France's Orano Med debuts radiotherapy manufacturing plant near Indianapolis

Amid a nuclear medicine boom, France’s Orano Med has chosen the U.S. to establish a manufacturing plant as it progresses on its radiopharma journey.

Orano Med—which is working on targeted alpha therapies for cancer—on Thursday inaugurated its first Alpha Therapy Laboratory (ATLab) in Brownsburg near Indianapolis, Indiana. The site marks the world’s first industrial-scale facility dedicated to production of lead-212-based radioligand therapies, according to the company.

Radiopharmaceuticals are guided radioactive drugs that can help diagnose diseases in smaller amounts and can treat cancers and other conditions in higher quantities.

Unlike current approved beta-emitting-isotope-based radiotherapies like Novartis’ Pluvicto and Lutathera, Orano Med’s approach leverages the alpha-emitting isotope lead-212.

Traditionally, radiotherapies have utilized beta particles because beta emitters were more easily available, Julien Dodet, CEO and president of Orano Med, said via email. That said, the Orano CEO figures using alpha particles can help boost the effectiveness of drug prospects.

Orano Med has invested $20 million into ATLab Indianapolis, which it says will cover 30,000 square feet of floor space and create 25 new jobs within the company.

The Indianapolis buildout follows Orano Med’s decision to start work on a similar facility in Valenciennes, France, to serve the European market.

Together, the facilities are expected to allow Orano Med to crank out 10,000 radiopharma doses per year across the globe by 2025. The company aims to be able to produce 100,000 doses by 2030, according to its press release.

Orano Med—a subsidiary of the nuclear materials leader Orano—is a clinical-stage biotech working to developing lead-212-based radiotherapies against cancer. 

Orano Med CEO Dodet noted that it’s important for radioligand therapy developers to hash out manufacturing and supply early given that radiotherapies must be produced “just-in-time” to be delivered to patients, thanks to the short half-life of isotopes.

Despite the growing demand for radiopharmaceuticals—and especially for alpha emitters—existing manufacturing facilities are aging, with many relying on radioisotopes derived from Cold War-era sources or purchased from the U.S. Department of Energy, “which cannot keep up with demand," the CEO added.

Radiopharmaceuticals have recently garnered significant interest among oncology-focused companies, with Novartis continuing to lead the charge.

While Novartis already markets two FDA-approved radiotherapies, the company showed its continued interest in the field with its recent purchase of Mariana Oncology for up to $1.75 billion. As for its approved radiotherapies, Pluvicto and Lutathera generated a combined $1.6 billion last year.

Manufacturers and suppliers have been getting in on the action too, such as CDMO Nucleus RadioPharma, which recently inked its first commercial contract to help manufacture ARTBIO’s Pb212-radiolabeled therapies from its facility in Rochester, Minnesota.