Eton Pharmaceuticals Announces Submission to FDA of New Drug Application for ET-400 (Hydrocortisone Oral Solution)
Eton Pharmaceuticals Announces Submission to FDA of New Drug Application for ET-400 (Hydrocortisone Oral Solution)
- Company anticipates 10-month review for potential approval in Q1 2025 -
- Eton expects ET-400 and Alkindi Sprinkle to achieve potential combined peak sales of more than $50 million annually -
- Product has patent protection through 2043 -
-公司预计将在2025年第一季度进行为期10个月的审批-
-伊顿公学预计 ET-400 和 Alkindi Sprinkle 实现每年超过5000万美元的潜在合并峰值销售额-
-产品在 2043 年之前享有专利保护-
DEER PARK, Ill., April 30, 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 the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of ET-400, Eton's proprietary patented formulation of hydrocortisone oral solution. The Company expects the application to be assigned a 10-month FDA review, allowing for potential approval and launch in the first quarter of 2025.
伊利诺伊州鹿园，2024年4月30日（GLOBE NEWSWIRE）——专注于开发和商业化罕见疾病治疗的创新制药公司伊顿制药公司（“伊顿” 或 “公司”）（纳斯达克股票代码：ETON）今天宣布向美国食品药品监督管理局（FDA）提交新药申请（NDA），以批准伊顿专有的氢化可的松口服溶液专利配方 ET-400。该公司预计，该申请将接受为期10个月的美国食品药品管理局审查，从而有可能在2025年第一季度获得批准并推出。
"With the completion of the NDA submission for ET-400, we are one step closer to bringing this critical medication to children in need. We continue to see very strong demand from patients, caregivers, and physicians, and are confident that ET-400, once approved, and Alkindi Sprinkle can achieve potential combined peak sales of more than $50 million annually," said Sean Brynjelsen, CEO of Eton Pharmaceuticals.
“随着 ET-400 保密协议的提交完成，我们离向有需要的儿童提供这种关键药物又近了一步。伊顿制药首席执行官肖恩·布林杰尔森说，我们继续看到患者、护理人员和医生的强劲需求，并相信 ET-400 一旦获得批准，Alkindi Sprinkle可以实现每年超过5000万美元的潜在峰值总销售额。
Eton has been issued a patent by the U.S. Patent and Trademark Office on ET-400, which expires in 2043 and has additional patent applications under review.
伊顿已获得美国专利商标局颁发的 ET-400 专利，该专利将于 2043 年到期，还有其他专利申请正在审查中。
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. For more information, please visit our website at www.etonpharma.com.
伊顿是一家创新制药公司，专注于开发和商业化罕见疾病的治疗方法。该公司目前有五种商用罕见病产品：ALKINDI SPRINKLE、PKU GOLIKE、Carglumic Acid、无水甜菜碱和尼替西农。该公司还有另外三种候选产品处于后期开发阶段：ET-400、ET-600 和ZENEO氢化可的松自动注射器。欲了解更多信息，请访问我们的网站 www.etonpharma.com。
Forward-Looking Statements
前瞻性陈述
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. 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. 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. 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. 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 Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Eton undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
本新闻稿中有关非历史事实事项的陈述是1995年《私人证券诉讼改革法》所指的 “前瞻性陈述”，包括与伊顿公学开展某些活动和实现某些目的和目标的预期能力相关的陈述。这些声明包括但不限于有关伊顿商业战略、伊顿开发和商业化其候选产品的计划、伊顿候选产品的安全性和有效性、伊顿在监管申报和批准方面的计划和预期时机以及伊顿候选产品的市场规模和增长潜力的声明。由于此类陈述受风险和不确定性的影响，因此实际结果可能与此类前瞻性陈述所表达或暗示的结果存在重大差异。诸如 “相信”、“预期”、“计划”、“期望”、“打算”、“将”、“目标”、“潜力” 等词语以及类似的表述旨在识别前瞻性陈述。这些前瞻性陈述基于伊顿当前的预期，涉及可能永远无法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，包括但不限于发现、开发和商业化可用作人类疗法的安全有效药物的过程以及围绕此类药物开展业务的努力，实际结果和事件发生时间可能与此类前瞻性陈述中的预期存在重大差异。伊顿向美国证券交易委员会提交的文件中进一步详细描述了这些风险以及其他与伊顿公学发展计划和财务状况有关的风险。本新闻稿中包含的所有前瞻性陈述仅代表其发布之日。伊顿没有义务更新此类声明以反映在声明发表之日后发生的事件或存在的情况。
Investor Relations:
Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com
投资者关系：
丽莎·威尔逊，现场通信公司
T: 212-452-2793
E: lwilson@insitecony.com
Source: Eton Pharmaceuticals.
资料来源：伊顿制药。
Source: Eton Pharmaceuticals
来源：伊顿制药
译文内容由第三方软件翻译。