Novartis Takes Radiotherapy Lead With New US Isotope Plant On West Coast

Novartis is committing over $200 million to enhance its radiotherapy infrastructure through significant new investments. The company is launching its third radioligand therapy production facility in the U.S., strategically positioned in Carlsbad, California. This new site will complement Novartis's existing facilities in Millburn, New Jersey, and Indianapolis, Indiana, and is set to improve the distribution of treatments to patients on the West Coast.

In addition, the Indianapolis location is undergoing a major upgrade. Novartis has initiated the construction of a new plant on this site to manufacture radioactive isotopes, essential components of radiopharmaceuticals. The total investment for these expansions exceeds $200 million, with the new facilities expected to achieve regulatory approval and become operational by 2026. The company has also designed both sites with potential for future expansion.

“We are investing in our supply chain capabilities today to ensure that we are prepared to consistently deliver these complex treatments to the growing number of eligible patients in the long-term,” stated Victor Bulto, Novartis’ U.S. president.

Novartis is set to launch its first U.S.-based isotope production facility in Indianapolis, as confirmed by a company spokesperson to Fierce Pharma. While Novartis will maintain collaborations with external isotope providers for global markets, this move is a response to a worldwide scarcity of nuclear isotopes. This shortage recently impacted Bristol Myers Squibb, which halted enrollment in a Phase 3 trial for RYZ101—central to its $4.1 billion acquisition of RayzeBio—due to a deficit of the alpha-emitting isotope actinium-225.

The isotope scarcity stems from several issues, including the shutdown of a major medical isotope producer in Canada and the ongoing Russia-Ukraine conflict. Additionally, the rising demand for isotopes in both diagnostic and therapeutic applications has exacerbated the supply challenges.

Radioligand therapy has become a pivotal focus for Novartis, following the success of their neuroendocrine tumor medication Lutathera and the prostate cancer treatment Pluvicto. The Swiss pharmaceutical giant has made substantial investments in global manufacturing to support this area. With the FDA's recent green light for their Indianapolis facility to produce Pluvicto commercially, Novartis now boasts the ability to manufacture up to 250,000 doses annually.

Beyond its U.S. operations, Novartis also runs radiotherapy facilities in Ivrea, Italy, and Zaragoza, Spain. The company has recently started construction on a new site in China and is planning another in Japan. Both Lutathera and Pluvicto utilize lutetium-177 as their beta-emitting radiation source. Novartis is also exploring a range of other isotopes, ligands, and final products in their radioligand therapy research. 

Novartis has recently acquired Mariana Oncology, a preclinical biotech specializing in radiotherapy, for an initial payment of $1 billion. Mariana Oncology’s primary focus is an actinium-based radiotherapy currently being tested for small cell lung cancer. Additionally, Novartis is engaged in a separate collaboration with PeptiDream, potentially valued at close to $3 billion. This partnership aims to develop peptide-drug conjugates featuring radionuclide payloads.