Amglidia® has been approved by the European Medicines Agency (EMA) and is commercially available in Europe

Amglidia®已获得欧洲药品管理局（EMA）的批准，并在欧洲上市

Strong strategic fit with Eton’s existing pediatric endocrinology focus

与伊顿公学现有的儿科内分泌学重点有很强的战略契合度

Amglidia has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA)

Amglidia已被美国食品和药物管理局（FDA）授予孤儿药称号

Potential New Drug Application (NDA) submission in 2026

2026年潜在新药申请（NDA）提交

DEER PARK, Ill., Nov. 25, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that it has acquired the U.S. rights to Amglidia (glyburide oral suspension, known as glibenclamide in Europe) for the treatment of neonatal diabetes mellitus from AMMTeK..

伊利诺伊州鹿园，2024年11月25日（环球通讯社）--伊顿制药公司（“伊顿”或“公司”）（纳斯达克：伊顿），一家专注于开发罕见疾病治疗方法并将其商业化的创新制药公司，今天宣布，它已从AMMTeK收购了用于治疗新生儿糖尿病的阿格列迪亚（格列本脲口服混悬液，在欧洲称为格列本脲）的美国权利。。

“This exciting transaction adds another attractive, patented product candidate to our growing pediatric endocrinology portfolio. In addition, the product aligns with Eton’s expertise and wealth of experience in bringing to market liquid and precision dose formulations for pediatric patients,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals..

“这项令人兴奋的交易为我们不断增长的儿科内分泌学产品组合增添了另一个有吸引力的专利产品候选产品。此外，该产品与伊顿公学在为儿科患者提供液体和精确剂量配方方面的专业知识和丰富经验相一致，”伊顿公学制药首席执行官肖恩·布林杰尔森（SeanBrynjelsen）表示。

patients as quickly as possible,” concluded Brynjelsen..

布莱恩·杰尔森总结道。

Amglidia is a proprietary, patented liquid product that was developed for the treatment of neonatal diabetes mellitus by AMMTeK, a French biotechnology company. The product was approved by the EMA in 2018. The product has already been granted Orphan Drug Designation by the U.S. FDA. Neonatal diabetes mellitus is a rare condition estimated to impact approximately 300 patients in the United States.

Amglidia是一种专利液体产品，由法国生物技术公司AMMTeK开发用于治疗新生儿糖尿病。该产品于2018年获得EMA批准。该产品已被美国FDA授予孤儿药称号。新生儿糖尿病是一种罕见病，估计会影响美国约300名患者。

Currently, there are no FDA-approved oral treatment options and as a result, U.S. patients frequently either rely on compounded products that are not FDA-approved or administer products off-label by making homemade suspensions..

目前，没有FDA批准的口服治疗方案，因此，美国患者经常依赖未经FDA批准的复合产品，或者通过自制混悬液管理标签外的产品。

AMMTeK has conducted a post-approval study tracking five years of real-world safety and efficacy in European patients, which will be used to support Eton’s NDA submission. Eton plans to hold a meeting with the FDA in the first quarter of 2025 and anticipates submitting an NDA for the product in 2026..

AMMTeK进行了一项批准后研究，追踪欧洲患者五年的真实安全性和有效性，该研究将用于支持伊顿公学提交的NDA。

About Eton Pharmaceuticals

关于伊顿制药

Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has five commercial rare disease products: ALKINDI SPRINKLE®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has three additional product candidates in late-stage development: ET-400, ET-600, and ZENEO® hydrocortisone autoinjector.

伊顿是一家创新的制药公司，专注于开发罕见疾病的治疗方法并将其商业化。该公司目前有五种商业罕见病产品：ALKINDI Spread®，PKU GOLIKE®，Carglumic Acid，甜菜碱无水和尼替尼酮。该公司在后期开发中还有三种候选产品：ET-400、ET-600和ZENEO®氢化可的松自动注射器。

For more information, please visit our website at www.etonpharma.com..

有关更多信息，请访问我们的网站www.etonpharma.com。

Forward-Looking Statements

前瞻性声明

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Eton to undertake certain activities and accomplish certain goals and objectives.

本新闻稿中关于非历史事实的声明是1995年《私人证券诉讼改革法案》所指的“前瞻性声明”，包括与伊顿公学开展某些活动和实现某些目标的预期能力相关的声明。

These statements include but are not limited to statements regarding Eton’s business strategy, Eton’s plans to develop and commercialize its product candidates, the safety and efficacy of Eton’s product candidates, Eton’s plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Eton’s product candidates.

这些声明包括但不限于关于伊顿公学的商业战略、伊顿公学开发和商业化其候选产品的计划、伊顿公学候选产品的安全性和有效性、伊顿公学的计划和监管备案和批准的预期时间，以及伊顿公学候选产品市场的规模和增长潜力的声明。

Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements.

由于此类声明存在风险和不确定性，实际结果可能与此类前瞻性声明明示或暗示的结果存在重大差异。诸如“相信”、“预期”、“计划”、“期望”、“打算”、“意志”、“目标”、“潜力”等词语以及类似的表达方式旨在识别前瞻性陈述。

These forward-looking statements are based upon Eton’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs.

这些前瞻性陈述基于伊顿公学目前的预期，并涉及可能永远不会实现或可能被证明不正确的假设。由于各种风险和不确定性，实际结果和事件发生的时间可能与这些前瞻性声明中预期的结果有很大不同，这些风险和不确定性包括但不限于与发现、开发和商业化安全有效的药物过程相关的风险，这些药物可用作人类治疗药物，以及围绕这些药物建立业务的努力。

These and other risks concerning Eton’s development programs and financial position are described in additional detail in Eton’s filings with the Securities and Ex.

关于伊顿公学的发展计划和财务状况的这些风险和其他风险，在伊顿公学向证券和交易所提交的文件中有详细描述。

Investor Relations:Lisa M. Wilson, In-Site Communications, Inc.T: 212-452-2793E: lwilson@insitecony.com

投资者关系部：Lisa M.Wilson，In-Site Communications，Inc.电话：212-452-2793E：lwilson@insitecony.com

Source: Eton Pharmaceuticals

来源：伊顿制药