The agreement applies to Europe, specifically, where an application for the drug’s approval has already been filed.
Cx601 is a suspension of allogeneic adipose-derived stem cells (eASC) applied as an injection directly into lesions. Perianal fistulas are a serious and disabling complication of this intestinal disease and currently have no effective treatments.
Because Crohn’s disease is considered an orphan disease – a condition affecting only a small percentage of the population – the European Commission designated Cx601 an orphan drug in 2009, speeding its development as a possible treatment of complex perianal fistulas. More recently, TiGenix filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in March requesting its approval. The filing was based on the 24-week results from the ADMIRE-CD Phase 3 clinical trial sponsored by TiGenix.
Trial results, announced in August 2015, showed Cx601 was significantly superior in inducing combined remission in treated Crohn’s patients with complex perianal fistulas compared to a placebo. Specifically, 49.5% of treated patients achieved combined remission (the study’s primary endpoint) at week 24 compared to 34.3% in the placebo arm. Efficacy results were consistent and robust, and treatment-related adverse events were comparable between the two arms.
“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,” Marc Princen, Takeda’s president for Europe and Canada, said in a press release.
If the MAA is approved, Takeda will become its holder and be responsible for all regulatory activities, as well as for all development activities concerning Cx601.
Under the licensing agreement, €25 million will be paid upfront to TiGenix, and the company will be eligible to receive further regulatory and sales milestone payments, up to a total of €355 million, plus additional royalties on net sales.
“This agreement … 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” across Europe, said Eduardo Bravo, TiGenix’s CEO. “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.”