By John Stang
BWX Technologies this week contended it by 2019 will begin operations to produce sufficient amounts of a critical medical isotope to fill all of North America’s needs.
“We’d have enough capacity for all the North American supply right off the bat” for molybdenum-99 (Mo-99), BWXT President and CEO Rex Geveden said in a Monday quarterly earnings conference call with stock analysts.
Geveden spoke shortly after the Lynchburg, Va.-based company announced a new proprietary patent-pending neutron capture process for manufacturing Mo-99. The material would be used in production of technetium-99m generators that would be sold to radiopharmacies.
The United States since 1989 has had no production capacity for molybdenum-99, leaving it at the mercy of sometimes problematic supplies from foreign producers.
“Supply continuity is a continuing problem. … All (molybdenum-99 irradiation sources) are regularly shut down for refueling and other unscheduled maintenance,” Geveden said. “With a globally dispersed and extremely aged infrastructure producing a product that loses value as it decays, logistics are burdensome, to say the least.”
Molybdenum-99 decays into technetium-99m, which annually is employed in over 30 million medical procedures around the world. The BWXT generators would extract the technetium from its parent isotope, for use in processes including medical imaging for heart disease, lung disease, cancer, and other health threats.
The global generator sales market is worth $400 million per year, BWXT said. The company would focus first on the North American market, which Geveden said is valued at about $160 million annually. “We’re making both the radioisotope, the moly-99, and delivering also the generator from which the ultimate medical product, the technetium-99 can be extracted,” he said.
The CEO highlighted a number of benefits of the BWXT production approach, which would not use enriched uranium that could pose a nuclear proliferation threat and would trim radioactive wastes produced under current processes.
BWXT’s venture will require obtain regulatory approvals from the U.S. Nuclear Regulatory Commission, the U.S. Food and Drug Administration, Health Canada, and the Canadian Nuclear Safety Commission.
This project is the start of BWXT’s more ambitious entry into the isotope market, Geveden said.
In April, the company announced its planned acquisition this year of Canada-based health company Nordion’s medical isotope business. The deal, pending regulatory approvals in Canada and the United States, would involve about 150 Nordion employees and two sites: Nordion’s primary medical isotope production plant in Kanata, Ontario; and an isotopes processing site in Vancouver, British Columbia.
“We expect to bolster Nordion’s existing portfolio of products as we employ this technology to develop other medical isotopes following the introduction of the moly-99 product line,” Geveden said. He added that the molybdenum-99 market has the potential to expand to $1 billion, and emphasized both the supply stability and price point BWXT would offer.
BXWT spokesman Jud Simmons added that significant North American production of molybdenum-99 will add to clinics’ confidence in using the resulting technetium-99m. He contended that would accelerate growth in the technetium-99m market already growing by 4 percent to 5 percent annually.
But BWXT has confirmed rivals that are also eyeing big chunks of the North American molybdenum-99 market.
The NRC last week authorized Northwest Medical Isotopes (NWMI) to build a molybdenum-99 production facility in Missouri. The company plans to break ground on the facility in the third quarter of 2018 in Discovery Ridge Research Park in Columbia, and hopes to begin operations in 2021. It aims to provide 50 percent of North America’s needs for molybdenum-99.
The NRC previously issued a construction permit to another molybdenum-99 venture: SHINE Medical Technologies, which wants to open a $100 million isotope production plant in Janesville, Wis. The company is expected to apply for its operations license by the end of 2018 — with at least two years of technical reviews to follow.
“There are a number of players that are in that market right now who make moly-99 using the traditional technique with uranium targets, and a number of potential entrants to the market, and they include NorthStar and SHINE and others,” Geveden said. “They have different techniques for manufacturing that product. I would assert that our technology is simple and very cost effective and has no radio waste streams to deal with, and so we like what we’re doing relative to both the current supply approach and also the potential entrants.”
