Innoviva Specialty Therapeutics Earns Strong Performance Rating in Access to Medicine Foundation’s 2026 Antimicrobial Resistance Benchmark Report
WALTHAM, Mass.--( BUSINESS WIRE)--Innoviva Specialty Therapeutics, a subsidiary of Innoviva Inc., today announced that its infectious disease therapeutic portfolio earned a strong performance rating of 80% in the 2026 Antimicrobial Resistance (AMR) Benchmark Report published by the Access to Medicine Foundation. The score represents the highest rating in the small- and medium-sized enterprise (SME) category, achieved by only one other company in this year’s report. The AMR Benchmark evaluates pharmaceutical companies’ efforts to combat antimicrobial resistance and expand global access to effective treatments.
“We are honored to be recognized in this important global assessment of the antibiotic treatment landscape, particularly at a time when there is a growing need for new therapies as antibiotic resistance continues to rise across many regions, challenging our ability to treat life-threatening infections effectively,” said David Altarac, M.D., Chief Medical Officer of Innoviva Specialty Therapeutics. “Addressing this urgent public health crisis is central to our mission, and we remain committed to developing innovative therapies that target high-priority and difficult-to-treat pathogens.”
The Foundation’s recognition highlights Innoviva Specialty Therapeutics’ commitment to advancing therapies for serious and life-threatening infections, including those caused by priority pathogens, classified by the World Health Organization (WHO), as well as for its innovation and best practices in research and development. The report cites the Company’s recently U.S. FDA-approved first-in-class single-dose oral therapy, NUZOLVENCE ® (zoliflodacin) for oral suspension in adults and adolescents, which treats susceptible strains of Neisseria gonorrhoeae, including those resistant to cephalosporins, and meets three of four WHO innovation criteria. The report notes that the Company’s work in this area demonstrates Best Practice for its innovative candidate and stands out for its integration of access and stewardship considerations within its development plan, which was created in partnership with the Global Antibiotics Research and Development Partnership (GARDP).
Innoviva was evaluated in the SME category based on its performance in the R&D Technical Area. This assessment examines the strength and innovation of the Company’s pipeline, including alignment with WHO criteria, demonstrated clinical value, and relevance to critical gaps in the global antimicrobial R&D landscape. It also considers whether late-stage (Phase II/III) projects are supported by comprehensive access and stewardship plans.
The 2026 AMR Benchmark report will be formally presented at a high-level launch event in London, underscoring the growing global urgency to combat antimicrobial resistance and accelerate coordinated action across governments, industry, and healthcare systems. Co-hosted by the Access to Medicine Foundation and the Fleming Initiative, the event will convene approximately 100 global health leaders for a focused discussion on recent progress, persistent challenges, and practical steps to accelerate industry action against drug resistance.
Since its establishment in 2023, Innoviva Specialty Therapeutics has built a comprehensive portfolio of hospital-focused therapies addressing urgent, challenging, and unmet medical needs. The portfolio includes a novel vasopressor for patients with septic or other distributive shock, as well as four FDA-approved antimicrobial agents, including NUZOLVENCE ® (zoliflodacin) for oral suspension. The Company remains focused on expanding its infectious disease portfolio and collaborating with global partners to help address one of the most pressing public health challenges of our time.
About NUZOLVENCE ® (zoliflodacin) for oral suspension
NUZOLVENCE is a first-in-class, single-dose, oral antibiotic FDA-approved for the treatment of uncomplicated urogenital gonorrhea, including strains resistant to current first-line therapies.
NUZOLVENCE is a spiropyrimidinetrione bacterial type II topoisomerase inhibitor indicated for the treatment of uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeae in adults and pediatric patients 12 years of age and older, weighing at least 35 kg. The NUZOLVENCE mechanism of action is distinct from that of currently approved antibiotics and has demonstrated activity against drug-resistant Neisseria gonorrhoeae.
Important Safety Information (ISI)
Indication and Usage
Indication
NUZOLVENCE ® is a spiropyrimidinetrione bacterial type II topoisomerase inhibitor indicated for the treatment of uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeae in adults and pediatric patients 12 years of age and older, weighing at least 35 kg.
Usage to Reduce Development of Drug-Resistant Bacteria: To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZOLVENCE and other antibacterial drugs, NUZOLVENCE should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Contraindications
Warnings and Precautions
Adverse Reactions
The most common adverse reactions (≥2%) are headache, dizziness, nausea, and diarrhea. Laboratory abnormalities (neutropenia, leukopenia) were also observed.
Drug Interactions
Concomitant use with moderate or strong CYP3A4 inducers is contraindicated.
Use in Specific Populations
Reporting Adverse Events
You are encouraged to report negative side effects of prescription drugs to the FDA. To report SUSPECTED ADVERSE REACTIONS, please contact:
Innoviva Specialty Therapeutics™
1-800-651-3861
medinfo@istx.com
U.S. Food and Drug Administration
1-800-FDA-1088
www.fda.gov/medwatch
Before administering, please see the Full Prescribing Information for NUZOLVENCE.
About Innoviva Specialty Therapeutics
Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc., is focused on delivering innovative therapies in critical care and infectious disease. Innoviva Specialty Therapeutics’ products, through its affiliate, La Jolla Pharmaceutical Company, include GIAPREZA ® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock, and XERAVA ® (eravacycline) for the treatment of complicated intra-abdominal infections in adults. Innoviva Specialty Therapeutics’ products, through its affiliate, Entasis Therapeutics Inc., include XACDURO ® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter), and NUZOLVENCE ® (zoliflodacin), a first-in-class, single-dose, oral antibiotic FDA-approved for the treatment of uncomplicated urogenital gonorrhea, including strains resistant to current first-line therapies. Through a licensing agreement with Basilea Pharmaceutica, Ltd., Innoviva Specialty Therapeutics retains U.S. marketing rights for ZEVTERA ® (ceftobiprole), the only FDA-approved cephalosporin specifically designed to treat adult patients with acute bacterial skin and skin structure infections (ABSSSI), adult patients with Staphylococcus aureus bloodstream infections (bacteremia), including those with right-sided infective endocarditis, and adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP). For more information about Innoviva Specialty Therapeutics, please visit here.
Forward Looking Statements
This press release contains certain “forward-looking” statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, and future events. Innoviva intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. The words “anticipate”, “expect”, “goal”, “intend”, “objective”, “opportunity”, “plan”, “potential”, “target” and similar expressions are intended to identify such forward-looking statements. Such forward-looking statements involve substantial risks, uncertainties, and assumptions. These statements are based on the current estimates and assumptions of the management of Innoviva as of the date of this press release and are subject to known and unknown risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Innoviva to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: expected cost savings; lower than expected future royalty revenue from respiratory products partnered with GSK; the commercialization of RELVAR ®/BREO ® ELLIPTA ®, ANORO ® ELLIPTA ®, GIAPREZA ®, NUZOLVENCE ®, XERAVA ®, XACDURO ® and ZEVTERA, the jurisdictions in which these products have been approved; the strategies, plans and objectives of Innoviva (including Innoviva’s growth strategy and corporate development initiatives); the timing, manner, and amount of potential capital returns to shareholders; the status and timing of clinical studies, data analysis and communication of results; the potential benefits and mechanisms of action of product candidates; expectations for product candidates through development and commercialization; the timing of regulatory approval of product candidates; and projections of revenue, expenses and other financial items; the impact of the novel coronavirus (“COVID-19”); the timing, manner and amount of capital deployment, including potential capital returns to stockholders; and risks related to the Company’s growth strategy. Other risks affecting Innoviva are described under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained in Innoviva’s Annual Report on Form 10-K for the year ended December 31, 2024 and Quarterly Reports on Form 10-Q, which are on file with the Securities and Exchange Commission (“SEC”) and available on the SEC’s website at www.sec.gov. Past performance is not necessarily indicative of future results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The information in this press release is provided only as of the date hereof, and Innoviva assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law.