TiGenix and Takeda announce Alofisel® (darvadstrocel) receives approval to treat complex perianal fistulas in Crohn's disease in Europe - Seite 2

"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 needs," said Dr. María Pascual, VP Regulatory Affairs and Corporate Quality at TiGenix. "We are pleased to offer the medical community an important new treatment option for patients with Crohn's disease who do not respond to currently available therapies."

Alofisel has been licensed to Takeda for the exclusive development and commercialization outside of the US. Receipt of the MA will trigger a milestone payment from Takeda to TiGenix of €15 million, and initiation of the process of transferring MA from TiGenix to Takeda.

"Today's marketing authorization, the first for an allogeneic stem cell therapy, represents a positive advancement in the treatment of patients with complex perianal fistulas in Crohn's disease," said Dr. Asit Parikh, Head of Takeda's Gastroenterology Therapeutic Area Unit. "We look forward to bringing this much needed treatment option to patients across Europe in the coming months."  

The receipt of MA from the EC is one of the conditions to completion of the tender offer announced by Takeda on January 5, 2018.

The consummation of the tender offer remains subject to other conditions, including the tender into the offer (in Belgium and the US), in aggregate, of a number of shares, warrants and American Depositary Shares that, together with all shares, warrants and American Depositary Shares owned by Takeda and its affiliates, represents or gives access to 85% or more of the voting rights represented or given access to by all of the outstanding shares, warrants and American Depositary Shares of TiGenix on a fully diluted basis as of the end of the initial acceptance period.

Contacts

For TiGenix:
Claudia Jiménez                                                           
Senior Director                                                              
Investor Relations and Communications                         
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Media enquiries:
Consilium Strategic Communications
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For Takeda:

Kazumi Kobayashi                                                         
Media in Japan