Innoviva Specialty Therapeutics Announces FDA Approval for XACDURO® (sulbactam for injection; durlobactam for injection), Co-packaged for Intravenous Use

• Indicated for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter
• First pathogen-targeted therapy addressing Acinetobacter, including resistant strains, an emerging global health threat and growing unmet need

Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (Nasdaq: INVA), today announced that the U.S. Food and Drug Administration (FDA) approved XACDURO^® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use in patients 18 years of age and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter). Innoviva Specialty Therapeutics is focused on delivering innovative therapies in critical care and infectious disease.

“XACDURO is the first pathogen-targeted therapy approved to treat hospital-acquired and ventilator-associated pneumonias caused by Acinetobacter. The FDA approval of XACDURO marks an important milestone in our aim to deliver differentiated therapies to critically ill patients who have limited treatment options,” said David Altarac, MD, Chief Medical Officer, Innoviva Specialty Therapeutics. “Drug-resistant Acinetobacter can cause serious and even life-threatening infections that are associated with high morbidity and mortality, and long, expensive hospital stays, as the pathogen continues to acquire resistance genes for almost all antibiotics used to treat Gram-negative bacteria.”

The FDA approval was based on an array of scientific evidence, including results from the landmark Phase 3 ATTACK trial evaluating the safety and efficacy of XACDURO versus colistin in patients with infections caused by Acinetobacter. In the trial, XACDURO demonstrated statistical non-inferiority versus colistin for the primary endpoint of 28-day all-cause mortality in patients with carbapenem-resistant Acinetobacter infections and a significant difference in clinical cure rates. XACDURO was well tolerated and exhibited a favorable safety profile across the clinical program.

“Acinetobacter poses a significant danger to hospitalized patients, who are generally very ill and particularly susceptible to infections. Effectively treating infections caused by drug-resistant Acinetobacter is a challenge and makes this patient population in high need of new, effective treatment options,” stated Andrew F. Shorr, MD, MPH, MBA, Clinical Professor of Medicine, Georgetown University School of Medicine, Washington, D.C. “I’m encouraged by the approval of co-packaged sulbactam-durlobactam as it means physicians will soon have a novel therapeutic option that may help to address this urgent public health threat.”

The New Drug Application (NDA) for XACDURO was filed by Entasis Therapeutics Inc., an affiliate of Innoviva Specialty Therapeutics. XACDURO was granted Priority Review and designated as a Qualified Infectious Disease Product (QIDP). We anticipate that XACDURO will be available to patients later this year.

About Acinetobacter

Members of the Acinetobacter baumannii-calcoaceticus complex (Acinetobacter) are Gram-negative, opportunistic human pathogens that predominantly infect critically ill patients often resulting in severe pneumonia and bloodstream infections.¹ They can also infect other body sites, such as the urinary tract and the skin. Acinetobacter is considered a global threat in the healthcare setting due in part to its ability to acquire multidrug resistance. Acinetobacter is resistant to penicillins and has also acquired resistance genes for almost all antibiotics used to treat Gram-negative bacteria, including fluoroquinolones, aminoglycosides, cephalosporins, and carbapenems.

The Centers for Disease Control and Prevention (CDC) has identified carbapenem-resistant micro-organisms as an urgent threat.² Globally, Acinetobacter baumannii was among the top six leading pathogens for deaths associated with resistance in 2019.³ Carbapenem-resistant Acinetobacter is considered a Priority 1 pathogen by the World Health Organization (WHO).⁴

In the U.S., there are an estimated 40,000 to 80,000 cases of Acinetobacter each year, and about 40 percent of those are carbapenem-resistant Acinetobacter.^5,6 Globally, there are about a million cases each year of Acinetobacter, and about two-thirds of those are carbapenem-resistant Acinetobacter baumannii.⁵ More than 300,000 global deaths annually are associated with carbapenem-resistant Acinetobacter.⁷

About XACDURO^®

XACDURO^® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use is a combination of sulbactam, a beta-lactam antibacterial, and durlobactam, a beta-lactamase inhibitor, approved in patients 18 years of age and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter). XACDURO is not indicated for the treatment of HABP/VABP caused by pathogens other than susceptible isolates of Acinetobacter.

XACDURO^® IMPORTANT SAFETY INFORMATION

Contraindications: XACDURO is contraindicated in patients with a history of known severe hypersensitivity to the components of XACDURO or other beta-lactam antibacterial drugs.

Warnings and Precautions:

• Hypersensitivity was observed in patients treated with XACDURO in clinical trials. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving betalactam antibacterial drugs. Before initiating therapy with XACDURO, careful inquiry should be made concerning previous hypersensitivity reactions to carbapenems, penicillins, cephalosporins, other beta lactams, and other allergens. If an allergic reaction occurs, discontinue XACDURO.

• Clostridioides difficile-associated diarrhea (CDAD) 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. If CDAD is suspected or confirmed, the risk/benefit of continuing treatment with XACDURO should be assessed.
• Prescribing XACDURO in the absence of a proven or strongly suspected bacterial infection or a 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 reported in >5% of patients treated with XACDURO were liver test abnormalities (19%), diarrhea (17%), anemia (13%), and hypokalemia (12%).

Before administering, please see the Full Prescribing Information for XACDURO.

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). For more information about Innoviva Specialty Therapeutics, please visit here.

About Innoviva

Innoviva, Inc., is a diversified holding company with a portfolio of royalties and other healthcare assets, including Innoviva Specialty Therapeutics, a subsidiary focused on delivering innovative therapies in critical care and infectious disease. Innoviva’s royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (GSK), including RELVAR^®/BREO^® ELLIPTA^® (fluticasone furoate/vilanterol, FF/VI) and ANORO^® ELLIPTA^® (umeclidinium bromide/vilanterol, UMEC/VI). Under the Long-Acting Beta2 Agonist (LABA) Collaboration Agreement, Innoviva is entitled to receive royalties from GSK on sales of RELVAR^®/BREO^® ELLIPTA^® and ANORO^® ELLIPTA^®. ANORO^®, RELVAR^® and BREO^® are trademarks of the GSK group of companies. For more information on Innoviva, 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^® and, formerly, TRELEGY^® ELLIPTA^® in 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 beyond the existing respiratory portfolio); 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). 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, 2022 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.

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¹ Tala, B., Jad, A., Claude, A., Jihad, I., Chantal, L., Rakan, N.,& Eid, A. (2017). Risk Factors, Clinical Presentation, and Outcome of Acinetobacter baumannii Bacteremia. Front. Cell. Infect. Microbiol., 04 May 2017, Sec. Molecular Bacterial Pathogenesis Volume 7 – 2017: https://doi.org/10.3389/fcimb.2017.00156

² Centers for Disease Control and Prevention, “Carbapenem-resistant Acinetobacter baumannii (CRAB): An urgent public health threat in United States healthcare facilities,” August 2021: https://arpsp.cdc.gov/story/cra-urgent-public-health-threat

³ Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet. 2022; 399(10325):629-655. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02724-0/fulltext

⁴ World Health Organization, “WHO publishes list of bacteria for which new antibiotics are urgently needed,” February 27, 2017: https://www.who.int/news/item/27-02-2017-who-publishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed

⁵ Spellberg B, Rex JH. The value of single-pathogen antibacterial agents. Nat Rev Drug Discov. 2013 Dec;12(12):963. doi: 10.1038/nrd3957-c1. Epub 2013 Nov 15.

⁶ Centers for Disease Control and Prevention. Antibiotic Resistance & Patient Safety Portal. “Carbapenem-resistant Acinetobacter,” May 2023: https://arpsp.cdc.gov/profile/antibiotic-resistance/carbapenem-resistant-acinetobacter

⁷ Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet. 2022; 399(10325):629-655. Supplementary Material. Supplementary appendix. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02724-0/fulltext

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