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The proprietary Self-Emulsifying Drug Delivery System (SEDDS) formulation in form of orally dispersible films allows absorption of sublingually administrated peptides such as GLP-1 (Semaglutide, Liraglutide etc.).
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The new formulation is expected to offer alternatives to both approved injectable semaglutide (Ozempic© and Wegovy©) and oral form (Rybelsus©), providing a non-invasive route that allows the medication to enter the bloodstream through the oral mucous membranes.
TEL AVIV, Israel, April 28, 2025 /– Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) (“Galmed” or the “Company”), a clinical-stage biopharmaceutical company for cardiometabolic diseases and GI oncological indications announced today that it has signed a binding term-sheet with Entomus s.r.o. for a license agreement for the development and commercialization of a proprietary Self-Emulsifying Drug Delivery System (SEDDS) formulation that allows absorption of sublingually administrated peptides such as GLP-1 (Semaglutide, Liraglutide etc.). A definitive agreement determining, among other things, the milestones payments and future royalty payments is to be executed within ninety (90) days.
Oral medications often face the challenge of the first-pass effect, where a significant portion of the drug is metabolized in the liver before reaching systemic circulation, potentially reducing its efficacy. Injectable medications, while bypassing the gastrointestinal tract, can cause discomfort, needless anxiety, and inconvenience for many patients. Sublingual administration offers a potential alternative to both the approved injectable semaglutide (Ozempic and Wegovy) and the oral form (Rybelsus), providing a non-invasive route that allows the medication to directly enter the bloodstream through the oral mucous membranes.
The use of GLP-1 (semaglutide) is growing exponentially, and it is now tested for various metabolic, cardiovascular, oncology and other indications. Jefferies projects global GLP-1 market to reach $120B+ in obesity and type 2 diabetes mellitus (T2DM) by 2030. Projected ex-US Peak Sales in 2032 are ~$20B.
While in the US, EU, Japan and some other countries semaglutide has IP protection until 2028-2031, other significant markets have no such restrictions and patents start expiring as early as 2026. These markets include among others: India, Brazil, GCC (Saudi, Gulf, Emirates), Singapore, Hong Kong, South Africa and possibly Turkey, Mexico and others. These countries have high rates of T2DM and obesity, driven by factors such as urbanization, sedentary lifestyles, and shifts in dietary habits. These epidemiological trends are similar to those seen in other developed markets, and they create an environment where GLP-1 therapies become increasingly relevant.
Galmed has the opportunity to license, patent and commercialize a novel sublingual Semaglutide initially in these countries and eventually expand to other territories once allowed. The development program could potentially be approved by the expedient 505(b)2 type of route.
Allen Baharaff, President and CEO of Galmed Pharmaceuticals commented: “We signed a term sheet that provides Galmed the opportunity to license, develop and commercialize a novel Semaglutide formulation based on Self-Emulsifying Drug Delivery System (SEDDS) which is absorbed sublingually into the lymphatic system. We believe this will allow Galmed to embark on a rapid development program in the highly lucrative GLP-1 space which potentially may be approved via the rapid 505(b)2 route. The proposed transmucosal administration route could potentially enhance the bioavailability in comparison with Rybelsus and reduce the daily dose of Semaglutide. We also expect less side effects and more rigid pharmacokinetic profile with more precise control of blood sugar level. This delivery method’s appeal is offering an alternative to injectable routes which can be a barrier for some patients. We believe the potential for improved patient compliance through sublingual administration has the potential to position it as a pivotal tool in the healthcare arsenal against some of the major chronic health challenges treated with GLP-1 based therapeutics.”
About Semaglutide
Semaglutide belongs to a class of medications known as GLP-1 receptor agonists, which mimic the action of a natural hormone involved in glucose regulation. Its efficacy in controlling blood glucose levels and promoting weight loss has positioned it as a game-changer in the treatment landscape of type 2 diabetes, obesity and MASH.
About Galmed Pharmaceuticals Ltd.
We are a biopharmaceutical company focused on the development of Aramchol. We have focused almost exclusively on developing Aramchol for the treatment of liver disease and we are currently seeking to advance the development of Aramchol for oncological indications outside of NASH and fibrosis. In addition, as part of our growth strategy, we are actively pursuing opportunities to expand and diversify our product pipeline specifically targeting cardiometabolic indications and other innovative product candidates that align with our core expertise in drug development.