The quest to become the first domestic producer in decades of a crucial medical radioisotope is heating up, as the industry tries to avert a looming potential shortage when a key supplier in Canada begins winding down production next year.
The interesting, and apparently coincidental, twist is that two of the companies leading that competition, NorthStar Medical Radioisotopes and Shine Medical Technologies, are based in the same city—Madison, WI.
“We’ve been racing each other for a while,” says Shine founder and CEO Greg Piefer. “Looking at when other companies have submitted license materials to the [Nuclear Regulatory Commission], the nearest competitor is two or three years behind.” (Others jockeying for position in this market include Coral Gables, FL-based Coquí RadioPharmaceuticals, Atlanta-based Perma-Fix Medical, and more.)
As we’ll see later, the Madison neighbors can get chippy when defending their competing methods for producing molybdenum-99, the material that decays into technetium-99m, the most widely used radioisotope in medical diagnostic imaging.
It’s been more than 20 years since molybdenum-99 was last manufactured domestically, despite the U.S. accounting for about half of global demand for medical isotopes. According to a World Nuclear News report, molybdenum-99 is used in about 20 million procedures in the U.S. annually. It allows clinicians to assess blood flow and determine whether a cancer has spread through a patient’s bones, among other uses.
Molybdenum-99 represents a big business opportunity—the global market for the isotope is about $600 million per year, Piefer says. The Canadian government has said the Chalk River nuclear reactor in Ontario, which Piefer says supplies about one-third of the world’s molybdenum-99, will cease regular production in late 2016 and go offline in 2018. That’s the same year Shine plans to begin producing the isotope at a facility in Janesville, WI, on which construction has not yet started.
NorthStar chief science officer James Harvey says his company will start making the isotope in mid-2016. “NorthStar will be first to market by more than a year,” he says.
Production will initially take place at the University of Missouri Research Reactor Center in Columbia, MO, though NorthStar plans to eventually produce molybdenum-99 at a new facility under construction in Beloit, WI, near Janesville. (For the record, Harvey calls NorthStar’s geographic proximity to Shine “pure coincidence.”)
Harvey says the Beloit facility currently comprises about 50,000 square feet, and the company plans to add another 35,000 in the next year. NorthStar is readying that facility and its space within the Missouri reactor for inspection by FDA officials, he says, a requirement to begin production.
But it’s possible that the demand for the radioisotope in healthcare is so great, and the supply chain so fragile at the moment, that reaching commercial-scale production first might not make a difference in the long run. Both companies have a shot at carving out a piece of the market if they can effectively execute their plans for building up their manufacturing capabilities.
Piefer says that even if Shine isn’t the first to start producing the isotope in the U.S. this century, the company’s price point will be attractive to the product’s distributors, two of whom have already signed supply agreements with Shine. Those contracts with GE Healthcare and Lantheus Medical Imaging are one reason Piefer feels confident Shine will see a return on the nearly $50 million pre-revenue investment it has made to date.
“This is not a first-to-market scenario,” Piefer says. “I believe very thoroughly that Shine’s technology provides a cost advantage, and once we get the plant built, our low-cost dynamic will allow us to succeed, essentially no matter what.”
Meanwhile, Harvey says NorthStar’s approach will also have cost advantages that could help it attract customers. The company has signed prospective supply agreements with GE Healthcare and Triad Isotopes.
Reactor vs. accelerator
Outside of Canada’s Chalk River reactor, virtually all molybdenum-99 is made in the Eastern Hemisphere, in countries like Australia, South Africa, Belgium, and
