Gamida Cell and Lonza ink manufacturing deal for omidubicel

Boston, USA-based cell therapy developer Gamida Cell (Nasdaq: GMDA) and Switzerland’s Lonza (VTX: LONN) today announced that they have entered into a strategic manufacturing agreement.

The agreement provides for the future commercial production after potential US Food and Drug Administration  approval of omidubicel, Gamida Cell’s investigational advanced cell therapy currently in Phase III clinical development, designed to enhance the life-saving benefits of hematopoietic stem cell (bone marrow) transplant. An international, randomized Phase III study of omidubicel in patients with hematologic malignancies is currently ongoing, and omidubicel has not yet been approved for marketing in the USA or any other jurisdiction.

This agreement follows a successful multi-year clinical manufacturing relationship and provides Gamida Cell with a path to commercial supply of omidubicel. Under this multi-year agreement, Lonza will construct and dedicate production suites at its Geleen, NL site, for the anticipated commercial launch. Additionally, the agreement enables Gamida Cell to increase the number of dedicated production suites over time to ensure commercial supply. Gamida Cell also has the option of expanding further into Lonza's global cell and gene therapy manufacturing network