WALTHAM, Mass. — Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (NASDAQ: INVA), announced that its infectious disease therapies ZEVTERA (ceftobiprole medocaril sodium for injection) and XACDURO (sulbactam/durlobactam for injection) have been nominated for the 2025 Prix Galien USA “Best Pharmaceutical Product” award.
“We are honored that both ZEVTERA and XACDURO have been recognized among the most innovative therapies of the year by The Galien Foundation,” said Pavel Raifeld, chief executive officer of Innoviva, Inc. “These nominations reflect the strength of our scientific innovation and the urgent clinical need our therapies address.”
The Prix Galien USA is regarded as one of the most prestigious honors in biopharmaceutical and medical technology, often compared to the Nobel Prize in the field. The 2025 winners will be announced October 30 in New York City.
“As antimicrobial resistance continues to rise globally, we remain committed to delivering therapies and life-saving solutions for these difficult-to-treat infections. This recognition reinforces the value of our portfolio and our mission to improve outcomes for patients while creating long-term value for our stakeholders,” said David Altarac, M.D., chief medical officer at Innoviva Specialty Therapeutics.
ZEVTERA, approved by the U.S. Food and Drug Administration in April 2024, is the first and only advanced-generation cephalosporin cleared to treat adults with Staphylococcus aureus bloodstream infections (bacteremia), including right-side endocarditis caused by both methicillin-susceptible and methicillin-resistant strains (MRSA). It is also indicated for adults with acute bacterial skin and skin structure infections, as well as adult and pediatric patients aged three months to under 18 years with community-acquired bacterial pneumonia. Innoviva acquired exclusive U.S. marketing rights to ZEVTERA from Basilea Pharmaceutica Ltd. in December 2024.
XACDURO, approved by the FDA in May 2023, is the first and only antibiotic indicated for patients 18 years and older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex.
Since its founding in 2022, Innoviva Specialty Therapeutics has commercialized four therapies in its critical care and infectious disease portfolio, including ZEVTERA and XACDURO. The company, in partnership with the Global Antibiotic Research and Development Partnership, is also awaiting an FDA decision on zoliflodacin, an investigational treatment for uncomplicated gonorrhea in adults and adolescents aged 12 and older, with a ruling expected by the end of 2025.
