TiGenix NV and Takeda Pharmaceutical Co. Ltd. received European Commission approval for Alofisel to treat conditions associated with Crohn's disease — an inflammatory bowel disease that affects the lining of the digestive tract.
The marketing authorization would allow Alofisel, or darvadstrocel, to treat complex perianal fistulas, or tunnels caused by ulcers around the anus, in adult patients with nonactive/mildly active luminal Crohn's disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy.
Alofisel is the first allogeneic stem cell therapy to receive central marketing authorization approval in Europe.
The drug received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use in December 2017.
Takeda agreed to buy Belgium-based TiGenix in January for about €520 million in cash, subject to certain conditions including the receipt of European marketing authorization for Alofisel.
Earlier, Belgium-based TiGenix had licensed Alofisel to Takeda for its exclusive development and commercialization outside the U.S.
The European approval will trigger a €15 million milestone payment from Takeda to TiGenix, along with the transfer of marketing application to the Japanese drugmaker.
Takeda's tender offer for TiGenix will also be subject to other conditions, including tendering of TiGenix securities representing 85% or more of its voting rights.