Kyowa Kirin Announces a New Drug Application for Partial Change of Fentos_® Tape in Japan

Tokyo, Japan, September 10, 2020 ––– Kyowa Kirin Co., Ltd., (Kyowa Kirin, TSE:4151, President and CEO: Masashi Miyamoto) today announced that Hisamitsu Pharmaceutical Co., Inc. (Hisamitsu Pharmaceutical, President and CEO: Kazuhide Nakatomi) has submitted a new drug application for the additional indications of cancer pain relief for pediatric patients for Fentos_® Tape, transdermal, pain management patch (Development code: HFT-290, generic name: fentanyl citrate, hereinafter referred to as “the product”) in Japan as of today.

Hisamitsu Pharmaceutical, Kyowa Kirin’s business partner on the product, conducted a clinical study in pediatric cancer pain patients (aged 2 to 19 years old) and confirmed the efficacy and safety of the product.

The product was approved in April 2010 with indication for pain relief in various cancers that accompany moderate to severe pain, and later approved for the additional indications of pain relief in chronic pain in June 2014, the additional new dose of 0.5mg in July 2018 and cancer pain relief for opioid analgesic naïve patients in June 2020.

Hisamitsu Pharmaceutical expects to receive a manufacturing and marketing approval of the additional indications by February 2022.

Kyowa Kirin and Hisamitsu Pharmaceutical have jointly carried out product distribution and activities for the provision and collection of information (1 brand, 2 channels) since June 2010. Under the collaboration with Hisamitsu Pharmaceutical, Kyowa Kirin expects that the product could be a new treatment option for pediatric cancer pain patients and improve their quality of life.

The Kyowa Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.