Niowave has started building a $75 million facility in Lansing, Michigan, to increase its capacity to make a radioisotope, according to a May 26 announcement.
The company already operates a site in Lansing. Adding a second dedicated production facility at the site will increase Niowave’s capacity to support growing global demand for actinium-225 and other medical isotopes. The company expanded its agreement to deliver actinium-225 to AstraZeneca in December and struck a deal to supply actinium-225 to Novartis in February.
Niowave is installing multiple proprietary superconducting linear accelerators at its latest actinium-225 plant, which will also house processing and quality systems. The facility is scheduled to start operations in 2028 and create about 70 jobs in research and development, engineering, and quality assurance.
Historically, Oak Ridge National Laboratory met demand for actinium-225 by making the radioisotope through the decay of thorium-229 left over from nuclear programs in the 1940s and 1950s. However, rising investment in actinium-225 drug development has necessitated the addition of new sources of the radioisotope. In recent years, companies such as AstraZeneca, Bristol Myers Squibb, and Eli Lilly have invested in drug candidates based on the alpha-emitting radioisotope actinium-225. The choice of isotope differentiates these candidates from approved products such as Novartis’ Lutathera and Pluvicto, which deliver lutetium-177.
Compared to lutetium-177, actinium-225 emits more energy over a smaller area. Shortages of actinium-225 drove Bristol Myers Squibb’s RayzeBio to pause a Phase 3 trial in 2024. Since then, companies have invested in adding production capacity for the radioisotope; Cardinal Health recently expanded its capabilities at an Indianapolis site while TerraPower Isotopes broke ground on a $450 million plant in Philadelphia that will produce it.
Niowave’s deals with AstraZeneca and Novartis are part of several agreements formed by drug developers seeking reliable supplies of actinium-225. Bayer agreed to source the isotope from BWXT, Ionetix, NorthStar Medical Radioisotopes, and PanTera between 2022 and 2024. Lilly invested in manufacturer Ionetix during that period.
