- Strategic manufacturing agreement is signed for the future commercial production of omidubicel, a Phase 3 investigational advanced cell therapy designed to enhance the life-saving benefits of hematopoietic stem cell (bone marrow) transplant
- The 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 for anticipated commercial launch
Quote from Alberto Santagostino, SVP Head of Cell & Gene Technologies, Lonza Pharma & Biotech:
“This agreement is an example of our long-term manufacturing partnership capabilities and efforts to drive the industrialization of the cell therapy industry. Our cell therapy experience and expertise will enable us to best support Gamida Cell at this important phase in the development of omidubicel. We seek to partner with such innovative companies who are pioneering important new treatment options for patients, and we look forward to enabling Gamida Cell to deliver omidubicel at a commercial scale after potential FDA approval.”
Quote from Julian Adams, Chief Executive Officer, Gamida Cell:
“Gamida Cell and Lonza have had a strong relationship for the clinical supply of omidubicel, and we are pleased to extend our relationship as we prepare to potentially bring omidubicel to patients in a commercial setting after potential FDA approval. The ability to reliably provide an advanced cellular therapy to patients is critical, and this agreement provides Gamida Cell with access to a top-tier manufacturing site for the long-term commercial supply of omidubicel after potential FDA approval. Additionally, this agreement enables the supply of commercial product as we plan for the build-out of Gamida Cell's own commercial-scale cGMP manufacturing facility to augment production.”
Basel, Switzerland and Boston, MA – June 19, 2019 – Gamida Cell Ltd. (Nasdaq: GMDA), a leading cellular and immune therapeutics company, and Lonza (SWX: LONN) today announced that the companies have entered into a strategic manufacturing agreement. The agreement provides for the future commercial production after potential FDA approval of omidubicel, Gamida Cell's investigational advanced cell therapy currently in Phase 3 clinical development, designed to enhance the life-saving benefits of hematopoietic stem cell (bone marrow) transplant. An international, randomized Phase 3 study of omidubicel in patients with hematologic malignancies is currently ongoing, and omidubicel has not yet been approved for marketing in the United States 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.