TiGenix

Market position

Developer of the first allogeneic stem cell therapy to receive central marketing authorization approval in Europe, positioned in inflammatory bowel disease, an area described as having high unmet medical need.

Alofisel was the first allogeneic stem cell therapy to obtain a central EU marketing authorization; the Phase III ADMIRE-CD trial showed statistically significant superiority over control on the primary endpoint of combined remission at 24 weeks and follow-up data indicating maintained remission over 52 weeks in treatment-refractory complex perianal fistulas.

Technology

A proprietary, validated allogeneic expanded adipose-derived stem cell (eASC) platform for autoimmune and inflammatory diseases, plus a cardiac stem cell (CSC) based platform for heart disease. The therapeutic approach centers on living cells rather than conventional drugs. Lead asset Cx601/Alofisel is a locally administered suspension of allogeneic eASCs used after conditioning of the fistula.

Go-to-market

Commercialization outside the United States was handled through an exclusive license, development and commercialization agreement with Takeda signed in July 2016; TiGenix retained U.S. rights and pursued a global pivotal Phase III trial for U.S. registration.

Patients with autoimmune and inflammatory diseases, in particular adults with complex perianal fistulas associated with non-active/mildly active luminal Crohn's disease who have not responded adequately to conventional or biologic therapy, reached via gastroenterology clinicians and surgeons.

Geography

Corporate headquarters in Leuven, Belgium, with operations in Madrid, Spain and Cambridge, Massachusetts, USA. Alofisel was approved for the European market, and regulatory steps were being explored for Japan, Canada and emerging markets.

History

Founded in 2000 in Leuven, TiGenix developed an allogeneic expanded adipose-derived stem cell platform and advanced Cx601 through a Phase III ADMIRE-CD trial in Europe, with 24-week results published in The Lancet on 28 July 2016. In July 2016 the company entered an exclusive ex-U.S. license, development and commercialization agreement with Takeda for Cx601. In December 2017 the EMA's CHMP adopted a positive opinion for Cx601, and on 5 January 2018 Takeda announced its intention to acquire the company at EUR 1.78 per share, valuing the transaction at approximately EUR 520 million on a fully diluted basis. The European Commission approved Alofisel (darvadstrocel) in March 2018; the takeover bid opened on 30 April 2018 and Takeda completed the acquisition on 31 July 2018 after the squeeze-out period expired, following which TiGenix's shares were delisted from Euronext Brussels and its ADSs from Nasdaq.

Risks & controversies

Completion of the takeover was subject to conditions precedent including EU marketing authorization for Cx601, U.S. antitrust clearance, a minimum 85% tender threshold on a fully diluted basis, and the absence of a material adverse effect. Holders who did not tender during the squeeze-out had their consideration deposited with the Belgian Bank for Official Deposits, available for thirty years.