FUJIFILM : Launch of Therapeutic Radiopharmaceutical Product, Lutathera® Injection targeting neuroendocrine tumors in Japan (FUJIFILM Toyama Chemical)

TOKYO, August 31, 2021-FUJIFILM Toyama Chemical Co., Ltd. (Head Office: Chuo-ku, Tokyo; President: Junji Okada; hereinafter 'FUJIFILM Toyama Chemical') will launch, on September 29, 2021, Lutathera^®*1 Injection (INN: lutetium (¹⁷⁷Lu) oxodotreotide) (hereinafter 'Lutathera') in Japan, for the treatment of somatostatin receptor-positive neuroendocrine tumors^*2. Lutathera is the first approved Peptide Receptor Radionuclide Therapy (PRRT), a type of radioligand therapy^*3, in Japan.

Neuroendocrine tumors originate in neuroendocrine cells that secrete hormones and peptides. Tumors frequently develop in a variety of organs throughout the body, in particular, the pancreas, gastrointestinal tract, and lungs. Because of its limited options for drug therapy, the disease is considered to have high unmet medical needs. PRRT is widely used in many countries, as there is a need for additional effective treatment options for patients with neuroendocrine tumors.

Lutathera is a therapeutic radiopharmaceutical product in which a somatostatin analog is radiolabeled with lutetium-177 (¹⁷⁷Lu), a radioactive isotope. It binds to somatostatin receptors that are highly expressed in neuroendocrine tumors, and directly targets cancer cells with radiation released from ¹⁷⁷Lu.

Prior to the launch of Lutathera, FUJIFILM Toyama Chemical begins to accept orders for the product as of September 6, 2021. By adding therapeutic radiopharmaceutical product Lutathera, to OctreoScan^® Injection Kit^*4 (for the preparation of indium pentetreotide [¹¹¹In] injection fluid), a diagnostic radiopharmaceutical product for neuroendocrine tumors already marketed, FUJIFILM Toyama Chemical will expand its offerings of comprehensive solutions for patients with neuroendocrine tumors, from diagnosis to treatment.

Along with Lutathera, the company will launch LysaKare^®*5 Injection (hereinafter 'LysaKare') , an amino acid infusion solution used in combination with Lutathera for reduction of renal (kidney) radiation exposure during therapy with Lutathera.

To realize PRRT in Japan, in 2015 FUJIFILM Toyama Chemical concluded a licensing agreement with Advanced Accelerator Applications International S.A. (hereinafter 'AAA'), a Novartis company, for the domestic development and marketing of Lutathera^*6. After confirmation of the product's efficacy and safety in Japanese patients through clinical studies and filing of marketing authorization approval application in 2020, FUJIFILM Toyama Chemical received marketing authorization on June 23, 2021.

FUJIFILM Toyama Chemical will continue to contribute to enhancing medicine even further by delivering high value-added drugs.