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

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, 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 environmentallypreferred, 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.”

For more information: www.northstarnm.com