In-licensing announced of a novel clinical phase III-ready Exblifep, an oral antibiotic, ceftibuten-ledaborbactam etzadroxil to treat urinary tract infections – Basilea
Basilea Pharmaceutica announced that it has entered into an exclusive license agreement with Venatorx Pharmaceuticals Inc., to acquire the global rights to ceftibuten-ledaborbactam etzadroxil (Exblifep), a clinical phase III-ready oral beta-lactam/beta-lactamase inhibitor (BL/BLI) combination for the potential treatment of complicated urinary tract infections (cUTI), including pyelonephritis. Under the terms of the agreement, Basilea will make an upfront payment and potential milestone payments in 2025. Following the successful completion of the phase III clinical development program and after the grant of regulatory approval and start of commercialization, Venatorx is eligible to receive tiered mid-single-digit royalties and additional potential milestone payments of up to USD 325 million in total, if all agreed commercial milestone events are triggered over the term of the contract.
The transaction is expected to result in approximately CHF 15 million of additional research and development expenses in 2025, including the full upfront payment, all potential pre-commercial milestone payments and expected R&D expenses in 2025. Basilea will provide updated financial guidance for the full-year 2025, reflecting this transaction, with the half-year earnings report on August 19, 2025.
David Veitch, Chief Executive Officer of Basilea, said: “This agreement allows us to strengthen our late-stage clinical pipeline and supports our strategy of ensuring that we have a continuous stream of potential new product launches in the near-term future, positioning us for sustainable substantial revenue growth. Ceftibuten-ledaborbactam etzadroxil holds strong promise in addressing the critical unmet need for the oral treatment of cUTI caused by multidrug-resistant Gram-negative bacteria and represents a compelling global commercial opportunity. We expect starting a registrational phase 3 program in cUTI in about 18 months.
