CPDC to manufacture Azedra for Progenics Pharmaceuticals

Currently, Azedra is in Phase II registrational trial in patients suffering from pheochromocytoma and paraganglioma.

Progenics CEO Mark Baker said CPDC, and their host, McMaster University, serve as a model of how collaborative efforts can advance medical discoveries to commercialization.

"As we move forward in the radiopharmaceutical space, we recognize the significance of our selection of a manufacturing partner," Baker said.

"We believe CPDC has the proven ability to meet our demanding standards and timelines, in tandem with the ingenuity and flexibility necessary to manufacture small batches of radiopharmaceuticals in a cost-effective manner; a value creation point of great relevance to the ultra-orphan market."

Azedra is in a Phase IIb registrational trial under a Special Protocol Assessment with the US Food and Drug Administration (FDA) using a surrogate marker registrational endpoint.

After completion of the Phase IIb trial, the company plans to submit a new drug application (NDA) and request priority review to receive FDA action on the application within six months instead of the standard ten.

CPDC CEO and scientific director John Valliant said the company’s industry expertise and manufacturing capabilities, the skilled support staff and world-class facilities available to us at McMaster University and the support of the Canadian Government, make us uniquely qualified to collaborate with companies like Progenics.

"We believe this partnership between two innovative industry leaders will play a pivotal role in advancing new technologies for the treatment of cancers," Valliant said.

Apart from potentially treating pheochromocytomas and paragangliomas, the drug may also have utility in treating neuroblastomas and other neuroendocrine diseases.