Takeda Pharma is positioning itself to take over stem cell production in Europe from its partner TiGenix by 2021 after Swissmedic—the Swiss Agency for Therapeutic Products—said last week it has accepted for review the file for an investigational drug to treat patients with Crohn’s disease.
The compound, which is dubbed Cx601, was granted orphan status by Swissmedic last year and is currently up for review by the European Medicines Agency to treat complex perianal fistulas in Crohn’s patients. It’s highly anticipated Cx601 will get approved by the EU later this year.
The drug is currently being produced by Tigenix at its Madrid facility.
“After a transition period for technology transfer, during which TiGenix will manufacture Cx601, Takeda will assume responsibility for manufacturing the compound,” Luke Willats, a Takeda spokesman, told Fierce. “We are currently exploring how Takeda can best meet this responsibility following a potential European Commission (EC) approval decision for the compound in 2017.”
Willats did not say if Cx601 would continue to be produced in Madrid or at one of the Japanese pharma’s production facilities located in Austria, Belgium, Denmark, Estonia, Germany, Ireland, Italy, Norway, Poland and Russia.
TiGenix currently has U.S. rights to the compound, and has said it is in discussions with the FDA to work toward garnering marketing approval.