Basilea announces in-licensing of a novel clinical phase 3-ready oral antibiotic

Company Overview - Basilea Pharmaceutica Ltd is a commercial-stage biopharmaceutical company focused on addressing severe bacterial and fungal infections, headquartered in Allschwil, Switzerland [11] - The company has successfully launched two hospital brands: Cresemba for invasive fungal infections and Zevtera for bacterial infections [11] Licensing Agreement - Basilea has entered into an exclusive license agreement with Venatorx Pharmaceuticals to acquire global rights to ceftibuten-ledaborbactam etzadroxil, a clinical phase 3-ready oral beta-lactam/beta-lactamase inhibitor combination for complicated urinary tract infections (cUTI) [1][3] - The agreement includes an upfront payment and potential milestone payments in 2025, with total potential milestone payments of up to USD 325 million [3] Product Details - Ceftibuten-ledaborbactam etzadroxil combines ceftibuten, an orally bioavailable cephalosporin antibiotic, with ledaborbactam etzadroxil, a prodrug of a novel beta-lactamase inhibitor [2][6] - This combination shows bactericidal activity against multidrug-resistant pathogens, which are a major cause of cUTI, with over 600,000 hospital admissions annually in the USA [2] Clinical Development - Basilea plans to start a registrational phase 3 program for cUTI in approximately 18 months [3] - The product has received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the US FDA for cUTI and uncomplicated urinary tract infections [6] Financial Impact - The transaction is expected to incur approximately CHF 15 million in additional research and development expenses in 2025, including the upfront payment and potential pre-commercial milestone payments [4]