The U.S. National Nuclear Security Administration (NNSA) said Monday it had issued three cooperative agreements, each worth $15 million in matching funds, to companies aiming to produce the medical isotope molybdenum-99 (Mo-99).
The recipients are: Niowave, of Lansing, Mich.; NorthStar Medical Radioisotopes, of Beloit, Wis.; and SHINE Medical Technologies, of Janesville, Wis. An agreement with a fourth company, Northwest Medical Isotopes, of Corvallis, Ore., is pending.
The NNSA began negotiations with the companies in early 2019 to distribute $60 million in funding from its fiscal 2018 and 2019 budgets. The money is intended to promote production of Mo-99 through means other than reactors powered by highly enriched uranium, which can be used to build nuclear weapons.
The companies will submit monthly invoices to the NNSA for reimbursement of costs, through July 2022, a spokesman for the semiautonomous Department of Energy agency said by email.
Molybdenum-99 decays into the isotope technetium-99m, which is used globally in 80% of all nuclear medicine procedures. For decades starting in 1989, the United States had no domestic production source, forcing the nation to rely on sometimes-erratic supplies from other nations.
The four companies in the NNSA program are just some of those that aim to help the United States provide its own supply of the isotope. The agency’s goal is production of roughly 3,000 six-day curies of Mo-99 each week.
NorthStar today is already delivering Mo-99 source vessels to the market in collaboration with the University of Missouri Research Reactor in Columbia, Mo. The company announced last week that it had completed construction of a second, 20,000-square-foot isotope processing facility in Beloit, which would begin operations following a year of equipment installation and pending state and federal regulatory approval. Both sites eventually are intended to provide the Mo-99 for source vessels, which radiopharmacy customers would use to generate technetium-99 through NorthStar’s RadioGenix System.
The NNSA funding, plus the $15 million match from the company, “will be used to further advance NorthStar’s current neutron capture technology, which enables non-uranium based production of the important medical radioisotope Mo-99, and in continuing development of enhancements for the FDA-approved and commercially available RadioGenix® System,” NorthStar said.
SHINE last week filed its operations license application with the U.S. Nuclear Regulatory Commission for production of molyndenum-99 and other isotopes at a facility in Janesville. The company expects the agency review to last 18 to 24 months. Meanwhile, construction is due to be completed in 2020. “We will initiate operations at the plant as quickly as we can after receiving the operating license,” SHINE spokesman Rod Hise said by email Tuesday.
Hise said SHINE would use the $15 million from the NNSA to cover expenses including the NRC license application and review. He declined to say how much SHINE believes the NRC review will cost.
Niowave intends to use a superconducting electron linear accelerator for Mo-99 production. When the cooperative agreement negotiations were announced in February, the company said it hoped within 12 months to ramp up from research and development to production. Niowave declined to comment further this week.
Northwest Medical Isotopes is also building its manufacturing plant, which it plans to finish in 2020 and begin operating in 2021. Chief Operating Officer Carolyn Haass said completion of negotiations for the NNSA agreement was delayed by an agency request late last week on one “legal item.” That issue has been addressed, Haass said Friday, and Northwest Medical is waiting on final paperwork from the NNSA.
“Clarification on certain data was required and is currently progressing through the standard review and approval process,” according to the NNSA spokesman. “NNSA expects to award NWMI a Cooperative Agreement soon.”
The NNSA in 2010 issued $100 million worth of cost-matching cooperative agreements for Mo-99 projects managed by NorthStar, SHINE, and General Atomics. NorthStar took $50 million through two agreements for separate production approaches, while the other companies each received $25 million commitments. General Atomics later terminated its program following the withdrawal of a partner, Nordion.
The agency did not request funding in the upcoming fiscal 2020 for additional Mo-99 production cooperative agreements.
