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Will cover manufacture and supply of diagnostic imaging agent for trials
May 16, 2013
By: Tim Wright
Editor-in-Chief, Contract Pharma
Nordion, Inc. has signed a three-year contract with Navidea Biopharmaceuticals to manufacture NAV5001, a diagnostic imaging agent used to detect Parkinsonian Syndromes and Dementia with Lewy Bodies. The agreement includes 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 trials scheduled to begin in 2013. Nordion is also responsible for managing the logistics of NAV5001 to third-party clinical trial sites and plans to manufacture NAV5001 at its Vancouver, B.C. 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. This agreement underlines Nordion’s competency in contract manufacturing and providing customized solutions to efficiently bring products to market,” said Tom Burnett, general manager, Medical Isotopes, Nordion. “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,” said Thomas Tulip, PhD, Navidea’s president and chief business officer.
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