- Galmed Pharmaceuticals (GLMD, Financial) has signed a binding term sheet with Entomus for a sublingual semaglutide formulation.
- The novel formulation aims to improve bioavailability and use SEDDS technology for better patient compliance.
- The agreement targets markets where semaglutide patents are set to expire starting 2026.
Galmed Pharmaceuticals (GLMD) has entered into a binding term sheet with Entomus to license a pioneering sublingual formulation of semaglutide, utilizing Self-Emulsifying Drug Delivery System (SEDDS) technology. This novel formulation offers a promising alternative to both injectable (Ozempic/Wegovy) and oral (Rybelsus) semaglutide, aiming to enhance bioavailability and reduce dosage through sublingual administration.
Under this agreement, to be finalized within 90 days, milestone and royalty payments will be defined. The development is keenly positioned to exploit markets such as India, Brazil, and GCC countries, where semaglutide patents will begin to expire as early as 2026. This timing could afford Galmed entry into these markets ahead of competition, with potential approval via the 505(b)2 regulatory route, which may expedite both development and commercialization.
The global market for GLP-1 receptor agonists is forecasted to exceed $120 billion by 2030, driven by its application in treating obesity and type 2 diabetes. Notably, ex-US peak sales are estimated to approach $20 billion by 2032. The sublingual approach may offer reduced side effects and a more precise control of blood sugar levels compared to current options, presenting a significant opportunity for patient compliance improvement in these high-growth therapeutic areas.
