ARLINGTON, Va. — The U.S. National Nuclear Security Administration (NNSA) could soon award a new tranche of funding to support U.S. commercial manufacturing of the medical isotope molybdenum-99 (Mo-99), a senior official said this week.
“We’re working through the competitive procurement process and I hope that we can make an announcement on that soon,” William “Ike” White, chief of staff at the NNSA, said during a presentation Tuesday at the ExchangeMonitor’s Nuclear Deterrence Summit. He did not elaborate.
After last May announcing $40 million in anticipated cooperative agreements, the NNSA now expects to commit $60 million via an additional $20 million appropriated for the Mo-99 program in the current 2019 federal fiscal year.
When it initially discussed the upcoming agreements, the semiautonomous Department of Energy agency said it would likely provide $10 million each to four programs. However, it said more money could be divided between a smaller number of programs if four suitable proposals were not submitted. That flexibility is expected to remain in dividing the $60 million.
The NNSA issued the funding opportunity in July 2018. Recipients will be required to match the amount received from the government.
“Selections will be based upon the technical evaluations and recommendations of the independent Merit Review Panel,” the NNSA said in a statement Wednesday. It did not say when the agreements would be finalized.
Last year, three companies working to help re-establish a domestic production capacity for molybdenum-99 – NorthStar Medical Radioisotopes, SHINE Medical Technologies, and Northwest Medical Isotopes – said they were at least considering applying for the funding agreements. NorthStar and Northwest Medical declined to confirm this week whether they applied for cooperative agreements, while SHINE did not respond to a request for comment.
One company, Coqui RadioPharmaceuticals, said last fall it had applied for funding.
Department of Energy contractor BWX Technologies, which has been moving assertively into the medical isotopes business, said this week it was too soon to discuss future funding opportunities.
Unofficially, there are believed to be seven applications for the latest agreements.
Molybdenum-99 decays into the isotope technetium-99m, which is employed extensively around the globe in medical procedures including diagnosing cancer and heart disease. In the United States alone, 56,000 people undergo procedures each day that involve the isotope.
The United States last had its own domestic molybdenum-99 production capacity in 1989, and since then has been at the mercy of foreign supplies. That has proven problematic at times. In November, scheduled and unplanned outages at foreign reactors led to a significant shortage of Mo-99, NorthStar noted recently.
The aim of the NNSA program is also to promote production sources that do not employ highly enriched uranium, which could be used in production of nuclear weapons.
The NNSA previously committed $100 million to four Mo-99 projects managed by three companies: SHINE, NorthStar, and General Atomics. Each project received $25 million, to be matched by the company.
Beloit, Wis.-based NorthStar was pledged $50 million for two programs. Its program for neutron capture production of molybdenum-99 has received the full $25 million for first-phase development and regulatory approval. A separate initiative for accelerator-based manufacturing is due to receive that amount by December 2020 for initial-stage development, the NNSA said Thursday.
In a business update last week, NorthStar highlighted the U.S. Food and Drug Administration’s approval for a facility to produce the RadioGenix System, a technetium-99m generator that is now on the market. It also noted continued expansion of its Beloit production plant to 70,000 square feet, which is intended to increase the company’s capacity for filling Mo-99 source vessels by twofold. The expansion is scheduled for completion in early spring, followed by installation and testing of equipment and FDA approval of production processes
SHINE has also received the full $25 million for its accelerator-based program in Janesville, Wis. The company has received a Nuclear Regulatory Commission construction license for a new 43,000-square-foot production plant, and is expected in the first half of 2019 to submit an application for its operating license. It has said the review should last up to two years and hopes by 2022 to be producing commercial-level amounts of the isotope.
General Atomics terminated its gas-extraction program for Mo-99 production in 2018 after one of its partners, Nordion, withdrew. Nordion’s parent company subsequently sold its medical isotopes business to BWX Technologies.
Northwest Medical and BWXT did not apply for the original set of cooperative agreements.
