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NorthStar Medical Radioisotopes Advances Focus on Therapeutic and Specialized SPECT Radiopharmaceuticals

March 3, 2021 Off By BusinessWire

− Organizational change positions NorthStar for next stage of growth and ongoing U.S. molybdenum-99 (Mo-99) production expansion −

− NorthStar poised to be first commercial-scale supplier of important therapeutic radioisotopes Copper-67 (Cu-67) and Actinium-225 (Ac-225); Initial specialized SPECT imaging portfolio includes fibrin-targeted FibroScint, with potential indications in cardiovascular disease −

BELOIT, Wis.–(BUSINESS WIRE)–NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for medical imaging and therapeutic applications, today announced organizational changes to drive focused growth for its therapeutic and specialized single photon emission computed tomography (SPECT) radioisotopes business. The new structure enables NorthStar to advance its efforts in radioisotope development and commercialization planning in parallel with its ongoing expansion programs for increased U.S. molybdenum-99 (Mo-99) capacity and production.

In conjunction with other organizational changes, NorthStar has appointed Dave Wilson, RPh., BCNP, as Vice President, Advanced Radiopharmaceutical and Therapeutic Technologies. He will have responsibility to advance NorthStar’s Copper-67 (Cu-67), Actinium-225 (Ac-225) and FibroScint programs to commercialization. Mr. Wilson, a five-year veteran at NorthStar, was previously Vice President, Commercial Operations for the Company, and has more than 25 years of experience in cGMP radiopharmaceutical manufacturing and radiopharmaceutical operations.

NorthStar is poised to be the first commercial-scale supplier of the important therapeutic radioisotopes Cu-67 and Ac-225, used in nuclear medicine to directly target and deliver therapeutic doses of radiation to destroy cancer cells in patients with serious disease. Development of promising therapies has been severely constrained by current production technology limitations and resultant limited supply. NorthStar is applying its commercial-scale radioisotope production technology expertise to provide reliable Cu-67 and Ac-225 supply for use in advancing clinical research and for commercial radiopharmaceutical products. The Company has agreements in place with several large pharmaceutical companies to provide clinical trial supply and commercial-scale quantities of Cu-67 and Ac-225.

NorthStar is also actively developing and growing its strategic portfolio of specialized SPECT radiopharmaceuticals to meet increasing clinical needs for SPECT imaging, driven by scientific advancements in cardiology and oncology. NorthStar has an exclusive, global licensing agreement with Capella Imaging, Inc. for FibroScint, a novel fibrin-specific diagnostic imaging agent labeled with the radioisotope technetium-99m (Tc-99m) for SPECT imaging. Pending successful development, FibroScint will have an initial application in the imaging of thrombus (blood clots) associated with left ventricular assist devices (LVADs). Other potential imaging applications include deep vein thrombosis and pulmonary embolism. Preclinical development of FibroScint is well underway, with an exploratory Investigational New Drug filing planned for later in 2021.

“NorthStar is now optimally positioned for continued growth and success in developing and delivering on our portfolio of medical radioisotopes to meet the needs of patients and advance clinical research,” said Stephen Merrick, President and Chief Executive Officer of NorthStar Medical Radioisotopes. “With a dedicated focus to developing commercial-scale production technologies for Cu-67 and Ac-225 radioisotopes, we can bring much-needed therapies to patients and researchers. The proven expertise and innovative approach as demonstrated in the successful development and commercialization of U.S.-produced, non-uranium based Mo-99 and the RadioGenix® System (technetium Tc-99 generator) will be brought to our therapeutic radioisotope programs.

Mr. Merrick continued, “We are also evaluating additional potential opportunities in specialized SPECT radiopharmaceuticals, with an eye to addressing unmet healthcare needs and synergies with our product portfolio. FibroScint has the potential to inform the management of multiple serious cardiovascular conditions, and complements the RadioGenix System in that we intend to use RadioGenix System-produced Tc-99m as we advance the compound into clinical studies.”

NorthStar is the only commercial producer of Mo-99 in the United States, having provided more than two years of stable U.S. production to date, and continues ongoing activities to expand U.S.-Mo-99 capacity and production. The Company is nearing completion of its Accelerator Production facility in Beloit, Wisconsin. This will ensure continued domestic Mo-99 supply for the United States through dual production and processing hubs for additional capacity and scheduling flexibility. The expansion of this facility will augment current processing in Columbia, Missouri to continue joint production of Mo-99 in partnership with the University of Missouri Research Reactor (MURR®).

About NorthStar Medical Radioisotopes, LLC (NorthStar)

NorthStar Medical Radioisotopes is a commercial-stage nuclear medicine company that develops, produces and manufactures reliable and environmentally-friendly diagnostic and therapeutic radiopharmaceuticals. Its first FDA-approved diagnostic imaging product is technetium-99m (Tc-99m), which is used in 40,000 patient imaging studies per day in the United States as standard of care to assess extent and severity of heart disease and cancer. Tc-99m is generated by NorthStar’s novel RadioGenix® System (technetium Tc 99m generator) which uses U.S.-produced, non-uranium based molybdenum-99 (Mo-99) as its source material. The Company is executing a well-defined plan to consistently increase the scale of Mo-99 production and to continuously improve efficiencies to meet anticipated increased demand. Therapeutic radioisotopes are increasingly important cancer treatment options, and NorthStar is developing commercial-scale production technologies to meet high demand for their use in ongoing clinical trials by multiple pharmaceutical companies. In addition, the Company is advancing a portfolio of other radiopharmaceuticals for use in therapeutic and diagnostic applications. For more information, visit: www.northstarnm.com.