Alixorexton

DUBLIN--(BUSINESS WIRE)--Alkermes plc (Nasdaq: ALKS) (“Alkermes”) and Avadel Pharmaceuticals plc (Nasdaq: AVDL) (“Avadel”) today announced Alkermes’ completion of its acquisition of Avadel, a commercial-stage biopharmaceutical company. The acquisition adds Avadel’s FDA-approved product, LUMRYZ®, to Alkermes’ commercial portfolio, and provides Alkermes with a commercial organization experienced in this disease state. This strategic move accelerates Alkermes’ entry into the sleep medicine market and enhances its ability to unlock the full potential of its late-stage development pipeline focused on central disorders of hypersomnolence. The transaction was completed pursuant to an Irish High Court sanctioned scheme of arrangement (the “Scheme”) under Chapter 1 of Part 9 of the Companies Act 2014 of Ireland. LUMRYZ® (sodium oxybate) for extended-release oral suspension is approved for the treatment of cataplexy or excessive daytime sleepiness in patients seven years of age and older with narcolepsy. “With the close of this acquisition, Alkermes achieved an important milestone in the continued advancement of our strategy, accelerating our entry into the commercial sleep medicine market at a pivotal moment as we work to initiate the planned phase 3 program for alixorexton in narcolepsy this quarter. Avadel’s commercial and R&D portfolio, established commercial infrastructure, and talented team strengthen our organization and expand our capabilities in this important therapeutic area. Supported by our strong balance sheet, this all‑cash acquisition is expected to enhance our revenue growth profile and underscores our ongoing commitment to creating long‑term value for shareholders,” said Richard Pops, Chief Executive Officer of Alkermes. The transaction is expected to be accretive in 2026 and represents a compelling financial and strategic opportunity, leveraging Alkermes’ existing commercial expertise and operational infrastructure and adding new capabilities in rare disease. Avadel is a recognized innovator in the sleep medicine space, committed to addressing significant unmet needs for patients. Since launching LUMRYZ in 2023, Avadel has successfully built and scaled a commercial organization that has driven strong demand. With an estimated population of >50,000 oxybate-eligible narcolepsy patients in the United States, LUMRYZ has significant opportunity for growth ahead. The acquisition also includes valiloxybate, Avadel's in-licensed salt-free, once-at-bedtime oxybate candidate in phase 1 clinical development. To finance the acquisition, Alkermes will use approximately $775 million of cash from its balance sheet and borrowed a total of $1.525 billion in term loans that are due in 2031. The company expects to pay down the debt quickly with cash flows from the business. Alkermes will provide its 2026 financial expectations for the combined organization on Feb. 25, 2026 as part of its financial results announcement for the quarter and year ended Dec. 31, 2025. Alkermes’ financial expectations for 2026 will include certain expenses related to the transaction, including: In the first quarter of 2026, Alkermes will record transaction-related costs of $40 million. Alkermes will record approximately $180 million of LUMRYZ inventory fair value step-up, which will be expensed as cost of goods sold as the inventory is sold in 2026. Alkermes will record approximately $1.5 billion of intellectual property related to LUMRYZ, which will be amortized over an expected life of 13 years. Alkermes expects amortization of intangible assets to be in the range of $95 to $105 million in 2026. Net interest expense is expected to be in the range of $75 to $85 million in 2026. The acquisition was approved by Avadel shareholders at a scheme meeting of shareholders and at an extraordinary general meeting of shareholders, each held on Jan. 12, 2026. The Irish High Court sanctioned the Scheme on Feb. 10, 2026. On Feb. 12, 2026 (the “Effective Date”), the Scheme and the acquisition became effective upon delivery of the court order of the Irish High Court to the Irish Companies Registration Office. Prior to the opening of trading on Feb. 12, 2026, all of Avadel’s shares will cease trading on the Nasdaq Global Market (“Nasdaq”), and Avadel intends to promptly cause such shares to be delisted from Nasdaq and deregistered under the Securities Exchange Act of 1934, as amended. Payment of the Cash Consideration to the Scheme Shareholders pursuant to the Scheme is being commenced by Alkermes today, Feb. 12, 2026. The Rights Agent will record the Scheme Shareholders as the owners of the CVR Consideration in the CVR Register in accordance with the terms of the CVR Agreement dated as of today, Feb. 12, 2026. Except as otherwise defined herein, capitalized terms used but not defined in this announcement have the same meanings as given to them in the definitive proxy statement filed by Avadel with the U.S. Securities and Exchange Commission (“SEC”) on Dec. 3, 2025, which also constitutes a scheme circular under Irish law. About Alkermes plc Alkermes plc (Nasdaq: ALKS), a mid-cap growth and value equity, is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy. Alkermes’ pipeline includes late-stage clinical candidates in development for narcolepsy and idiopathic hypersomnia, and orexin 2 receptor agonists in early clinical development for other neurological disorders, including attention-deficit hyperactivity disorder (ADHD) and fatigue associated with multiple sclerosis and Parkinson’s disease. Headquartered in Ireland, Alkermes also has a corporate office and research and development center in Massachusetts and a manufacturing facility in Ohio. For more information, please visit Alkermes’ website at www.alkermes.com. About LUMRYZ® (sodium oxybate) for extended-release oral suspension LUMRYZ is an extended-release sodium oxybate medication approved by the FDA on May 1, 2023, as the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. On Oct. 16, 2024, LUMRYZ was additionally approved as a once-at-bedtime treatment for cataplexy or EDS in pediatric patients seven years of age and older with narcolepsy. The LUMRYZ prescribing information includes Boxed Warnings for central nervous system (CNS) depression and abuse and misuse. LUMRYZ is a CNS depressant. Clinically significant respiratory depression and obtundation may occur in patients treated with LUMRYZ at recommended doses. Many patients who received LUMRYZ during clinical trials in narcolepsy were receiving CNS stimulants. LUMRYZ is the sodium salt of gamma-hydroxybutyrate (GHB). Abuse or misuse of illicit GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreased consciousness, coma, and death. Because of the risks of CNS depression and abuse and misuse, LUMRYZ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the LUMRYZ REMS. Please see full Prescribing Information for additional safety information including BOXED Warnings. Further information about the REMS is available at www.LUMRYZREMS.com or by calling 1-877-453-1029. Note Regarding Forward-Looking Statements Certain statements set forth in this announcement constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: Alkermes’ expectations concerning the combined organization’s future financial and operating performance, business plans or prospects, including expected transaction costs and accounting, the company’s anticipated growth profile, financial expectations and plans for LUMRYZ and expected timelines for paying down the company’s debt; and Alkermes’ expectations regarding development plans, activities and timelines for, and the potential therapeutic and commercial value of, the combined organization’s portfolio of development candidates. Alkermes cautions that forward-looking statements are inherently uncertain. The forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: the businesses of Alkermes and Avadel may not be effectively integrated and the expected benefits and value of the acquisition may not be achieved; there may be unknown or inestimable liabilities, potential litigation and transaction costs associated with the acquisition; whether any general economic, political, market and business conditions, or future exchange and interest rates, changes in tax laws, regulations, rates and policies, may have a negative impact on the combined organization following consummation of the acquisition; the completion of the acquisition could result in disruption to the business and make it more difficult to maintain business and operational relationships of Alkermes and Avadel, including the ability of Alkermes to retain highly qualified personnel; the company may not be able to pay down its debt on expected timelines or at all; clinical development activities may not be initiated or completed on expected timelines or at all; the results of development activities may not be positive, or predictive of future results from such activities, results of future development activities or real-world results; Alkermes’ products or product candidates could be shown to be ineffective or unsafe; the FDA or regulatory authorities outside the U.S. may not agree with Alkermes’ regulatory approval strategies or may make adverse decisions regarding its products; Alkermes may not be able to continue to successfully commercialize its products or support revenue growth from such products; there may be a reduction in payment rate or reimbursement for Alkermes’ products or an increase in related financial obligations to government payers; Alkermes’ products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading “Risk Factors” in Alkermes’ Annual Report on Form 10-K for the year ended Dec. 31, 2024 and in subsequent filings made by Alkermes with the SEC, which are available on the SEC’s website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, Alkermes and/or its directors disclaim any intention or responsibility for updating or revising any forward-looking statements contained in this announcement. LUMRYZ® is a registered trademark of Flamel Ireland Limited, an affiliate of Alkermes plc. Statement Required by the Irish Takeover Rules The Alkermes directors accept responsibility for the information contained in this announcement other than that relating to Avadel, its Subsidiaries and the Avadel directors and members of their immediate families, related trusts and persons connected with them. To the best of the knowledge and belief of the Alkermes directors (who have taken all reasonable care to ensure that this is the case), the information contained in this announcement for which they accept responsibility is in accordance with the facts and does not omit anything likely to affect the import of such information. The Avadel directors accept responsibility for the information contained in this announcement other than that relating to Alkermes, its Subsidiaries and the Alkermes directors and members of their immediate families, related trusts and persons connected with them. To the best of the knowledge and belief of the Avadel directors (who have taken all reasonable care to ensure that this is the case), the information contained in this announcement for which they accept responsibility is in accordance with the facts and does not omit anything likely to affect the import of such information. Important Notices Relating to Financial Advisors J.P. Morgan Securities LLC, together with its affiliate J.P. Morgan Securities plc (which is authorized in the United Kingdom by the Prudential Regulation Authority and regulated in the United Kingdom by the Prudential Regulation Authority and the Financial Conduct Authority) (together, "J.P. Morgan") acted as financial advisor exclusively for Alkermes and no one else in connection with the acquisition and will not regard any other person as its client in relation to the acquisition and will not be responsible to anyone other than Alkermes for providing the protections afforded to clients of J.P. Morgan or its affiliates, nor for providing advice in relation to the acquisition or any other matter or arrangement referred to herein. Goldman Sachs & Co. LLC, which is authorized and regulated by the Financial Industry Regulatory Authority, is acting exclusively as financial advisor for Avadel and for no one else in connection with the matters set out in this announcement and will not regard any other person as its client in relation to the matters set out in this announcement and will not be responsible to anyone other than Avadel for providing the protections afforded to clients of Goldman Sachs & Co. LLC nor for providing advice in relation to the acquisition or any other matter referred to in this announcement. Neither Goldman Sachs & Co. LLC nor any of its affiliates (nor their respective directors, officers, employees or agents) owes or accepts any duty, liability or responsibility whatsoever (whether direct or indirect, whether in contract, in tort, under statute or otherwise) to any person who is not a client of Goldman Sachs & Co. LLC in connection with this announcement, any statement contained herein or otherwise. Morgan Stanley & Co. LLC, acting through its affiliate Morgan Stanley & Co. International plc (together, "Morgan Stanley"), which is authorized by the Prudential Regulation Authority and regulated by the Financial Conduct Authority in the United Kingdom, is acting exclusively for Avadel as financial advisor and for no one else in relation to the matters referred to in this announcement. In connection with such matters, Morgan Stanley and its directors, officers, employees and agents will not regard any other person as its client, nor will it be responsible to anyone other than Avadel for providing the protections afforded to their clients or for providing advice in connection with the matters described in this announcement or any matter referred to herein. Publication on a Website In accordance with Rule 26.1 of the Irish Takeover Rules, a copy of this announcement will be available on Avadel’s website at www.avadel.com and on Alkermes’ website at www.alkermes.com by no later than 12:00 noon (U.S. Eastern Time) on the business day following publication of this announcement. Neither the content of any such websites referred to in this announcement nor the content of any other websites accessible from hyperlinks on such websites is incorporated into, or forms part of, this announcement.

点击蓝字关注“基因狐” 点亮星标 获取更多精彩内容~ ▉ 导语 发作性睡病 (narcolepsy, NP) 是一种罕见的睡眠觉醒维持困难的慢性神经系统罕见疾病，发病高峰年龄在8～15岁，临床上以日间过度思睡、猝倒及夜间睡眠紊乱为主要特征，患者因无法正常调节睡眠与苏醒的循环，严重影响其学习、生活和社会活动。国际睡眠障碍分类第3版将发作性睡病分为1型 (NT1, 伴猝倒) 和2型 (NT2, 不伴猝倒)，其中1型约占85%，全球各地区患病率从 2.3/10000~5/0000不等，已纳入《中国第二批罕见病目录》。 近日，Alkermes公司宣布，其用于治疗1型发作性睡病 (NT1) 的在研口服选择性食欲素2受体 (OX2R) 激动剂Alixorexton (ALKS 2680) 已获得美国FDA授予的突破性疗法资格认定 (BTD)。这一里程碑进展有望使其成为首款能够功能性恢复食欲素信号通路的口服药物，为罕见睡眠障碍治疗带来了新的希望。 ▲ 来源 iStock ▲ 好物推荐 ▉ 食欲素系统：被锁定的觉醒“总开关” 近日，Alkermes公司 (Nasdaq: ALKS) 宣布，其用于治疗1型发作性睡病 (narcolepsy type 1, NT1) 的在研口服选择性食欲素2受体 (orexin 2 receptor, OX2R) 激动剂Alixorexton (ALKS 2680) 已获得美国FDA授予的突破性疗法资格认定 (Breakthrough Therapy Designation, BTD)。Alkermes计划于2026年第一季度启动全球III期临床研究。 ▲新闻稿截图 发作性睡病 (narcolepsy, NP) 是一种罕见的中枢性睡眠障碍疾病，以日间过度思睡、猝倒发作、入睡前幻觉、睡眠瘫痪为主要临床表现，治疗以改善临床症状为主，包括缓解日间过度思睡和猝倒等症状的药物治疗。国际睡眠障碍分类第3版将发作性睡病分为1型 (NT1, 伴猝倒) 和2型 (NT2, 不伴猝倒)，其中1型约占85%。目前，发作性睡病 的发病机制尚不明确，与人类白细胞抗原免疫 (HLA)、感染、表观遗传沉默等多种因素相关，其中下丘脑食欲素 (hypocretin, Hcrt) 神经元选择性丧失是关键的病理生理机制。长期以来，发作性睡病的治疗主要依赖哌甲酯、莫达非尼等中枢兴奋剂或羟丁酸钠等对症治疗药物，这些疗法虽能部分缓解症状，但往往伴随副作用，且未能从根本上解决食欲素信号缺失的核心问题。 ▲Alixorexton (ALKS 2680) 开发进展 Alixorexton (ALKS 2680) 是一种靶向食欲素2受体 (OX2R) 的新型大环化合物，其设计理念是为了绕过受损的食欲素神经元，直接模拟天然食欲素的功能，激活下游的OX2R，从而“重启”觉醒信号通路。这种“替代疗法”策略，被视为发作性睡病治疗从“对症”走向“对因”的革命性一步。 ▲Alixorexton (ALKS 2680) 结构式 Alixorexton (ALKS 2680) 此次突破性疗法资格认定 (BTD) 的核心依据，来源于其在1期和2期临床试验中展现出的积极数据，特别是在纳入92名1型发作性睡病的Vibrance-1 II期 (NCT06358950) 双盲、安慰剂对照、剂量范围探索研究中，该药物的潜力得到了充分验证。结果显示，在清醒维持时间 (MWT) 测试中，与安慰剂组相比，所有三个测试剂量组 (4mg、6mg、8mg) 患者的患者入睡潜伏期从基线的3分钟提升至20分钟以上，表现出统计学上显著、具有临床意义且呈剂量依赖性的改善。 ▲Alixorexton (ALKS 2680)临床数据 在关键次要终点Epworth嗜睡量表 (ESS)上，Alixorexton (ALKS 2680) 同样表现出色。ESS是评估患者主观日间嗜睡严重程度的常用工具，所有剂量组的ESS评分均获得统计学上的显著降低 (P <0.0001)，表明患者能切实感受到日间过度嗜睡症状的缓解。除了嗜睡，猝倒是1型发作性睡病最具特异性的症状。Vibrance-1研究显示，Alixorexton (ALKS 2680) 能有效控制猝倒发作。所有剂量组均观察到每周猝倒率的改善趋势，其中6mg剂量组达到了统计学显著性 (P=0.005)。 ▲Alixorexton (ALKS 2680)临床数据 安全性方面，Alixorexton (ALKS 2680) 在I期及II期研究中均表现出良好的耐受性，大多数治疗期间出现的不良事件 (TEAEs) 的严重程度为轻度至中度。所有剂量组不良事件发生率与安慰剂相当，未出现肝功能异常或严重不良事件，为未来的临床应用提供了保障。值得一提的是，Alixorexton (ALKS 2680) 是首个也是唯一一种在1/2型发作性睡病患者中，通过多剂量每日一次给药的大型随机双盲多周II期临床研究中显示出疗效的口服OX2R激动剂。 Alixorexton (ALKS 2680) 获得突破性疗法资格认定 (BTD)，是食欲素激动剂研发赛道的一个重要里程碑。近十年来，尽管业界对食欲素靶点寄予厚望，但开发选择性高、口服生物利用度好且安全性可控的小分子激动剂充满了挑战，此前已有多家知名药企的项目折戟。Alkermes的成功突围，不仅展示了其在小分子神经科学药物研发领域的深厚实力，也为整个赛道带来了新希望。 ▲Alkermes公司研发管线 信息基于公开资料，仅供参考，不构成医疗或投资建议。本公众号署名原创文章，未经授权禁止转载。 资料来源 [1]. https://www.alkermes.com/ [2]. 国家卫健委: 发作性睡病诊疗指南（2025） [3]. 向雪峰,张红菊.发作性睡病的研究进展[J].中风与神经疾病杂志,2025,42(3):217-220. [4]. 其它公开资料 版权声明：本公众号署名原创的文章仅为个人学习笔记，且只用于交流学习目的，无意剽窃和抄袭，若涉及版权问题或标记有误，烦请留言联系，将第一时间更正或删除。 免责声明：本公众号对转载、分享的内容、陈述、观点判断保持中立，不对所包含内容的准确性、可靠性或完善性提供任何明示或暗示的保证，仅供读者参考。 推荐阅读 2020-2025：AAV基因治疗安全警示录！ 重磅，全球首个DMD AAV基因疗法Ⅲ期临床2年随访数据公布！ 2026突破之年：值得关注的六项杜氏肌营养不良症(DMD)创新疗法！ 突破，又一款DMD外显子跳跃疗法冲刺2027年上市！ FDA批准全球首款DMD基因疗法标签更新，严格适用范围和强化临床监测，Sarepta迎来监管“压力测试”！ 又一款罕见病AAV基因疗法获FDA批准上市，定价259万美元！ Nature | 刘如谦教授团队发布“通用型”基因编辑策略，罕见病有望进入“广谱治疗”新时代！ 重大突破！FDA开启个性化基因编辑“平台化”审评时代，罕见病治疗有望迎来新纪元！ 重磅突破！首款体内(in vivo)基因编辑疗法临床前数据惊艳，即将进入人体试验，我们离治愈遗传性罕见病还有多远？ 100%响应率，又一款罕见病AAV基因疗法获美FDA突破性疗法认定，上市进展加速！ 千亿AAV赛道大洗牌：巨头退场、天价困局，基因疗法的“下半场”怎么玩？ 突破，首款罕见病体内基因编辑疗法完成III期临床患者入组，冲刺2027年上市！ 《自然-生物技术》| 个体定制化CRISPR基因编辑治疗迈入新纪元！ “点赞”“分享”“推荐”，让更多人看到 撰文/排版/编辑：基因狐 转载、投稿、合作请联系：25378137@qq.com