Orano Med of France opens radiotherapy plant near Indianapolis

Amid a nuclear medicine surge, Orano Med, a French company specializing in targeted alpha therapies for cancer, has chosen the U.S. to set up a new manufacturing plant. This move is a significant step in the company's radiopharmaceutical development journey. On Thursday, Orano Med launched its first Alpha Therapy Laboratory (ATLab) in Brownsburg, near Indianapolis, Indiana. This facility is touted as the world’s first industrial-scale site dedicated to the production of lead-212-based radioligand therapies.

Radiopharmaceuticals are guided radioactive drugs used to diagnose diseases in small quantities and treat cancers and other conditions in larger doses. Unlike current beta-emitting isotope radiotherapies like Novartis’ Pluvicto and Lutathera, Orano Med’s approach is based on the alpha-emitting isotope lead-212. Traditionally, beta particles have been used in radiotherapies due to their availability. However, Julien Dodet, CEO and president of Orano Med, believes that alpha particles can significantly enhance the effectiveness of drug candidates.

Orano Med has allocated $20 million for the ATLab Indianapolis project. The facility, spanning 30,000 square feet, is expected to create 25 new jobs. This buildout in Indianapolis follows Orano Med’s plan to establish a similar facility in Valenciennes, France, aimed at serving the European market. Together, these facilities are projected to produce 10,000 radiopharma doses annually by 2025, with an ambitious goal of reaching 100,000 doses by 2030.

Orano Med is a clinical-stage biotech firm and a subsidiary of Orano, a leader in nuclear materials. The company focuses on developing lead-212-based radiotherapies to combat cancer. CEO Dodet emphasized the importance of early planning in manufacturing and supply for radioligand therapy developers. Radiotherapies need to be produced "just-in-time" due to the short half-life of isotopes, making timely delivery to patients crucial.

Despite the increasing demand for radiopharmaceuticals, particularly alpha emitters, existing manufacturing facilities are becoming outdated. Many of these facilities depend on radioisotopes sourced from Cold War-era materials or purchased from the U.S. Department of Energy, which is struggling to meet the growing demand, according to Dodet.

Radiopharmaceuticals have recently attracted substantial interest from oncology-focused companies. Novartis continues to lead in this area, already marketing two FDA-approved radiotherapies. The company has shown its ongoing commitment by acquiring Mariana Oncology for up to $1.75 billion. Novartis' approved radiotherapies, Pluvicto and Lutathera, collectively generated $1.6 billion last year.

Manufacturers and suppliers are also getting involved in the radiopharmaceutical sector. For instance, CDMO Nucleus RadioPharma has recently secured its first commercial contract to help manufacture ARTBIO’s Pb212-radiolabeled therapies at its facility in Rochester, Minnesota.

The establishment of new facilities by Orano Med in the U.S. and Europe represents a pivotal moment in the radiopharmaceutical industry. These developments are set to meet the rising demand for advanced cancer treatments and ensure that cutting-edge therapies are available to patients globally.