Takeda and TiGenix announce that Swissmedic has accepted for review the file on Cx601 for the treatment of complex perianal fistulas in Crohn’s disease patients

Takeda Pharma AG (TSE: 4502) (“Takeda”) and TiGenix NV (Euronext Brussels and Nasdaq: TIG) (“TiGenix”) today announced that the Swiss Agency for Therapeutic Products (Swissmedic) has accepted for review the file on investigational compound Cx601 to treat complex perianal fistulas in patients with Crohn’s disease.

Filing follows Swissmedic granting orphan drug status for Cx601 in September 2016, 1 which recognize s the rare and debilitating nature of the disease . The marketing authorization application (MAA) for Cx601 is already under review for the same indication by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Cx601 is a suspension of allogeneic expanded adipose - derived stem cells (eASC) locally administered for the treatment of complex perianal fistulas in patients with Crohn’s disease, who have had an inadequate response to at least one conventional or biologic therapy . 2 The Swissmedic filing submission incl uded the Phase III ADMIRE - CD trial data for Cx601. The ADMIRE - CD trial is a randomized, double - blind, controlled, Phase III trial designed to investigate the efficacy and safety of investigational compound Cx601 . 2 24 - and 52 - week data were included in the Swissmedic filing submission . The 24 - week data were published in the Lancet and showed both the primary endpoint and the safety and efficacy profile were met.(3)

“ Cx601 may have the potential to offer an alternative treatment option to current therapies, which are often associated with complications and a high failure rate for a disease that is difficult to treat and often leads to pain, swelling, infection and incontinence .” said Julie Puype, General Manager, Takeda Pharma Switzerland . “The submission to Swissmedic is a key milestone in the commercialization of Cx601 and reflects Takeda’s continued commitment to delivering innovative, therapeutic options for patients with gastrointestinal diseases.”

“Complications from Crohn’s disease, such as complex perianal fistulas, can have a severe impact on the lives of those affected .” said Dr. María Pascual, VP of Regulatory Affairs and Corporate QA at TiGenix . “ This submission by our partner Takeda reflects our joined continued efforts to make Cx601 available to patients and physicians beyond the European Union.”

Crohn’s disease is a chronic inflammatory disease of the gastrointestinal tract , which is thought to affect an estimated 6,100 people in Switzerland 4 and up to 1.6 million people in Europe . 5 Complex perianal fistulas are a complication for people living with Crohn’s disease . Despite modern medical and surgical advancements, they remain challenging for clinicians to treat 6 and are considered one of the most disabling manifestations of Crohn’s disease .( 7)