Takeda and TiGenix enter into licensing agreement for Ex-U.S. rights to Cx601 for the treatment of complex perianal fistulas in patients with crohn’s disease

Takeda Pharmaceutical Company Limited (TSE: 4502) (“Takeda”) and TiGenix NV (Euronext Brussels: TIG) (“TiGenix”) today announced that the companies have entered into an exclusive ex-U.S. license, development and commercialization agreement for Cx601, a suspension of allogeneic adipose-derived stem cells (eASC) injected intra-lesionally for the treatment of complex perianal fistulas in patients with Crohn’s disease. TiGenix will receive an upfront cash payment of €25 million. TiGenix will be eligible to receive additional regulatory and sales milestone payments for up to a potential total of €355 million and double digit royalties on net sales by Takeda. The first anticipated milestone payment is €15 million upon obtaining the Marketing Authorization of Cx601 in the European Economic Area (EEA). In addition, Takeda will make an equity investment of €10 million in the share capital of TiGenix within the next 12 months.

Crohn’s disease is a chronic inflammatory disease of the gastrointestinal tract. People living with Crohn’s disease often experience complex perianal fistulas for which there are limited treatment options. Recognizing the debilitating nature of the disorder and the lack of treatment options, in 2009 the European Commission granted Cx601 orphan designation for the treatment of complex perianal fistulas. In March 2016, TiGenix announced that it submitted the Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Cx601. The filing was based on the 24 week results of the ADMIRE-CD Phase 3 clinical trial. The company also recently announced top-line 52 week data confirming the efficacy and safety of a single injection of Cx601.

Following 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 be responsible for additional 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.

“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,” said Marc Princen, President of Europe and Canada, Takeda. “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.”

“TiGenix is pleased to partner with Takeda, a global pharmaceutical company with a strong track record and strong leadership position in gastroenterology. 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” said Eduardo Bravo, CEO, TiGenix. "This agreement further provides TiGenix with the financial strength to move forward with the clinical development of Cx601 in the U.S., which represents approximately 50 percent of the world’s Crohn’s market."