• The approval of QUVIVIQ™, a novel dual orexin receptor antagonist, is based on robust clinical efficacy and safety data, including from a Phase 3 trial in Japan that met all primary and secondary endpoints
• Plans to make QUVIVIQ available as soon as possible to insomnia patients in Japan are underway

Nxera Pharma Co., Ltd. (“Nxera” or “the Company”; TSE 4565) – formerly known as Sosei Group or Sosei Heptares – announces that Nxera Pharma Japan Co., Ltd. (“NPJ”) has received approval from the Ministry of Health, Labour and Welfare of Japan (“MHLW”) of its New Drug Application (“NDA”) for QUVIVIQ™ (daridorexant; ACT-541468) 25 and 50 mg for the treatment of adult patients with insomnia. The approval of QUVIVIQ, a novel dual orexin receptor antagonist, is based on robust clinical efficacy and safety data including from a dedicated Japanese Phase 3 trial. Plans to make QUVIVIQ available as soon as possible to insomnia patients in Japan are underway.

Insomnia, characterized by difficulties in sleep onset and/or sleep maintenance, is highly prevalent in Japan, affecting about 20% of Japanese adults according to the MHLW, and is recognized as an important national issue impacting both physical and mental health.

Makoto Uchiyama, M.D., Ph.D., medical advisor of the Japanese Phase 3 study, Director of Tokyo Adachi Hospital, Lecturer of Nihon University School of Medicine, and Visiting Professor of Toho University, commented: “Insomnia is highly prevalent in Japan and is recognized as an important national health issue. The disorder is not only a problem of the night but affects a patient’s ability to function during the day. QUVIVIQ is the first drug for a decade, clinically investigated in more than 100 centers in Japan, to show increased total sleep time and shortened sleep latency in patients with insomnia without marked hangover symptoms the next morning. Providing QUVIVIQ to Japanese healthcare professionals is of great significance and I believe we can change the quality of life of many patients with insomnia.”

Satoshi Tanaka, Dr Med Sci., President of Nxera Pharma Japan, and Executive Officer and Executive Vice President of Nxera Pharma, added: “We are grateful to the investigators who have cooperated in conducting clinical studies in more than 600 Japanese patients and to the patients who have participated in the trials. I also thank the Nxera Pharma Japan team, many of whom have worked on QUVIVIQ for many years and never doubted the benefit that it could bring to patients, I’m very proud of the whole team. The unique characteristics of QUVIVIQ offer patients with insomnia not only a better night sleep but also an improvement in daytime functioning. We are very pleased to bring this dual orexin receptor antagonist, QUVIVIQ, to patients with insomnia in Japan where orexin was discovered.”

The approval of QUVIVIQ by the MHLW is supported by positive results of a randomized, double-blind, placebo-controlled Phase 3 study in Japan to investigate the efficacy and safety of daridorexant. The study met all primary and secondary efficacy endpoints. Daridorexant significantly improved subjective Total Sleep Time (“sTST”), a primary endpoint defined as the change from baseline compared to placebo at 28 days (p<0.001 for 50 mg, p=0.042 for 25 mg). Daridorexant also significantly improved sleep onset as measured by a decrease in subjective Latency for Sleep Onset (“sLSO”), a primary endpoint defined as the change from baseline compared to placebo at 28 days (p<0.001 for 50 mg, p=0.006 for 25 mg). The rate of adverse events was comparable between placebo and daridorexant at both treatment doses. Treatment-emergent adverse events (“TEAEs”) during the double-blind study period were reported in 23.5% and 22.7% of the patients treated with 50 mg and 25 mg daridorexant, respectively (24.4% for placebo).