On March 16, 2020 NorthStar Medical Radioisotopes, LLC, a global innovator in the production and distribution of radioisotopes used for medical imaging, reported a corporate update highlighting the continued commercial progress of its RadioGenix System (technetium Tc 99m generator) (Press release, NorthStar Medical Radiostopes, MAR 23, 2020, View Source [SID1234555616]). NorthStar’s RadioGenix System is an innovative, high tech radioisotope separation platform indicated for use in producing the widely used medical radioisotope Tc-99m from non-uranium based molybdenum-99 (Mo-99). Since becoming commercially available in 2018, NorthStar has provided RadioGenix System customers with reliable Mo-99 production and supply, despite ongoing industry supply shortages incurred with legacy, uranium-based production methods. NorthStar also announced progress in its multi-pronged expansion efforts to ensure a reliable, domestically produced Mo-99 supply for the U.S. healthcare system, an expanded product portfolio and deployment of its technological expertise in scaling up commercial production for therapeutic radioisotopes copper-67 (Cu-67) and actinium (Ac-225).

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"Since the RadioGenix System became commercially available in 2018, NorthStar has demonstrated strong, consistent progress in advancing our plans to ensure reliable, non-uranium based radioisotope supply for the United States," said Steve Merrick, President and CEO of NorthStar Medical Radioisotopes. "During the past 16 months and despite disruptive supply shortages from other Mo-99 producers, NorthStar’s RadioGenix System customers have experienced reliable Mo-99 supply, enabling U.S. healthcare providers and their patients to have ready access to medically important Tc-99m diagnostic imaging studies, on time and when they need them. Recent FDA approval of two state-of-the-art filling lines at our Columbia, Mo. facility substantially increases our Mo-99 production efficiencies in filling Mo-99 source vessels that we provide to our customers. In line with our multi-pronged strategy to deploy dual Mo-99 processing hubs in Columbia and Beloit, Wis., we have completed construction of the isotope processing facility in Beloit. Upon completion of equipment installation and qualification, appropriate licensure and FDA approval, the isotope processing facility will augment current processing in Columbia, Mo. and provide dual production hubs for source vessels used by radiopharmacies having RadioGenix Systems. We would like to recognize the support that our partners at the University of Missouri Research Reactor (MURR), with whom we jointly produce Mo-99 in Columbia, Mo., continue to provide to NorthStar. Construction of NorthStar’s electron accelerator facility expansion in Beloit is well underway, with the first pair of accelerators being built in Belgium and planned for installation in Q4 2020. The accelerators will be used to convert Mo-100 to medically useful Mo-99, which will be processed in the adjacent isotope processing facility. 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."

"In further planning for future growth, NorthStar has expanded our product portfolio through acquisition of exclusive worldwide rights to an investigational fibrin-targeted cardiac diagnostic imaging agent, known as FibroScint, from Capella Imaging," added Mr. Merrick. "This Tc-99m agent may have potential applications across multiple cardiovascular conditions, and we intend to use RadioGenix System-produced Tc-99m in planned clinical studies. Additionally, NorthStar is broadening its technology platform to address important unmet needs in radioisotope supply. We are applying our development expertise towards commercial-scale production of promising therapeutic radioisotopes such as Cu-67 and Ac-225, which may have potential in treating a range of cancers. As recently announced, NorthStar and Clarity Pharmaceuticals signed a Letter of Intent for U.S. clinical and commercial supply of Cu-67, and the company has similar arrangements in place to supply Ac-225 to several undisclosed customers."

Mr. Merrick concluded, "Through successful financing efforts, and in conjunction with the U.S. Department of Energy’s National Nuclear Security Administration (DOE/NNSA) Cooperative Agreement awards, NorthStar is strongly positioned to continue its momentum towards being an industry leader in radioisotope technology, production and supply. DOE/NNSA has been instrumental in development of the RadioGenix System, system enhancements and our Mo-99 production activities. We are grateful for the efforts of all our government and business partners, and in particular, the team at MURR, and the many contributions that they have had on our programs. Together with our talented team of more than 200 employees, supply chain partners and our customers, we are working together to provide U.S. patients with reliable access to radioisotopes that can make a difference in healthcare for patients in the United States."

RadioGenix System commercial progress

NorthStar’s successful commercialization of the RadioGenix System continues its steady, planned growth with U.S. radiopharmacy customers.

Since becoming commercially available 16 months ago, RadioGenix Systems have provided customers with reliable Tc-99m supply through U.S. production of Mo-99, despite ongoing shortages from suppliers using legacy, uranium-based production methods.
The number of patient doses available from RadioGenix Systems continues to increase, with tens of thousands of doses provided for patients’ diagnostic imaging studies to date, and product growth continuing to track with the company’s plan.
Ongoing product development programs such as the FDA-approved RadioGenix System version 1.2 continue to help maximize operational utility and efficiency for customers in the production of Tc-99m.
Progress on initiatives to increase U.S. Mo-99 manufacturing and production

In its efforts to support increased Mo-99 production efficiencies and capacity, NorthStar is aggressively expanding for the future to ensure continued reliable domestic Mo-99 supply for the U.S. healthcare system. The company is executing on its multi-pronged expansion strategy for dual production hubs in Beloit, Wis., and Columbia, Mo.

In February, 2020, the FDA approved the addition of two Mo-99 filling lines at NorthStar’s facility in Columbia, Mo., enabling an immediate and significant increase in the speed in which RadioGenix System source vessels are filled, and thus increasing production efficiency and output. NorthStar produces non-uranium based Mo-99 in collaboration with its manufacturing partner, MURR.
NorthStar has two ongoing expansion projects underway in Beloit. The company’s isotope processing facility is nearing completion, and will augment processing at MURR once approved. Upon appropriate licensure by Wisconsin DHS and FDA approval, the facility will enable NorthStar to more than double its production of source vessels, which are used by radiopharmacies with RadioGenix Systems to produce Tc-99m for physicians and their patients.
In March 2019, NorthStar signed a contract with IBA for eight electron beam accelerators. Groundbreaking on its accelerator production facility took place in September 2019, and construction in Beloit is well underway. The initial pair of accelerators is being assembled in Belgium, with installation planned for Q4 2020. Like other NorthStar processes, accelerator production of Mo-99 using the "neutron knock-out" method is non-uranium based, highly efficient and, pending FDA approval, can provide customized scheduling flexibility and minimize supply risks for customers.
In mid-2020, NorthStar anticipates submitting a Prior Approval Supplement (PAS) to the FDA for concentrated Mo-98 (cMo-98). Pending FDA approval, the cMo-98 production process will improve Mo-99 specific activity concentration up to four-fold, and immediately enable larger capacity and multiple sizing options for Mo-99 source vessels for RadioGenix System customers.
NorthStar currently has the capability to meet up to approximately 10% of the U.S. demand for Mo-99. The company’s production capacity is expanding approximately every six months, with the expectation 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.
Strategic product portfolio expansion

NorthStar is expanding its company portfolio through strategic acquisitions that complement its current products.

In March 2020, NorthStar announced exclusive, worldwide licensing of an investigational fibrin-targeted cardiac diagnostic imaging agent, from Capella Imaging. The agent, known as FibroScint, may have potential applications across multiple cardiovascular conditions. Clinical investigation of FibroScint will begin with an exploratory Phase 1 study for its potential use in identifying thrombus (blood clots) in patients with serious heart failure who use a left ventricular assist device (LVAD). This Tc-99m imaging agent complements the commercially available RadioGenix System, and NorthStar intends to use RadioGenix System-produced Tc-99m in planned clinical studies.
Development of commercial-scale therapeutic radioisotope production

NorthStar is applying its expertise in the development and commercialization of innovative radioisotope technologies to advance commercial-scale production of therapeutic radiopharmaceuticals such as copper-67 (Cu-67) and actinium-225 (Ac-225).

In February 2020, NorthStar and Clarity Pharmaceuticals signed a Letter of Intent for NorthStar to supply Clarity with Cu-67, a radiopharmaceutical with potential for treating a range of cancers. NorthStar will be a major U.S. supplier of Cu-67 for Clarity in its clinical development and commercialization plans.
Additionally, NorthStar will supply Ac-225 to several undisclosed companies to support their clinical development and commercialization plans for therapeutic radiopharmaceuticals.
Corporate development and industry leadership activities

NorthStar is firmly positioned for sustained growth and increasing industry leadership.

NorthStar completed a $100 million financing with Oberland Capital in July 2019, with proceeds to be used to increase domestic production capacity efforts for Mo-99, implement additional RadioGenix System enhancements and advance its R&D activities.
In July 2019, NorthStar was awarded an additional $30 million Cooperative Agreement by DOE/NNSA to accelerate domestic Mo-99 production, as part of DOE/NNSA’s objective to establish reliable domestic Mo-99 production without the use of highly enriched uranium. NorthStar will use funds from the award to further advance its current neutron capture technology for domestic, non-uranium based Mo-99 production, and to continue development of enhancements for the RadioGenix System.
With an eye to the future, NorthStar is highly engaged in advancing educational initiatives for the nuclear medicine community and widely regarded/recognized as a leader in radioisotope technology development and commercialization.
At the June 2019 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging, the company presented information about the RadioGenix System and Tc-99m production using non-uranium based Mo-99 to an audience of nuclear medicine technologists, and provided an update on the outlook for current and future Mo-99 supply in the general session.
In August 2019, NorthStar and Purdue University College of Pharmacy announced a collaborative agreement expanding the College’s nuclear pharmacy training curriculum. NorthStar provided the College of Pharmacy with a RadioGenix System to enable nuclear pharmacy students the opportunity to become familiar with the advanced yet easy to operate equipment, and the College will provide NorthStar with feedback about the RadioGenix System and early testing of planned enhancements.
In August 2019, NorthStar participated in the Atoms for Humanity Summit, a forum of nuclear experts convened to look at the future of nuclear energy, and participated in a panel discussion around the next generation of nuclear medicine and health.
In February 2020, NorthStar was awarded the World Council on Isotopes’ President’s Award, which recognizes outstanding contributions to the promotion of isotope technologies and the use of isotopes to benefit mankind.
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/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 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 12 hour expiration time from elution is reached, whichever occurs earlier.