Northstar Medical Radioisotopes, LLC, a global provider of radiopharmaceuticals used for therapeutic applications, signed a supply agreement with Bayer for the therapeutic medical radioisotope, actinium-225 (Ac-225). NorthStar will provide Bayer with its environmentally preferred, non-carrier added (n.c.a.) Ac-225 for several of Bayer’s 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. 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 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.

Frank Scholz, President and CEO, NorthStar Medical Radioisotopes, said, “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 soon, and upon acceptance, will allow the company to provide cGMP grade Ac-225.