takeda

Japanese company Takeda Pharmaceutical and Belgium-based TiGenix have entered into an ex-US licence, development and marketing agreement for Cx601 to treat complex perianal fistulas in patients with Crohn’s disease.

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

Crohn’s disease is a chronic inflammatory disease that affects the patient’s gastrointestinal tract, often leading to complex perianal fistulas that do not have much treatment options.

Takeda Europe and Canada president Marc Princen said: "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."

Under the deal, TiGenix will receive upfront cash payment of €25m from Takeda Pharmaceutical, and be eligible to receive additional regulatory and sales milestone payments for up to €355m.

TiGenix CEO Eduardo Bravo said: "This agreement reduces the investment risks associated with building a pan-European marketing and selling infrastructure, and helps get this much-needed treatment option to patients and gives to Cx601 the best partner with the needed capabilities and resources to secure its commercial success."

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"With the completion of the deal, Takeda will become the marketing authorisation holder, along with being responsible for all commercialisation and regulatory activities."

In 2009, the European Commission (EC) granted orphan designation to Cx601 for the treatment of complex perianal fistulas owing to the debilitating nature of the disorder and the lack of proper treatment options.

With the completion of the deal, Takeda will become the marketing authorisation holder, along with being responsible for all commercialisation and regulatory activities.

The company will also be responsible for additional development activities of Cx601 for the indication of complex perianal fistulas in patients with Crohn’s disease.

TiGenix, on the other hand, will continue to enjoy the rights to develop Cx601 in new indications.


Image: CT scan of patient showing Crohn’s disease in the fundus of the stomach. Photo: courtesy of Samir.