Aug 30, 2021   SOURCE: BusinessWire

U.S. Department of Energy’s National Nuclear Security Administration Awards NorthStar Medical Radioisotopes $37 Million in Cooperative Agreement Funds to Further Domestic Molybdenum-99 (Mo-99) Production

NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for medical imaging and therapeutic applications, announced today that it has been awarded $37 million in cooperative agreement funds with the U.S. Department of Energy’s National Nuclear Security Administration (DOE/NNSA) as part of an industry outreach initiative to establish reliable domestic molybdenum-99 (Mo-99) production without the use of highly enriched uranium (HEU). NorthStar will use funds from the award to complete its neutron capture technology program and continue development and expansion of its accelerator production program. Both projects support non-uranium based, environmentally friendly production of the important medical radioisotope Mo-99. DOE/NNSA will provide $16.3M in funding for the neutron capture project and $20.7M for the accelerator project. NorthStar will also be required to provide an equal amount of matching funds. The awards will also be used in continuing development of enhancements for the FDA-approved and commercially available RadioGenix® System (technetium Tc-99m generator). The RadioGenix System uses reliable, domestic, non-uranium based Mo-99 to supply physicians and patients with technetium-99m (Tc-99m). Mo-99 is the parent radioisotope of Tc-99m, the most widely used medical imaging radioisotope, which is used to inform healthcare decisions for 40,000 U.S. patients daily.

“NorthStar deeply appreciates these new cooperative agreement awards and this financial and technical support provided by DOE/NNSA,” said Stephen Merrick, President and Chief Executive Officer. “NorthStar is the only commercialized U.S. producer of Mo-99, having provided reliable Mo-99/Tc-99m supply to the nation for nearly three years. We are proud to be the first and only company to achieve commercialized Mo-99 production through collaboration with DOE/NNSA to date. We are working aggressively to ensure sustainable domestic Mo-99 supply through dual production and processing hubs for additional capacity and scheduling flexibility. Funds from these cooperative agreements will be used for completion of our neutron capture technology program and Isotope Processing facility, for completing Phase 1 of our accelerator technology program and first Accelerator Production facility and progressing Phase 2 of the accelerator program. The funds will also support enhancements to the RadioGenix System to continue optimizing its utility with new technologies.”

Mr. Merrick continued, “Previous DOE/NNSA awards to NorthStar have been instrumental to our successful efforts to provide the nuclear medicine community and the patients it serves with a reliable domestic supply of Mo-99 produced without highly enriched uranium. They have supported our development and approval of U.S.-produced, non-uranium Mo-99 and the RadioGenix System as well as the development of FDA-approved concentrated Mo-98 (cMo-98), which has enabled a near four-fold increase in our Mo-99 production capacity. Equipment for two facility expansions has been partially funded with DOE/NNSA cooperative awards to date. They include our Isotope Processing facility, which is near completion and which will more than double production capacity for Mo-99, and our first-of-its-kind Accelerator Production facility, which has been completed, and is now being fitted out with advanced production equipment. I also want to recognize the work that our partners at the University of Missouri Research Reactor (MURR®) have done to help ensure that Mo-99/Tc-99m is available for radiopharmacies, healthcare providers, and, most importantly, patients.”

DOE/NNSA supports the establishment of a reliable domestic supply of Mo-99 produced in the United States without the use of HEU, and with support from Congress, is providing several cooperative agreement awards under a recent Funding Opportunity Announcement. As with all DOE/NNSA cooperative agreements for domestic Mo-99 partners, DOE/NNSA matches NorthStar funding dollar for dollar. NorthStar was selected by DOE/NNSA based on the evaluations and recommendations of an independent Merit Review Panel. With inclusion of the current and past awards, NorthStar has been awarded a total of over $100 million in cooperative agreement funds by DOE/NNSA.

NorthStar has a strategic, multi-pronged approach to increasing Mo-99 radioisotope production capacity across several platforms,” stated James T. Harvey, PhD, Senior Vice President and Chief Science Officer at NorthStar. “It includes our commercially utilized cMo-98 neutron capture process, and programs that are underway for addition of the use of electron beam accelerators, which is one of the most effective methods of producing Mo-99. Accelerator production will use commercially proven electron beam accelerators to “knock-off” a neutron from concentrated molybdenum-100 (Mo-100) to produce medically useful Mo-99. Like all of our Mo-99 processes, NorthStar’s Mo-99 accelerator production process is non-uranium based and environmentally friendly.”

About DOE/NNSA

Established by Congress in 2000, NNSA is a semi-autonomous agency within the U.S. Department of Energy responsible for enhancing national security through the military application of nuclear science. NNSA maintains and enhances the safety, security, and effectiveness of the U.S. nuclear weapons stockpile without nuclear explosive testing; works to reduce the global danger from weapons of mass destruction; provides the U.S. Navy with safe and effective nuclear propulsion; and responds to nuclear and radiological emergencies in the U.S. and abroad. Visit energy.gov/nnsa for more information.

About the RadioGenix® System (Technetium Tc- 99m Generator)

The RadioGenix System is an innovative, high tech separation platform that is approved for processing non-uranium based molybdenum-99 (Mo-99) for the production of the important medical radioisotope, technetium-99m (Tc-99m). Prior to availability of RadioGenix technology, the U.S. supply chain for Mo-99 has been subject to frequent and sometimes severe interruptions which negatively impact patient healthcare. Approved by the U.S. Food and Drug Administration (FDA) in 2018, the RadioGenix System is the first and only on-site, automated isotope separation system of its kind for use with non-uranium based Mo-99, designed to help alleviate shortage situations and expand domestic supply.

Indication and Important Risk Information about the RadioGenix® System and Sodium Pertechnetate Tc 99m Injection USP

The RadioGenix® System is a technetium Tc-99m generator used to produce Sodium Pertechnetate Tc 99m Injection, USP. Sodium Pertechnetate Tc 99m Injection is a radioactive diagnostic agent and can be used in the preparation of FDA-approved diagnostic radiopharmaceuticals.

Sodium Pertechnetate Tc 99m Injection is also indicated in

  • Adults for Salivary Gland Imaging and Nasolacrimal Drainage System Imaging (dacryoscintigraphy).
  • Adults and pediatric patients for Thyroid Imaging and Vesicoureteral Imaging (direct isotopic cystography) for detection of vesicoureteral reflux.

IMPORTANT RISK INFORMATION

  • Allergic reactions (skin rash, hives, or itching) including anaphylaxis have been reported following the administration of Sodium Pertechnetate Tc 99m Injection. Monitor all patients for hypersensitivity reactions.
  • Sodium Pertechnetate Tc 99m Injection contributes to a patient’s long-term cumulative radiation exposure. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure. Use the lowest dose of Sodium Pertechnetate Tc 99m Injection necessary for imaging and ensure safe handling and preparation to protect the patient and health care worker from unintentional radiation exposure. Encourage patients to drink fluids and void as frequently as possible after intravenous or intravesicular administration. Advise patients to blow their nose and wash their eyes with water after ophthalmic administration.
  • Radiation risks associated with the use of Sodium Pertechnetate Tc 99m Injection are greater in children than in adults and, in general, the younger the child, the greater the risk owing to greater absorbed radiation doses and longer life expectancy. These greater risks should be taken firmly into account in all benefit-risk assessments involving children. Long-term cumulative radiation exposure may be associated with an increased risk of cancer.
  • Temporarily discontinue breastfeeding. A lactating woman should pump and discard breastmilk for 12 to 24 hours after Sodium Pertechnetate Tc 99m Injection administration.
  • Sodium Pertechnetate Tc 99m Injection should be given to pregnant women only if the expected benefits to be gained clearly outweigh the potential hazards.
  • Only use potassium molybdate Mo-99, processing reagents, saline and other supplies, including kit/packs, provided by NorthStar Medical Radioisotopes. Do not administer Sodium Pertechnetate Tc 99m Injection after the 0.15 microCi of Mo-99/mCi of Tc-99m limit has been reached or when the 24 hour expiration time from elution is reached, whichever occurs earlier. Follow step-by-step instructions for use provided in the Operator’s Guide, RadioGenix System 1.2.

To report SUSPECTED ADVERSE REACTIONS, contact NorthStar® Medical Radioisotopes, LLC at 1-844-438-6659; or FDA at 1-800-332-1088 or www.fda.gov/medwatch.

For RadioGenix® System version 1.2 Full Prescribing Information, click here or visit https://www.northstarnm.com/wp-content/uploads/2021/08/RadioGenix-System-version-1.2-Package-Insert-Rev-05-July-2021.pdf.

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.