NorthStar Medical Radioisotopes Advances Focus on Therapeutic and Specialized SPECT Radiopharmaceuticals
BELOIT, Wis .– (BUSINESS WIRE) – NorthStar Medical Radioisotopes, LLC, a global innovator in the development, manufacture, and marketing of radiopharmaceuticals for medical imaging and therapeutic applications, today announced organizational changes to drive the focused growth of its therapeutic and specialized single photon emission computed tomography (SPECT). Radioisotope business. The new structure allows NorthStar to advance its radioisotope development and commercialization efforts in parallel with its ongoing expansion programs to increase the capacity and production of Molybdenum-99 (Mo-99) in the United States.
In conjunction with other organizational changes, NorthStar has named Dave Wilson, RPh., BCNP, as vice president of Advanced Radiopharmaceutical and Therapeutic Technologies. He will be responsible for bringing NorthStar’s Copper-67 (Cu-67), Actinium-225 (Ac-225) and FibroScint programs to market. Mr. Wilson, a five year veteran at NorthStar, previously served as Vice President Commercial Operations for the company and has more than 25 years of experience in the cGMP radiopharmaceutical manufacturing and radiopharmaceutical industries.
NorthStar stands ready to be the first commercial supplier of the critical 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 severe disease. The development of promising therapies has been severely restricted by the current limitations in production technology and the resulting limited supply. NorthStar leverages its expertise in radioisotope production technology on a commercial scale to provide a reliable supply of Cu-67 and Ac-225 for further clinical research and commercial radiopharmaceutical products. The company has entered into agreements with several major pharmaceutical companies to provide clinical trials and quantities of Cu-67 and Ac-225 on a commercial scale.
NorthStar is also actively developing and expanding its strategic portfolio of specialized SPECT radiopharmaceuticals to meet the growing clinical needs for SPECT imaging based on scientific advances in cardiology and oncology. NorthStar has an exclusive global license 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 imaging thrombus (blood clots) associated with left ventricular assistive devices (LVADs). Other possible imaging uses include deep vein thrombosis and pulmonary embolism. FibroScint’s preclinical development is in full swing. An exploratory submission of Investigational New Drug is planned for late 2021.
“NorthStar is now optimally positioned for continued growth and success in developing and delivering our portfolio of medical radioisotopes to meet patient needs and advance clinical research,” said Stephen Merrick, President and Chief Executive Officer of NorthStar Medical Radioisotopes . “With a special focus on developing commercial production technologies for Cu-67 and Ac-225 radioisotopes, we can offer urgently needed therapies to patients and researchers. The proven expertise and innovative approach demonstrated in the successful development and commercialization of US-made Mo-99 without uranium and the RadioGenix® system (Technetium Tc-99 generator) are incorporated into our therapeutic radioisotope programs flow in.
Mr. Merrick continued, “We are also exploring additional potential opportunities for specialized SPECT radiopharmaceuticals to address unmet health needs and synergies with our product portfolio. FibroScint has the potential to educate management of several serious cardiovascular diseases and complements the RadioGenix system with the intention of using Tc-99m manufactured by the RadioGenix system when we bring the compound into clinical trials. ”
NorthStar is the only US commercial Mo-99 manufacturer to have delivered more than two years of stable US production and continues its ongoing efforts to expand the capacity and production of US Mo-99. The company is close to completing its Accelerator Production facility in Beloit, Wisconsin. This will ensure continued domestic supply of Mo-99 to the United States through two manufacturing and processing centers for additional capacity and planning flexibility. The expansion of this facility will expand current processing in Columbia, Missouri, to continue the joint production of Mo-99 in collaboration 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, manufactures and manufactures reliable and environmentally friendly diagnostic and therapeutic radiopharmaceuticals. The first FDA-cleared diagnostic imaging product is Technetium-99m (Tc-99m), which is used as the standard for assessing the extent and severity of heart disease and cancer in 40,000 daily imaging studies. Tc-99m is generated by NorthStar’s novel RadioGenix® system (Technetium Tc 99m generator), which uses US-made non-uranium-based Molybdenum-99 (Mo-99) as the feedstock. The company is implementing a well-defined plan to continuously increase the scale of Mo-99 production and continuously improve efficiency to meet the expected increased demand. Therapeutic radioisotopes are playing an increasingly important role in the treatment of cancer, and NorthStar is developing commercial-scale manufacturing technologies to meet the high demand for their use in ongoing clinical trials by several pharmaceutical companies. The company is also expanding a portfolio of other radiopharmaceuticals for use in therapeutic and diagnostic applications. More information is available at: www.northstarnm.com.