Dalfampridine

PEARL RIVER, N.Y.--(BUSINESS WIRE)-- Acorda Therapeutics, Inc. today announced that its common stock is no longer listed on the Nasdaq Stock Market. The delisting is a result of the Company’s failure to demonstrate compliance with Nasdaq Listing Rules 5101, 5110(b), and IM-5101-1 as a result of the Company’s commencement of Chapter 11 proceedings and Nasdaq Listing Rule 5450(b)(1)(A) for failure to maintain stockholders’ equity of at least $10 million. Trading in the Company’s common stock on the Nasdaq exchange was suspended on April 12, 2024. The Company’s common stock is quoted on the OTC Pink® Open Market platform operated by OTC Markets Group Inc. since April 12, 2024 under the “ACORQ” ticker symbol. About Acorda Therapeutics Acorda Therapeutics develops therapies to restore function and improve the lives of people with neurological disorders. INBRIJA® is approved for intermittent treatment of OFF episodes in adults with Parkinson’s disease treated with carbidopa/levodopa. INBRIJA is not to be used by patients who take or have taken a nonselective monoamine oxidase inhibitor such as phenelzine or tranylcypromine within the last two weeks. INBRIJA utilizes Acorda’s innovative ARCUS® pulmonary delivery system, a technology platform designed to deliver medication through inhalation. Acorda also markets the branded AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg. Forward-Looking Statements This press release includes forward-looking statements. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including: our ability to negotiate and confirm a sale of substantially all of our assets under Section 363 of the Bankruptcy Code (or any other plan of reorganization); the high costs and related fees of cases instituted under the Bankruptcy Code; our ability to obtain sufficient financing to allow us to operate our business during the course of the Chapter 11 proceedings; our ability to satisfy the conditions and milestones in the Restructuring Support Agreement; our ability to maintain our relationships with our suppliers, service providers, customers, employees and other third parties; our ability to maintain contracts that are critical to our operations; our ability to execute competitive contracts with third parties; the ability of third parties to seek and obtain court approval to terminate contracts and other agreements with us; our ability to retain our current management team and to attract, motivate and retain key employees; the ability of third parties to seek and obtain court approval to convert the Chapter 11 proceedings to a proceeding under Chapter 7 of the Bankruptcy Code; the actions and decisions of our shareholders, creditors and other third parties who have interests in the Chapter 11 proceedings that may be inconsistent with our plans; our ability to successfully market INBRIJA, AMPYRA, FAMPYRA or any other products that we may develop; our ability to attract and retain key management and other personnel, or maintain access to expert advisors; our ability to raise additional funds to finance our operations, repay outstanding indebtedness or satisfy other obligations, and our ability to control our costs or reduce planned expenditures and take other actions which are necessary for us to continue as a going concern; risks related to the successful implementation of our business plan, including the accuracy of our key assumptions; risks related to our corporate restructurings, including our ability to outsource certain operations, realize expected cost savings and maintain the workforce needed for continued operations; risks associated with complex, regulated manufacturing processes for pharmaceuticals, which could affect whether we have sufficient commercial supply of INBRIJA, AMPYRA or FAMPYRA to meet market demand; our reliance on third-party manufacturers for the production of commercial supplies of INBRIJA, AMPYRA and FAMPYRA; third-party payers (including governmental agencies) may not reimburse for the use of INBRIJA, AMPYRA or FAMPYRA at acceptable rates or at all and may impose restrictive prior authorization requirements that limit or block prescriptions; reliance on collaborators and distributors to commercialize INBRIJA and FAMPYRA outside the U.S.; our ability to satisfy our obligations to distributors and collaboration partners outside the U.S. relating to commercialization and supply of INBRIJA and FAMPYRA; competition for INBRIJA and AMPYRA, including increasing competition and accompanying loss of revenues in the U.S. from generic versions of AMPYRA (dalfampridine) following our loss of patent exclusivity; competition from generic versions of FAMPYRA (dalfampridine) following patent challenges in jurisdictions outside of the U.S.; the ability to realize the benefits anticipated from acquisitions because, among other reasons, acquired development programs are generally subject to all the risks inherent in the drug development process and our knowledge of the risks specifically relevant to acquired programs generally improves over time; the risk of unfavorable results from future studies of INBRIJA (levodopa inhalation powder) or from other research and development programs, or any other acquired or in-licensed programs; the occurrence of adverse safety events with our products; the outcome (by judgment or settlement) and costs of legal, administrative or regulatory proceedings, investigations or inspections, including, without limitation, collective, representative or class-action litigation; failure to protect our intellectual property, to defend against the intellectual property claims of others or to obtain third-party intellectual property licenses needed for the commercialization of our products; and failure to comply with regulatory requirements could result in adverse action by regulatory agencies. These and other risks are described in greater detail in our filings with the Securities and Exchange Commission. We may not actually achieve the goals or plans described in our forward-looking statements, and investors should not place undue reliance on these statements. Forward-looking statements made in this press release are made only as of the date hereof, and we disclaim any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release, except as may be required by law. View source version on businesswire.com: Contacts Tierney Saccavino tsaccavino@acorda.com Source: Acorda Therapeutics View this news release online at:

在经过多年与仿制药激烈竞争，核心产品销售明显低于预期后，生物技术公司Acorda Therapeutics申请破产，并正在以1.85亿美元的价格出售其资产。德国生物技术公司Merz Therapeutics收购了Acorda的核心资产：帕金森药物Inbrija和多发性硬化症药物Amprya（在欧洲和加拿大为Fampyra）。“Acorda的管理团队和董事会已经评估了我们所有的战略选择，并经过详尽的流程，相信这一选择符合利益相关者的最佳利益，”Acorda首席执行官Ron Cohen说。“公司的首要任务之一是确保患者能够继续接受药物治疗，”Cohen补充说，“Acorda相信Merz 在收购后，能够无缝衔接继续满足患者的需求。”Merz集团首席商务官Jörg Bergler指出，Merz希望利用这些产品来加强其在北美的业务。Acorda将继续正常运营，直到美国纽约南区破产法院批准出售，预计将于6月批准。上市产品销售不及预期Inbrija是一种便于患者自己操作的吸入性左旋多巴（左旋多巴是一种可以转化为神经递质的物质，可以改善帕金森病患者的运动功能），利用了Acorda公司专有的ARCUS平台开发，能向患者肺部提供精确剂量的左旋多巴干粉制剂。2018年12月，FDA批准Inbrija用于接受卡比多巴/左旋多巴治疗的帕金森病患者关闭期(OFF)的间歇性治疗。Inbrija是第一个获得FDA批准的吸入性左旋多巴，也是全球首款帕金森病吸入治疗药物。在口服的情况下，药物会先通过肠胃吸收再到达大脑，所以起效过程会有变化。而吸入式治疗可以通过肺部进入身体，直达大脑，快速起效。2023年5月8日，中国药企畅溪制药与Acorda签订协议，花费250万美元的首付款，以及后续多至1.41亿美元的潜在里程碑付款引进Inbrija进入中国。Acorda很看好Inbrija，预计最高销售额能达到8亿美元，但是后来将这一估值调整为3.5至5亿美元。但是，事实更加残酷，2022年Inbrija的销售额仅为3090万美元。Amprya是一种钾通道阻滞剂，于2010 年1 月获准用于改善患有多发性硬化症（MS）的成人的行走能力。Amprya在2018年创造了4.55亿美元的收入，但是在失去四项专利后，面对仿制药带来的巨大压力，该药物在2022年销售额已经下滑至7290万美元，2023年第三季度仅仅获得1570万美元的收入。2009年7月，渤健以5.1亿美元的总交易额获得了Amprya在美国以外的开发和商业化权益。今年1月11日，渤健终止了该合作，涉及多发性硬化症药物Amprya（fampridine）的全球商业化权益。退还协议将于2025年1月1日生效，这也意味着两家公司长达15年协议的终止。财务状况根据Acorda公布的2023年第三季度财报和全年财报显示，公司的业绩不容乐观。2023财年前三财季公司累计收入7964.80万美元，去年同期累计收入为8709.60万美元，同比减少8.55%。其中Inbrija 2023年第三季度美国净营收为810万美元，比2022年第三季度增长4%，但是Amprya2023年第三季度净营收仅为1570万美元，同比下降26%。Amprya前三季度的净收入比2022年同期下降了17%。Fampyra特许权使用费收入为250万美元，与2022年同期相比下降3%。Amprya失去了排他性，仿制药于2018年进入市场。公司预计Amprya收入将继续下降。截至2023年9月30日，公司拥有现金、现金等价物和限制性现金3,360万美元，而2022年底为4,470万美元。对于2023年全年，公司重申INBRIJA美国净收入指引为3400万美元至3800万美元，期末现金余额指引为3900万美元至4400万美元，AMPYRA净收入指引为6500万美元至7000万美元。Acorda 取消原定于2024年4月1日举行的2023年第四季度和年终财报电话会议，所以其2023年全年财报未公布。为了应对上市产品收入不断下降，公司已经进行了多轮裁员。包括2019年裁员25%，2021年初裁员16%，并在当年晚些时候再裁员15%，以试图每年节省约2000万美元。参考来源：1.https://ir.acorda.com/investors/investor-news/default.aspx本周好文推荐如需转载请联系佰傲谷并在醒目位置注明出处···