Eton Pharmaceuticals Announces Acquisition of U.S. Rights to Amglidia (Glyburide Oral Suspension)

• Amglidia® is 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 US Food and Drug Administration (FDA).
• Potential New Drug Application (NDA) submission in 2026

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 neonatal diabetes announced that it purchased the US rights to Amglidia (glyburide oral suspension, known as glibenclamide in Europe) for the treatment of AMMTeK.

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

“There is currently no FDA-approved oral treatment for neonatal diabetes. Amglidia has been used successfully for years to treat European patients, and families and pediatric endocrinologists have expressed to us that there is a significant need for this treatment in the United States. I look forward to working with AMMTeK to bring it to patients with disease as quickly as possible,” concluded Brynjelsen.

Amglidia is a proprietary, patented liquid product developed by the French biotechnology company AMMTeK for the treatment of neonatal diabetes. The product was approved by EMA in 2018. The product has currently been granted Orphan Drug Designation by the US FDA. Neonatal diabetes is a rare condition estimated to affect approximately 300 patients in the United States. There are currently no FDA-approved oral treatment options available, and as a result, US patients often either rely on non-FDA-approved compounded products or administer products off-label by making homemade suspensions.

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

About Eton Pharmaceuticals

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 other product candidates in late-stage development: ET-400, ET-600, and the ZENEO® hydrocortisone auto-injector. For more information, please visit our website at www.etonpharma.com.

Forward-Looking Statements

Statements in this press release that relate to matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding Eton’s expected ability to undertake certain activities and achieve certain objectives and targets. These statements include, but are not limited to, statements regarding Eton’s business strategy, Eton’s plans to develop and commercialize product candidates, the safety and effectiveness of Eton’s product candidates, Eton’s plans and the expected timing and extent of regulatory filings and approvals. is not limited. Growth potential of 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 like “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “target,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on Eton’s current expectations and involve assumptions that may never be realized or may prove to be incorrect. Actual results and the timing of events may differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, but not limited to, risks associated with the process of discovery, development and commercialization of safe and secure medicines. effective in human treatment and efforts to build businesses around such drugs. These and other risks relating to Eton’s development programs and financial condition are described in more 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 they are made. Eton undertakes no obligation to update such statements to reflect events occurring or existing circumstances after the date on which they were made.

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