Shionogi & Co., Ltd. (Head Office: Osaka, Japan; CEO: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) has announced the conclusion of a sales partnership agreement with Nxera Pharma Japan Co., Ltd. (hereafter “Nxera Pharma Japan”), a subsidiary of Nxera Pharma Co., Ltd. (Head Office: Tokyo, CEO: Christopher Cargill). This agreement pertains to the insomnia treatment “QUVIVIQ® Tablets” 25mg and 50mg (daridorexant, hereafter “QUVIVIQ®”), which received manufacturing and marketing approval in Japan as of September 24, 2024, for treating adult patients with insomnia.
QUVIVIQ® is an oral medication for insomnia that selectively binds to the OX1R and OX2R receptors of the wake-promoting neuropeptide orexin, thereby reducing excessive wakefulness and facilitating the transition to sleep. In Japan, Nxera Pharma Japan, in collaboration with Mochida Pharmaceutical Co., Ltd. (Head Office: Tokyo, Japan; President: Naoyuki Mochida; hereafter “Mochida”), conducted a domestic Phase III clinical trial. Based on the results of this trial, the manufacturing and marketing approval for QUVIVIQ® was obtained.
Under the new sales partnership agreement, Shionogi has secured exclusive distribution rights for QUVIVIQ® in Japan. Shionogi will pay an upfront fee and royalties to Nxera Pharma Japan in connection with this agreement. The prior sales partnership agreement with Mochida has been terminated, and Shionogi will now oversee distribution and sales activities independently. An upfront payment will also be made to Mochida. Nxera Pharma Japan will retain the role of manufacturing and marketing authorization holder and will manage part of the product supply, while Mochida’s subsidiary, Mochida Pharmaceutical Plant Co., Ltd., will be responsible for finished product manufacturing.
Shionogi is dedicated to contributing to a healthy and prosperous life and aims to create a society where people can lead longer, healthier lives while pursuing their aspirations. The company remains committed to delivering QUVIVIQ® to patients suffering from insomnia as soon as possible.
