NorthStar Medical Radioisotopes, LLC Signs Contract with IBA for Eight Rhodotron® Electron Beam Accelerators to Expand U.S. Production of Non-uranium Based Radioisotope Mo-99
– Accelerator technology key component of NorthStar’s multi-pronged Mo-99 production strategy –
BELOIT, Wis. – March 29, 2019 – NorthStar Medical Radioisotopes, LLC, a global innovator in the production and distribution of radioisotopes used for medical imaging, and IBA (Ion Beam Applications S.A., EURONEXT), the world’s leading provider of proton therapy solutions for the treatment of cancer, today announced the signing of a contract with NorthStar for the purchase of as many as eight Rhodotron® TT300 HE electron beam accelerators from IBA. NorthStar has issued purchase orders for the two initial units and intends to order the remaining units in coming years.
“We are very pleased to sign this important contract and look forward to working with IBA, based on its extensive, proven commercial expertise and ability to deliver electron beam accelerators designed for our specific requirements,” said Stephen Merrick, President and Chief Executive Officer of NorthStar. “Investing in accelerator technology is a key component of NorthStar’s multi-pronged approach to deliver domestic and non-uranium based production of the medical radioisotope molybdenum-99 (Mo-99) across multiple processing platforms. We plan to use these accelerators to expand production capacity, enhance production efficiencies and create manufacturing redundancies to further secure reliable, non-uranium based Mo-99 radioisotope supply for U.S. customers and patients. NorthStar successfully pioneered the first domestic production of Mo-99 in nearly 30 years, and with our RadioGenix® Systems commercially available and increasingly providing U.S. customers with reliable supply of the important medical radioisotope technetium-99m (Tc-99m) for patients’ diagnostic tests, our growth continues in line with plan. We are nearing completion of a facility expansion to more than double Mo-99 Source Vessel capacity production, and additional fill lines at our Columbia, Mo. facilities will increase the number of Mo-99 Source Vessels that we are able to ship weekly – both projects pending FDA approval. Groundbreaking on the accelerator facility in Beloit, Wis. is planned for later this year.”
Olivier Legrain, Chief Executive Officer of IBA commented, “We are delighted to sign this significant contract with NorthStar Medical Radioisotopes and thank them for the past and future years of collaboration. The Rhodotron® is the machine of choice to enable this type of advanced electron accelerator technology, helping to avoid shortages of the widely used radioisotope Mo-99. It also opens the opportunity to create new radiopharmaceuticals for diagnosis and/or treatment.”
“Electron beam accelerators are a highly effective method of producing Mo-99 that can provide customized scheduling flexibility and minimize supply risk for our customers,” said James T. Harvey, Ph.D., Senior Vice President and Chief Science Officer of NorthStar. “Like other Mo-99 production processes that we employ, the “neutron knock-out” (photo transmutation) process for electron accelerator production of Mo-99 is non-uranium based. It uses Mo-100 (which is enriched to more than 95% Mo-100) that is originally derived from natural molybdenum. The enriched product is then bombarded in electron beam accelerators to “knock-off” the extra neutron to form Mo-99.”
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 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 in February 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.
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.
• 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 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/2018/04/PI_Rev04_23mar2018.pdf.
About Medical Radioisotopes – Molybdenum-99 (Mo-99) and Technetium-99m (Tc-99m)
Tc-99m is a radioisotope used in a variety of diagnostic testing procedures. It is currently the most widely used medical radioisotope in the United States, used in more than 10 million diagnostic procedures annually. Tc-99m-based radiopharmaceuticals are used to diagnose and stage heart disease, cancer, infection, inflammation and other conditions.
Tc-99m is derived from the radioisotope Mo-99. The United States uses about 50% of the world’s Mo-99/Tc-99m for medical purposes, but U.S. supply of Mo-99 has been completely reliant on foreign sources and subject to frequent and sometimes protracted interruptions which negatively impact patient healthcare. Other Mo-99 producers continue to use enriched uranium in their processing which poses significant environmental concerns. NorthStar’s technology uses stable isotopes of molybdenum to produce Mo-99 domestically without incurring the concerns related to the management of toxic waste associated with Mo-99 production from enriched uranium.
IBA (Ion Beam Applications S.A.) is a global medical technology company focused on bringing integrated and innovative solutions for the diagnosis and treatment of cancer. The company is the worldwide technology leader in the field of proton therapy, considered to be the most advanced form of radiation therapy available today. IBA’s proton therapy solutions are flexible and adaptable, allowing customers to choose from universal full-scale proton therapy centers as well as compact, single room solutions. In addition, IBA also has a radiation dosimetry business and develops particle accelerators for the medical world and industry. Headquartered in Belgium and employing about 1,400 people worldwide, IBA has installed systems across the world.
IBA is listed on the pan-European stock exchange EURONEXT (IBA: Reuters IBAB.BR and Bloomberg IBAB.BB). More information can be found at: www.iba-worldwide.com
About IBA Industrial
IBA Industrial is part of the Other Accelerators division of IBA (Ion Beam Application S.A.). IBA Industrial develops, installs and maintains solutions for customers in a wide range of markets and applications, including (but not exclusive to) Medical Device sterilization in E-beam and X-ray. These applications are supported by two types of accelerators, the Dynamitron® and the Rhodotron®.
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.
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