Lantheus has inked a deal giving GE HealthCare the rights to carry its prostate cancer PET imaging agent in Japan, with the latter planning to pull it up through its recent acquisition of one of the leading radiopharmaceutical providers in the country.
GE HealthCare completed its buyout of Nihon Medi-Physics this past March after previously splitting its ownership 50-50 with Tokyo-based Sumitomo Chemical.
The company said it plans to lean on NMP’s R&D and manufacturing network to develop, produce and commercialize Lantheus’ Pylarify (piflufolastat), a fluorine-18 diagnostic tracer that targets tumors laden with prostate-specific membrane antigen, or PSMA.
The agreement covers the transfer of regulatory documents and manufacturing specs, with the goal of obtaining a marketing green light and setting up a future commercial launch guided by a joint steering committee.
“This partnership is expected to meaningfully extend the reach of our diagnostic imaging agent in key international markets,” Lantheus CEO Brian Markison said in a statement. “GE HealthCare and NMP’s deep regional expertise will enable us to advance the detection and care of prostate cancer and drive significant impact in an important market.”
GE HealthCare will pay Lantheus an upfront licensing fee plus milestone and royalty payments; the amounts were not disclosed.
“Working alongside Lantheus gives us access to one of the best-in-class PET imaging agents that is already approved in the U.S. and in Europe, and if approved locally, could provide clinicians and their patients with a powerful new option for detecting and monitoring prostate cancer,” added Kevin O’Neill, president of NMP and leader of GE HealthCare’s pharmaceutical diagnostics segment.
Pylarify has been used in more than 500,000 scans in the contiguous U.S. since the small molecule’s FDA approval in 2021, according to the companies. It can also be used to detect the metastatic spread of prostate tumors to lymph nodes, bones and other organs as well as the cancer’s recurrence in treated patients.
The FDA is currently reviewing a new formulation of the imaging agent—which claimed the title of the first blockbuster radiodiagnostic with more than $1 billion in 2024 sales—that would increase its batch production size by about 50%. That decision is expected by March 2026.
Earlier this year, as part of Lantheus’ second-quarter earnings release, Markison cited increased competition in PET radiotracers for prostate cancer—such as Blue Earth Diagnostics’ Posluma and an upcoming copper-isotope-based theranostic from Clarity Pharmaceuticals.
“We are taking actions to reinforce Pylarify’s clinical differentiation and support the value of our PSMA PET franchise,” Markison said in August. Pylarify accounted for about two-thirds of Lantheus’ revenue in the first six months of this year, bringing in $508 million out of a total of $750 million.
The diagnostic is known as Pylclari in the EU, where distribution rights are held by nuclear medicine provider Curium. Following its European Commission approval in 2023, Curium recently obtained a new green light this past May from Switzerland’s regulatory authority Swissmedic.