NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging, announced that it has achieved a major milestone in its efforts to deliver commercial-scale production of the scarce therapeutic radioisotope actinium-225 (Ac-225). A custom-built IBA Rhodotron®TT 300-HE (High Energy) electron beam accelerator has been delivered to NorthStar’s new Ac-225 Production facility in Beloit, Wisconsin and installed in a specially designed building. This state-of-the-art facility will be dedicated exclusively to the production of non-carrier added (n.c.a.) Ac-225 and is part of NorthStar’s expansion plan to ensure scalable, reliable and environmentally preferable production of Ac-225 for treatment of patients with cancer and other serious diseases.
Ac-225 is a high energy alpha-emitting radioisotope of increasing interest by the medical community for use in clinical studies that use targeted radiopharmaceutical therapy (RPT). RPT combines specialized molecules with therapeutic radioisotopes, such as Ac-225 or copper-67 (Cu-67), to directly target and deliver therapeutic doses of radiation that destroy cancer cells in patients with serious disease, while sparing healthy tissue. Availability of Ac-225 for clinical trials, research, and eventual commercialized products is inadequate, due to limitations of current production technologies. Successful commercial-scale production is critical to ensuring that this promising therapeutic option is available for patients.
NorthStar is positioned to be the first commercial-scale producer of the therapeutic radioisotopes Ac-225 and Cu-67 and is applying its expertise in production technology to provide robust, reliable supply for advancing clinical research and supplying commercial radiopharmaceutical products. The electron accelerator technology will produce high purity, non-carrier added (n.c.a.) Ac-225 that is free of long-lived radioactive byproducts associated with other production methods, which pose regulatory and waste management challenges for hospitals, health systems and other healthcare institutions.
“Delivery of this electron beam accelerator brings NorthStar Medical Radioisotopes a step closer to commercial production of Ac-225 and marks a tremendous milestone event for NorthStar, nuclear medicine and patient health,” said Stephen Merrick, Chief Executive Officer, NorthStar Medical Radioisotopes. “NorthStar is applying the same development expertise to our therapeutic radioisotope programs that positioned us at the forefront of U.S. radioisotope production thanks to our novel Mo-99 program. We are utilizing innovative electron beam accelerator technology, which is one of the most effective methods of producing medical radioisotopes such as Ac-225 and Cu-67. The process is highly efficient, non-uranium based and environmentally preferable, and will provide scalable, flexible production capacity. With delivery and installation of this accelerator, progress on the new Ac-225 Production facility is well underway, with initial production of radiochemical grade Ac-225 planned for late 2023/early 2024. We expect to submit a Drug Master File to the FDA in 2024, which, upon acceptance, will allow NorthStar to provide cGMP grade Ac-225. NorthStar has n.c.a. Ac-225 production capacity to meet all customer needs from research through commercialization, and we can readily scale up further as market demand increases.”
Mr. Merrick continued, “We are extremely appreciative to all of our partners and stakeholders for their support in achieving this milestone: our private commercial investors, NorthStar’s committed and talented employees, our supply chain partners and our customers. In particular, we are grateful for the important contributions of IBA, (Ion Beam Applications S.A., EURONEXT), a leading global supplier of accelerators that is focused on bringing integrated and innovative solutions for the diagnosis and treatment of cancer, continues to be a tremendous collaborator in this effort, and we look forward to additional projects with them in the United States and globally. This is a very exciting time for NorthStar and those involved in nuclear medicine. We all share a vision to accelerate the future of patient health by providing innovative solutions to ensure robust, reliable access to radioisotopes that can make a positive difference in healthcare for people around the world.”
About NorthStar Medical Radioisotopes, LLC
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/CMO) services 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.