July 5, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Takeda Pharmaceutical , based in Osaka, Japan, and TiGenix NV (TIG), headquartered in Leuven, Belgium, announced an exclusive licensing and development deal for Cx601 to treat complex perianal fistulas in patients with Crohn’s disease.
Cx601 is a suspension of allogeneic adipose-derived stem cells (eASC). Crohn’s disease is chronic inflammation of the gastrointestinal tract. Crohn’s patients often have complex perianal fistulas, which have few treatment options.
Takeda is paying TiGenix an upfront cash payment of 25 million euros. There are potential regulatory and sales milestone payments up to 355 million euros, as well as double digit royalties. Takeda will pay 10 million euros in an equity payment to TiGenix in the next 12 months.
“TiGenix is pleased to partner with Takeda, a global pharmaceutical company with a strong track record and strong leadership position in gastroenterology,” said Eduardo Bravo, TiGenix’s chief executive officer, in a statement. “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. 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.”
TiGenix submitted a marketing authorization application to the European Medicines Agency (EMA) for the compound recently based on 24-week data from the ADMIRE-CD Phase III clinical trial, which lasted 24 weeks. It also announced top-line data for 52 weeks that confirmed the efficacy and safety of a single injection of the drug.
TiGenix will maintain the rights to develop the compound for new indications, and also will hold onto U.S. rights.
“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,” said Marc Prince, Takeda’s president of Europe and Canada, in a statement.
On June 8, Takeda signed a global licensing, development and commercialization deal with Theravance Biopharma to develop TD-8954. TD-8954 is a drug to treat gastrointestinal motility disorders, including enteral feeding intolerance. That drug is currently in Phase II trials. The deal could bring in more than $125 million for Theravance.
On June 17, TiGenix announced preliminary six-month data from its Phase I/II trial of AlloCSC-01, a cardiac stem cell treatment for acute myocardial infarction.
