Nordion (NDZ) announced it has signed a contract manufacturing agreement with Navidea Biopharmaceuticals (NAVB). Under terms of the agreement, Nordion will manufacture NAV5001 a diagnostic imaging agent used to detect Parkinsonian Syndromes and Dementia with Lewy Bodies. The scope of the agreement includes two phases: a facility preparation and readiness phase and a clinical trial supply phase. The manufacture of NAV5001 is expected to support Navidea's Phase 2b and Phase 3 clinical trials slated to begin in 2013, with this agreement extending over an initial three-year term. Nordion is also responsible for managing the logistics and making arrangements for shipment of NAV5001 to third-party clinical trial sites on behalf of Navidea. Nordion is planning to manufacture NAV5001 at the company's Vancouver, B.C. operations. The agreement focuses on Nordion's cGMP manufacturing and supply of NAV5001 clinical trial material to be produced at Nordion's Vancouver, British Columbia, facility. Accordingly, Nordion will radiolabel Navidea's precursor drug product with Iodine-123 to form NAV5001, manage the logistics and make arrangements for shipment of NAV5001 to third-party clinical trial sites on behalf of Navidea. The agreement may serve as a predecessor to a commercial supply arrangement in the future.
- Health Care Industry
- Pharmaceuticals & Drug Trials