While radiopharmaceuticals have attracted significant interest in recent years thanks to their cancer-fighting prowess, the unique makeup of the meds has presented a host of production challenges for many drugmakers.
Now, with those nuclear medicine supply hurdles top of mind, Indianapolis-based radiopharma CDMO SpectronRx is closing in on the debut of a new overseas facility.
SpectronRx on Thursday revealed that it’s inked a binding agreement to complete its first European radiolabeling plant at the Belgian Nuclear Research Center (SCK CEN) in Mol, Belgium.
The build-out of the new facility is expected to wrap up next month in time for operations to kick off by 2025’s first quarter, pending manufacturing certification, SpectronRx said. The company did not reveal how much it’s investing in the project.
SpectronRx first signed a memorandum of understanding with SCK CEN for the new facility in 2023. With the new agreement, the CDMO is now officially on deck to provide equipment and offer up its manufacturing services at the site, while the Nuclear Research Center itself will provide the resources needed for SpectronRx’s development and production efforts.
The facility will initially focus on the labeling of actinium-225-based (Ac-225) radiopharmaceuticals. When wedded with a molecule, Ac-225-powered nuclear medicines can selectively target cancer sites and destroy malignant tissue with minimal damage to healthy cells, SpectronRx explained. Historically, only small amounts of Ac-255 have been available.
“With the ever-expanding pipeline of Ac-225-based radiopharmaceuticals making progress toward EMA approval, there are promising perspectives that the prognosis and quality of life for cancer patients and those with other diseases could substantially improve,” Koen Hasaers, director of nuclear medical applications at SCK CEN, said in a statement. “However, the excitement around these therapies has consequently increased demand for Ac-225-labeled drugs, leading to notable shortages.”
SpectronRx, for its part, says it’s developed a method to produce Ac-225 from multiple source elements. “As such, we are confident in our ability to manufacture Ac-225-labeled drugs at scale,” the company’s president, Anwer Rizvi, said in SpectronRx’s release.
Beyond the upcoming Belgian facility, SpectronRx operates more than 170,000 square feet of radiopharmaceutical manufacturing and development space across five locations serving 29 countries. The company has about 150 employees and works with more than 31 pharmaceutical firms.
The radiopharma field has been booming as of late, with multiple nuclear medicine projects cropping up in September alone.
Early last month, Novartis said it would invest millions of dollars to establish its third radioligand therapy manufacturing site—this time in Carlsbad, California—to help optimize delivery of doses to patients on the West Coast. At the same time, the company announced an upgrade to its existing location in Indianapolis to produce radioactive isotopes, for a total investment of more than $200 million.
Novartis markets two approved radiopharmaceuticals in neuroendocrine tumor drug Lutathera and Pluvicto for prostate cancer.
Meanwhile, radioisotope producer PanTera recently snared 93 million euros ($102.5 million) in an oversubscribed series A investment round. PanTera said it would largely channel the cash toward the construction of a new manufacturing facility in Belgium.
Plus, Telix Pharmaceuticals late last month penned a deal worth up to $250 million to acquire Florida-based RLS Radiopharmacies, granting Telix access to RLS’ network of 31 radiopharmacies spread out across 18 U.S. states. The deal is expected to close in 2025’s first quarter.