StemCell Therapy

Takeda Pharma is positioning itself to take over stem cell production in Europe from its partner TiGenix by 2021 after Swissmedicthe Swiss Agency for Therapeutic Productssaid last weekit has accepted for review the file for an investigational drug to treat patients with Crohns 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 Crohns patients. Its 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 pharmas 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.

See the original post here:
Takeda positioning itself to assume EU stem cell production within 5 years - FiercePharma

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