Clinigen Launches Managed Access Program for Progenics Pharmaceuticals for AZEDRA Outside the US

Clinigen Group plc has launched a Managed Access Program for Progenics Pharmaceuticals, Inc., an oncology company developing innovative targeted medicines and artificial intelligence to find, fight and follow cancer, to provide AZEDRA (iobenguane I 131) via a global Managed Access Program, outside the United States.

AZEDRA, a high-specific-activity radiotherapeutic agent, is approved in the United States for the treatment of adult and pediatric patients 12 years and older with iobenguane scan-positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy. AZEDRA is not approved for use outside of the United States.

Pheochromocytomas and paragangliomas are ultra-rare adrenal gland tumors, with approximately 55,000 new cases each year world-wide. Over a quarter of cases are genetically linked; the tumors frequently secrete high levels of hormones that can lead to life-threatening high blood pressure, heart failure, and stroke (2). The prognosis after diagnosis of metastatic pheochromocytoma or paraganglioma is highly variable, with 5-year survival rate estimates as low as 12%.

James Winterman, Senior Vice President, Unlicensed Medicines, Clinigen, said: “Clinigen’s new partnership with Progenics aligns with our mission to deliver the right medicine to the right patient at the right time.
“Through our global infrastructure and expertise in the supply of unlicensed medicines, eligible patients with pheochromocytomas and paragangliomas will now be able to gain access to this new medicine.”