madrid, Spain run by TiGenix.
TiGenix partnered with Japanese firm Takeda Pharmaceuticals in July 2016 for the development and commercialisation of the product.
Earlier this year, Takeda launched a voluntary conditional takeover bid for TiGenix valued at €520m ($647m). The deal has not yet been completed, and as such Takeda will pay TiGenix €15m for the successful approval of Alofisel.