INNOVIVA licenses XACDURO to Dr. Reddy's for select international markets

Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (NASDAQ: INVA), has entered into an exclusive distribution and licensing agreement with Dr. Reddy's Laboratories Ltd. for XACDURO® (sulbactam for injection; durlobactam for injection) in South and Central America, the Caribbean, Russia, and Commonwealth of Independent States countries.

Under the agreement, Dr. Reddy's will be responsible for development, regulatory, and commercialization activities in the licensed territories. Innoviva Specialty Therapeutics retains 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. Financial terms were not disclosed.

XACDURO is approved by the U.S. FDA, as of May 2023, for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex in adults 18 years and older. Commercialization in the newly licensed territories is subject to applicable regional regulatory approvals.

According to the press release, the rate of carbapenem-resistant Acinetobacter in the licensed territories exceeds 70%, citing published research from 2021 and 2026. The World Health Organization classifies Acinetobacter as a "critical threat" pathogen on its global bacterial priority pathogens list.

"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.

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