Navidea Biopharmaceuticals, Inc. announced that it has entered into an agreement with Nordion (Canada) Inc. to produce and supply 123I-labeled NAV5001 for Navidea’s late-phase clinical trials.
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 [123I]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.
“This manufacturing and supply agreement with Nordion moves us closer to commencing our critical NAV5001 clinical programs in the differential diagnosis of Parkinsonian Syndromes and Dementia with Lewy Bodies,” stated Thomas Tulip, PhD, Navidea’s President and Chief Business Officer. “Nordion has extensive expertise in high quality production of 123I radiopharmaceuticals and a world class distribution system to reliably manage logistics to ensure that radiolabeled NAV5001 reaches clinical trial site destinations according to rigorous standards.”
“We are proud that Navidea has chosen Nordion manufacturing and distribution services for one of its important neurological radiopharmaceuticals,” said Tom Burnett, General Manager, Medical Isotopes, Nordion. “We offer a strong base of technical expertise, production and distribution services that we expect will enable Navidea to efficiently provide their investigational product candidate to doctors and medical centers involved in NAV5001 clinical trials throughout North America.”