Galmed Pharmaceuticals Licenses SEDDS Formulation for GLP-1 Peptide Delivery.

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) formulation that enables sublingual absorption of GLP-1 peptides. This new formulation offers a non-invasive route for medication to enter the bloodstream, potentially replacing injectable and oral forms of semaglutide.

Galmed Pharmaceuticals (NASDAQ: GLMD) has signed a binding term-sheet with Entomus for a license agreement to develop and commercialize a proprietary Self-Emulsifying Drug Delivery System (SEDDS) formulation that enables sublingual absorption of GLP-1 peptides. This new formulation offers a non-invasive route for medication to enter the bloodstream, potentially replacing injectable and oral forms of semaglutide.

The agreement, which is expected to be finalized within 90 days, will determine milestone and royalty payments. The development targets markets where semaglutide patents expire as early as 2026, including India, Brazil, GCC countries, and other emerging regions with rising T2DM and obesity rates. The sublingual delivery system is expected to enhance bioavailability compared to Rybelsus, reduce daily dosage, and potentially offer fewer side effects with more precise blood sugar control. The global GLP-1 market is projected to reach $120B+ in obesity and type 2 diabetes by 2030, with ex-US peak sales of ~$20B in 2032 [1].

Galmed's licensing deal for sublingual semaglutide taps into the massive GLP-1 market, offering strategic entry in emerging markets where patents expire soon. The sublingual formulation using SEDDS technology addresses critical market gaps: patient resistance to injections and the bioavailability limitations of oral formulations. The 505(b)(2) regulatory pathway mentioned could significantly accelerate time-to-market compared to traditional approval routes, potentially giving Galmed first-mover advantage in these territories [2].

The SEDDS formulation in orally dispersible films represents a potentially significant innovation in peptide drug delivery. Current semaglutide formulations face substantial limitations: injectable versions (Ozempic/Wegovy) encounter patient adherence challenges, while the oral formulation (Rybelsus) suffers from low bioavailability (1%) requiring higher doses and specific administration protocols. The sublingual route offers distinct advantages by bypassing hepatic first-pass metabolism while avoiding injections. By delivering semaglutide directly to the lymphatic system through oral mucosa, this approach could theoretically achieve higher bioavailability than Rybelsus with reduced gastrointestinal side effects [1].

However, significant technical challenges remain. Peptide drugs like semaglutide traditionally have poor permeability across mucosal membranes due to their size and hydrophilicity. The SEDDS technology must overcome these barriers through permeation enhancers and stabilizers while maintaining pharmaceutical elegance and shelf stability. The 505(b)(2) pathway is feasible since semaglutide's safety profile is well-established, but will still require bioequivalence studies demonstrating comparable pharmacokinetics to reference products [1].

For Galmed, this represents an opportunistic expansion beyond their historical focus on NASH treatments, leveraging existing expertise in metabolic conditions while entering the high-growth weight management sector. This strategic diversification could substantially alter the company's commercial outlook in the medium term, though much depends on the yet-undisclosed financial terms and development timeline [1].

References:
[1] https://www.stocktitan.net/news/GLMD/galmed-signed-term-sheet-for-the-development-of-novel-semaglutide-3621c0is40zn.html
[2] https://www.prnewswire.com/news-releases/galmed-signed-term-sheet-for-the-development-of-novel-semaglutide-sublingual-formulation-302439641.html