The agreement provides for the future commercial production after potential FDA approval of omidubicel, Gamida Cell’s investigational advanced cell therapy currently in 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.
“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,” stated Julian Adams, chief executive officer of Gamida Cell.
“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.”
“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,” said Alberto Santagostino, SVP, head of cell & gene technologies at Lonza.
“We seek to partner with such innovative companies who are pioneering important new treatment options to patients and look forward to enabling Gamida Cell to deliver omidubicel at a commercial scale after potential FDA approval.”
Lonza is an integrated solutions provider that creates value along the Healthcare Continuum. Through our Pharma Biotech & Nutrition segment and our Specialty Ingredients segment businesses, we harness science and technology to serve markets along this continuum.
We focus on creating a healthy environment, promoting a healthier lifestyle and preventing illness through consumers’ preventive healthcare, as well as improving patient healthcare by supporting our customers to deliver innovative medicines that help treat or even cure severe diseases.
Patients and consumers benefit from our ability to transfer our pharma know-how to the healthcare, hygiene and fast-moving consumer goods environment and to the preservation and protection of the world where we live.
Source: Company Press Release