George Messina believes the federal government’s commitment to producing a medical isotope in the U.S. for the first time in more than 30 years is among the country’s highest achievements.
“There was World War II, the Manhattan Project and going to the moon,” said Messina, CEO of NorthStar Medical Radioisotopes. “Then there’s moly-99 with NorthStar.”
Messina delivered the lofty statement Tuesday from a podium outside the company’s Beloit headquarters.
The tent was packed with employees, politicians and key investors who turned out to see the startup celebrate its recent federal approval to sell the medical isotope molybdenum-99, known as moly-99, to North American radiopharamacies.
NorthStar officials and investors dug shovels into the snowy ground to toast construction of a new 20,000-square-foot facility, where NorthStar plans to dissolve radioactive moly-99 targets and fill insulated vessels with moly-99 to ship to customers.
The company could begin shipping its product by this summer, a company official told The Gazette.
In February, NorthStar got U.S. Food and Drug Administration approval to use RadioGenix, a proprietary technology it developed and patented that radiopharmacies will use to mete out doses of moly-99 for medical bone, heart and tissue tests.
Within months, NorthStar likely will be selling the moly-99 it now produces at a university reactor in Columbia, Missouri. By about 2021, the company hopes to begin producing the material in Beloit.
NorthStar will be the first U.S. company to crack the market with domestically produced moly-99 for medical use since the 1980s, officials said.
The company is producing moly-99 without high-enriched uranium. Efforts to secure a domestic supply of non-high-enriched moly-99 have been heavily subsidized by the U.S. Department of Energy, and federal officials are lauding those efforts as a step toward nuclear nonproliferation.
Moly-99 is a critical material used in thousands of medical tests every day. The supply is increasingly interrupted and bottlenecked because almost all moly-99 is now produced by aging foreign reactors and shipped internationally.
Stephen Merrick, NorthStar’s chief operating officer, told The Gazette that several radiopharmacy customers are working through a regulatory licensing process with the U.S. Nuclear Regulatory Commission. He said NorthStar likely will begin shipping moly-99 to those customers this summer.
“Several customers have had sites submit applications for their license to be amended,” Merrick said. “If it’s very lucky, it’ll be May—more likely, though, June—when some of those amendments will come through. In parallel, our contract negotiations are happening. So we would expect by the end of June at the latest to be shipping commercial products.”
Merrick said the company’s new facility, located just east of its Beloit headquarters, could be built in about a year. He said it might take NorthStar a few years to get approval to dissolve moly-99 targets and fill customer vessels in Beloit.
In the meantime, he said, NorthStar will operate production and supply chains in Beloit and Missouri in tandem.
NorthStar believes that within a year it could supply as much as 10 percent of moly-99 and technetium-99m in the nation’s $350 million to $400 million market.
Lisa Gordon-Haggerty, U.S. Department of Energy undersecretary, said projections are that NorthStar could supply two-thirds of the domestic market in coming years.
NorthStar also plans to produce more than a half-dozen isotopes that could be used to treat cancer and immune-system diseases such as HIV, Messina said Tuesday.
Currently, all of NorthStar’s clients are North American because of the limits of the company’s regulatory license.
“One step at a time, I think,” Merrick said. “Whilst our product can be used globally, it starts with the United States.”
Among those with their hands on ceremonial shovels Tuesday was Beloit business mogul Diane Hendricks, one of about 50 investors who have helped NorthStar launch into the domestic market—work Messina said has taken 16 years.
Hendricks said her commitment to NorthStar has grown since the company’s early days, but she said she always stressed that her investment depended on NorthStar setting firm roots in Beloit.
Beloit City Manager Lori Luther said NorthStar, with its 70 skilled employees, brings “significant versatility” to the city’s high-tech sector.
NorthStar’s chief competitor, Janesville startup SHINE Medical Technologies, has developed particle accelerator technology it plans to use in a production facility that could be operating on Janesville’s south side by 2020.
SHINE is now building a testing and demonstration facility near its future production site. That facility, SHINE says, will help it set up and test equipment that will be used in the production facility.
In an email to The Gazette on Tuesday, SHINE Vice President Katrina Pitas said the company is installing equipment in its demonstration facility and still has plans to break ground on the production facility later this year.