Lantheus And GE HealthCare Sign Licensing Deal For PYLARIFY In Japan

(RTTNews) - Lantheus Holdings Inc. (LNTH) and GE HealthCare (GEHC) announced an exclusive licensing agreement under which GE HealthCare will develop, manufacture, and commercialize Lantheus' piflufolastat F18—marketed in the U.S. as PYLARIFY—in Japan for prostate cancer diagnostics and companion diagnostic use. PYLARIFY is used in positron emission tomography (PET) imaging to detect 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 2025 of Nihon Medi-Physics Co., Ltd. (NMP), a radiopharmaceutical company in Japan.

As per 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 commercialization activities.

Piflufolastat F 18, also known as 18F-DCFPyL, PYLARIFY, or PYLCLARI, received FDA approval in 2021 and is marketed in the United States as PYLARIFY. It has significantly impacted the lives of patients battling prostate cancer and is currently the most widely used PSMA PET imaging agent in the U.S. Backed by real-world experience, it has been utilized in over 500,000 scans across 48 states. In 2023, it was approved in the European Union and is marketed there as PYLCLARI. The European rights were licensed to Curium by Progenics Pharmaceuticals, Inc., a Lantheus company.