Eton Pharmaceuticals Enters Licensing Agreement with AMMTeK for Acquisition of U.S. Rights to Amglidia

On November 22, 2024, Eton Pharmaceuticals, Inc. disclosed in a Form 8-K filing with the Securities and Exchange Commission that the company has entered into a significant licensing agreement with AMMTeK. This agreement involves the acquisition of U.S. rights to Amglidia, a glyburide oral suspension developed for the treatment of neonatal diabetes mellitus, a rare condition impacting an estimated 300 patients in the United States.

Amglidia, which received approval from the European Medicines Agency in 2018 and has been granted Orphan Drug Designation by the U.S. Food and Drug Administration, is currently under development. The Seller of the product has conducted a five-year post-approval study focusing on the real-world safety and efficacy of Amglidia in European patients. This data will be instrumental in supporting Eton Pharmaceuticals’ forthcoming New Drug Application (NDA) submission.

Eton Pharmaceuticals intends to engage in a meeting with the FDA during the first quarter of 2025 regarding the development of Amglidia. The company also retains the option to terminate the licensing agreement within 30 days of receiving FDA meeting minutes, without incurring any liability for milestone payments to the Seller. Under the terms of the agreement, Eton Pharmaceuticals will not be making any upfront payments to the Seller and could potentially pay up to $2.35 million as per the following milestones:

– $0.50 million post-receipt of FDA meeting minutes
– $0.55 million upon acceptance of the NDA for review by the FDA
– $1.30 million following NDA approval by the FDA and the first commercial sale

Furthermore, Eton Pharmaceuticals has agreed to pay a royalty of 14% of net sales to the Seller as part of the agreement. The Form 8-K filing included an exhibit of the press release related to this transaction, dated November 25, 2024.

Alongside the licensing agreement, Eton Pharmaceuticals disclosed in the filing additional information pertaining to financial statements and exhibits, including the aforementioned press release as Exhibit 99.1. The Form 8-K filing was signed on behalf of the registrant by James R. Gruber, Chief Financial Officer and Secretary, on November 25, 2024.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Eton Pharmaceuticals’s 8K filing here.

About Eton Pharmaceuticals

Eton Pharmaceuticals, Inc, a specialty pharmaceutical company, focuses on developing, acquiring, and commercializing pharmaceutical products for rare diseases. The company offers ALKINDI SPRINKLE, a replacement therapy for adrenocortical insufficiency in children under 17 years of age; Carglumic Acid for the treatment of acute and chronic hyperammonemia due to N-acetylglutamate Synthase deficiency; Betaine Anhydrous for the treatment of homocystinuria; and Nitisinone for the treatment of tyrosinemia type 1.