Innoviva's only FDA-approved antibiotic for carbapenem-resistant Acinetobacter baumannii is heading to some of the world's most resistance-burdened hospital markets, via Innoviva Specialty Therapeutics' exclusive distribution and licensing agreement with India-based Dr. Reddy's Laboratories Ltd. (NYSE: RDY). The deal focuses on for Xacduro (sulbactam for injection; durlobactam for injection) across the territories of South and Central America, the Caribbean, Russia, and Commonwealth of Independent States countries. The deal positions Dr. Reddy's as Innoviva's commercialization arm across a geographically diverse block of markets where carbapenem-resistant Acinetobacter baumannii (CRAB) infection rates reportedly exceed 70%, and where Innoviva has no existing commercial infrastructure. Innoviva, Inc. (Nasdaq: INVA) holds Xacduro through its Innoviva Specialty Therapeutics subsidiary.
Financial terms related to the deal were not disclosed. Innoviva confirmed it is eligible to receive an upfront payment, regulatory milestone payments, commercial milestone payments, and tiered royalties on net sales in the licensed territory. Dr. Reddy's assumes full responsibility for development, regulatory, and commercialization activities in the licensed markets.
Deal context
Xacduro is a fixed-dose combination of sulbactam, a beta-lactam antibacterial, and durlobactam, a beta-lactamase inhibitor. Sulbactam has direct bactericidal activity against Acinetobacter baumannii-calcoaceticus complex (Acinetobacter), while durlobactam inhibits the beta-lactamases that would otherwise degrade sulbactam, restoring its activity against carbapenem-resistant strains. The US FDA approved Xacduro in May 2023 for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible Acinetobacter isolates in adults — making it the only antibiotic specifically approved in the US for this indication. In its Phase III trial, Xacduro demonstrated non-inferiority to colistin with a more favorable safety profile, including lower rates of nephrotoxicity.
The WHO classifies carbapenem-resistant Acinetobacter baumannii as a Priority 1: Critical pathogen on its 2024 bacterial priority pathogen list. Russia and CIS countries carry disproportionately high CRAB burden relative to Western Europe, driven by high antibiotic consumption in hospital settings and limited antimicrobial stewardship programs, making the Russia/CIS portion of the licensed territory potentially significant.