Nordion, a provider of products and services to the global health science market, has signed a contract manufacturing agreement with Navidea Biopharmaceuticals, a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals. Nordion will manufacture [123I] 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 IIb and phase III 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 operations.
"We are pleased to be able to work with biopharmaceutical firms such as Navidea and support the progress of their clinical trials through the use of our expertise and service capabilities in clinical supply manufacturing,” said Tom Burnett, general manager, medical isotopes, Nordion. “This agreement underlines Nordion's competency in contract manufacturing and providing customized solutions to efficiently bring products to market.”
Thomas Tulip, PhD, president and chief business officer, Navidea, said, "Nordion's world-class expertise in the production of 123I and proven core competency in global logistics will enable us to continue to drive forward our NAV5001 clinical programs in the differential diagnosis of Parkinsonian syndromes and dementia with Lewy bodies.”