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news.Nordion has entered into a contract manufacturing agreement with Navidea Biopharmaceuticals for NAV5001 a diagnostic imaging agent used to detect Parkinsonian Syndromes and Dementia with Lewy Bodies.
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The possibility of the agreement includes two phases such as a facility preparation and readiness phase and a clinical trial supply phase.
Nordion medical isotopes general manager Tom Burnett said, "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."
NAV5001 manufacturing will support Navidea’s Phase 2b and Phase 3 trials scheduled to begin in 2013.
The agreement extends over an initial three-year period.
Nordion will carry out the logistics and shipment operations of NAV5001 to third-party clinical trial sites.
Nordion is planning to manufacture NAV5001 at the Company’s Vancouver, B.C. operations.
Navidea president and chief business officer Thomas Tulip 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."