Novartis is investing more than $200 million to further bolster its radiotherapy infrastructure with a brand-new facility and the expansion of an existing site.
Novartis is establishing its third radioligand therapy manufacturing site in the U.S. Joining the company’s two existing locations stateside in Millburn, New Jersey, and Indianapolis, Indiana, the new facility is located in Carlsbad, California, to help optimize the delivery of doses to patients on the West Coast.
Separately, the Indianapolis site is getting an important upgrade. Novartis has broken ground on a new plant at the campus to produce radioactive isotopes, which are the critical backbone of radiopharmaceuticals.
All told, Novartis is investing more than $200 million in the expansions, a company spokesperson told Fierce Pharma. Qualifications and regulatory approvals of the new facilities are expected to be completed by 2026, the spokesperson said. Both facilities will be built with room for further expansion, according to the company.
“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,” Victor Bulto, Novartis’ U.S. president, said in a statement Wednesday.
The Indianapolis facility is slated to be the first Novartis-owned isotope production source in the U.S., the Novartis spokesperson confirmed to Fierce Pharma. The company will continue to partner with external isotope suppliers for the international market.
Novartis is establishing in-house production of isotopes amid a global shortage of the nuclear component. Earlier this year, Bristol Myers Squibb paused enrollment in a phase 3 study of RYZ101, which served as the centerpiece of its $4.1 billion acquisition of RayzeBio, because of a shortage of the alpha-emitting isotope actinium-225.
Many factors have contributed to the shortage of isotopes, including the closure of a large medical isotope producer in Canada a few years ago. In addition, the ongoing Russia-Ukraine war and growing isotope demand—for both diagnostic and therapeutic purposes—have played roles in the limited supply situation.
Built on the success of the neuroendocrine tumor drug Lutathera and the prostate cancer drug Pluvicto, radioligand therapy is a key area of focus for Novartis. The Swiss pharma has invested heavily in its manufacturing globally. With the FDA’s approval of its Indianapolis site for commercial manufacturing of Pluvicto earlier this year, Novartis touts a radioligand therapy production capacity of 250,000 doses per year.
In addition to the U.S. sites, Novartis operates radiotherapy facilities in Ivrea, Italy, and Zaragoza, Spain. The company recently broke ground on a site in China and is plotting another one in Japan.
Both Lutathera and Pluvicto uses the beta emitter lutetium-177 as their radiation molecule. Novartis is further investigating different isotopes, ligands and final products.
The company recently bought Mariana Oncology, a preclinical radiotherapy biotech, for $1 billion upfront. The small firm’s lead candidate is an actinium-based radiotherapy being studied in small cell lung cancer. In a separate deal potentially worth nearly $3 billion, Novartis is working with PeptiDream to design peptide-drug conjugates that use radionuclide payloads.