Galmed Signed Term Sheet for the Development of Novel Semaglutide Sublingual Formulation

Core Insights - Galmed Pharmaceuticals has signed a binding term-sheet with Entomus for a license agreement to develop and commercialize a proprietary Self-Emulsifying Drug Delivery System (SEDDS) for sublingual administration of peptides like GLP-1 [1] - The global GLP-1 market is projected to exceed $120 billion by 2030, with peak sales outside the US expected to reach approximately $20 billion by 2032 [3] - The new sublingual formulation aims to enhance bioavailability, reduce side effects, and improve patient compliance compared to existing injectable and oral forms of semaglutide [6][9] Company Developments - The definitive agreement with Entomus will outline milestone payments and future royalty payments, expected to be finalized within 90 days [1] - The sublingual semaglutide formulation is anticipated to be approved through the expedited 505(b)(2) regulatory pathway [5][6] - Galmed aims to initially target markets with high rates of type 2 diabetes and obesity, such as India, Brazil, and the GCC region, where patent protections for semaglutide are less stringent [4][5] Industry Context - The first-pass effect in oral medications can reduce efficacy, while sublingual administration offers a non-invasive alternative that allows direct entry into the bloodstream [2] - The increasing prevalence of type 2 diabetes and obesity in various global markets creates a favorable environment for GLP-1 therapies [4] - Semaglutide, as a GLP-1 receptor agonist, has shown significant efficacy in managing blood glucose levels and promoting weight loss, positioning it as a transformative treatment option [7]