The U.S. National Nuclear Security Administration said Wednesday it is gearing up to provide another $40 million in cooperative agreements supporting commercial programs to develop production capabilities for the medical isotope molybdenum-99 (Mo-99).
That would be on top of $100 million pledged in recent years to four projects led by three companies: NorthStar Medical Radioisotopes, SHINE Medical Technologies, and General Atomics. In each case, the NNSA is providing $25 million, to be matched by the recipient.
However, General Atomics as of April has officially canceled its program following the withdrawal of partner Nordion, officials from the NNSA and Nuclear Regulatory Commission said during a Mo-99 stakeholders meeting in Arlington, Va.
Molybdenum-99 decays into the isotope technetium-99m, which is used globally in a range of medical services, including diagnosing heart disease and cancer as well as cardiac stress tests. The United States has not had a domestic production capability since 1989 and relies on sometimes-precarious foreign supplies. A number of companies, some receiving NNSA support and others not, are rushing to fill this gap.
The NNSA’s goal is to ensure a steady domestic U.S. supply of Mo-99 and to deter use in production of highly enriched uranium that could pose a nuclear proliferation threat.
Toward that, it received nearly $75 million for its isotope programs for fiscal 2018 in the omnibus budget signed into law in March. That will cover $15 million for technical support from national laboratories to companies developing Mo-99 production systems, $19.6 million to finish funding the existing cooperative agreements, and the $40 million for new opportunities that will be competed.
The new cooperative agreements would also be a 50-50 cost-sharing arrangement, with the plan to provide $10 million each to four projects. However, the NNSA could award fewer agreements if it does not identify four suitable proposals.
The funding opportunity announcement is being drafted and should be published around July, according to Crystal Trujillo, the NNSA’s domestic program manager for its Mo-99 program. The opportunity will be open for 30 calendar days.
“Each applicant must demonstrate its ability to scale up commercial production and the ability to produce 3,000 6-day curies of moly per week,” Trujillo said at the meeting.
Any company would have to forecast the point at which it could reach that production level, and how it would get there, the NNSA said.
Negotiations for funding awards should begin around January 2019, with awards expected early in the year, agency officials said.
NorthStar intends to file at least one application for the new funding, a spokeswoman said Friday. The Beloit, Wis., company has already received $50 million in pledged NNSA funding to support development of two separate production approaches: accelerator and neutron capture, the latter of which received approval earlier this year from the Food and Drug Administration.
SHINE and Northwest Medical Isotopes, both of which have secured NRC construction licenses for production plants they hope to open in a handful of years, both said Thursday they are considering whether to apply for NNSA funding. While SHINE received $25 million from the agency for its accelerator technology in Janesville, Wisc., Northwest Medical did not apply for a cooperative agreement for its Columbia, Mo., plant for extracting the isotope from low-enriched uranium targets.
BWXT Technologies, which has been recently been moving aggressivly into the medical isotope market, said its policy is not to disclose whether it is pursuing such opportunities.
Wednesday’s session included updates from the major U.S. companies developing Mo-99 production systems, including NorthStar, SHINE, Northwest Medical Isotopes, BWXT, Coqui Radiopharmaceuticals, and Niowave.
Missing at the meeting was General Atomics, which had partnered with Nordion and the University of Missouri Research Reactor on an NNSA-backed project to use selective gas extraction technology for Mo-99 manufacturing. But Nordion withdrew from the project in April, shortly before announcing the sale of its medical isotope business to BWXT.
General Atomics “notified us in April of this year that they would be terminating that, and we’re in the process of closing out that cooperative agreement,” said Pete Karcz, an NNSA senior program manager.
The company declined to comment on Thursday.
Following payment of General Atomics’ final invoices, the cooperative agreement will have “minimal funds” remaining, NNSA spokeswoman Lindsey Geisler said by email. “NNSA will evaluate options for the remaining funds once all activities have been closed out.”
