Highlights:
Collaboration will work to provide Ac-225 for clinical trials and commercial supply
NorthStar Medical Radioisotopes, LLC (NorthStar) and BWXT Medical Ltd., a subsidiary of BWX Technologies, Inc. (NYSE: BWXT) today announced that they have signed a Master Services Agreement (MSA), which will facilitate the production of actinium-225 (Ac-225), a critical medical isotope used to kill cancer cells while minimizing the impact to healthy tissues.
Medical isotopes are essential for a wide range of diagnostic and therapeutic procedures, including cancer treatments and advanced imaging techniques. Pursuant to the multi-year MSA, the companies will work together to process and purify radium-226 that will be irradiated to produce Ac-225. The scope of the agreement also includes potential target design projects and exploration of opportunities to provide backup supply to each other’s customers.
Jonathan Cirtain, president and chief executive officer of BWXT Medical, stated, “We are pleased to enter into this agreement with NorthStar. This collaboration is a significant step forward in our mission to support healthcare providers and patients by providing high-quality medical isotopes. Together, we are accelerating our radium-226 target design and fabrication efforts and establishing another irradiation relationship that will enable us to expand our production of Ac-225.”
BWXT Medical will collaborate closely with NorthStar, a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging, to streamline production processes, enhance safety protocols and innovate new methods of isotope generation. This collaboration will leverage the strengths of both organizations, combining cutting-edge technology with extensive industry knowledge.
“At NorthStar, we believe we’re on the cusp of a global paradigm shift in the development and commercialization of effective new radiodiagnostics and radiotherapies that can potentially be applied to devastating cancers and rare, complex conditions,” said Dr. Frank Scholz, NorthStar’s president and chief executive officer. “This agreement could be instrumental to the radiopharmaceutical industry and patient health. We are excited to collaborate with BWXT on actinium production and believe our complementary technical capabilities will play a critical role in bringing novel therapies to patients who so urgently need them.”
BWXT Medical recently announced that it has submitted a Drug Master File (DMF) for Actinium-225 API to U.S. Food and Drug Administration (FDA). DMFs are submissions to FDA used to provide confidential, detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of human drug products.
An active DMF enables clinical investigators or pharmaceutical companies to reference the filing in their regulatory submissions. BWXT Medical’s Ac-225 has been used in an early clinical study, and the DMF is now ready for reference to support later stage clinical studies and, ultimately, new drug applications.
