NorthStar Medical Radioisotopes, LLC (NorthStar) and BWXT Medical Ltd., a subsidiary of BWX Technologies, Inc. (NYSE: BWXT), have entered into a Master Services Agreement (MSA) to enhance the production of actinium-225 (Ac-225), a crucial isotope in medical treatments aimed at eliminating cancer cells while sparing healthy tissue.
Medical isotopes are essential in both diagnostic and therapeutic medical procedures, encompassing cancer therapies and advanced imaging techniques. Under the terms of this multi-year MSA, NorthStar and BWXT Medical will collaborate on the processing and purification of radium-226, which will be irradiated to generate Ac-225. The agreement also covers potential target design projects and examines opportunities for mutual backup supply to each other’s customers.
Jonathan Cirtain, President and CEO of BWXT Medical, expressed enthusiasm about the partnership with NorthStar, emphasizing that the collaboration is a significant advancement in their mission to support healthcare providers and patients by delivering high-quality medical isotopes. He stated that the joint effort will accelerate their radium-226 target design and fabrication initiatives and establish another irradiation partnership to expand Ac-225 production.
The partnership aims to streamline production processes, enhance safety protocols, and innovate new methods for isotope generation. This collaboration will leverage the strengths of both companies, combining advanced technology with extensive industry expertise. Dr. Frank Scholz, President and CEO of NorthStar, highlighted the potential impact of this agreement on the radiopharmaceutical industry and patient health. He stressed that the collaboration with BWXT on actinium production could play a critical role in introducing new therapies for patients in need.
BWXT Medical recently announced the submission of a Drug Master File (DMF) for Actinium-225 API to the U.S. Food and Drug Administration (FDA). DMFs provide confidential, detailed information about manufacturing facilities, processes, or articles used in the production of human drug products. An active DMF allows clinical investigators or pharmaceutical companies to reference the filing in their regulatory submissions. BWXT Medical’s Ac-225 has already been utilized in an early clinical study, and the DMF is now ready to support later-stage clinical studies and new drug applications.
BWXT Medical manufactures custom radiopharmaceuticals, radiotherapies, and medical isotopes in an advanced manufacturing facility in Ottawa and a commercial cyclotron facility within TRIUMF, Canada’s particle accelerator center. As a subsidiary of BWX Technologies, Inc., BWXT Medical is dedicated to providing innovative nuclear solutions for global security, clean energy, environmental restoration, nuclear medicine, and space exploration.
NorthStar Medical Radioisotopes is a commercial-stage company at the forefront of advancing patient care through novel technologies to produce commercial-scale radioisotopes. These isotopes, when attached to molecules, can detect and treat cancer and other serious diseases. NorthStar’s leading position in radiopharmaceutical therapy is supported by its expertise in sophisticated radioisotope production, a proven management team, and state-of-the-art, environmentally friendly technologies. The company produces copper-67 (Cu-67) and is set to become the first commercial-scale producer of non-carrier-added (n.c.a.) actinium-225 (Ac-225). NorthStar’s Radiopharmaceutical Contract Development and Manufacturing Organization (CDMO) offers customized services and specialized expertise to help biopharmaceutical companies advance their development and commercial programs.
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