Waltham, Mass. — Innoviva Specialty Therapeutics has entered into an exclusive distribution and licensing agreement with Dr. Reddy’s Laboratories Ltd. for XACDURO in select international markets.
Under the agreement, Dr. Reddy’s will develop and commercialize XACDURO, or sulbactam for injection and durlobactam for injection, in South and Central America, the Caribbean, Russia and Commonwealth of Independent States countries, following applicable regional regulatory approvals.
XACDURO is co-packaged for intravenous use. In the United States, it is approved for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex, or Acinetobacter, in patients 18 years of age and older.
Innoviva said the agreement is intended to expand access to XACDURO in regions where the rate of carbapenem-resistant Acinetobacter exceeds 70%, representing a significant unmet medical need.
Acinetobacter is considered a major public health concern and is classified as a “critical threat” pathogen on the World Health Organization’s global bacterial priority pathogens list.
Under the terms of the deal, Dr. Reddy’s will be responsible for development, regulatory and commercialization 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.
“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,” said Patricia Drake, Chief Commercial Officer of Innoviva Specialty Therapeutics. “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 United States for adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter. The U.S. Food and Drug Administration approved XACDURO in May 2023.
The drug is not indicated for the treatment of hospital-acquired bacterial pneumonia or ventilator-associated bacterial pneumonia caused by pathogens other than susceptible isolates of Acinetobacter. (Source: IANS)
