The deal supports early-access programs for the UM171 cell therapy after the European Commission granted conditional approval for certain adult blood cancers.
Cordex has signed an agreement giving FarmaMondo distribution rights for Zemcelpro (dorocubicel), also known as the UM171 cell therapy, in Argentina, Hong Kong and Singapore. The arrangement is designed to support early-access programs in those markets and broaden availability of the treatment for eligible patients through applicable early-access pathways. Zemcelpro is a personalized cryopreserved hematopoietic stem cell transplant product made from two cell components drawn from the same umbilical cord blood unit: UM171-expanded CD34+ cells and non-expanded CD34- cells. In the European Union, it is indicated for adults with malignant hematologic diseases who need an allogeneic hematopoietic stem cell transplant after myeloablative conditioning when no matched donor is available. ExCellThera, the parent company of Cordex, said the agreement marks another step in Cordex's strategy to expand global access to Zemcelpro. The product recently received conditional marketing authorization from the European Commission, and additional regulatory filings are planned in the United States, Canada, the United Kingdom and Switzerland. The therapy has been evaluated in more than 120 patients with hematologic tumors across clinical trials in the United States, Europe and Canada. It has received orphan drug and RMAT (regenerative medicine advanced therapy) designations from the FDA (U.S. Food and Drug Administration), and orphan drug, ATMP (advanced therapy medicinal product) and PRIME (priority medicines) designations from the EMA (European Medicines Agency).