Axsome Therapeutics与Unichem Laboratories解决Sunosi®（solriamfetol）专利诉讼-动脉网

Axsome Therapeutics Settles Sunosi® (solriamfetol) Patent Litigation with Unichem Laboratories

BioSpace 等信源发布 2024-06-05 19:50

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NEW YORK, June 05, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM) (Axsome), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system disorders, today announced that it has entered into a settlement agreement with Unichem Laboratories Ltd. (Unichem) resolving patent litigation related to Axsome’s product Sunosi® (solriamfetol).

2024年6月5日，纽约（环球通讯社）--Axsome Therapeutics，Inc.（纳斯达克：AXSM）（Axsome），一家开发和提供中枢神经系统疾病治疗新疗法的生物制药公司，今天宣布，它已与Unichem Laboratories Ltd.（Unichem）达成和解协议，解决与Axsome产品Sunosi®（solriamfetol）相关的专利诉讼。

The litigation, which is pending in the United States District Court for the District of New Jersey, resulted from submission by Unichem of an Abbreviated New Drug Application to the U.S. Food and Drug Administration seeking approval to market a generic equivalent of Sunosi in the United States. The settlement agreement permits Unichem to begin selling its generic version of Sunosi on June 30, 2042, or earlier under certain circumstances.

这起诉讼在美国新泽西州地区地方法院悬而未决，原因是Unichem向美国食品和药物管理局提交了一份简化的新药申请，寻求批准在美国销售相当于Sunosi的仿制药。和解协议允许Unichem在2042年6月30日或某些情况下更早开始销售其通用版Sunosi。

The June 30, 2042 date is also subject to potential extension for pediatric exclusivity..

2042年6月30日的日期也可能因儿科排他性而延长。。

As required by law, Axsome and Unichem will submit the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review. Similar patent litigation brought by Axsome against other parties remains pending in the U.S. District Court for the District of New Jersey..

根据法律要求，Axsome和Unichem将把和解协议提交给美国联邦贸易委员会和美国司法部审查。Axsome针对其他方提起的类似专利诉讼仍在美国新泽西州地区法院未决。。

About Axsome Therapeutics, Inc.

关于Axsome Therapeutics，Inc。

Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for central nervous system (CNS) conditions that have limited treatment options. Through development of therapeutic options with novel mechanisms of action, we are transforming the approach to treating CNS conditions.

Axsome Therapeutics，Inc.是一家生物制药公司，开发并提供针对治疗选择有限的中枢神经系统（CNS）疾病的新型疗法。通过开发具有新作用机制的治疗选择，我们正在改变治疗中枢神经系统疾病的方法。

At Axsome, we are committed to developing products that meaningfully improve the lives of patients and provide new therapeutic options for physicians. For more information, please visit the Company’s website at axsome.com. The Company may occasionally disseminate material, nonpublic information on the company website..

在Axsome，我们致力于开发有意义地改善患者生活的产品，并为医生提供新的治疗选择。有关更多信息，请访问公司网站axsome.com。公司可能偶尔会在公司网站上传播材料、非公开信息。。

Forward Looking Statements

前瞻性声明

Certain matters discussed in this press release are “forward-looking statements”. We 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，我们可能会使用诸如“预测”、“相信”、“潜在”、“继续”、“估计”、“预期”、“预期”、“计划”、“打算”、“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 continued commercial success of our Sunosi® (“SUNOSI”) and Auvelity® (“AUVELITY”) products and the success of our efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of our 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 our current product candidates; our ability to fund additional clinical trials to continue the advancement of our product candidates; the timing of and our ability to obtain and maintain U.S.

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。前瞻性声明包括风险和不确定性，包括但不限于我们的Sunosi®（“Sunosi”）和Auvelity®（“Auvelity”）产品的持续商业成功，以及我们努力获得有关solriamfetol和/或AXS-05的任何其他指征的成功；我们正在进行的临床试验和当前候选产品的预期临床试验的成功，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（包括我们为我们披露的临床试验提供全额资金的能力，假设我们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，这些不一定表明我们正在进行的临床试验的最终结果，和/或数据读数，以及支持提交任何当前候选产品的新药申请（“NDA”）所需的研究数量或类型或结果的性质；我们有能力资助额外的临床试验，以继续推进我们的候选产品；获取和维护美国的时间和能力。

Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with re.

食品和药物管理局（“FDA”）或其他监管机构批准或采取其他行动。

Axsome Contacts:

Axsome联系人：

Investors:

投资者：

Mark Jacobson

马克·雅各布森

Chief Operating Officer

首席运营官

Axsome Therapeutics, Inc.

Axsome Therapeutics公司。