TiGenix licenses ex-US rights for Cx601 stem cell treatment to Takeda

Cx601 is a suspension of allogeneic adipose-derived stem cells (eASC) injected intra-lesionally.

Under the terms of the deal, TiGenix will receive an upfront cash payment of €25M, milestones up to €355M and double-digit royalties on net sales.

The initial anticipated milestone payment of €15m will be made after securing the marketing authorization of Cx601 in the European Economic Area (EEA).

In addition, Takeda will make a €10M equity investment in TiGenix sometime over the next 12 months.

After marketing authorization in the European Union, Takeda will become the marketing authorization holder and will be responsible for all commercialization and regulatory activities.

Takeda will also oversee further development activities of Cx601 for the indication of complex perianal fistulas in Crohn’s disease.TiGenix will retain the rights to develop Cx601 in new indications.

Takeda president of Europe and Canada Marc Princen said: "In Europe approximately one million people suffer from Crohn’s disease, with rising incidence. As a leader in gastroenterology, Takeda aspires to bring innovative treatments to patients where unmet medical needs exist.

"This collaboration and the addition of Cx601 to our portfolio highlights Takeda’s commitment to the development of treatments to improve the health of people living with gastroenterological disorders, leveraging our expertise in Inflammatory Bowel Disease and Crohn’s specifically."

In 2009, the European Commission granted Cx601 orphan designation to treat perianal fistulas, recognizing the debilitating nature of the disease and the lack of treatment options.