SpectronRx earns European approval for nuclear meds
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As Indiana strengthens its foothold in radiopharmaceuticals, SpectronRx has earned the seal of approval to send its life-saving agents across the pond to Europe. The Indianapolis-based company is just one on a growing roster of Hoosier players in the nuclear medicine sector, a relatively new area of pharmaceuticals. Now with approval to manufacture radiopharmaceuticals for Europe at its South Bend operation, SpectronRx says it’s positioned to fill a void for the European industry and patients who need the cancer-destroying medicine.
Employing more than 100 Hoosiers, the radiopharmaceutical contract developer and manufacturer began in Fishers as Nukemed. The company rebranded as SpectronRx and now has several Indiana locations, including a new facility near Grissom Air Reserve Base in Bunker Hill.
“[Nuclear medicine] is a relatively new industry. There are plenty of contract manufacturers that do non-radioactive product, but there are very few that do radioactive product, especially with any scale or quality system up to standards,” says SpectronRx Chief Executive Officer John Zehner.
Using existing drugs or proteins that are specially designed to seek out cancer cells, SpectronRx attaches a radioactive material “that basically super-charges them to destroy the DNA—or destroy the cancer.”
At its inception, nuclear medicine specialized in diagnostics, or identifying what’s wrong; theranostics is an even newer and emerging specialty that attaches a therapeutic agent to deliver treatment.
“[Nuclear medicine] has always been more diagnostic-focused, and now we’re more therapeutic-focused,” says Zehner, “which is really nice, because the diagnostic side is typically bad news, and the therapy side is hope.”
Zehner says it’s “a stamp of approval and a major milestone” that SpectronRx is now able to extend that hope to Europe for “the big cancers”—mostly breast and prostate. The company recently announced that the U.S. Food and Drug Administration completed inspection of its South Bend facility on behalf of the European Medicines Agency (EMA). The development paves the way for SpectronRx’s products to be manufactured for Europe and more easily imported—a critical step forward as the company aims to quickly scale operations to meet growing European demand.
“Right now, there are very few contract manufacturers for radio isotopes in Europe, so it’s a need for us to do this manufacturing to provide the drugs to Europe,” says Zehner. “Our customers are very aware of this need, and they’ve engaged us to help them seek out or even look at installing a green field manufacturing location (building a facility from the ground up) in Europe—and maybe more than one, because right now, they have nowhere to go [for contract manufacturing of radio isotopes].”
Due to the radioactive materials in nuclear medicines, the drugs have an extremely short shelf life, which can limit how far the product can travel from the place where it’s manufactured. However, Zehner says SpectronRx works to extend its clients’ drugs’ shelf life to four to six days.
“That gives us one or two days to [fly] it to Europe,” says Zehner. “We actually have a tracking system where we track it. We can see it in real time; what altitude it’s at, where it’s at with GPS and a light sensor to see if it’s been opened. There’s been a couple times that we helped the airline locate our package; the good news is since it’s a radioactive package, it gets everyone’s attention.”
Zehner says the South Bend location being approved to manufacture drugs for Europe will also help it attract customers that are closer to being fully approved, noting if the operation is “safe and appropriate for the manufacture of drugs for Europe, it’s likely appropriate around the world.” He believes having the seal of approval from Europe also adds stature to Indiana’s nuclear medicine sector.
“Indiana is a great place for nuclear medicine given [its strength in] logistics. Even though we could be viewed as being competitive with many of [the other nuclear medicine companies in Indiana], we’re all here to improve patients’ lives—we all have the same goal,” says Zehner. “To see the investment and to see nuclear medicine expand—especially into the therapy side—is just wonderful news; not only for Indiana, but for the world, since we can ship these drugs around the world.”
Zehner says Indiana’s strengths in logistics make it “a good spot” to do business in nuclear medicine.
Zehner says SpectronRx is also in the process of expanding its U.S. Nuclear Regulatory Commission (NRC) Materials License to include the handling of Radium-226, an isotope that—once converted—will allow customers to ramp up production of nuclear medicines.