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Lantheus Holdings, Inc. and GE HealthCare have announced an exclusive licensing agreement for GE HealthCare to develop, manufacture, and commercialise Lantheus’ piflufolastat F18 (PYLARIFY® in US market) in Japan for prostate cancer diagnostics and companion diagnostic use.
PYLARIFY is used for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.
The agreement includes the transfer of regulatory dossiers, manufacturing competencies and technical support to enable GE HealthCare to drive clinical development in Japan, towards potential regulatory submissions and commercial launch.
GE HealthCare will draw on its extensive manufacturing network and R&D expertise following its acquisition in March 2025of Nihon Medi-Physics Co. (NMP), a leading radiopharmaceutical company in Japan.
Prostate cancer is the fourth most common cancer worldwide, with Japan recording the third highest number of cases in the world in 2022, after the US and China.
Under the terms of the agreement, GE HealthCare will pay Lantheus an upfront license fee, development milestones and tiered royalties based on product sales in Japan. The companies will also establish a Joint Steering Committee to oversee development and commercialisation activities.
