Essential Tremor

Biogen and Sage Therapeutics are discontinuing further development of their drug Zurzuvae as a potential treatment for major depressive disorder, a move that follows last year’s FDA rejection of the therapy in that indication. The regulator had asked the companies to provide more evidence of efficacy from additional clinical testing. In its report of third quarter 2024 financial results posted Wednesday, Biogen said the discontinuation decision is based on the “significant new investment and time we expect would be needed to conduct additional studies.” Going forward, the two Cambridge, Massachusetts-based companies plan to focus their efforts on commercializing this drug in postpartum depression, for which it was approved last year. But postpartum depression is a much smaller market than major depressive disorder, which means Zurzuvae is unlikely to achieve the lofty sales once expected for the pill. With the renewed focus on Zurzuvae for postpartum depression, Sage will discontinue Zulresso, a product that in 2019 became the first FDA-approved postpartum depression drug. Zulresso is administered as a 60-hour infusion, a challenging dosing regimen that has limited market uptake of this Sage drug. By contrast, Zurzuvae is a pill taken once daily for 14 days. For the nine months ended Sept. 30, Sage reported Zulresso accounted for $3.1 million in revenue, down 63% compared to the same period in 2023. Sage said Zulresso will be commercially available until Dec. 31. Sponsored Post The Future of Hospitals and Pharma Companies Will Depend on Strength of Healthcare Analytics Insights PurpleLab® stands out from others in this sector by providing its data analytics services to several different groups of users across healthcare and pharma companies. By Stephanie Baum The collaboration between Biogen and Sage dates to 2020. Biogen committed $1.5 billion up front to begin the R&D alliance focused on depression and movement disorders. Results have been disappointing. Besides Zurzuvae’s rejection in major depressive disorder, collaboration on the movement disorders program SAGE-324 is ending. In July, the companies reported this oral drug failed a Phase 2 test in essential tremor. Biogen gave Sage a termination notice for SAGE-324 last month. When the termination becomes effective in February, Sage will become fully responsible for the program. In its quarterly report, Sage said it plans to evaluate other potential indications for this drug. In a note sent to investors, Leerink Partners analyst Marc Goodman said the discontinuation of further development of Zurzuvae in major depressive disorder was expected. While Leerink projects the drug could achieve $200 million to $300 million in peak sales in postpartum depression, physicians have told the firm they’re skeptical of a paradigm shift in treatment and the black box warning on the product’s label could further limit use. Sage does have other programs in the pipeline, but the company will have fewer workers to support them. In its quarterly report, the company said it will commence a business restructuring to strengthen its balance sheet and focus on the ongoing launch of Zurzuvae for postpartum depression. Sage said it will shed about 33% of its workforce. With the restructuring, the company said it expects to have enough capital to support operations into 2026.

EDEN PRAIRIE, Minn., Oct. 24, 2024 (GLOBE NEWSWIRE) -- NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) (“NeuroOne” or the “Company”), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announced that it will be participating in The ThinkEquity Conference on October 30, 2024, at the Mandarin Oriental Hotel in New York. The ThinkEquity Conference gathers institutional investors, corporate clients, and other industry professionals to highlight groundbreaking innovations and financial strategies. Ron McClurg, CFO, will be presenting at 9:00 am ET on October 30th. The Company will also hold one-on-one investor meetings throughout the day. Interested investors can register to attend and schedule on-on-one meetings here. The presentation will also be live-streamed at the following link: https://wsw.com/webcast/tep25/nmtc/1682208. About ThinkEquityThinkEquity is a boutique investment bank founded by professionals who have collaborated for over a decade, collectively financing over $50 billion in public and private capital raises, restructurings, and mergers and acquisitions. Past ThinkEquity conferences have featured over 70 company presentations, 700+ attendees, and 500+ one-on-one meetings, providing a valuable platform for companies and investors to connect. To register to attend The ThinkEquity Conference, please follow this link. About NeuroOneNeuroOne Medical Technologies Corporation is a developmental stage company committed to providing minimally invasive and hi-definition solutions for EEG recording, brain stimulation and ablation solutions for patients suffering from epilepsy, Parkinson's disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders that may improve patient outcomes and reduce procedural costs. The Company may also pursue applications for other areas such as depression, mood disorders, pain, incontinence, high blood pressure, and artificial intelligence. For more information, visit www.nmtc1.com. IR ContactQuinn Callanan, CFA or Brian Prenoveau, CFAMZ Group – MZ North AmericaNMTC@mzgroup.us (949) 694-9594

2024年11月5日至10日，第七届中国国际进口博览会（以下简称“进博会”）将在上海举办。今年正值复星医药创立30周年，作为七届进博会的“全勤生”，复星医药将在7.1馆医疗器械及医药保健展区（展位号：7.1B3-02），继续携手全球合作伙伴展现其致力于成为全球领先的医疗创新整合者的强大实力和深远影响。 10月23日，“如期而至 共享全球机遇”复星医药第七届进博会媒体开放日在上海举行。复星医药管理层和业务负责人与三十余家媒体代表进行了深入交流。详细介绍了公司在创新产品和解决方案方面取得的最新突破，同时揭秘了即将在进博会上展出的一系列创新产品和主题活动。 复星医药董事长吴以芳在欢迎辞中表示：“过去三十年，复星医药始终坚持创新驱动，积极拥抱全球化，深化国际合作。我们与医药产业的发展脉搏同步，通过进博会这一开放合作的重要平台，展示了我们的创新成果和全球化战略布局。我们将继续推进全球化运营，加速源头创新转化，为‘健康中国’的宏伟蓝图贡献力量。” “溢出效应”不断扩大，Ion实现由“展品”到“商品” 在医疗器械及医药保健展区，继往届“网红产品”达芬奇手术机器人之后，直观复星又一“明星产品”Ion支气管镜机器人将迎来国内获批上市后的进博首秀。2019年，Ion在进博会首次展出，被专业人士及大众所熟知；2022年底，Ion通过国家药监局评审进入创新产品“绿色通道”2024年3月成功通过国家药品监督管理局审批，获准上市，同年9月实现首台Ion商业装机并顺利完成首次商业应用。可以说，借助进博会的“溢出效应”，Ion完成了由“展品”到“商品”的转变。 肺癌被称为癌症“头号杀手”，2022年中国新发肺癌高达106.06万例¹。肺癌患者5年生存率仅为19.7%²。肺癌I期患者的五年生存率则达到了77%-92%。“早筛早诊”在提高肺癌治疗效果方面至关重要。支气管镜检查是肺癌早期诊断的重要手段之一，但由于早期的肺结节通常位于支气管深部，以现有的技术较难识别和诊断。Ion支气管镜操作控制系统作为前沿科技的最新成果，其在支气管导航操作控制方面的创新性能，为临床诊疗提供了全新的便利度与精准度，可为患者提供新的医疗方案。截至2024年第三季度，全球已安装了736套Ion，实施了超过15万例Ion手术。 CNS创新治疗技术“磁波刀”全新V2机型中国首展 全球医疗科技的前沿发展为特发性震颤和帕金森病患者带来新的希望。在即将到来的第七届进博会上，“磁波刀”V2机型的首次亮相备受期待。这一全新机型已获得欧洲CE认证和美国FDA批准，并于2024年正式递交中国国家药品监督管理局（NMPA）注册申请。V2机型的创新之处在于，它能够为临床上难以用药物控制的特发性震颤和以震颤为主要症状的帕金森病提供一种无创的手术治疗方案。此外，能适配更多品牌和型号的磁共振设备，极大地扩展了该技术的普及和应用范围。 中国特发性震颤发病率0.9%，65岁以上4.6%，发病人数超过1000万人³；帕金森在65岁以上人群患病率为1.7%，发病人数超过360万⁴。“磁波刀”技术在全球的应用已经取得了显著成效，成功治疗了超过20,000例特发性震颤及帕金森病患者，相关临床研究成果连续3次刊登于国际顶级杂志《The New England Journal of Medicine》⁵⁷。这一技术通过结合聚焦超声和磁共振成像（MRI）的精准定位，使得高强度聚焦超声能够精确消融病灶，实现治疗目的。这种无创治疗方式不仅减少了患者的身体负担，还降低了手术风险，提高了治疗的安全性和有效性。 复星医药战略伙伴北京未磁科技自主研发的全球首款128通道无液氦脑磁图仪将同时展出，这一创新无创脑功能成像技术为人类脑科学研究和脑疾病诊疗再建新猷。这也展示了复星医药在中枢神经系统（CNS）诊疗解决方案上的创新及推动高科技医疗手段普及化方面的努力，为全球神经系统疾病患者带来了更多高效、可及的治疗选择。 聚焦未被满足的临床需求 提升创新药品可及性 复星医药成立三十年来，以患者为中心，围绕未被满足的临床需求，聚焦实体瘤、血液瘤、免疫炎症等核心治疗领域持续深耕，得益于进博会的展示舞台，复星医药多款创新产品和疗法让更多人熟知，从展品到商品，不仅提升了创新药物的可及性，也使更多的中国患者受益。 作为进博老友，连续第7年参展的CAR-T细胞治疗产品奕凯达®（阿基仑赛注射液）每年都在分享淋巴瘤治疗领域“可及可愈”的最新进展。超过110款城市惠民保、超过80款商业保险为更多患者畅通创新支付路径；全国28个省区市170家奕凯达®高标准治疗中心，治疗超过900位淋巴瘤患者；奕凯达®药品安全性处于国际领先水平。 多款涵盖肿瘤、自身免疫、慢病等治疗领域的创新产品将继续亮相，包括创新药奥康泽®（奈妥匹坦帕洛诺司琼胶囊），这是全球首个且迄今为止唯一同时阻断NK-1受体和5-HT3受体的双通道固定剂量组合口服复方止吐制剂，为肿瘤患者化疗引起的恶心呕吐提供了更优解决方案；由Neovii开发的复可舒®（抗人T细胞兔免疫球蛋白），已在50多个国家获批，用于改善接受移植患者的预后，已惠及超过25万名患者，解决了未满足的重大需求。 此外，全球首个磷吸收抑制剂万缇乐®(盐酸替那帕诺片）迎来中国首展；得益于进博会开放兼容的国际化平台及独特影响力，用于治疗成人帕金森病患者症状波动的全新第三代COMT抑制剂欧捷能®（奥吡卡朋）自第六届进博会正式官宣在博鳌乐城试点以来，迈出了商业化旅程坚实的第一步；展示的创新产品还包括全球首款银屑病口服靶向药物欧泰乐®（阿普米司特片）、用于治疗慢性肾病接受血液透析的成人患者的继发性甲状腺功能亢进症的唯一的多肽类拟钙剂旁必福®（盐酸依特卡肽注射液）等，将如数与观众见面。 复星医药的三十年，是不断创新和突破的三十年。与上海生物医药产业政策同频共振，从引进全球领先的医疗产品到推动本土化生产，复星医药始终走在创新前沿。展望未来，复星医药期待借助进博会这一开放平台，进一步推动创新药物和疗法的可及性，惠及更多中国患者。 1． B. Han, R. Zheng, H. Zeng et al., Cancer incidence and mortality in China, 2022, Journal of the National Cancer Center, https://doi.org/10.1016/j.jncc.2024.01.006 2．中华医学会呼吸病学分会,中国肺癌防治联盟专家组.肺结节诊治中国专家共识（2024年版）[J].中华结核和呼吸杂志,2024,47(8):716-729. 3． 中华医学会神经病学分会帕金森病及运动障碍学组, 中国原发性震颤的诊断和治疗指南（2020） [J] . 中华神经科杂志, 2020, 53(12) : 987-995 4．Shige Qi, Peng Yin, Linhong Wang et al., Prevalence of Parkinson's Disease: A Community-Based Study in China Mov Disord. 2021 Dec;36(12):2940-2944 5.  Krishna V, Fishman PS, Eisenberg HM et al.,Trial of Globus Pallidus Focused Ultrasound Ablation in Parkinson's Disease. N Engl J Med. 2023 Feb 23;388(8):683-693. 6. Martínez-Fernández R, Máñez-Miró JU, Rodríguez-Rojas R et al.,Randomized Trial of Focused Ultrasound Subthalamotomy for Parkinson's Disease. N Engl J Med. 2020 Dec 24;383(26):2501-2513. 7. Elias WJ, Lipsman N, Ondo WG, et al., A Randomized Trial of Focused Ultrasound Thalamotomy for Essential Tremor. N Engl J Med. 2016 Aug 25;375(8):730-9.