Otsuka Subsidiary to Receive Payment and Royalties from US Approval of Radioligand Therapy for Metastatic Castration-Resistant Prostate Cancer

Out-licensed by ABX in Germany, an indirectly owned subsidiary of Otsuka Pharmaceutical

Otsuka Pharmaceutical Co., Ltd (Otsuka) is pleased to announce that ABX advanced biochemical compounds GmbH (ABX), a subsidiary of Cambridge Isotope Laboratories, Inc. (CIL), which in turn is a wholly owned subsidiary of Otsuka, expects to receive payments and royalties from Endocyte Inc., a Novartis company, based on the US FDA regulatory approval of Pluvicto™ (lutetium Lu 177 vipivotide tetraxetan), formerly referred to as 177Lu-PSMA-617, a radioligand therapy for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy.

Advanced Accelerator Applications (AAA) and Endocyte, Inc., both Novartis companies, successfully completed full-scale development of Pluvicto and also received Breakthrough Therapy designation from the US FDA last year. (Note: Novartis announced the FDA approval of Pluvicto in a press release on March 23, 2022.)

In 2017, ABX entered into a license agreement to license the rights to further develop and commercialize the radiopharmaceutical to Endocyte, Inc. in the US, which was later acquired by Novartis in 2018. ABX expects to receive payments and royalties from Endocyte Inc., based on approval and marketing milestones and the level of future sales.

About ABX advanced biochemical compounds GmbH
ABX, a global supplier of PET diagnostic precursors and FDG reagent kits with approximately 350 employees, has been a wholly owned subsidiary of CIL since 2006. Furthermore ABX is developing a PET diagnostic for prostate cancer, 18F-PSMA-1007, which received marketing authorization in France in December 2021.