AZEDRA is not approved for use outside of the United States.
BURTON-ON-TRENT, England, October 10, 2019 / B3C newswire / -- Clinigen Group plc (AIM: CLIN, ‘Clinigen’), the global pharmaceutical and services company, has launched a Managed Access Program for Progenics Pharmaceuticals, Inc. (NASDAQ: PGNX), 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 (1). 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% (3).
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.”
Healthcare professionals can obtain details about the AZEDRA Managed Access Program by calling the Clinigen customer service team on +44 1932 824001 or emailing managedaccess@clinigengroup.com.
Patients seeking medical information should contact their physician.
About AZEDRA®
AZEDRA is a radiotherapeutic agent indicated, 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.
About Clinigen Group
Clinigen Group plc (AIM: CLIN) is a global pharmaceutical and services company with a unique combination of businesses focused on providing ethical access to medicines. Its mission is to deliver the right medicine to the right patient at the right time through three areas of global medicine supply; clinical trial, unlicensed and licensed medicines. The Group has sites in North America, Europe, Africa and Asia Pacific.
Clinigen now has over 1,100 employees across five continents in 14 countries, with supply and distribution hubs and operational centres of excellence in key long-term growth regions. The Group works with 22 of the top 25 pharmaceutical companies; interacting with over 15,000 registered users across over 100 countries, shipping approximately 6.4 million units in the year.
About Progenics
Progenics is an oncology company focused on the development and commercialization of innovative targeted medicines and artificial intelligence to find, fight and follow cancer, including: therapeutic agents designed to treat cancer (AZEDRA®, 1095, and PSMA TTC); prostate-specific membrane antigen (“PSMA”) targeted imaging agents for prostate cancer (PyL™ and 1404); and imaging analysis technology (aBSI and PSMA AI). Progenics has two commercial products, AZEDRA, for the treatment of patients with unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma (rare neuroendocrine tumors of neural crest origin) who require systemic anticancer therapy; and RELISTOR® (methylnaltrexone bromide) for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies Inc.
Contacts
Clinigen Group plc
James Winterman, Senior Vice President, Unlicensed Medicines
+44 (0) 1283 495010
Instinctif Partners
Melanie Toyne-Sewell / Rozi Morris / Phillip Marriage
+44 (0) 20 7457 2020
clinigen@instinctif.com
1. Ayala-Ramirez, et al. J Clin Endocrinol Metab 96:717-725, 2011.
2. Martucci VL, Pacak K. Curr Probl Cancer. 2014;38(1):7-41.
3, Park J, Song C, Park M, et al. Korean J Urol. 2011;52:241-246.
Tags: Pheochromocytoma; 3-Iodobenzylguanidine; methylnaltrexone; Constipation; Survival Rate; Neural Crest; Paraganglioma; Adrenal Gland Neoplasms; Naltrexone; Quaternary Ammonium Compounds; Hypertension; Prognosis; Stroke; Heart Failure; Prostatic Neoplasms; Artificial Intelligence; Adrenal Glands;
