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纽约

,

,

Feb. 10, 2025

2025年2月10日

(GLOBE NEWSWIRE) --

（环球通讯社）--

Axsome Therapeutics, Inc.

Axsome Therapeutics公司。

(NASDAQ: AXSM) (Axsome), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that it has entered into a settlement agreement with

引领中枢神经系统（CNS）疾病治疗新时代的生物制药公司（纳斯达克：AXSM）（Axsome）今天宣布，已与

Teva Pharmaceuticals, Inc.

Teva 制药公司

(Teva) resolving all patent litigation related to Axsome’s AUVELITY® (dextromethorphan HBr – bupropion HCl) product. The litigation resulted from submission by Teva of an Abbreviated New Drug Application to the

（Teva）解决与Axsome的AUVELITY®（右美沙芬HBr–盐酸安非他酮）产品有关的所有专利诉讼。该诉讼是由Teva向

U.S. Food and Drug Administration

U、 美国食品和药物管理局

(FDA) seeking approval to market a generic version of AUVELITY in

（FDA）寻求批准在

the United States

prior to the expiration of applicable Axsome patents.

在适用的Axsome专利到期之前。

Under the terms of the settlement agreement, Axsome will grant Teva a license to sell its generic version of AUVELITY beginning on or after

根据和解协议的条款，Axsome将授予特瓦一份许可证，从当天或之后开始销售其通用版本的AUVELITY

March 31, 2039

2039年3月31日

, if pediatric exclusivity is granted for AUVELITY, or on or after

，如果儿科排他性被授予AUVELITY，或在或之后

September 30, 2038

2038年9月30日

, if no pediatric exclusivity is granted, subject to FDA approval and conditions and exceptions customary for agreements of this type. In accordance with the agreement, the parties will terminate all ongoing litigation between Axsome and Teva regarding AUVELITY patents pending in the

，如果没有授予儿科排他性，则须经FDA批准以及此类协议的条件和例外情况。根据协议，双方将终止Axsome和Teva之间正在进行的关于AUVELITY专利的所有诉讼

U.S. District Court for the District of New Jersey

U、 美国新泽西州地区法院

.

.

The settlement agreement resolves all outstanding patent litigation relating to AUVELITY.

和解协议解决了所有与AUVELITY有关的未决专利诉讼。

“Axsome is proud of its commitment to innovating treatments aimed at improving the lives of the millions of patients living with central nervous system disorders. The resolution of this patent litigation underscores the value of that innovation as it relates to AUVELITY, and more broadly reflects the strength of Axsome’s intellectual property portfolio,” said .

“Axsome为其致力于创新旨在改善数百万中枢神经系统疾病患者生活的治疗方法而感到自豪。这项专利诉讼的解决突显了这项创新的价值，因为它与生存能力有关，更广泛地反映了Axsome知识产权组合的优势，”他说。

Herriot Tabuteau

Herriot Tabuteau

, MD, Chief Executive Officer of

，医学博士，首席执行官

Axsome Therapeutics

Axsome疗法

. “With our industry-leading neuroscience pipeline addressing difficult-to-treat conditions, we look forward to continuing to serve our patient communities through innovation and delivery of differentiated new medicines.”

“随着我们业界领先的神经科学管道解决难以治疗的疾病，我们期待着通过创新和提供差异化的新药，继续为我们的患者社区服务。”

As required by law, Axsome and Teva will submit the settlement agreement to the

根据法律要求，Axsome和Teva将向

U.S. Federal Trade Commission

U、

and the

和

U.S. Department of Justice

U、 美国司法部

for review.

供审查。

About

关于

Axsome Therapeutics

Axsome疗法

Axsome Therapeutics

Axsome疗法

is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes.

是一家生物制药公司，引领中枢神经系统（CNS）疾病治疗的新时代。我们通过确定护理中的关键差距来实现科学突破，并开发差异化产品，重点关注新的行动机制，从而在患者预后方面取得有意义的进步。

Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder and excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in .

我们业界领先的神经科学产品组合包括FDA批准的与嗜睡症和阻塞性睡眠呼吸暂停相关的重度抑郁症和白天过度嗜睡的治疗方法，以及针对影响1.5亿多人的广泛严重神经和精神疾病的多个晚期发展计划。

the United States

美国

. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit the Company’s website at

.我们共同致力于解决大脑的一些最大问题，使患者及其亲人能够茁壮成长。欲了解更多信息，请访问公司网站

www.axsome.com

www.axsome.com

.

.

Forward Looking Statements

前瞻性声明

Certain matters discussed in this press release are “forward-looking statements”. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements.

本新闻稿中讨论的某些事项是“前瞻性声明”。在某些情况下，公司可能会使用“预测”，“相信”，“潜在”，“继续”，“估计”，“预期”，“预期”，“计划”，“打算”，“可能”，“可能”，“可能”，“可能”，“将会”，“应该”或其他表达未来事件或结果不确定性的词语来识别这些前瞻性陈述。

In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the commercial success of the Company’s Sunosi®, Auvelity®, and Symbravo® products and the success of the Company’s efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company’s ability to maintain and expand payer coverage; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material changes to the Company’s currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of the Company’s current product candidates; the Company’s ability to fund additional clinical trials to continue the advancement of the Company’s product candidates; the.

特别是，公司关于趋势和潜在未来结果的声明就是此类前瞻性声明的例子。前瞻性陈述包括风险和不确定性，包括但不限于公司Sunosi®、Auvelity®和Symbravo®产品的商业成功，以及公司努力获得有关solriamfetol和/或AXS-05的任何其他指示的成功；公司维持和扩大付款人覆盖范围的能力；公司正在进行的临床试验和公司当前候选产品的预期临床试验的成功率、时间和成本，包括关于开始时间、注册速度和完成试验的声明（包括公司为公司披露的临床试验提供全额资金的能力，假设公司目前预计的收入或费用没有实质性变化），无效分析和中期结果的接收，这些结果不一定表明公司正在进行的临床试验的最终结果，和/或数据读数，以及支持提交公司当前候选产品新药申请（“NDA”）所需的研究数量或类型或结果的性质；公司有能力资助额外的临床试验，以继续推进公司的候选产品；的。

U.S. Food and Drug Administration

U、 美国食品和药物管理局

(“FDA”) or other regulatory authority approval of, or other action with respect to, the Company’s product candidates, including statements regarding the timing of any NDA submission; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the commercialization of Sunosi, Auvelity, and Symbravo and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; the Company’s ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control.

（“FDA”）或其他监管机构对公司候选产品的批准或其他行动，包括关于任何NDA提交时间的声明；公司成功保护其知识产权或以公司可接受的成本获得必要许可的能力（如果有的话）；公司研发计划和合作的成功实施；公司许可协议的成功；公司产品和候选产品的市场接受度（如果批准）；公司的预期资本要求，包括Sunosi、Auvelity和Symbravo商业化所需的资本金额，以及公司商业推出其他候选产品所需的资本金额（如果获得批准），以及对公司预期现金跑道的潜在影响；公司将销售额转换为已确认收入并保持有利的总销售额与净销售额的能力；国内政治气候、地缘政治冲突或全球流行病以及其他不在公司控制范围内的因素（包括一般经济状况和监管发展）引起或与之相关的不可预见的情况或正常业务运营的其他中断。

The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstance..

本文讨论的因素可能导致实际结果和发展与此类声明中表达或暗示的结果和发展存在实质性差异。前瞻性声明仅在本新闻稿发布之日做出，公司没有义务公开更新此类前瞻性声明以反映后续事件或情况。。

Investors:

投资者：

Mark Jacobson

马克·雅各布森

Chief Operating Officer

首席运营官

(212) 332-3243

(212) 332-3243

mjacobson@axsome.com

mjacobson@axsome.com

Media:

媒体：

Darren Opland

达伦·奥普兰

Director, Corporate Communications

企业传播总监

(929) 837-1065

(929) 837-1065

dopland@axsome.com

dopland@axsome.com

Source: Axsome Therapeutics, Inc.

来源：Axsome Therapeutics，Inc。