Innoviva Specialty Therapeutics Earns Dual Nominations for 2025 Prix Galien USA Best Pharmaceutical Product Award for ZEVTERA® and XACDURO®
Innoviva Specialty Therapeutics, a wholly owned subsidiary of Innoviva, Inc. (NASDAQ: INVA), announced that two of its flagship infectious disease therapies — ZEVTERA® (ceftobiprole medocaril sodium for injection) and XACDURO® (sulbactam/durlobactam for injection) — have been shortlisted for one of the biopharmaceutical industry’s highest honors: the 2025 Prix Galien USA Award for “Best Pharmaceutical Product.”
The nomination of these two antimicrobial agents underscores Innoviva’s rapid emergence as a leading innovator in the fight against antimicrobial resistance (AMR) and its commitment to delivering therapies that address some of the most pressing unmet needs in infectious disease care.
Recognition from One of the Industry’s Most Prestigious Awards
The Prix Galien USA is widely considered the pinnacle of recognition for innovation in the biopharmaceutical and medical technology sectors. Established to honor outstanding achievements that improve human health, the award celebrates products that represent the highest level of scientific excellence and societal impact. Globally, the Prix Galien has been likened to the “Nobel Prize” for pharmaceutical and medical technology research.
For the 2025 awards cycle, the winners will be announced on October 30, 2025, at a formal ceremony in New York City, bringing together leaders from the life sciences, regulatory agencies, academic institutions, and patient advocacy groups.
“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 not only the strength of our scientific innovation but also the urgent clinical needs our therapies address.”
The Growing Global Challenge of Antimicrobial Resistance
Antimicrobial resistance remains one of the greatest threats to modern medicine. The World Health Organization (WHO) has repeatedly warned that without new, effective antibiotics, the world could enter a “post-antibiotic era” where common infections and minor injuries can once again become life-threatening. The problem is compounded by the limited number of new antibiotics reaching the market in recent decades, particularly those capable of combating highly resistant bacterial strains.
“Innoviva Specialty Therapeutics is committed to developing and delivering life-saving solutions for patients facing difficult-to-treat infections,” said Dr. David Altarac, Chief Medical Officer at Innoviva Specialty Therapeutics. “The recognition by the Prix Galien USA reinforces the value of our portfolio and our mission to improve outcomes while creating sustainable value for our stakeholders.”
ZEVTERA® — Addressing a Critical Gap in Serious Bacterial Infections
One of the nominated products, ZEVTERA®, received U.S. Food and Drug Administration (FDA) approval in April 2024, marking a milestone in the evolution of Innoviva’s antibiotic portfolio.
ZEVTERA is a next-generation cephalosporin with a broad spectrum of activity, and it is the first and only advanced-generation cephalosporin approved in the United States to treat Staphylococcus aureus bloodstream infections (SAB) — including right-sided endocarditis — caused by both methicillin-susceptible (MSSA) and methicillin-resistant (MRSA) strains. This distinction is significant because MRSA remains one of the most virulent and treatment-resistant pathogens encountered in hospital settings.
Notably, ZEVTERA is the first FDA-approved therapy for MRSA-related SAB in nearly 20 years, addressing a persistent unmet medical need. Bloodstream infections caused by MRSA are associated with high morbidity and mortality rates, making the availability of an effective new therapy a major advancement for infectious disease specialists.
Approved Indications for ZEVTERA in the U.S.:
- Adults with Staphylococcus aureus bloodstream infections (SAB), including right-sided endocarditis, caused by MSSA and MRSA
- Adults with acute bacterial skin and skin structure infections (ABSSSI)
- Adults and pediatric patients (3 months to <18 years old) with community-acquired bacterial pneumonia (CABP)
ZEVTERA was originally developed by Basilea Pharmaceutica Ltd of Allschwil, Switzerland. In December 2024, Innoviva Specialty Therapeutics entered into an exclusive U.S. licensing agreement with Basilea, securing the rights to market and distribute ZEVTERA in the United States.
XACDURO® — A Breakthrough Against Multidrug-Resistant Acinetobacter
The second Innoviva therapy nominated for the Prix Galien award, XACDURO®, is the first and only antibiotic approved in the United States for the treatment of hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible isolates of the Acinetobacter baumannii-calcoaceticus complex.
These infections are among the most challenging to treat due to their prevalence in critically ill, hospitalized patients — especially those in intensive care units (ICUs) — and the high level of antibiotic resistance exhibited by Acinetobacter species. Infections caused by multidrug-resistant Acinetobacter are associated with prolonged hospital stays, increased healthcare costs, and mortality rates that can exceed 40%.
The FDA approved XACDURO in May 2023, recognizing its ability to address this high-priority pathogen. The treatment combines sulbactam, a β-lactamase inhibitor with intrinsic antibacterial activity against Acinetobacter, and durlobactam, a novel broad-spectrum β-lactamase inhibitor that protects sulbactam from degradation by resistant bacterial enzymes. This synergistic mechanism restores antibacterial activity against otherwise resistant strains.
A Growing Portfolio with a Strong Development Pipeline
Since its formation in 2022, Innoviva Specialty Therapeutics has rapidly built a commercial portfolio of four therapies targeting critical care and infectious disease settings. The launches of ZEVTERA and XACDURO in the past two years have strengthened its market position in antimicrobial innovation.
Beyond its marketed products, the company is collaborating with the Global Antibiotic Research and Development Partnership (GARDP) on zoliflodacin, a first-in-class oral antibiotic for the treatment of uncomplicated gonorrhea in adults and adolescents aged 12 years and older. Gonorrhea, particularly strains resistant to current therapies, is a growing global public health concern, with the WHO estimating more than 80 million new cases annually.
The FDA is currently reviewing zoliflodacin, and a decision is expected by the end of 2025. If approved, it would be the first new antibiotic for gonorrhea in decades and a major tool in combating rising resistance.
Industry and Market Implications
The dual nomination for the Prix Galien USA is more than just a symbolic achievement — it reflects Innoviva’s strategic execution in identifying, acquiring, and advancing high-value assets with clear clinical relevance.
From an industry perspective, the recognition of two antimicrobial agents in the same year highlights an encouraging trend: despite the challenging economics of antibiotic development, companies like Innoviva are finding viable pathways to bring new products to market.
Market analysts note that ZEVTERA and XACDURO both target therapeutic niches with limited competition and high unmet need, which could translate into strong adoption in hospital and critical care settings. Given the FDA’s emphasis on combating AMR through expedited regulatory pathways, Innoviva is well-positioned to continue its trajectory of growth.
Commitment to Public Health
Both nominations also serve as a reminder that effective antibiotic stewardship depends on having access to innovative therapies that are backed by strong clinical evidence. Innoviva’s approach — combining targeted drug development with strategic licensing and partnerships — aligns with global health priorities set forth by organizations like the WHO, the U.S. Centers for Disease Control and Prevention (CDC), and the Infectious Diseases Society of America (IDSA).
As AMR continues to threaten the effectiveness of modern healthcare systems, the need for novel antibiotics that can address resistant pathogens in real-world clinical practice has never been greater. The recognition from the Prix Galien Foundation signals that Innoviva’s contributions are not only scientifically significant but also essential for safeguarding the future of infection treatment.
With the Prix Galien USA 2025 Awards Ceremony scheduled for October 30 in New York City, attention will remain on Innoviva and the other nominees as the industry awaits the announcement of winners. Whether or not ZEVTERA or XACDURO take home the top honor, their nomination alone places Innoviva Specialty Therapeutics among the elite group of companies driving the next generation of medical innovation.
In parallel, the company continues to focus on expanding its infectious disease portfolio, advancing its development programs, and ensuring that its marketed therapies reach patients who need them most.
“In the face of rising global health threats from resistant bacteria, we see our role as both innovators and stewards of these important therapies,” said Raifeld. “Recognition from the Prix Galien Foundation is an important validation of the path we are on — and a call to continue our work with urgency.”
About Innoviva Specialty Therapeutics
Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc., focuses on delivering life-saving solutions for patients in critical care and infectious disease settings. Since its founding in 2022, the company has launched four therapies in the U.S. market, with a strong development pipeline aimed at addressing unmet medical needs in antimicrobial resistance.
About the Prix Galien USA
The Prix Galien USA Awards are presented annually by The Galien Foundation to honor outstanding achievements in improving the human condition through the development of innovative medicines and technologies.
