News | Molecular Imaging | July 18, 2023

NorthStar’s non-carrier added (n.c.a.) Ac-225 to be used in Bayer’s radiopharmaceutical programs 

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 

 

Related Radioisotope Content: 

NorthStar Medical Radioisotopes Provides Updates on Corporate Progress and Upcoming Milestones  

NorthStar Medical Radioisotopes Announces Supply Agreement with Aktis Oncology, Inc. for Alpha-Emitting Therapeutic Radioisotope Actinium-225 (Ac-225)    

NorthStar Medical Radioisotopes and Convergent Therapeutics Announce Supply Agreement for Therapeutic Radioisotope Actinium-225 (Ac-225)      

Update on HFR Reactor Outage – Medical Isotope Supply Returning to Normal      

Update on Unplanned Outage of the HFR Reactor      

SNMMI Issues Alert That HFR Outage Will Impact Isotope Supply      

NorthStar Medical Radioisotopes Advances Focus on Therapeutic and Specialized SPECT Radiopharmaceuticals      

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FDA Approves Additional Molybdenum-99 (Mo-99) Filling Lines at NorthStar Medical Radioisotopes      

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