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November 27th, 2019   /   Press Releases

NorthStar Medical Radioisotopes Marks 12 Months of Continuous U.S. Molybdenum-99 (Mo-99) Production and Supply


− RadioGenix® Systems have enabled reliable technetium 99m (Tc-99m) supply for patients’ diagnostic imaging procedures since product launch, despite ongoing industry supply shortages –

Beloit, Wis., November 27, 2019 – NorthStar Medical Radioisotopes, LLC, a global innovator in the production and distribution of radioisotopes used for medical imaging, announced a landmark for its RadioGenix System (technetium 99m generator) product and success in its efforts to provide the United States with dependable radioisotope supply. In the 12 months since becoming commercially available, NorthStar’s RadioGenix Systems have provided customers with reliable, uninterrupted Tc-99m supply through U.S. production of the medical radioisotope molybdenum 99 (Mo-99). Mo-99 is used to produce technetium-99m (Tc-99m), the most widely used diagnostic imaging radioisotope and of critical importance for patient healthcare. The FDA-approved RadioGenix System is an innovative, high tech radioisotope separation platform for use in producing Tc-99m from non-uranium based Mo-99.

NorthStar produces non-uranium based Mo-99 in collaboration with its manufacturing partner, the University of Missouri Research Reactor (MURR®). Other suppliers use overseas, uranium-based Mo-99 production technology, which has resulted in frequent and sometimes prolonged supply shortages of Mo-99, impacting Tc-99m availability for U.S. radiopharmacies and the patients they serve.

“Achieving 52 weeks of continual domestic Mo-99 production is a significant milestone for NorthStar Medical Radioisotopes, the nuclear medicine industry and U.S. healthcare providers,” said Stephen Merrick, President and Chief Executive Officer of NorthStar. “In its approval announcement in 2018, the FDA recognized the RadioGenix System as marking ‘the first domestic supply of Mo-99 in 30 years’1, and we are pleased with the progress we have demonstrated since that time. The number of patient doses available from RadioGenix Systems continues to increase, and growth of the product continues to track with our plan. We hear from customers that having RadioGenix Systems in their radiopharmacies has a positive impact in helping them consistently meet patient scheduling demands, and we are proud that NorthStar is leading the way in the domestic production of non-uranium based radioisotope supply.“

“NorthStar continues to advance our expansion plans for reliable U.S. radioisotope supply, and to plan for the future,” continued Mr. Merrick. “We have completed construction of our isotope processing facility in Beloit, Wis., which, upon completion of equipment installation and qualification, appropriate licensure and FDA approval, will augment current processing at MURR and provide dual production hubs for Mo-99. The facility will enable us to more than double production of the source vessels used by radiopharmacies having RadioGenix Systems to produce Tc-99m for physicians and their patients. Additionally, we are working toward final validation of two state-of-the-art fill lines at our Columbia, Missouri facility that, pending expected FDA approval, will further substantially increase the number of Mo-99 source vessels that we are able to ship to customers weekly. We recently broke ground on our 20,000 square foot electron accelerator facility expansion, with the first two accelerators currently being assembled and on schedule for delivery next year. We will use the accelerators to convert Mo-100 to the medically useful Mo-99, which will be processed in the adjacent Beloit isotope processing building. This will enhance production efficiencies and complete the creation of dual manufacturing operations to further secure reliable, non-uranium based Mo-99 radioisotope supply for U.S. customers and patients.”

About the RadioGenix® System
The RadioGenix System is an innovative, high tech separation platform that is approved for processing non-uranium/non-highly enriched uranium 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 in 2018, the RadioGenix System is the first and only on-site, automated isotope separation system of its kind for use with non-uranium/non-highly enriched 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

INDICATION
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.

• 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.

• Discard the first eluate from every new Potassium Molybdate Mo-99 Source Vessel to minimize the risk of unintended radiation exposure from Rhenium Re-186.

• 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 kits, 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 12 hour expiration time from elution is reached, whichever occurs earlier.

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 Full RadioGenix® System Prescribing Information, click here or visit
https://www.northstarnm.com/wp-content/uploads/2019/08/radiogenix-system-pi-july2019.pdf.

About NorthStar Medical Radioisotopes, LLC (NorthStar)
NorthStar Medical Radioisotopes is a nuclear medicine technology company committed to providing the United States with reliable and environmentally friendly radioisotope supply solutions to meet the needs of patients and to advance clinical research. The Company’s first product is the RadioGenix® System, an innovative and flexible platform technology initially approved by the U.S. Food and Drug Administration in February 2018 for the processing of non-uranium/non-highly enriched uranium based molybdenum-99 (Mo-99), the parent isotope of technetium-99m (Tc-99m), which is currently the most widely used diagnostic radioisotope for medical purposes. NorthStar’s proprietary and patented technologies include non-uranium based molybdenum-99 domestic production methods, patented separation chemistry systems, patented sterilization systems and a technology platform that potentially allows expanded product offerings to provide solutions in both the diagnostic and therapeutic markets. Founded in 2006 and based in Beloit, Wis., NorthStar Medical Radioisotopes, LLC is a wholly-owned subsidiary of NorthStar Medical Technologies, LLC. For more information, visit: www.northstarnm.com.

1https://www.fda.gov/news-events/press-announcements/fda-and-nrc-pave-way-first-domestic-supply-most-commonly-used-medical-isotope-diagnostic-imaging

CONTACTS:
For NorthStar Medical Radioisotopes, LLC
Corporate:
Lisa Holst
Vice President Sales and Marketing
678-471-9027
[email protected]

Media:
Priscilla Harlan
781-799-7917
[email protected]


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