(Tokyo, Japan, March 7, 2023) Advanced Medical Science-Planning (AMS), a Japanese nuclear medicine start-up company, announced the launch of collaborative research with Kyoto University to introduce Gallium-68 DOTATOC (68Ga-DOTATOC) targeting somatostatin receptors in Japan.

AMS has been working with Hokkaido University since 2019 to bring 68Ga-PSMA-11 into the Japanese marketplace for the diagnosis of prostate cancer. Furthermore, based on consultation with the Japan Pharmaceutical and Medical Devices Agency (PMDA), AMS has adopted a unique regulatory approach to obtain marketing approval for the automated synthesizer as a medical device producing 68Ga-PSMA-11, which differs from a common regulatory path among Western countries for radiopharmaceuticals as a drug.

Kyoto University has led 68Ga-DOTATOC clinical studies in Japan, and Kyoto University Hospital has been providing 68Ga-DOTATOC PET/CT scan, which has been conducted on a self-pay care fee basis without healthcare insurance coverage since July 2021.

AMS and Kyoto University have now agreed to seek the early marketing approval of 68Ga-DOTATOC produced by an automated synthesizer.

As for somatostatin receptor-positive neuroendocrine tumors, the radiopharmaceutical drug LUTATHERA® Injection (INN: Lutetium oxodotreotide “177Lu”) obtained the marketing authorization on June 23, 2021. On the diagnosis side, the kit for preparing In-111 Pentetreotide Injection (INN: Octreoscan®) has already been approved and insured for neuroendocrine tumors (NET) in Japan. However, we expect that PET/CT or PET/MRI using 68Ga-DOTATOC provide more accurate information on the tumor localization and evaluation of the therapeutic effect of 177Lu-DOTATATE. 68Ga-DOTATOC (68Ga-Edotreotide, INN: TOCscan®) has become mainstream in Europe and the United States.

In this collaborative study, we will establish an in-house preparation procedure of 68Ga-DOTATOC in compliance with the GMP standards set by the Japanese Nuclear Medicine Society and consult with the PMDA as a first step toward the marketing approval.

AMS President Yuichiro Sugawara stated, “AMS deeply appreciates the start of a strategic relationship with Kyoto University to conduct research for pre-clinical development of 68Ga-DOTATOC as a part of our market partnership with ITM Isotope Technologies Munich SE, a privately owned biotechnology and radiopharmaceutical group of companies in Germany. Japanese NET cancer patients deserve access to the same diagnostic methods as those in Western nations under healthcare insurance coverage. Collaborative research between AMS and Kyoto University will play an indispensable role in demonstrating the licensing basis for 68Ga-DOTATOC.”

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