NorthStar Medical Radioisotopes and IBA Sign Contract for Rhodotron® Electron Beam Accelerator for Commercial Production of Therapeutic Radioisotope Actinium-225 (Ac-225)

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actinium-225 (Ac-225), an important therapeutic radioisotope that is in highly limited supply and for which no commercial-scale production technology currently exists.

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Thursday, November 18, 2021
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Research, Medical Devices, Biotechnology, Radiology, Health, Pharmaceutical, Other Science, Science, Oncology, Patient, Cell, Radiopharmaceutical, Technology, Google Images, Diagnosis, Radionuclide, Cancer, RPT, Actinium-225, Proton therapy, Cell death, Bloomberg, LLC, Sterilization, NorthStar, Drug Master File, B Corporation (certification), Reuters, Degenerative disease, Ion Beam Applications, FDA, Radiation, Multimedia, Disease, IBA, Medical imaging, Pharmaceutical industry, IBA, NorthStar Medical Radioisotopes, LLC (NorthStar), IBA, NORTHSTAR MEDICAL RADIOISOTOPES, LLC (NORTHSTAR)
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Wisconsin, BELGIUM, Europe, United States, LEUVEN
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IBA, NORTHSTAR MEDICAL RADIOISOTOPES, LLC (NORTHSTAR)
Summary
Key Points: 
  • actinium-225 (Ac-225), an important therapeutic radioisotope that is in highly limited supply and for which no commercial-scale production technology currently exists.
  • NorthStar previously purchased two Rhodotron accelerators from IBA for its newly completed molybdenum-99 (Mo-99) production facility.
  • NorthStar is at the forefront of U.S. radioisotope production as the only commercialized producer of the diagnostic imaging radioisotope molybdenum-99 (Mo-99).
  • Using first-in-kind and environmentally-sound electron accelerator technology, NorthStar is poised to be the first commercial-scale producer of therapeutic radioisotopes actinium-225 (Ac-225) and copper-67 (Cu-67).


NorthStar Medical Radioisotopes, LLC (‘NorthStar’), a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging, and IBA (Ion Beam Applications S.A., EURONEXT), the world leader in particle accelerator technology, today announced a new contract in which NorthStar will purchase a third Rhodotron® TT300 HE electron beam accelerator from IBA.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211118005633/en/

The accelerator will be exclusively used for the production of no-carrier added (n.c.a.) actinium-225 (Ac-225), an important therapeutic radioisotope that is in highly limited supply and for which no commercial-scale production technology currently exists. NorthStar previously purchased two Rhodotron® accelerators from IBA for its newly completed molybdenum-99 (Mo-99) production facility.

“We look forward to continuing to work with IBA, who have shown extensive commercial expertise and excellent performance in delivering electron beam accelerators for our Mo-99 production expansion project,” said Stephen Merrick, President and Chief Executive Officer of NorthStar. “NorthStar is at the forefront of U.S. radioisotope production as the only commercialized producer of the diagnostic imaging radioisotope molybdenum-99 (Mo-99). We are applying that same development expertise to rapidly advance large-scale availability of the therapeutic radioisotope Ac-225 for use in oncology and other indications, and we are excited about its potential in these disease areas.”

Olivier Legrain, Chief Executive Officer of IBA commented, “We are delighted to sign this latest contract with NorthStar Medical Radioisotopes and to continue to deliver innovative solutions for reliable radioisotope supply. IBA’s Rhodotron® accelerators provide the most advanced electron accelerator technology in the world, and we are excited for the opportunity to create new therapeutic radioisotopes such as Ac-225. With its radiotheranostic capabilities, combining targeted diagnosis and therapy, we believe that this radioisotope has significant potential in the treatment of cancer.”

The final stage of facility design is underway for NorthStar’s state-of-the-art Therapeutic Radioisotope production facility, which will be exclusively dedicated to Ac-225 production, with construction scheduled to begin in early 2022. Initial production of Ac-225 is planned for late 2023, and a Drug Master File will be submitted to the FDA in 2024. NorthStar’s proprietary process for the production of Ac-225 will use IBA’s Rhodotron® to enable commercial-scale n.c.a. Ac-225 production that is free of long-life radioactive byproducts associated with other production methods.

About Actinium-225 (Ac-225) and Therapeutic Radiopharmaceuticals

Ac-225 is a high energy alpha-emitting radioisotope of significant interest by the medical community for extensive use in clinical studies of targeted radiopharmaceutical therapy (RPT). RPT combines select molecules with therapeutic radioisotopes, such as Ac-225, to directly target and deliver therapeutic doses of radiation to destroy cancer cells in patients with serious disease. Ac-225 carries sufficient radiation to cause cell death in a localized area of targeted cells, while minimizing undesired dose to adjacent cells in patients. Clinical research and commercial use of Ac-225 are severely constrained by chronic short supply due to limitations of current production technology. NorthStar’s electron accelerator technology will produce high purity, no-carrier added (n.c.a.) Ac-225, free of long-lived radioactive byproducts. NorthStar is positioned to be the first commercial-scale producer of therapeutic radioisotopes Ac-225 and copper-67 (Cu-67) by applying its production technology expertise to provide reliable supply for advancing clinical research and supplying commercial radiopharmaceutical products.

About IBA

IBA (Ion Beam Applications S.A.) is the world leader in particle accelerator technology. The company is the leading supplier of equipment and services in the field of proton therapy, considered to be the most advanced form of radiation therapy available today. IBA is also a leading player in the fields of industrial sterilization, radiopharmaceuticals and dosimetry. The company, based in Louvain-la-Neuve, Belgium, employs approximately 1,500 people worldwide. IBA is a certified B Corporation (B Corp) meeting the highest standards of verified social and environmental performance.

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 NorthStar Medical Radioisotopes, LLC (NorthStar)

NorthStar Medical Radioisotopes is a commercial-stage nuclear medicine company that manufactures and distributes diagnostic and therapeutic radiopharmaceuticals. The Company’s proprietary state-of-the-art technology and proven management team have propelled it to the forefront of U.S. medical radioisotope production as the sole domestic producer of the diagnostic imaging radioisotope molybdenum-99 (Mo-99). Mo-99 is used to generate technetium-99m (Tc-99m), the standard of care in diagnostic imaging to assess the extent and severity of heart disease and cancer. NorthStar’s unique Mo-99 production process is non-uranium based and environmentally friendly. NorthStar is expanding its industry-leading position in the emerging area of therapeutic radioisotopes, which are used in targeted radiopharmaceutical therapy to treat cancer, respiratory and other diseases. Using first-in-kind and environmentally-sound electron accelerator technology, NorthStar is poised to be the first commercial-scale producer of therapeutic radioisotopes actinium-225 (Ac-225) and copper-67 (Cu-67). For more information about NorthStar’s comprehensive radiopharmaceutical portfolio, visit: www.northstarnm.com.

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