DOE to cut Moly-99 deals with four US firms

February 25, 2019
by Thomas Dworetzky, Contributing Reporter
The DOE has finished its evaluations and picked four U.S. companies “to begin negotiations for potential new cooperative agreement awards.”

The winning applicants were among those responding to a “funding opportunity” to make Molybdenum-99 (Mo-99) without using highly-enriched uranium (HEU).

“Mo-99 is such a critical tool in healthcare. Doctors count on it every day,” said U.S. Secretary of Energy Rick Perry in the Department of Energy statement, adding, “this industry outreach helps to develop a reliable domestic supply of a vital medical isotope, reduce dependence on foreign imports, and bring new opportunity to the heartland.”

At present, the U.S. does not have a domestic commercial supply of Mo-99, and depends on importing it from foreign producers, mostly located in Europe, South Africa and Australia – or relying on a small amount created at DOE national laboratories.

The four U.S. firms about to begin negotiating include, NorthStar Medical Radioisotopes in Beloit, Wisconsin; SHINE Medical Technologies in Janesville, Wisconsin; Northwest Medical Isotopes in Corvallis, Oregon; and Niowave in Lansing, Michigan.

The funding available for the cooperative agreements could be as much as $15 million per company, with industry partners matching the awarded amounts.

DOE also funds, in its labs, work to advance the progress of Mo-99 production without HEU.

The challenge of producing Mo-99 without HEU is part of the worldwide challenge of production of the material by any means in the face of aging nuclear plants and growing demand.

In fact, in July, 2018, Congress was urged by SNMMI, OEMs, advocacy groups and nuclear medicine providers worldwide to provide money toward a domestic supply of Mo-99 in the U.S.

The group's letter called for the Subcommittee on Energy and Water Development to approve a provision in both the House of Representatives and Senate Fiscal Year 2019 Energy and Water Appropriation bills that would help fund production of Mo-99 as part of the National Nuclear Safety Administration’s medical isotope program.

“We are experiencing problems with international sources due to various technical reasons. Mo-99 and Tc-99m are used every day in the clinic, from cancer staging to the detection of cardiac disease to neurological evaluation,” Satoshi Minoshima, the president of the Society of Nuclear Medicine and Molecular Imaging and one of the signatories of the letter, told HCB News at the time. “It is critical for the U.S. to develop sustainable sources of Mo-99 so that we will not be reliant on foreign sources for a product that is essential to healthcare in the U.S.”

The firms chosen have been in the news of late, for both scientific and funding reasons.

In early February, NorthStar announced continued commercial progress of its RadioGenix System, which the FDA approved in 2018.

“The 12 months since FDA approval of the RadioGenix System and domestic Mo-99 have been pivotal for NorthStar successfully executing on our carefully planned strategy for rollout into the commercial marketplace and advancing our commitment to provide the U.S. healthcare system with a reliable, domestic, non-uranium-based Mo-99 supply for production of the important medical diagnostic imaging radioisotope, Tc-99m,” said Stephen Merrick, president and chief executive officer of NorthStar, adding, “with the RadioGenix System on the market, NorthStar has commercialized the first innovative technology for production of domestic Mo-99 in nearly 30 years, and we continue to execute upon our carefully staged launch of the product. Every week, a significant and growing number of Tc-99m patient doses are dispensed using RadioGenix Systems and non-uranium Mo-99, with market uptake continuing to be strong and growing.”

In November, 2018, SHINE announced that healthcare investor Deerfield Management Company had signed an agreement to provide $150 million to support diagnostic and therapeutic medical isotope manufacturing.

“We are enthusiastic about partnering with SHINE to help create a permanent and dependable solution to the industry’s Mo-99 shortage and to work on developing other medical isotopes for therapeutic use,” said Steve Hochberg, partner at Deerfield. “We look forward to continuing to work with the talented SHINE team and supporting them as the company scales and executes to address this important need.”

Northwest Medical Isotopes was in the news in January, when theColumbia Business Times reviewed the present state of its efforts in a partnership with Missouri University to make Mo-99 at the university's MURR reactor.

Plans now call for Northwest to be producing Mo-99 in a new facility in Columbia within the next three years, according to the paper, noting that, MURR will irradiate low-enriched uranium, which will then go to the Northwest plant to create Mo-99.

“The U.S. consumes about 80 percent of worldwide Moly-99, and it has not been produced domestically since the 1980s,” Northwest chief operating officer Carolyn Haass told the publication. “Our country has been developing a strategy for the production of Moly-99 since 2007. MURR has supported Northwest in research and development of Moly-99, which has helped them advance their science.”

The final selection, Michigan-based Niowave, just announced in mid-February that it had taken another step forward when it confirmed that it had produced several medical radioisotopes by fissioning low-enriched uranium using a superconducting electron linear accelerator.

The isotopes included Mo-99, Iodine-131 (I-131), Xenon-133 (Xe-133) and Strontium-89 (Sr-89).