Saniona to receive US

Saniona 将收到美国

$42.5 million

4250万美元

upfront;

预先；事先； upfront;

potential for development, regulatory and sales milestone payments in addition to royalties on future net sales

未来发展、监管和销售里程碑付款的潜力，以及未来净销售额的特许权使用费

Jazz obtains exclusive worldwide rights to develop and commercialize preclinical asset SAN2355 in epilepsy and other potential indications

Jazz 获得癫痫和其他潜在适应症的临床前资产 SAN2355 的全球独家开发和商业化权利。

For

为了

U.S.

美国

media and investors only

媒体和投资者专用

DUBLIN

都柏林

and

和

COPENHAGEN, Denmark

哥本哈根，丹麦

,

，

Aug. 20, 2025

2025年8月20日

/PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) and Saniona (Nasdaq OMX: SANION) today announce that the companies have entered into a global license agreement for Jazz to obtain exclusive worldwide rights to develop SAN2355, a highly differentiated, subtype-selective Kv7.2/Kv7.3 activator in preclinical development for epilepsy and other potential indications, designed to overcome the limitations of non-selective Kv7-targeting compounds.

/PRNewswire/ -- Jazz Pharmaceuticals plc（纳斯达克股票代码：JAZZ）和Saniona（纳斯达克OMX股票代码：SANION）今天宣布，两家公司已达成一项全球许可协议，Jazz将获得开发SAN2355的独家全球权利。SAN2355是一种高度差异化的、亚型选择性Kv7.2/Kv7.3激活剂，目前正处于针对癫痫及其他潜在适应症的临床前开发阶段，旨在克服非选择性Kv7靶向化合物的局限性。

Jazz will lead and fund further development, regulatory submissions, and global commercialization activities..

Jazz将主导并资助进一步的开发、监管提交和全球商业化活动。

'Our collaboration with Jazz leverages their leading position in epilepsy and their strong track record of rapidly advancing clinical development programs and effectively commercializing novel therapies in neuroscience, positioning SAN2355 as a promising option for epilepsy and neurological conditions, while enabling us to advance several of our other valuable pipeline programs to key inflection points,' said Thomas Feldthus, CEO of Saniona.

“我们与Jazz的合作利用了他们在癫痫领域的领先地位以及快速推进临床开发项目并有效商业化神经科学领域新型疗法的卓越记录，将SAN2355定位为治疗癫痫和神经系统疾病的有前景的选择，同时也使我们能够将其他几个重要的管道项目推进到关键转折点，”Saniona首席执行官Thomas Feldthus表示。

'Jazz's commitment to develop life-changing medicines for people with serious diseases aligns with our mission to improve outcomes for those affected by neurological and psychiatric disorders, and both companies aim to expand treatment possibilities for patients in need.'.

“Jazz致力于为患有严重疾病的患者开发改变生活的药物，这与我们改善受神经和精神疾病影响患者的预后的使命是一致的，并且两家公司都旨在为有需要的患者拓展治疗可能性。”

'SAN2355 is a unique and highly promising preclinical asset that has the potential to become a best-in-class Kv7 activator for the treatment of epilepsy. We are pleased to enter this exclusive agreement with Saniona to lead the SAN2355 clinical development program,' said Robert Iannone, M.D., M.S.C.E., executive vice president, global head of research and development, and chief medical officer of .

“SAN2355 是一种独特且极具前景的临床前资产，有潜力成为治疗癫痫的最佳 Kv7 激活剂。我们很高兴与 Saniona 达成这项独家协议，主导 SAN2355 的临床开发计划，”Robert Iannone 医学博士、理学硕士、执行副总裁、全球研发主管兼首席医学官表示。

Jazz Pharmaceuticals

爵士制药公司

. 'This transaction further expands our early-stage neuroscience pipeline building on our existing expertise in the treatment of epilepsy and our R&D team remains committed to developing novel approaches to improving treatment options for people living with epilepsy and other neurologic conditions.'.

“此次交易进一步扩展了我们早期的神经科学管线，基于我们在癫痫治疗方面的现有专业知识，我们的研发团队仍然致力于开发改善癫痫和其他神经系统疾病患者治疗选择的新方法。”

Transaction Terms

交易条款

Under the terms of the exclusive licensing agreement, Saniona will receive an upfront payment of US

根据独家许可协议的条款，Saniona将获得一笔首付款。

$42.5 million

4250万美元

. Saniona is eligible to receive: up to US

Saniona有资格获得：最高达美国

$192.5 million

1.925亿美元

in development and regulatory milestones, including a US

在发展和监管里程碑方面，包括美国

$7.5 million

750万美元

milestone payment upon initiation of the first Phase 1 clinical study; up to US

在首个1期临床研究启动时的里程碑付款；高达US

$800 million

8亿美元

in commercial milestone payments based on the achievement of significant and pre-specified annual net sales thresholds; and tiered royalties ranging from the mid-single digits to low-double digits on net sales of commercial products resulting from the development of SAN2355.

基于实现显著且预先规定的年度净销售额门槛的商业里程碑付款；以及按SAN2355开发产生的商业产品净销售额计算，从中个位数到低两位数的分级特许权使用费。

About SAN2355

关于 SAN2355

SAN2355 is a preclinical, selective small molecule activator of Kv7.2/Kv7.3 potassium channels, a mechanism validated for seizure suppression. Prior Kv7-targeting agents have demonstrated clinical efficacy, but dosing appears to be limited by adverse events associated with off-target activation. SAN2355 is uniquely selective for Kv7.2/Kv7.3, the Kv7-subtypes responsible for seizure suppression, and avoids activation of other Kv7-subtypes.

SAN2355 是一种处于临床前阶段的选择性小分子 Kv7.2/Kv7.3 钾通道激活剂，这一机制已被验证具有抑制癫痫发作的作用。以往针对 Kv7 的药物已显示出临床疗效，但其剂量似乎受到与非靶点激活相关的不良事件的限制。SAN2355 对 Kv7.2/Kv7.3 具有独特选择性，这些 Kv7 亚型是负责抑制癫痫发作的关键亚型，并且避免了对其他 Kv7 亚型的激活。

This selectivity enables SAN2355 to deliver dosing to optimal efficacy and supports its potential as a best-in-class treatment for epilepsy..

这种选择性使得SAN2355能够以最佳疗效进行给药，并支持其作为癫痫治疗领域潜在的同类最佳疗法。

About Jazz Pharmaceuticals

关于Jazz Pharmaceuticals

Jazz Pharmaceuticals

爵士制药公司

plc (Nasdaq: JAZZ) is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing potentially life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments.

plc（纳斯达克股票代码：JAZZ）是一家全球生物制药公司，其宗旨是通过创新来改变患者及其家庭的生活。我们致力于为患有严重疾病的人群开发可能改变生命的药物——这些疾病通常缺乏或根本没有治疗选择。我们拥有多样化的已上市药物组合，包括用于睡眠障碍和癫痫的领先疗法，并且我们的癌症治疗药物组合也在不断增长。

Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide.

我们以患者为中心、以科学为驱动的方法，推动了我们在肿瘤学和神经科学领域强大的创新型治疗药物研发管线的开创性研究和发展进步。Jazz 总部位于爱尔兰都柏林，在多个国家设有研发实验室、生产设施和员工，致力于为全球患者服务。

Please visit .

请访问 。

www.jazzpharmaceuticals.com

www.jazzpharmaceuticals.com

for more information.

欲了解更多信息。

About Saniona

关于Saniona

Saniona is a clinical-stage biopharmaceutical company focused on discovering, developing, and delivering innovative treatments for neurological and psychiatric disorders. The company's internal pipeline includes SAN2219 for epilepsy and SAN2465 for major depressive disorder. Saniona has established strategic collaborations with leading pharmaceutical companies, including .

Saniona是一家临床阶段的生物制药公司，专注于发现、开发和提供治疗神经和精神疾病的创新疗法。该公司内部研发管线包括用于癫痫的SAN2219和用于重度抑郁症的SAN2465。Saniona已与领先的制药公司建立了战略合作伙伴关系，包括 。

Jazz Pharmaceuticals

Jazz制药公司

, which holds global rights to SAN2355 for epilepsy, Acadia Pharmaceuticals, which holds worldwide rights to ACP-711 for essential tremor, and with Medix, which holds rights to tesofensine for obesity in

，该机构拥有癫痫药物SAN2355的全球权利，Acadia Pharmaceuticals拥有治疗特发性震颤的ACP-711的全球权利，以及Medix拥有肥胖症药物tesofensine的权利在

Mexico

墨西哥

and

和

Argentina

阿根廷

, where a market authorization application is currently under review. In addition, Saniona has two clinical-stage programs available for partnering: Tesomet™, ready to advance to Phase 2b trials in rare eating disorders, and SAN903, ready to enter Phase 1 trials in inflammatory bowel disease. Saniona's ion channel discovery platform is further validated through research collaborations with .

，其市场授权申请目前正在审查中。此外，Saniona还有两个临床阶段的项目可供合作：Tesomet™，准备推进到罕见饮食失调的第二阶段试验，以及SAN903，准备进入炎症性肠病的第一阶段试验。Saniona的离子通道发现平台还通过与.的研究合作得到了进一步验证。

Boehringer Ingelheim

勃林格殷格翰

, AstronauTx, and Cephagenix. Headquartered in

，AstronauTx 和 Cephagenix。总部位于

Copenhagen

哥本哈根

, Saniona is listed on the Nasdaq Stockholm Main Market. For more information, visit

，Saniona 在纳斯达克斯德哥尔摩主板市场上市。欲了解更多信息，请访问

www.saniona.com

www.saniona.com

.

。

Jazz Pharmaceuticals plc Caution Concerning Forward-Looking Statements

Jazz Pharmaceuticals plc 前瞻性声明的谨慎提示

This press release contains forward-looking statements, including, but not limited to, statements related to SAN2355's potential to be a best-in-class Kv7 activator for the treatment of epilepsy; the potential future development, manufacturing, regulatory and commercialization activities; potential future payments by .

本新闻稿包含前瞻性陈述，包括但不限于与 SAN2355 有望成为治疗癫痫的最佳 Kv7 激活剂相关的陈述；潜在的未来开发、制造、监管和商业化活动；潜在的未来付款由 。

Jazz Pharmaceuticals

爵士制药公司

to Saniona for development, regulatory and commercial milestones as well as tiered royalties based on future net sales; and other statements that are not historical facts. These forward-looking statements are based on

向Saniona支付开发、监管和商业里程碑款项，以及基于未来净销售额的阶梯式特许权使用费；以及其他非历史事实的声明。这些前瞻性声明基于

Jazz Pharmaceuticals'

Jazz制药公司

current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with: .

当前的计划、目标、估计、预期和意图均涉及重大风险和不确定性。由于这些风险和不确定性，实际结果和事件的时间安排可能与这些前瞻性陈述中预期的情况大相径庭，这些风险和不确定性包括但不限于： 。

Jazz Pharmaceuticals'

Jazz制药公司

ability to achieve the expected benefits (commercial or otherwise) from the license agreement; pharmaceutical product development and clinical success thereof; the regulatory approval process; effectively commercializing any product candidates; and other risks and uncertainties affecting

从许可协议中获得预期利益（商业或其他）的能力；药品开发及其临床成功；监管审批流程；有效商业化任何产品候选者；以及影响的其他风险和不确定性

Jazz Pharmaceuticals

爵士制药公司

, including the Company's Annual Report on Form 10-K for the year ended

，包括公司年度报告表格10-K截止年度结束的

December 31, 2024

2024年12月31日

, the Company's Quarterly Report on Form 10-Q for the quarter ended

，公司截至季度结束的10-Q表季度报告

June 30, 2025

2025年6月30日

, and future filings and reports by the Company. Other risks and uncertainties of which

，并且公司未来的文件和报告中也会有所提及。其他风险和不确定性包括哪些

Jazz Pharmaceuticals

爵士制药公司

is not currently aware may also affect

当前尚未意识到的也可能影响

Jazz Pharmaceuticals'

爵士制药公司

forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof or as of the dates indicated in the forward-looking statements, even if they are subsequently made available by .

前瞻性声明，可能导致实际结果和事件发生的时间与预期产生重大差异。本前瞻性声明仅于本文件发布之日或前瞻性声明中指明的日期作出，即使其后可能由其他信息更新或提供。

Jazz Pharmaceuticals

爵士制药公司

on its website or otherwise.

在其网站上或以其他方式。

Jazz Pharmaceuticals

爵士制药公司

undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made.

不承担更新或补充任何前瞻性陈述的义务，以反映实际结果、新信息、未来事件、其预期的变化或在作出前瞻性陈述的日期之后存在的其他情况。

Jazz Pharmaceuticals Contacts:

爵士制药联系人：

Investors:

投资者：

Jack Spinks

杰克·斯平克斯

Executive Director, Investor Relations

投资者关系执行董事

Pharmaceuticals plc

制药公司

investorinfo@jazzpharma.com

投资者信息@爵士制药.com

Ireland

爱尔兰

+353 1 634 3211

+353 1 634 3211

U.S.

美国

+1 650 496 2717

+1 650 496 2717

Media Contact:

媒体联系人:

Kristin Bhavnani

克莉丝汀·巴夫纳尼

Head of

头部

Global Corporate Communications

全球企业传播

Jazz Pharmaceuticals plc

Jazz制药公司

CorporateAffairsMediaInfo@jazzpharma.com

企业事务媒体信息@jazzpharma.com

Ireland

爱尔兰

+353 1 637 2141

+353 1 637 2141

U.S.

美国

+1 215 867 4948

+1 215 867 4948

Saniona Contact:

Saniona 联系人:

Johnny Stilou

约翰尼·斯蒂洛

CFO

首席财务官

Saniona AB

Saniona AB

Johnny.stilou@saniona.com

约翰尼·斯蒂洛@萨尼奥纳·康姆

+45 21 227 227

+45 21 227 227

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https://www.prnewswire.com/news-releases/jazz-pharmaceuticals-enters-exclusive-licensing-agreement-with-saniona-to-develop-and-commercialize-san2355-302534545.html

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SOURCE

源文件

Jazz Pharmaceuticals plc

爵士制药公司