NorthStar Medical Radioisotopes Executes Supply Agreement with Bayer for Therapeutic Radioisotope Actinium‐225 (Ac‐225)
−NorthStar’s non‐carrier added (n.c.a.) Ac‐225 to be used in Bayer’s radiopharmaceutical programs −
BELOIT, Wis., July 18, 2023 – NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging, today announced the signing of a supply agreement for the therapeutic medical radioisotope, actinium‐225 (Ac‐225) with Bayer. Under the terms of the agreement, NorthStar will provide Bayer with its environmentally preferred, non‐carrier added (n.c.a.) Ac‐225.
NorthStar’s Ac‐225 will be used by Bayer for several of its radiopharmaceutical programs.
Ac‐225 is a high energy alpha‐emitting radioisotope of increasing interest for clinical studies investigating the use of radiopharmaceutical therapy (RPT), which combines select molecules with therapeutic radioisotopes, such as Ac‐225, to directly target and deliver therapeutic doses of radiation to destroy cancer cells in patients with serious disease. Ac‐225 carries sufficient radiation to cause cell death in a localized area of targeted cells while limiting damage to nearby healthy tissue due to the short range of alpha radiation. NorthStar is positioned to be the first commercial‐scale producer of n.c.a. Ac‐225 for advancing clinical research and commercial radiopharmaceutical products. The Company will use its environmentally preferred electron accelerator technology to produce n.c.a. Ac‐225 that is free of long‐lived radioactive contaminants and byproducts associated with other production methods, which pose regulatory and waste management challenges for hospitals and health systems.
“We are very pleased to enter this Ac‐225 supply agreement with Bayer, a global healthcare leader, and we look forward to working with them moving forward,” said Frank Scholz, Ph.D., President and Chief Executive Officer, NorthStar Medical Radioisotopes. “Our companies share a vision of developing and delivering innovative technology and compounds to drive research and ensure clinical availability of targeted radiopharmaceutical therapies for patients with cancer and other serious diseases. As a company at the forefront of U.S. radioisotope production, we are applying our proven accelerator technology expertise with molybdenum‐99 (Mo‐99) and copper‐67 (Cu‐67) to rapidly advance large‐ scale production of n.c.a. Ac‐225. The electron accelerator is installed and construction is progressing on schedule on our dedicated, state‐of‐the‐art Actinium‐225 Production facility, with initial production of radiochemical grade Ac‐225 planned in 2024. NorthStar expects to submit a Drug Master File to the FDA as quickly as possible thereafter, which, upon acceptance by the FDA, will allow it to provide cGMP grade Ac‐225.”
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’s molybdenum-99 (Mo-99) program is the sole source of domestic 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 (CDMO/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.
For NorthStar Medical Radioisotopes, LLC
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