Axsome Therapeutics与 Hikma Pharmaceuticals USA就 Sunosi® (solriamfetol)专利诉讼达成和解-动脉网

Axsome Therapeutics Settles Sunosi® (solriamfetol) Patent Litigation with Hikma Pharmaceuticals USA

Axsome Therapeutics 等信源发布 2025-03-05 20:41

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NEW YORK

纽约

，

March 05, 2025

2025年3月5日

(GLOBE NEWSWIRE) --

（环球新闻网）——

Axsome Therapeutics, Inc.

(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

(NASDAQ: AXSM)（Axsome），一家引领中枢神经系统（CNS）疾病治疗新时代的生物制药公司，今天宣布已与...达成和解协议。

Hikma Pharmaceuticals USA, Inc.

Hikma制药美国公司

(

Hikma

智慧

) resolving patent litigation related to Axsome’s product Sunosi

与Axsome的产品Sunosi相关的专利诉讼解决

(solriamfetol). The litigation, which is pending in the

（索利安非托）。诉讼仍在进行中，悬而未决。

United States District Court for the District of New Jersey

美国新泽西地区联邦地区法院

, resulted from submission by

，因提交而产生

Hikma

慧康

of an Abbreviated New Drug Application to the

简略新药申请

U.S. Food and Drug Administration

美国食品药品监督管理局

seeking approval to market a generic equivalent of Sunosi in

寻求批准以销售Sunosi的通用等效产品

the United States

美国

. Under the terms of the settlement agreement, Axsome will grant

根据和解协议的条款，Axsome将授予

Hikma

慧康

a license to sell its generic version of Sunosi beginning on or after

一份许可，允许其在 Sunosi 仿制药版本的销售于或在某个日期之后开始

September 1, 2040

2040年9月1日

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

，如果Sunosi获得儿科独占权，或在或之后

March 1, 2040

2040年3月1日

, if no pediatric exclusivity is granted, subject to FDA approval and conditions and exceptions customary for agreements of this type.

，如果未授予儿科独占权，则需经FDA批准，并受此类协议惯常的条件和例外情况的约束。

As required by law, Axsome and

根据法律要求，Axsome和

Hikma

慧康

will submit the settlement agreement to the

将提交和解协议给

U.S. Federal Trade Commission

美国联邦贸易委员会

and the

和

U.S. Department of Justice

美国司法部

for review. Similar patent litigation brought by Axsome against other parties related to Sunosi remains pending in the

供审查。Axsome针对其他方提起的与Sunosi相关的类似专利诉讼仍在进行中。

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

美国新泽西地区联邦地区法院

。

About

关于

Axsome Therapeutics

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.

是一家引领中枢神经系统（CNS）疾病治疗新时代的生物制药公司。我们通过识别护理中的关键差距来实现科学突破，并专注于新颖作用机制，开发差异化产品，从而推动患者治疗效果的显著进步。

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

我们行业领先的神经科学产品组合包括FDA批准的用于治疗重度抑郁症、与嗜睡症和阻塞性睡眠呼吸暂停相关的过度日间嗜睡以及偏头痛的药物，并且还有多个后期开发项目，针对影响超过1.5亿人的各种严重的神经和精神疾病。

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，以便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

。

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属于“前瞻性陈述”。公司在某些情况下可能会使用“预测”、“相信”、“潜在”、“继续”、“估计”、“预期”、“计划”、“意图”、“可能”、“能够”、“也许”、“将会”、“应该”等词语来表达未来事件或结果的不确定性，以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是此类前瞻性陈述的例子。前瞻性陈述包含风险和不确定性，包括但不限于公司Sunosi®、Auvelity®和Symbravo®产品的商业成功，以及公司为solriamfetol和/或AXS-05获得任何额外适应症的努力的成功；公司维持和扩大支付方覆盖范围的能力；公司正在进行的临床试验及预期临床试验的成功、时间和成本，包括关于试验启动时间、入组速度和完成情况的声明（包括公司全额资助其已披露临床试验的能力，这假设公司目前预计的收入或支出没有重大变化）、无效性分析和中期结果的接收，这些结果不一定代表公司正在进行的临床试验的最终结果，和/或数据读出，以及支持公司当前任何产品候选提交新药申请（“NDA”）所需的研究数量或类型或结果性质；公司为继续推进其产品候选而资助额外临床试验的能力；。

U.S. Food and Drug Administration

美国食品药品监督管理局

(“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 Company’s ability to successfully resolve any intellectual property litigation, and even if such disputes are settled, whether the applicable federal agencies will approve of such settlements; 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产品候选物的批准或其他行动，包括有关任何新药申请（NDA）提交时间的声明；公司成功捍卫其知识产权或以公司可接受的成本获得必要许可的能力（如果能够获得的话）；公司成功解决任何知识产权诉讼的能力，即使这些争议得以解决，相关联邦机构是否会批准此类和解；公司研究与开发计划及合作的成功实施；公司许可协议的成功执行；市场对公司产品及其候选产品的接受度（如获批准）；公司预期的资本需求，包括用于Sunosi、Auvelity和Symbravo商业化以及公司其他候选产品商业化推出（如获批准）所需的资本金额，以及对公司预期现金跑道的潜在影响；公司将销售转化为确认收入并保持有利的总销售额至净销售额比率的能力；由于国内政治气候、地缘政治冲突或全球疫情引发的意外情况或其他对正常业务运营的干扰，以及其他因素，包括一般经济状况和监管发展，这些均不在公司的控制范围内。

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 sta.

本文讨论的因素可能导致实际结果和发展与这些陈述所表达或暗示的有重大差异。前瞻性陈述仅在本新闻稿发布之日作出，公司不承担公开更新此类前瞻性陈述的义务。

Investors:

投资者：

Mark Jacobson

马克·雅各布森

Chief Operating Officer

首席运营官

(212) 332-3243

mjacobson@axsome.com

Media:

媒体：

Darren Opland