TiGenix and Takeda Announce Alofisel® (darvadstrocel) Receives Approval to Treat Complex Perianal Fistulas in Crohn's Disease in Europe

Leuven, Belgium and Osaka, Japan (ots/PRNewswire) -

- 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]

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.

(Logo: https://mma.prnewswire.com/media/658214/Takeda_Logo.jpg )

(Logo: https://mma.prnewswire.com/media/658215/TiGenix_Logo.jpg )

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 Panes, 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."

"This approval of Alofisel reflects our deep understanding and
recognized leadership in the development of allogeneic stem cells and
our firm commitment to developing innovative therapies for medical