TiGenix and Takeda announce Alofisel® (darvadstrocel) receives approval to treat complex perianal fistulas in Crohn's disease in Europe

PRESS RELEASE

REGULATED INFORMATION

INSIDE INFORMATION

TiGenix and Takeda announce Alofisel^® (darvadstrocel) receives approval to treat complex perianal fistulas in Crohn's disease in Europe

                  

• First allogeneic stem cell therapy to receive central marketing authorization approval in Europe
• Alofisel offers a new treatment option for patients who do not respond to current available therapies and may be subject to numerous invasive surgeries^[1]

Leuven, Belgium, March 23, 2018 and Osaka, Japan, March 24, 2018, 18:00h CET - TiGenix NV (Euronext Brussels and NASDAQ: TIG) ("TiGenix") and Takeda Pharmaceutical Company Limited (TSE: 4502) ("Takeda") today announced that the European Commission (EC) has approved Alofisel (darvadstrocel), previously Cx601, for the treatment of complex perianal fistulas 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 should be used after conditioning of fistula.^[2] This marks the first allogeneic stem cell therapy to receive central marketing authorization (MA) approval in Europe.

The European approval follows a positive opinion by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP), in conjunction with the Committee for Advanced Therapies (CAT), in December 2017. The recommendation was based on results from TiGenix's Phase III ADMIRE-CD pivotal trial, which showed that Alofisel achieved statistically significant superiority versus the control group in the primary efficacy endpoint of combined remission at 24 weeks,^*1 as well as further follow-up data that indicated Alofisel maintained long-term remission of treatment refractory complex perianal fistulas in patients with Crohn's disease over 52 weeks.^[3]

"I am extremely excited about this approval, which brings allogeneic stem cell therapy one step closer to patients in Europe," said Professor Julian Panés, Head of the Gastroenterology Department at the Hospital Clinic of Barcelona (Spain) and President of the European Crohn's and Colitis Organisation (ECCO). "Alofisel offers a novel, minimally invasive and well tolerated alternative treatment option for patients with Crohn's disease who do not respond to currently available therapies, and who have until now had limited treatment options available."