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NorthStar Medical Radioisotopes Provides Updates on Corporate Progress and Upcoming Milestones

April 13, 2021 Off By BusinessWire

− NorthStar has provided reliable molybdenum-99 (Mo-99)/technetium-99m (Tc-99m) supply for more than two years as the only U.S. commercial Mo-99 producer

− Second NorthStar Mo-99 production and processing facility nearing completion ensuring even more reliable supply and additional Mo-99 production capability

− RadioGenix^® System sales continue growth, reliably providing hundreds of thousands of Tc-99m doses to inform patient healthcare needs in diagnostic imaging

− Commercial scale-up activities for therapeutic radioisotopes actinium-225 (Ac-225) and copper-67 (Cu-67) production underway with multiple supply relationships in place; SPECT imaging candidate FibroScint holds potential across multiple cardiovascular indications; additional SPECT opportunities in evaluation

− Strategic collaborations with IBA and Monopar Therapeutics target unmet needs for global Tc-99m availability and radiotherapeutic agent for severe COVID-19 and acute respiratory diseases, respectively

BELOIT, Wis.–(BUSINESS WIRE)–NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for medical imaging and therapeutic applications, today announced a corporate update highlighting progress across its key programs during the past twelve months and upcoming milestones.

“NorthStar has made significant advancements across our portfolio over the past year and we are excited about the Company’s future,” said Stephen Merrick, President and Chief Executive Officer of NorthStar Medical Radioisotopes. “In advancing our plans to ensure reliable, non-uranium based radioisotope supply for the United States, RadioGenix System (technetium Tc 99m generator) sales continue to increase. Our facility expansions, designed to ensure additional production capacity and supply of Mo-99, are nearing completion. Additionally, NorthStar has broadened its technology platform to address critical unmet needs in radioisotope supply by advancing commercial-scale development of promising therapeutic radioisotopes, and our novel cardiovascular SPECT imaging agent, FibroScint, is advancing towards eIND-enabling studies. We are collaborating with IBA to increase global availability of Tc-99 and with Monopar Therapeutics to develop a targeted radiotherapeutic agent for severe COVID-19 and other acute respiratory diseases. NorthStar anticipates sustained progress and growth as we expand our horizons globally and execute strongly in our mission to provide reliable radioisotope supply to support patients’ healthcare needs.”

Corporate development and industry leadership

NorthStar is firmly positioned for long term growth and increasing global industry leadership.

In March 2021, NorthStar implemented organizational changes to drive focused growth for its therapeutic and specialized SPECT radioisotopes business. The new structure enables NorthStar to advance its radioisotope development and commercialization planning efforts in parallel with ongoing expansion programs for increased U.S. Mo-99 capacity and production. In conjunction with other organizational changes, NorthStar appointed Dave Wilson, RPh, BCNP, as Vice President, Advanced Radiopharmaceutical and Therapeutic Technologies to lead these initiatives to commercialization.
In October 2020, NorthStar promoted Chief Financial Officer Paul Estrem to Executive Vice President and he was appointed to the NorthStar Board of Managers. Mr. Estrem has been instrumental in building momentum to create and expand NorthStar’s product portfolio. The expanded role positions him to guide NorthStar’s corporate strategy and drive its planned corporate and business development initiatives.
NorthStar is a widely recognized leader in radioisotope technology development and commercialization and the nuclear medicine industry. In July 2020, NorthStar led an update on its ongoing commercial Mo-99 production, expansion plans and the RadioGenix System at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) event, “Industry Outlook on Current and Future Mo-99 Supply.” In September 2020, then-Deputy Secretary of Energy Mark W. Menezes visited NorthStar to learn about its U.S.-based Mo-99 production, underscoring the Department of Energy’s commitment to reviving and expanding the U.S. nuclear sector and to reduce dependence on foreign imports while bringing new opportunities to the heartland.

RadioGenix System commercial progress

NorthStar’s innovative, high tech radioisotope separation platform, the RadioGenix System, uses U.S.-produced, non-uranium based Mo-99 to produce Tc-99m, the most widely used medical radioisotope that informs patient management decisions in 40,000 U.S. imaging studies daily.

RadioGenix System sales continue to steadily increase, with hundreds of thousands of doses provided for patients’ diagnostic imaging studies to date. Since becoming commercially available, RadioGenix Systems have provided reliable Tc-99m supply for customers with U.S.-produced Mo-99, despite intermittent shortages from suppliers using legacy, uranium-based production methods.
Ongoing product development programs continue to maximize operational utility and efficiency in producing Tc-99m. Since initial approval in 2018, NorthStar has received five subsequent Food and Drug Administration (FDA) approvals, the latest in January 2021 for concentrated Mo-98 and RadioGenix System updates.

Commercial U.S. Mo-99 manufacturing and production expansion

NorthStar is the only commercialized U.S. producer of Mo-99. It is aggressively expanding and establishing dual production and processing hubs for additional Mo-99 capacity to better meet customer demand and to ensure sustainable U.S. supply. Two facility expansion projects nearing completion in Beloit, Wisconsin, will augment current Mo-99 production and processing in Columbia, Missouri, conducted in partnership with the University of Missouri Research Reactor (MURR^®).

NorthStar’s Isotope Processing facility in Beloit will complement current Columbia processing capacity for Mo-99 source vessels. The facility will enable NorthStar to more than double its production of Mo-99, used with RadioGenix Systems to produce Tc-99m. Equipment installation is nearing completion, testing is underway with full qualification to be completed by the end of 2021. NorthStar expects FDA approval for the Beloit Isotope Processing facility in 2022.
NorthStar’s Accelerator Production facility expansion in Beloit will ensure additional Mo-99 capacity, enable flexible production scheduling and minimize customer supply risks. Like other NorthStar processes, accelerator production of Mo-99 using the “neutron knock-out” method is non-uranium based and highly efficient. The first pair of IBA electron beam accelerators will arrive for installation at NorthStar’s facility in April 2021. The Company anticipates accelerator production to begin in 2023, pending appropriate licensure and FDA approval.
In January 2021, the FDA approved NorthStar’s process for producing Mo-99 from concentrated Mo-98 and related software updates for the RadioGenix System. This approval is the first and only commercial-scale production of Mo-99 using concentrated Mo-98 technology. It increases NorthStar’s Mo-99 production capacity up to four times above its current technology, to provide higher activity source vessels to better meet customer demand.
FDA approval of concentrated Mo-98 allows NorthStar to serve as much as 40% of the U.S. demand for Mo-99 by the end of 2021. The Company expects that within three to five years, it will have the capability to regularly supply an estimated 65% of U.S. Mo-99 demand, and up to 100% of U.S. demand in an emergency.

Commercial-scale therapeutic radioisotope production − Ac-225 and Cu-67

NorthStar is poised to be the first commercial-scale supplier of the important therapeutic radioisotopes Ac-225 and Cu-67, both used to directly target and deliver therapeutic doses of radiation to destroy cancer cells in patients with serious disease. Current production technology limitations and resultant limited supply have severely constrained development of these promising therapies.

NorthStar is applying its commercial-scale radioisotope production expertise to provide reliable Ac-225 and Cu-67 supply to advance clinical research and for commercial radiopharmaceutical products. The Company is leveraging the same technology expertise demonstrated by the successful launch of the RadioGenix System and non-uranium based Mo-99 supply.
NorthStar has relationships in place with several large pharmaceutical companies to provide clinical trial supply and commercial-scale quantities of Ac-225 and Cu-67. The Company expects to secure long-term supply agreements during 2021.

Specialized SPECT portfolio

NorthStar is actively developing and growing its strategic portfolio of specialized single photon emission computed tomography (SPECT) radiopharmaceuticals to meet increasing clinical needs for SPECT imaging, driven by scientific advancements in cardiology and oncology.

NorthStar has an exclusive, global licensing agreement with Capella Imaging, Inc. for FibroScint, a novel fibrin-specific diagnostic imaging agent labeled with Tc-99m for SPECT imaging. Pending successful development, FibroScint will have an initial application in the imaging of thrombus (blood clots) associated with left ventricular assist devices (LVADs), and other potential imaging applications in deep vein thrombosis and pulmonary embolism. NorthStar intends to use RadioGenix System-produced Tc-99m in planned clinical studies of FibroScint. Advanced preclinical development is underway, with an exploratory Investigational New Drug (IND) filing for a Phase 1 study planned for early 2022.
NorthStar is evaluating additional potential opportunities in specialized SPECT radiopharmaceuticals to address unmet healthcare needs and synergies with its product portfolio.

Partnerships and collaborations

NorthStar selectively partners with leading organizations in strategic collaborations designed to augment its portfolio, maximize synergies and drive growth in areas of unmet medical need.

In June 2020, NorthStar and Monopar Therapeutics Inc. (Nasdaq: MNPR) announced a collaboration to help combat severe COVID-19 and other severe respiratory diseases. The collaboration will couple Monopar’s targeted monoclonal antibody MNPR-101 to a therapeutic radioisotope supplied by NorthStar to create a highly selective agent with potential to spare healthy cells while quickly reducing cytokine storms and their harmful systemic effects. In December 2020, Monopar and NorthStar announced that a clinical candidate was selected, enabling preclinical studies to begin and advancing one step closer to reaching human clinical trials.
In March 2021, NorthStar and IBA (Ion Beam Applications S.A., EURONEXT) announced a collaboration to increase global availability of Tc-99m, with potential to result in non-uranium Mo-99 being the leading worldwide source of Tc-99m. Worldwide, diagnostic imaging studies using Tc-99m inform healthcare decisions for approximately 30 million patients annually. The collaboration enables companies outside the United States to access Tc-99m Generation Systems (TCM Generation Systems) that utilize NorthStar’s proprietary non-uranium based Mo-99 produced using IBA’s accelerators and beamlines. Early discussions with interested companies are underway.

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.
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.
Unintended Re-186 Exposure: 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 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.

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/2020/12/radiogenix-system-12-package-insert-rev-03-29-dec-2020.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.