NorthStar Medical Radioisotopes Statement on Availability of Technetium 99m Generators and the FDA Drug Shortages List
November 18, 2022
Statement Attributable to:
Frank Scholz, Ph.D., President and COO, NorthStar Medical Radioisotopes
NorthStar Medical Radioisotopes, located in Beloit, Wisconsin, (“NorthStar”) recognizes the urgent medical need for technetium-99m (Tc-99m) to ensure patients have access to critical diagnostic imaging tests. Tc-99m is generated from molybdenum-99 (Mo-99) and used in over 40,000 patient studies per day in the United States. The overseas Mo-99 supply chain has historically been fragile and remains so today. Currently, several overseas reactors that produce Mo-99 are offline. As a result, the U.S. Food and Drug Administration (FDA) has placed Technetium Tc 99m Sodium Pertechnetate generators on the Drug Shortages List, recognizing its importance as a medically necessary product.
NorthStar’s Mo-99 production remains on track, and customers that have the RadioGenix® System (technetium Tc 99m generator) continue to access domestically sourced Mo-99 without interruption. In response to the Mo-99 shortage, NorthStar has planned to produce additional source vessels (i.e., the NorthStar version of Tc-99m generators) to meet customer demand, and product will be made available as it is released.
NorthStar is the only commercial U.S. producer of Mo-99, having provided reliable Mo-99/Tc-99m supply to the nation for over four years. We are proud to be the first and only domestic company to achieve commercial Mo-99 production in more than 30 years.
NorthStar continues to work aggressively to ensure sustainable domestic Mo-99 supply through establishing dual production and processing pathways using our electron accelerator technology on our Beloit, Wisconsin campus. We are executing on our plans to ramp-up production capacity to better serve radiopharmacies, health systems, and patients. Our production technology provides an environmentally preferable solution for Mo-99 supply because it is non-uranium based and does not create the long-lived radioactive waste streams associated with enriched uranium-based production methods.
NorthStar is committed to providing the United States with domestic and reliable radioisotope supply solutions to meet the needs of patients and to advance clinical research.
NorthStar also wishes to recognize the work of its colleagues at the University of Missouri Research Reactor (MURR®) to help ensure that Mo-99/Tc-99m is available.
More information regarding the availability of Tc-99m generators is available on the FDA Drug Shortages List here.
About NorthStar Medical Radioisotopes, LLC (NorthStar)
NorthStar Medical Radioisotopes is a commercial-stage nuclear medicine company focused on advancing patient care by providing diagnostic and therapeutic radioisotopes, novel radiopharmaceuticals and customized radiopharmaceutical development services. Its proven management team and state-of-the-art, environmentally preferable and non-uranium based technologies have made it an emerging leader at the forefront of U.S. medical radioisotope and radiopharmaceutical production. NorthStar is the sole domestic producer of molybdenum-99 (Mo-99), used to generate the standard-of-care diagnostic imaging radioisotope for assessing heart disease and cancer. It is expanding its industry-leading position in the growing area of therapeutic radioisotopes, used in targeted radiopharmaceutical therapy to treat cancer and other serious diseases, and is poised to be the first commercial-scale producer of non-carrier added (n.c.a.) actinium-225 (Ac-225) and copper-67 (Cu-67). NorthStar’s Radiopharmaceutical Contract Development and Manufacturing Organization (CMDO) unit will provide customized service offerings and specialized radiopharmaceutical expertise to help biopharmaceutical companies rapidly advance their development and commercialization programs. For more information about NorthStar’s comprehensive portfolio and patient-focused services, visit: www.northstarnm.com.
For NorthStar Medical Radioisotopes, LLC
Vice President Sales and Marketing
Executive Vice President and Chief Financial Officer