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180216_MOLY01

NorthStar Medical Radioisotopes CEO George Messina showed off a conversation piece he keeps in his office at the company’s Beloit headquarters: A coin-shaped molybdenum “target”—a small disc similar to the kind NorthStar zaps with neutrons in a Missouri nuclear reactor to make the medical isotope molybdenum-99.

The molybdenum target was light gray, and because it had never been used in any nuclear reaction, Messina said, it was as safe to handle “as a garden rock.” The disc felt dense and heavy, even though it was small—about the size of a golf ball marker.

“If you put it in a reactor for a week, you’d have one heck of an expensive golf ball marker,” Messina joked.

Indeed.

NorthStar earlier this month received federal regulatory drug approval, which the company said will make it the first domestic, private company in a quarter century to actively produce and supply the medical imaging isotope molybdenum-99 and its active isotope, technetium-99m, in the U.S.

In cracking into the medical moly-99 market, 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. Within coming years, the company projects it could supply two-thirds of the domestic market, NorthStar officials said.

NorthStar now plans to add 20 people to its staff of 70 at its headquarters on Gateway Boulevard in Beloit, company officials told The Gazette during a recent interview. They said the company has plans in the near future to expand its 55,000-square-foot Beloit headquarters, starting in the coming weeks by setting up commercial production of its RadioGenix equipment there, along with other operations.

The company’s patented and now federally approved RadioGenix is the device NorthStar’s customers will use to separate moly-99 from technetium-99m. Technetium-99m is the radioactive material moly-99 naturally decays into. It’s the material used to illuminate bone, heart and body tissue in as many as 50,000 medical tests a day in the U.S. alone.

The RadioGenix devices are central to NorthStar’s business model. Through agreements with NorthStar, radiopharmacy customers would use RadioGenix units to handle moly-99 that NorthStar produces and packages in special, heavily insulated metal vessels the company also will manufacture.

Radiopharmacies must work through licensing processes to use NorthStar’s equipment, but some of NorthStar’s customers already are visiting the Beloit facility to train on RadioGenix devices NorthStar houses in Beloit, NorthStar President and Chief Operating Officer Stephen Merrick said. Some of those customers could begin getting NorthStar’s products shipped to them in the next several weeks, Merrick indicated.

Now, almost all the world’s moly-99 is made from highly enriched uranium in a few reactors outside the U.S. and is processed in four facilities worldwide, NorthStar officials said. Moly-99 now is shipped by airplane, sometimes making an 18-hour flight before it passes through just a few supplier companies in the U.S. on its way to medical use.

Because moly-99 is radioactive, it begins to decay within hours, which can make distant international distribution a logistical conundrum, NorthStar officials said. The supply chain also has seen interruptions and shortages of medical moly-99 in the last several years because some foreign reactors are aging and at times need to be shut down for regulatory reasons.

For those reasons, the U.S. government has pumped millions of dollars into programs and grants to help startup moly-99 producers such as NorthStar develop and get approval to produce and supply moly-99 domestically.

As NorthStar cracks the market with its RadioGenix, it would be the first domestic producer and direct supplier of moly-99. Its immediate bet would be that radiopharmacies would prefer to deal with NorthStar over foreign producers and the domestic suppliers who now separate Technetium-99m for foreign producers.

NorthStar is geared to compete directly with the domestic suppliers, Merrick said.

“We’re focusing on radiopharmacies,” Merrick said. “It’s a far bigger market than just being a business-to-business supplier of moly-99. I always use the analogy of a Keurig (single-brew coffee) machine. We make the Keurig machine (RadioGenix), we supply the coffee, and we put it in the pots so you can make your coffee.”

Beloit the ‘heart’ of moly-99?

Within the coming months, major parts of NorthStar’s processes—including manufacturing and distribution of moly-99 storage vessels and manufacture of RadioGenix devices—are expected to be handled in Beloit, although equipment manufacturing is launching now at a NorthStar facility in Madison.

Merrick said that work will roll out as NorthStar sets up equipment and completes a lesser, “supplemental” federal approval to handle equipment manufacturing in Beloit.

Other projects planned will over the next two or three years will transform the 33-acre parcel into a multi-building campus Merrick said could house all aspects of the company’s equipment manufacturing and some of its moly-99 production. NorthStar eventually plans to use particle accelerators to produce moly-99 at a facility to be built in Beloit, Merrick and NorthStar Chief Science Officer Jim Harvey said.

NorthStar now produces moly-99 using a reactor at the University of Missouri Research Reactor Center in Columbia, Missouri. The company would continue using the Missouri reactor to have multiple production operations, Harvey said.

Merrick said NorthStar plans a 20,000-square-foot expansion in Beloit to dissolve radioactive targets and fill insulated vessels with moly-99 solution. The Beloit facility already is set up and approved to be a distribution hub to handle moly-99 vessels coming and going from radiopharmacies, Merrick said. He said NorthStar also plans to develop a facility for recycling partially spent moly-99 material for reuse.

Merrick calls the Beloit campus the intended “heart” of NorthStar’s operations.

Messina and Merrick said production of moly-99 in Beloit could begin by about 2021, which could be months after its Rock County competitor, Janesville-based startup SHINE Medical Technologies, says it will begin producing its own moly-99 at a facility planned for Janesville’s south side.

SHINE has developed particle accelerator technology it would use in a production facility the company says could break ground later this year and be in operation by 2020.

But it appears NorthStar will be the first of the two Rock County companies to domestically produce and supply moly-99 in the U.S.

Immediately, NorthStar aims to hire about 20 more employees to staff its Beloit facility, bringing the company’s overall headcount to about 150 people. That would include about 90 employees in Beloit, 50 research and development staff at a NorthStar facility in Madison, and about 10 workers in Columbia, Missouri, Merrick said.

In Missouri, NorthStar now uses a method of making moly-99 called “neutron capture,” a process that involves a nuclear reactor firing neutrons into a molybdenum-98 target to produce molybdenum-99, all without the use of highly enriched uranium.

That’s different from moly-99 production methods scientists at foreign government reactors have used for years: a process that involves nuclear fission using highly enriched uranium—the same material that can be used to make nuclear weapons.

NorthStar’s process also differs from a method SHINE plans to use to make moly-99.

SHINE has said its accelerators would send a beam of ions into a gas target, inducing a reaction that produces neutrons. The neutrons would then hit a second target—a solution of low-enriched uranium—and induce fission, a process that would create moly-99 and other medically useful isotopes.

A moly-99 duel?

SHINE is now building a test and demonstration facility in Janesville that is expected to be operational sometime in 2018, the company has said.

In a news release last week, SHINE said that by summer 2018 the facility will house and demonstrate SHINE’s proprietary accelerator technology.

Earlier this month, SHINE Vice President Katrina Pitas waved away NorthStar’s move into the domestic moly-99 market, telling The Gazette in an email that NorthStar produces “low-specific-activity” moly-99—a type Pitas said would require pharmacy customers to adjust to “new and complex distribution equipment.”

Pitas wrote that SHINE aims to produce “high-specific-activity” moly-99, the kind now produced with foreign fission reactors. That’s the type of moly-99 she said the medical market has “long been served” by.

Pitas indicated it remains to be seen whether the market will want to “change behavior” and use a new type of distribution equipment geared for use with a different type of moly-99.

When asked about SHINE’s statements, Messina said the U.S. Food and Drug Administration approved NorthStar’s RadioGenix equipment because NorthStar proved it can separate the active medical isotope, technetium-99m, in a way that makes it “identical” to any technetium-99m now on the market—including types processed from foreign reactors and the type SHINE plans to produce.

“If you were to sit down and take a look at the same amount of (competitors’) technetium-99m and take a look at ours, it would be identical,” Messina said. “If you make a statement that our technetium-99m is somehow inferior to what’s on the marketplace today, that kind of insinuates that the end product, the (medical) image quality (it would provide), is going to be poorer. Which is a lie.”

Competitors might claim to be uninspired by NorthStar’s jump to market, but those who fund NorthStar’s development are unlacing their purse strings.

Messina told The Gazette this week that NorthStar recently landed about $27 million in new funding for its continued development, a development that hadn’t yet been announced. Along with facility buildouts in Beloit, NorthStar’s plans include further research and development and forays into production of more than a half-dozen isotopes that could be used to treat cancer and immune system diseases such as HIV, Messina said.

NorthStar didn’t disclose the sources of new funding, but Hendricks Holding Co., owned by Beloit business mogul Diane Hendricks, has been a major investor in NorthStar’s development.

“They’ve been remarkable to work with,” Messina said. “I mean, they funded the building here. They’re funding a building across (the way).”

Messina also gives credit to federal agencies, including the U.S. Department of Energy, the National Nuclear Security Administration, and the U.S. Food and Drug Administration, which have spent years and dedicated millions of dollars to run programs and regulatory processes aimed at bringing domestic moly-99 production to fruition.

“We really have been very fortunate to team up with people who have worked as hard as they’ve worked for us,” Messina said. “We’re very grateful for that.”