Sosei Heptares Announces Submission of New Drug Application in Japan for Daridorexant (ACT-541468), a Dual Orexin Receptor Antagonist for the Treatment of Insomnia - Seite 2

In relation to the filing of this NDA, Sosei Heptares will receive JPY 1.5 billion (US$10 million*). The milestone receipt will be recognized as revenue in the fourth quarter of the financial year ending 31 December 2023.

* USD1 = JPY149.86

Makoto Uchiyama, M.D., Ph.D., medical advisor of the Japanese Phase 3 study, Director of Tokyo Adachi Hospital, Visiting Professor of Nihon University, and Visiting Professor of Toho University, commented: “Insomnia is highly prevalent in Japan and is recognized as an important national health issue. Patients with insomnia have trouble falling or staying asleep, as well as waking up earlier than desired, all of which lead to detrimental effects on both physical and mental health. Daridorexant is the first drug for a decade to have been clinically investigated in more than 100 centers in Japan and showed marked positive results in the studies. The Japanese Phase 3 trial showed that daridorexant increased total sleep time and shortened sleep latency in patients with insomnia without marked hangover symptoms the next morning, which clearly indicates its potency to improve core symptoms of insomnia. Such a promising outcome was likely due to the unique characteristics of the drug, a dual orexin receptor antagonist with an optimal elimination half-life.”

Satoshi Tanaka, Dr Med Sci., President of Idorsia Pharmaceuticals Japan (a Sosei Group company), and Executive Officer and Executive Vice President of Sosei Heptares, added: “The team has worked rapidly to analyze the data and prepare the dossier for the PMDA so that we can bring daridorexant to patients as soon as possible. We will now work together with the authorities through the regulatory process, and in parallel, prepare the scientific publication and the commercial launch of 10, 25 and 50 mg tablets, which we hope to see in the second half of 2024. Together with the development partner Mochida, the whole team is eager to rapidly make daridorexant available to Japanese patients with insomnia.”

QUVIVIQ is a registered trademark of Idorsia Ltd.

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Notes to Editors

About Insomnia Disorder
Insomnia disorder is defined as difficulty initiating or maintaining sleep, causing clinically significant distress or impairment in important areas of daytime functioning. This impact on sleep quantity or quality should be present for at least three nights per week, lasts for at least three months, and occurs despite an adequate opportunity to sleep.