Innoviva Specialty Therapeutics Earns Strong Performance Rating in Access to Medicine Foundation’s 2026 Antimicrobial Resistance Benchmark Report

Report Highlights the Company’s Collaboration with GARDP to Develop NUZOLVENCE^® (zoliflodacin) for Oral Suspension for the Treatment of Uncomplicated Urogenital Gonorrhea in Adults and Pediatric Patients

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

• Known history of hypersensitivity to NUZOLVENCE.
• Concomitant use with moderate or strong CYP3A4 inducers because this is predicted to result in decreased plasma concentrations of zoliflodacin and may reduce the NUZOLVENCE efficacy.

Warnings and Precautions

• Embryo-Fetal Toxicity: Potential Risk for Pregnant Females
  • Based on data from animal studies, NUZOLVENCE may cause fetal harm when administered to a pregnant female at clinically relevant doses. Avoid use during pregnancy. Advise pregnant females about the potential risk to the fetus with maternal exposure to NUZOLVENCE. Obtain a pregnancy test prior to initiation in persons of reproductive potential.
• Embryo-Fetal Toxicity: Potential Risk Related to Males with Female Partners of Reproductive Potential:
  • Based on data from an animal toxicity study, the risk of early pregnancy loss may be increased in female partners of males treated with NUZOLVENCE. Advise males with female partners of reproductive potential to use effective contraception for at least 3 months after NUZOLVENCE administration.
• Testicular Toxicity and Risks to Male Fertility:
  • Based on findings from animal studies, NUZOLVENCE may cause testicular toxicity and impair male fertility. An assessment of spermatogenesis has not been conducted in humans. Advise males that NUZOLVENCE may cause testicular toxicity and impair male fertility.
• Hypersensitivity Reactions:
  • Hypersensitivity reactions, including rash and pruritus, have been reported in patients receiving NUZOLVENCE. Before therapy with NUZOLVENCE is instituted, carefully inquire about previous hypersensitivity reactions to NUZOLVENCE. If an allergic reaction to NUZOLVENCE occurs, discontinue NUZOLVENCE and institute appropriate supportive measures.
• Clostridioides difficile Infection (CDI):
  • CDI has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.
• Development of Drug-Resistant Bacteria:
  • Prescribing NUZOLVENCE in the absence of a proven or strongly suspected bacterial infection or prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

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

• Pregnancy: Based on findings from animal studies, NUZOLVENCE may cause fetal malformations or increased embryo-fetal loss when administered to a pregnant female. A postmarketing descriptive pregnancy safety study is available for NUZOLVENCE. If exposure occurs during pregnancy, pregnant females or their healthcare providers should report the pregnancy to Entasis Therapeutics at 1-800-651-3861.
• Lactation: There are no data on the presence of zoliflodacin in either human or animal milk, effects on the breastfed infant, or effects on milk production. If NUZOLVENCE is present in breast milk, intestinal flora alteration in the breastfed infant could occur.
• Females and Males of Reproductive Potential: Based on animal studies, NUZOLVENCE may cause fetal malformations when administered to a pregnant female at clinically relevant doses. Additionally, based on data from an animal study, the risk of early pregnancy loss may be increased in partners of males treated with NUZOLVENCE.
  • Pregnancy Testing: Obtain a pregnancy test in females of reproductive potential prior to initiating treatment with NUZOLVENCE.
  • Contraception: Advise males with female partners of reproductive potential to use effective contraception for at least 3 months after their single-dose treatment of NUZOLVENCE.
  • Infertility: Based on data from repeat-dose animal toxicity and fertility studies, NUZOLVENCE may cause testicular toxicity and impair male fertility.
• Pediatric Use: The safety and effectiveness of NUZOLVENCE in pediatric patients younger than 12 years of age or weighing less than 35 kg have not been established.
• Geriatric Use: Clinical studies of NUZOLVENCE did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients.

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

[email protected]

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.

Contacts

Media Contact:
David Patti

Corporate Communications

Innoviva Specialty Therapeutics

[email protected]

Investor Relations Contact:
Eleanor Barisser

Director of Investor Relations and Corporate Communications

Innoviva, Inc.

[email protected]