Navidea Biopharmaceuticals ($NAVB) has seen its fair share of CMO troubles, as problems with its last contract manufacturer delayed a much-anticipated FDA approval. Now, the diagnostics maker is hitching up with Nordion ($NDZ) to manufacture an in-development imaging agent, hoping to avoid more production setbacks.
Under the three-year deal, Nordion will produce NAV5001, Navidea's investigational diagnostic agent used to detect Parkinsonian syndromes and dementia with Lewy bodies. Nordion is tasked first with facility preparation and readiness, and then with manufacturing the radiopharmaceutical for clinical trials.
Nordion's work will support Navidea's Phase IIb and Phase III trials, beginning this year, and the CMO will also be responsible for producing and shipping NAV5001 to third-party clinical trial sites. Nordion will manufacture the imaging agent at its Vancouver operation, the company 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," Nordion's Medical Isotopes General Manager Tom Burnett said in a statement. "This agreement underlines Nordion's competency in contract manufacturing and providing customized solutions to efficiently bring products to market."
Back in September, Navidea endured an FDA rejection of its Lymphoseek diagnostic aid, as the agency took issue with the company's contract manufacturer. Navidea's shares plunged 23% on the news, and while Lymphoseek eventually won the FDA's blessing in March, Navidea is certainly looking to avoid similar problems as it works to get NAV5001 on the market.
- read Nordion's announcement