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A Gazette file photo shows company officials entering the headquarters of Beloit radioisotope producer and supplier NorthStar Medical Radioisotopes. NorthStar says it received federal drug approval Thursday to hit the market with medical molybdenum-99 it plans to sell to customers, including specialty pharmacies.

Gazette files

BELOIT

After months awaiting federal approval and years developing a system to become a domestic supplier of medical molybdenum-99, Beloit company NorthStar Medical Radioisotopes is clear to hit the market.

A company insider said NorthStar received approval Thursday from the U.S. Food and Drug Administration to sell and supply moly-99 it produces using a government nuclear reactor in Missouri.

Jon Coulter, managing director of Hendricks Holdings in Beloit and a member of NorthStar’s board of managers, said the FDA approval letter, which he said was dated Thursday, means NorthStar can begin ramping up for its entry into the domestic moly-99 market.

That makes NorthStar the first company in the U.S. in a quarter century to be a domestic seller and supplier of moly-99.

“Now, as of today, we’re able to sell it. That’s really what this (approval) means today,” Coulter said.

NorthStar and a Janesville company, SHINE Medical Technologies, have been vying for years to be the first private companies in the U.S. to produce and supply moly-99 and other radioactive compounds for use in medical tests.

The moly-99 produced by NorthStar would be metered into doses at specialty pharmacies using NorthStar-designed equipment that operates without the use of radioactive, high-enriched uranium, the company has said.

Moly-99 is used to light up bone and other tissue in thousands of medical tests a day.

Coulter said NorthStar on Thursday had teleconferences planned with the FDA and the U.S. Department of Energy. Both of those agencies have played major roles in moving NorthStar through the processes of planning and approval of domestically produced moly-99.

Hendricks Holdings has a financial stake in NorthStar, company officials have said.

In a news release Thursday morning, NorthStar CEO George Messina called NorthStar “the first and thus far only company to achieve the objective of being the first U.S. producer of Mo-99 in more than 25 years.”

He said the company was “extremely proud to pioneer domestic production of Mo-99 that is independent of uranium-based product.”

NorthStar has made no public announcements on how soon it could enter the market, but company sources have indicated NorthStar has been producing moly-99 for some time but not selling it.

The Gazette on Thursday could not immediately reach NorthStar officials for comment.

Moly-99 is produced mainly in foreign government laboratories using nuclear reactors, many of which operate off highly enriched uranium also used to make nuclear weapons. Moly-99 is projected to be in critically short supply as foreign governments phase out aging reactors.

The U.S. Energy Department issued a news release Thursday morning trumpeting the FDA’s approval of NorthStar’s technology, calling it a “win-win” for “national security and health care.”

The agency said NorthStar’s processes move moly-99 production away from processes that use weapons-grade uranium.

“The domestic production of this critical medical isotope without highly enriched uranium reduces global proliferation threats while also providing a more reliable supply to health care providers that need moly-99 for diagnostic medical procedures every single day,” said Steven C. Erhart, Department of Energy acting under secretary for nuclear security and National Nuclear Security Administration administrator, in a statement.

In 2012, Congress passed the American Medical Isotopes Production Act, a law that directed the Department of Energy to start a program to support projects that produced medical moly-99 without highly enriched uranium.

The federal government has awarded both NorthStar and SHINE millions of dollars in matching grants.

NorthStar has worked with the federal government on development of its own processes for seven years, the Department of Energy said.

NorthStar uses a government-owned research reactor in Missouri to produce its moly-99, and its Beloit headquarters is set up as a distribution hub for moly-99 that will be shipped to radiopharmacy laboratories nationwide.

SHINE seeks to build a moly-99 production facility in Janesville and use particle accelerators. SHINE has said it could be more than a year before it ramps up its own production facility.

SHINE is building a test and demonstration facility in Janesville that’s expected to be operational sometime in 2018, the company has said. The test site would be used to set up and demonstrate SHINE’s proprietary accelerator technology, which the company said will allow it to produce moly-99 in Janesville without using highly enriched uranium.

The test facility is being built on land next to a Janesville tax increment financing district where SHINE plans to eventually build its 55,000-square-foot production facility. That facility is on track to be built and operating by 2020, SHINE has said, and will break ground this year.

So far, Janesville has committed $10.5 million in tax incentives to SHINE’s project, according to city records.

Asked Thursday for comment on NorthStar’s FDA approval, SHINE Vice President Katrina Pitas responded to The Gazette in an email.

In the email, Pitas wrote that the type of moly-99 that NorthStar produces and the type SHINE plans to produce in Janesville are different.

Pitas wrote that SHINE plans to produce what is known as “high-specific-activity” moly-99, which Pitas said is the type many major medical operators, including SHINE clients GE Healthcare, are equipped to handle through current “distribution” methods.

Pitas wrote that NorthStar produces what’s known as “low-specific-activity” moly-99, a type that would require clients to adjust to “new and complex distribution equipment.”

“Now that it has FDA approval, we will find out whether or not the (medical) market wants to change behavior,” Pitas wrote.

Pitas wrote that SHINE does not view NorthStar’s FDA approval as a “first-to-market situation” because the market has “long been served” by high-specific-activity moly-99, rather than the type NorthStar produces.

“They (NorthStar) will need to take significant share from existing sources of supply before it would have an impact on SHINE,” Pitas wrote.

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