ORION CORPORATION PRESS RELEASE 30 SEPTEMBER 2025 at 13.00 EEST Orion’s phase 2 study of ODM-105 in insomnia did not meet primary goal Orion to discontinue development of ODM-105 for insomnia.ODM-105 (tasipimidine) was well tolerated. Detailed results, including safety data, and their assessment are to be finalized. Orion Corporation today announced that its candidate ODM-105 (tasipimidine) did not meet the primary goal in the clinical Phase 2 UNITAS study for the treatment of patients with insomnia. Acco ...

Core Insights - Vanda Pharmaceuticals announced the publication of a study demonstrating that HETLIOZ (tasimelteon) significantly improves sleep in patients with primary insomnia, meeting its primary endpoint with a mean improvement in latency to persistent sleep of 44.9 minutes (20mg) and 46.3 minutes (50mg) compared to 28.2 minutes for placebo [2][4]. Group 1: Study Findings - The study published in PLOS One showed that HETLIOZ met its primary endpoint with significant improvements in latency to persistent sleep (LPS) [2]. - Improvements in LPS were sustained through follow-up time points, indicating the potential long-term efficacy of HETLIOZ [2]. - No cognitive or mood changes were associated with HETLIOZ use, and no rebound or withdrawal effects were observed after discontinuation [2]. Group 2: Market Context - Insomnia affects over 10% of the American population, highlighting a significant health issue that Vanda Pharmaceuticals aims to address with HETLIOZ [3]. - HETLIOZ is already approved for Non-24-Hour Sleep-Wake Disorder and nighttime sleep disturbances in specific populations, with ongoing efforts for FDA approval for insomnia and Jet Lag Disorder [4]. Group 3: Company Overview - Vanda Pharmaceuticals is focused on developing innovative therapies to meet high unmet medical needs, particularly in the field of sleep disorders [5]. - The company is also pursuing the development of HETLIOZ for other sleep disorders, including Delayed Sleep Phase Disorder and pediatric insomnia [4].

Core Viewpoint - Idorsia Ltd. announces the launch of QUVIVIQ (daridorexant) in China by Simcere Pharmaceuticals, marking a significant advancement in insomnia treatment without the limitations of traditional psychotropic medications [1][4][5]. Group 1: Product Launch and Clinical Profile - QUVIVIQ is a dual orexin receptor antagonist indicated for adult patients with insomnia, specifically targeting difficulties in falling and maintaining sleep [1]. - The drug has been approved without psychotropic drug control labeling, highlighting its unique clinical profile compared to existing treatments [1][5]. - Daridorexant selectively blocks orexin neuropeptides, regulating wake signaling and promoting restorative sleep, with approximately 80% elimination within the first 8 hours of dosing [3]. Group 2: Market Need and Impact - Insomnia poses a significant public health challenge in China, with current treatments often leading to next-day drowsiness and dependence, creating a substantial unmet need for safer alternatives [2]. - Clinical trials have shown that daridorexant significantly improves sleep onset, maintenance, and total sleep time, with notable enhancements in daytime functioning as measured by the IDSIQ [5]. Group 3: Collaboration and Financial Aspects - Idorsia and Simcere entered an exclusive licensing agreement for QUVIVIQ in Greater China, with Idorsia receiving $80 million in milestone payments and potential future royalties [6]. - The collaboration aims to ensure rapid access to QUVIVIQ for patients in need, positioning it as a meaningful advancement in chronic insomnia treatment [5]. Group 4: Availability and Global Reach - Daridorexant is commercially available as QUVIVIQ in multiple countries, including the US, Germany, and now China, and is approved throughout the EU [7].

Core Viewpoint - Idorsia Ltd. announces the launch of QUVIVIQ® (daridorexant) in China by Simcere Pharmaceuticals, marking a significant advancement in insomnia treatment without psychotropic drug control labeling [1][4]. Group 1: Product Information - QUVIVIQ is a dual orexin receptor antagonist indicated for adult patients with insomnia characterized by difficulty falling asleep and/or maintaining sleep [1]. - Daridorexant selectively blocks orexin neuropeptides, regulating wake signaling, and promotes restorative sleep while reducing morning sleepiness [3]. - Clinical trials showed that 25mg and 50mg doses of daridorexant significantly improved sleep onset, maintenance, and total sleep time compared to placebo [5]. Group 2: Market Context - Insomnia is a major public health challenge in China, with existing treatments often leading to next-day drowsiness and dependence, highlighting the need for safer alternatives [2]. - The launch of QUVIVIQ addresses the unmet need for effective insomnia treatments, positioning it as a meaningful advancement in chronic insomnia management [5]. Group 3: Collaboration and Financials - Idorsia and Simcere entered an exclusive licensing agreement for QUVIVIQ in Greater China, with Idorsia receiving $80 million in milestone payments and eligible for additional payments and royalties on future sales [6]. Group 4: Availability - Daridorexant is commercially available as QUVIVIQ in multiple countries, including the US, Germany, and China, and is approved throughout the EU [7].

Core Insights - Idorsia Ltd presented new analyses of daridorexant for insomnia patients at World Sleep 2025, emphasizing its commitment to advancing sleep science [1][11] - The company highlighted the low abuse potential of daridorexant compared to other insomnia treatments, based on real-world data [3] - Daridorexant demonstrated efficacy in reducing wakefulness throughout the night, with significant improvements in sleep maintenance and daytime functioning [5][8] Efficacy and Safety of Daridorexant - A post-hoc analysis showed that daridorexant 50 mg effectively reduced wakefulness after sleep onset (WASO) in a dose-dependent manner, outperforming zolpidem in the second half of the night [5] - In women undergoing menopausal transition, daridorexant 50 mg improved sleep onset and maintenance without increasing next-morning sleepiness [6] - Patients with chronic insomnia and comorbid nocturia experienced improved sleep duration and reduced nocturia symptoms with daridorexant 50 mg, without adverse effects [8] Characterization of Insomnia Disorder - Analysis of over 5000 patients revealed that insomnia disorder negatively impacts both nighttime sleep and daytime functioning across various demographics [10] - The findings underscore the need for treatments that address the comprehensive burden of insomnia, improving both nocturnal and diurnal symptoms [10] Industry Context - World Sleep 2025 served as a platform for international collaboration among sleep professionals, focusing on advancements in sleep science and treatment [11] - Idorsia aims to challenge existing medical paradigms and develop transformative medicines, positioning itself as a leading biopharmaceutical company [12][13]

Core Insights - Idorsia Ltd is actively participating in World Sleep 2025, showcasing its commitment to advancing sleep science and insomnia treatment through various presentations and symposiums [1][6]. Company Activities - Idorsia will present eight scientific posters at World Sleep 2025, focusing on the abuse potential of insomnia therapies and the efficacy of daridorexant [1][2][3]. - The company will host an educational symposium on September 9, featuring experts discussing the relationship between insomnia and comorbid neurological or psychiatric conditions, along with new data on daridorexant [5]. Research Highlights - A significant study will analyze real-world data on the abuse potential of insomnia medications, utilizing the FDA Adverse Event Reporting System [1]. - The largest clinical characterization of insomnia patients to date will be presented, based on data from over 5,000 patients, providing insights into the disorder's impact on symptoms and functioning [4]. Industry Context - World Sleep 2025 serves as a global platform for sleep professionals to discuss advancements in sleep science and treatment, fostering collaboration among various stakeholders in the field [6][8].

Core Insights - Idorsia Ltd announced the publication of a study on daridorexant, highlighting its effectiveness in treating chronic insomnia by reducing nighttime wakefulness and improving next-morning sleepiness [1][2] Group 1: Study Findings - The Phase 3 study demonstrated that daridorexant significantly reduced wake after sleep onset (WASO) compared to placebo, with similar rates of daytime somnolence [4] - Data from 930 patients showed that both 25 mg and 50 mg doses of daridorexant significantly decreased WASO in the second, third, and fourth quarters of the night, with effects being dose-dependent [4] - Improvements in next-morning sleepiness, daytime alertness, and ability to function were observed from Day 1 and continued to improve over the 3-month treatment duration [7] Group 2: Mechanism of Action - Daridorexant is a dual orexin receptor antagonist that blocks wake-promoting orexin neuropeptides, providing a targeted approach to managing insomnia without broad inhibition of brain activity [6] - The drug's mechanism allows for restorative sleep while avoiding next-morning residual effects, a common issue with traditional sleep medications [5] Group 3: Market Context - Insomnia affects approximately 10% of the global population, translating to around 25 million adults in the US alone, indicating a significant market opportunity for effective treatments like daridorexant [9][10] - Current insomnia management strategies include sleep hygiene, cognitive behavioral therapy, and pharmacotherapy, with daridorexant offering a novel pharmacological option [11]