Basilea Pharmaceutica Ltd, (SIX:BSLN), a Switzerland-based commercial-stage biopharmaceutical company, announced on Thursday that it has entered into an exclusive license agreement with US-based Venatorx Pharmaceuticals, Inc., to acquire the global rights to ceftibuten-ledaborbactam etzadroxil, a clinical phase 3-ready oral beta-lactam/beta-lactamase inhibitor (BL/BLI) combination for the potential treatment of complicated urinary tract infections (cUTI), including pyelonephritis.

Ceftibuten-ledaborbactam etzadroxil is the combination of ceftibuten, an orally bioavailable cephalosporin antibiotic, and ledaborbactam etzadroxil, the orally bioavailable prodrug of the novel beta-lactamase inhibitor ledaborbactam. The combination is claimed to demonstrate bactericidal activity against Enterobacterales, including multidrug-resistant pathogens, a major cause of cUTI.

In the USA, cUTI account for more than 600,000 hospital admissions each year. The company says that in preclinical and clinical phase 1 studies, ceftibuten and ledaborbactam etzadroxil were shown to be safe and well tolerated.

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 3 clinical development program and after the grant of regulatory approval and start of commercialisation, Venatorx is eligible to receive tiered mid-single-digit royalties and additional potential milestone payments of up to USD325m in total, if all agreed commercial milestone events are triggered over the term of the contract.

The transaction is expected to result in approximately CHF15m 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, Basilea chief executive officer, 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."