FDA Nod for NorthStar Device Clears Way to Make Medical Radioisotope

A Wisconsin company has moved one step closer to becoming the first domestic producer in decades of a crucial medical radioisotope after receiving a key approval from the FDA on Thursday.

The agency approved a device developed by Beloit, WI-based NorthStar Medical Radioisotopes that could be key to supplying a radioisotope whose scarcity has sparked concern because it is so widely used in medical imaging. NorthStar said it plans to also produce and sell an isotope (molybdenum-99), which the device decays into technetium-99m, the most widely used radioisotope in medical diagnostic imaging.

Each day, technetium-99m is used on about 50,000 Americans who undergo imaging procedures, according to the FDA.

NorthStar said in a news release that it expects to begin shipping molybdenum-99, along with the company’s decaying device, in the next several weeks.

Some industry observers believe the FDA’s approval of NorthStar’s device, called the RadioGenix System, is significant because it’s been more than 25 years since molybdenum-99 was produced domestically. That’s despite the fact that the U.S. accounts for about half of global demand for medical isotopes, which can be used in procedures to detect cancer or to diagnose and stage coronary artery disease, to name two examples.

The isotope has previously been produced at a nuclear reactor in Ontario, Canada, though it will reportedly be shuttered later this year. Several Eastern Hemisphere nations, such as South Africa, Australia, and the Netherlands, also make molybdenum-99. However, importing the isotope from overseas is expensive because its 66-hour half-life means about 1 percent of finished product is lost each hour.

Ira Goldman, senior director of global strategic supply at Lantheus Medical Imaging, last month told The New York Times that molybdenum-99’s fragile global supply chain can create scenarios analogous to “running through the desert with an ice cream cone.”

Global shortages of the isotope can occur when nuclear reactors are shut down for maintenance, as happened in 2009. A shortage can force hospitals into using alternative scanning technologies that expose patients to higher doses of radioactivity.

NorthStar has produced test batches of molybdenum-99 at a reactor in Columbia, MO, as part of a collaboration between the company and the University of Missouri Research Reactor. In the near term, all of the molybdenum-99 NorthStar produces will be at that facility, said Steve Merrick, the company’s president and chief operating officer, through a spokesperson.

Merrick said NorthStar has completed the first phase of construction on a production facility at its headquarters in Southeastern Wisconsin, where it would produce the isotope, which is sometimes abbreviated as Mo-99.

“Additional phases will start in 2018 and 2019, to support increased production capacity and eventual manufacture of Mo-99 in Beloit, in parallel to manufacture of Mo-99 in Columbia,” Merrick said.

NorthStar said it plans to sell the molybdebum-99 it produces in Missouri, along with its RadioGenix System, to nuclear pharmacies. (A nuclear pharmacy compounds and dispenses radioactive materials for use in procedures involving radioisotopes and other nuclear medicines.) These organizations would in turn use NorthStar’s equipment to decay the isotopes into technetium-99m, and sell the finished product to hospitals.

The Nuclear Regulatory Commission, which is responsible for overseeing the production, distribution, and use of radioactive materials, will license NorthStar’s RadioGenix System “to enable the [technetium-99m] it produces to be used for its medical purpose,” according to the FDA.

The NRC “will advise medical and commercial nuclear pharmacy users on the licenses amendments they will need to possess and use the RadioGenix System,” the FDA said in a separate news release.

Merrick said NorthStar expects to supply 10 percent of the U.S. markets for both molybdebum-99 and technetium-99m by late 2018. A few years down the line, the company is aiming to supply two-thirds of U.S. demand for the two isotopes, he said.

Meanwhile, about 12 miles north of Beloit, in Janesville, WI, another company is contending to resume domestic production of the isotope, but with a different method. Shine Medical Technologies uses particle accelerators to make molybdenum-99m. Shine has said it expects to begin producing the isotope at a new plant in Janesville by 2020.

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