Innoviva Specialty Therapeutics has entered into an exclusive distribution and licensing agreement with Dr. Reddy’s Laboratories for the development and commercialisation of XACDURO (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use, in South and Central America, the Caribbean, Russia and Commonwealth of Independent States (CIS) countries.

In the US, XACDURO is approved and indicated for the treatment of Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter).

Acinetobacter is a significant public health concern and is classified as a ‘critical threat’ pathogen in World Health Organization (WHO) global bacterial priority pathogens list.

Under the terms of the agreement, Dr. Reddy’s will be responsible for development, regulatory and commercialisation activities in the licensed territory. Innoviva Specialty Therapeutics will retain rights to XACDURO in all unlicensed territories and is eligible to receive an upfront payment, regulatory and commercial milestone payments, and tiered royalties on net sales in the licensed territory.

Patricia Drake, Chief Commercial Officer, Innoviva Specialty Therapeutics, said, “This agreement reflects our ongoing commitment to addressing antimicrobial resistance by expanding access to important therapeutics for patients and healthcare systems facing serious, difficult-to-treat infections. Dr. Reddy’s brings strong regional capabilities and experience in infectious disease treatments, and we believe this partnership provides a practical path to broaden XACDURO’s global reach while maintaining our focus on disciplined execution.”

XACDURO is the first and only antibiotic approved in the US in patients 18 years of age and older for the treatment of HABP and VABP caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter). 

Acinetobacter infections remain a significant global health challenge, particularly in hospital settings where resistant pathogens can limit available treatment options.

The US FDA approved XACDURO in May 2023.