Otsuka Pharmaceutical Co., Ltd.

March 29, 2022

Otsuka Subsidiary to Receive Payment and Royalties from Approval in U.S. 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 U.S. FDA regulatory approval of Pluvicto™ (lutetium Lu 177 vipivotide tetraxetan). Pluvicto was 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 U.S. FDA last year.

(Note: Novartis announced the FDA approval of Pluvicto in a press release on March 23rd, 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 U.S., 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 Cambridge Isotope Laboratories, Inc.

CIL, the leading manufacturer in the world of stable isotopes and stable isotope-labeled compounds, became a wholly owned U.S. subsidiary of Otsuka in 1988. CIL has facilities in five countries and employs over 600 people.

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.