To successfully challenge Novartis on two planned fronts, Curium will need to overcome the unique challenges posed by radiopharmaceutical supply to get products to patients and win market share.
Novartis’ blockbuster radioligand therapy business faces emerging threats. Curium received FDA approval for Bexlutry, its rival to Novartis’ Lutathera, in September, and the biotech is in talks with the agency about a filing for a separate radiopharma treatment that could challenge the Swiss drugmaker’s Pluvicto.
Meanwhile, after agreeing to a $1.65 billion buyout of ITM Isotope Technologies Munich, Telix Pharmaceuticals will soon own therapies that could compete with both Novartis products.
The stakes are high. Lutathera and Pluvicto generated $1.7 billion over the first half of the year. Sales of the products are increasing at a time when Novartis’ growth prospects face scrutiny. Competition could increase pressure on Novartis, but the unique, exacting requirements of radioligand therapy (RLT) supply mean FDA approval is only one step toward a viable challenge for treatments currently on the market.
To compete, Curium and other potential challengers will need to master three steps.
1. Create a resilient manufacturing footprint
Access to lutetium-177 (Lu-177), the radioactive isotope in Lutathera, Pluvicto and Curium’s challengers, is the foundation of RLT supply. While the University of Missouri Research Reactor provides Lu-177 to Novartis, Curium has established multiple lines to produce its own Lu-177, North America CEO Michael Patterson told BioSpace in August, making it currently the only vertically integrated RLT manufacturer.
Curium secured access to Lu-177 capacity in 2024 by partnering with NRG PALLAS in the Netherlands and the Institut Laue–Langevin in France. That year, the company also opened a Lu-177 production facility in the Netherlands to support plans to supply the radioisotope to 100,000 patients globally in five years.
The actions reflect a broader focus on making the supply chain resilient. Controlling isotope production will enable Curium to adapt to demand, Patterson said, and installing multiple manufacturing lines at an Indiana facility will provide backup options.
Initially, Novartis only made Pluvicto in Italy. Lacking supply chain redundancy, the company struggled to get Pluvicto to patients when it suffered manufacturing interruptions, and the RLT ended up on the FDA’s shortage list for part of 2023. Novartis boosted its Pluvicto output and supply resilience by starting production in New Jersey in 2023 and in Indiana in 2024.
2. Reliably get RLTs from plants to patients
Patterson, like others in the industry, uses the ice cube analogy to explain the challenge of getting RLTs to patients. Much as an ice cube melts, radioisotopes immediately start to decay, creating a deadline for getting drugs to patients. Lu-177 has a half-life of 6.7 days.
The tight turnaround times mean delays that would be inconvenient when shipping other modalities can render RLTs unusable. Created when IBA Molecular and Mallinckrodt Nuclear Medicine merged in 2017, Curium is familiar with these logistical challenges.
Curium uses “a combination of truck routes and commercial airlines, weaving in charter aircraft, to make sure that we get product to the physicians on time,” Patterson said. Being based in the Midwest, Curium can reach many U.S. locations by truck and, because they offer more control and reliability, the company favors ground routes where possible, Patterson said.
Patterson’s preference for trucks is shared by other radiopharma leaders. However, the mix of a decaying product, treatment centers outside the U.S. mainland and hard-to-predict factors such as weather mean a flexible mix of transport is needed. Curium uses couriers for the last legs of journeys and charters planes when needed, such as during heavy snowstorms last winter, Patterson said.
3. Secure space at treatment centers
Curium could master every step from isotope production to last-mile logistics and still struggle to grow sales of its RLTs. That scenario aligns with the assessment of the current constraints on RLT availability that Sleuth, a biopharma intelligence platform, provided in its third-quarter radiopharma report, which points the finger squarely at “delivery infrastructure.”
“Watch how the availability of nuclear-medicine chairs, limited radiopharmacy staffing and difficulties in drug reimbursement dampen the growth rate, as no molecule can fix a shortage of treatment slots,” Sleuth said, discussing RLTs in general, not Curium’s assets in particular.
Sleuth argued that the sector shifted in 2024, following Novartis’ success at increasing Pluvicto production, from being constrained by manufacturing supply to being limited by treatment capacity. Despite improvements in the supply chain, patients can still face a two- to six-week wait to receive an RLT, Sleuth said.
The waits persist despite healthcare providers’ efforts to increase treatment capacity. Novartis currently lists more than 700 Pluvicto treatment centers, compared to 86 in November 2022. Yet Sleuth still sees treatment capacity as a “near-term ceiling” on RLT growth.
Adding capacity to administer RLTs poses challenges not seen when working with other modalities. Sites must have infrastructure and processes that support radiation protection and shielding, establish teams with multiple specialties and receive a license. If Curium wins FDA approval, it will be able to draw on long-standing connections to nuclear medicine physicians as it works to win market share.
“Certainly, we think that there are benefits to being in nuclear medicine for decades,” Patterson said.
