Eton Pharmaceuticals Announces Acquisition of U.S. Rights to Amglidia (Glyburide Oral Suspension)
Eton Pharmaceuticals Announces Acquisition of U.S. Rights to Amglidia (Glyburide Oral Suspension)
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. 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.- Amglidia has been approved by the European Medicines Agency (EMA) and is commercially available in Europe
- Strong strategic fit with Eton's existing pediatric endocrinology focus
- Amglidia has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA)
- Potential New Drug Application (NDA) submission in 2026
- Amglidia已獲得歐洲藥品管理局(EMA)的批准，在歐洲已經上市
- 與伊頓現有的兒科內分泌學重點領域緊密契合的強大戰略
- Amglidia已獲得美國食品和藥物管理局(FDA)頒發的孤兒藥品認定
- 潛在的新藥申請（NDA）計劃於2026年提交。
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.
伊頓製藥公司(Nasdaq: ETON)是一家專注於開發和商業化罕見疾病治療的創新藥品公司，總部位於伊利諾伊州迪爾帕克，今天宣佈已從AMMTek公司獲得Amglidia(格列本脲口服懸劑，在歐洲被稱爲格列本脲)在美國的使用權，用於治療新生兒糖尿病
"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.
"這筆令人興奮的交易爲我們不斷壯大的兒科內分泌學組合中增添了另一個有吸引力的，擁有專利的產品候選。此外，該產品與伊頓在爲兒童患者推出液體和精確劑量配方方面的專業知識和豐富經驗相契合，" 伊頓製藥公司的首席執行官肖恩·布瓊爾森表示
"Currently, there are no FDA-approved oral treatments for neonatal diabetes mellitus. Amglidia has been used successfully to treat European patients for years, and families and pediatric endocrinologists have expressed to us the significant need for this treatment in the United States. We look forward to working with AMMTeK to bring the product to U.S. patients as quickly as possible," concluded Brynjelsen.
"目前，沒有FDA批准的口服治療新生兒糖尿病的藥物。多年來，Amglidia已成功用於治療歐洲患者，家庭成員和兒科內分泌學家向我們表達了在美國急需該治療的重要性。我們期待與AMMTek合作，儘快將該產品推向美國患者，" 布瓊爾森先生總結道
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. 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.
Amglidia是一種專利的液體產品，由法國生物技術公司AMMTek開發，用於治療新生兒糖尿病。該產品於2018年獲得EMA批准。該產品已獲得美國FDA的孤兒藥資格。新生兒糖尿病是一種罕見控件，預計在美國約有300名患者。目前，尚無FDA批准的口服治療選項，因此，美國患者常常依賴不受FDA批准的配方產品，或通過製作自制懸液以非標籤方式使用產品。
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進行了一項批准後的研究，跟蹤歐洲患者五年的真實世界安全性和有效性，這將用於支持Eton的NDA提交。Eton計劃於2025年第一季度與FDA召開會議，並預計在2026年提交該產品的NDA。
About Eton Pharmaceuticals
關於Eton藥品公司
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 .
伊頓是一家專注於研發和商業化罕見病治療的創新性製藥公司。該公司目前擁有五種罕見病產品：ALKINDI SPRINKLE，PKU GOLIKE，Carglumic Acid，Betaine Anhydrous和Nitisinone。公司目前處於三個尾期開發的產品，包括ET-400，ET-600和ZENEO水楊酸巴利昂自動注射器。欲了解更多信息，請訪問我公司網站。
Forward-Looking Statements
前瞻性聲明
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. 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.
本新聞稿中的有關非歷史事實的事項的聲明屬於「前瞻性聲明」，涉及伊頓能夠承擔某些活動並實現某些目標和目的的預期能力。這些聲明包括但不限於涉及伊頓業務策略，伊頓計劃發展和商業化其產品候選者，伊頓產品候選者的安全性和有效性，伊頓在監管申報和批准方面的計劃和預期時間以及伊頓產品候選者市場規模和增長潛力的聲明。由於此類聲明存在風險和不確定性，實際結果可能與此類前瞻性聲明所表達或暗示的結果有所不同。本新聞稿旨在識別前瞻性聲明的單詞，例如「相信」，「預計」，「計劃」，「期望」，「打算」，「將」，「目標」，「潛力」等。這些前瞻性聲明基於伊頓目前的預期並涉及可能從未實現或可能證明不正確的假設。由於各種風險和不確定性，實際結果和事件的時間可能因正在進行發現，開發和商業化安全，有效用於人類治療的藥物的過程以及圍繞此類藥物建立業務所涉及的風險而與此類前瞻性聲明所預計的結果有所不同。有關伊頓發展項目和財務狀況的這些和其他風險在伊頓向證券交易委員會提交的文件中有更詳細的描述。本新聞稿中包含的所有前瞻性聲明僅適用於它們發表的日期。伊頓不承擔更新這些聲明以反映發生或存在於發表之後的事件或情況的義務。
Investor Relations:
Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com
投資者關係:
英未泰客，內部溝通公司
T: 212-452-2793
E: lwilson@insitecony.com
Source: Eton Pharmaceuticals
來源: 伊通藥品
譯文內容由第三人軟體翻譯。