Innoviva Specialty Therapeutics Presents New Data on its Critical Care Antibiotic Therapy Portfolio at Infectious Disease Week (IDWeek) 2023

• Oral presentation highlights new findings about the efficacy of XACDURO^® for the treatment of monomicrobial and polymicrobial Acinetobacter baumannii-calcoaceticus infections
• Researchers share global surveillance data on the in vitro activity of XERAVA^® (eravacycline) for injection on resistant isolates and Gram-positive clinical pathogens
• Total of nine presentations on XACDURO^® and XERAVA^® to be revealed during IDWeek 2023

Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (Nasdaq: INVA), announced today plans to present an oral abstract and four poster sessions from their portfolio of U.S. Food and Drug Administration (FDA)-approved critical care and infectious disease therapies at IDWeek 2023, October 11-15, held in Boston, MA.

The company will deliver one oral abstract presentation and two poster sessions highlighting findings on their newly approved therapy, XACDURO^® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use, which is the first and only antibiotic specifically developed to target the Acinetobacter pathogen in adults. XACDURO is indicated in adults for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex. In addition, four company-sponsored research studies on XACDURO will also be presented by the company’s research partners in poster sessions.

“Antibiotic-resistant pathogens are one of the most significant and challenging threats to healthcare providers on the frontlines of infectious disease care,” said Margaret Koziel, MD, Chief Medical Officer, Innoviva Specialty Therapeutics. “IDWeek is an opportunity for us and for our research partners to share new clinical insights that help us better understand these therapies on a deeper level to improve treatment strategies.”

Researchers from Innoviva Specialty Therapeutics will also present new surveillance data on XERAVA^® (eravacycline), an anti-bacterial for the treatment of complicated intra-abdominal infections (cIAI) caused by multidrug-resistant bacteria during the scientific poster sessions.

Company Presentations:

Oral Abstract Presentation

• Efficacy of Sulbactam-Durlobactam (SUL-DUR) Compared to Colistin (COL) Against Acinetobacter baumannii-calcoaceticus Complex (ABC) Monomicrobial and Polymicrobial Infections in a Phase 3 Trial
  
  Authors: Alita A. Miller, Sarah M. McLeod, Adam Shapiro, Khurram Rana, David Altarac
  
  Innoviva Specialty Therapeutics, Waltham, MA, United States
  
  Session Date: Thursday, October 12, 2023; 10:30 – 10:45 AM ET
  
  Session Topic: Clinical Trials
  
  Session Location: 102 AB

Poster Sessions

• Pharmacometric Analyses to Support Sulbactam-Durlobactam (SUL-DUR) Dosing Regimens in Patients with Altered Renal Function (2549)
  
  Authors: Kajal Larson, Sujata Bhavnani, Jeffrey Hammel, Anthony Cammarata, John O'Donnell, Christopher Rubino; Innoviva Specialty Therapeutics, Waltham, MA, United States, Institute for Clinical Pharmacodynamics, Inc. – Schenectady, NY United States
  
  Session Date: Saturday, October 14, 2023; 12:15 - 1:30 PM ET
  
  Session Topic: PK/PD Studies
  
  Session Location: Hall B + C

• In Vitro Susceptibility of Recent Clinical Isolates of P. aeruginosa and Enterobacterales to Imipenem or Meropenem Alone or in Combination with Sulbactam-Durlobactam (2138)
  
  Authors: Sarah M. McLeod, Nicole M. Carter, Samir H. Moussa, Alita A. Miller;
  
  Innoviva Specialty Therapeutics, Waltham, MA, United States
  
  Session Date: Saturday, October 14, 2023; 12:15 - 1:30 PM ET
  
  Session Topic: Antimicrobial Novel Agents
  
  Session Location: Hall B + C

• Surveillance of Eravacycline Against Enterobacterales and Non-Fermenter Clinical Isolates, Including Resistant Isolates, Collected Worldwide from
  
  Multiple Infection Sites During 2021 (2132)
  
  Authors: Stephen Hawser, Nimmi Kothari, Federica Monti, Tony Hodges, Kristie Zappas; IHMA Europe, Monthey (Valais), Switzerland; Innoviva Specialty Therapeutics, Inc, Waltham (MA), United States
  
  Session Date: Saturday, October 14, 2023; 12:15 – 1:30 PM ET
  
  Session Topic: Antimicrobial Novel Agents
  
  Session Location: Hall B + C

• Surveillance of Eravacycline Against Gram-Positive Clinical Pathogens, Including Resistant Isolates, Collected Worldwide From Multiple Infection Sites During 2021 (2133)
  
  Authors: Stephen Hawser, Nimmi Kothari, Federica Monti, Tony Hodges, Kristie Zappas; IHMA Europe, Monthey (Valais), Switzerland; Innoviva Specialty Therapeutics, Inc, Waltham (MA), United States
  
  Session Date: Saturday, October 14, 2023; 12:15 – 1:30 PM ET
  
  Session Topic: Antimicrobial Novel Agents
  
  Session Location: Hall B + C

Company-Sponsored Research Presentations:

Poster Sessions

• In vitro Synergy of the Combination of Sulbactam-Durlobactam and Cefepime at Clinically Relevant Concentrations Against A. baumannii, P. aeruginosa, and Enterobacterales (2121)
  
  Authors: Aliaa Fouad, PhD, David P. Nicolau, PharmD, FCCP, FIDSA, and Christian M. Gill, PharmD, Center for Anti-Infective Research and Development, Hartford Hospital, Hartford, CT, United States, Division of Infectious Diseases, Hartford Hospital, Hartford, CT United States
  
  Session Date: Saturday, October 14, 2023; 12:15 – 1:30 PM ET
  
  Session Topic: PK/PD Studies
  
  Session Location: Hall B + C

• Ex Vivo Assessment of Sulbactam-Durlobactam (SUL-DUR) Clearance During Continuous Renal Replacement Therapy (CRRT) (2526)
  
  Authors: Yasmeen Abouelhassan, Yuwei Shen, Xiaoyi Ye, David P Nicolau, Joseph L. Kuti
  
  Ctr. for Anti-Infect. Res. & Dev., Hartford Hospital, Hartford, CT Inpatient Hemo-Therapeutics, Hartford Hospital, Hartford, CT United States
  
  Session Date: Saturday, October 14, 2023; 12:15 – 1:30 PM ET
  
  Session Topic: New Antimicrobial Drug Development
  
  Session Location: Hall B + C

• (2515) Evaluation of the Equivalency of the Oxoid Sulbactam-Durlobactam (10/10µg) Antimicrobial Disc to the CLSI M07 Broth Microdilution Frozen Reference Method
  
  Authors: K. L. Hajek B.S., A.J Lovatt BSc., S. Bhalerao PhD., N. Khan BSc., D.T Staats M.S. M.M Hendrix B.S., N.M Holliday B.S., C.C Knapp M.S.
  
  Thermo Fisher Scientific, Cleveland, OH, United States; Thermo Fisher Scientific, Basingstoke, United Kingdom
  
  Session Date: Saturday, October 14, 2023; 12:15 – 1:30 PM
  
  Session Topic: New Antimicrobial Drug Development
  
  Session Location: Hall B + C

• (2517) Activity of Sulbactam-Durlobactam, Antibacterial Combinations, and Comparators Against a Challenge Set of 66 Acinetobacter Baumannii-Calcoaceticus Species Complex Isolates
  
  Authors: MD Huband, RE Mendes, G Bartleson, H Huynh, M Castanheira
  
  JMI Laboratories, North Liberty, IA, United States
  
  Session Date: Saturday, October 14, 2023; 12:15 – 1:30 PM
  
  Session Topic: New Antimicrobial Drug Development
  
  Session Location: Hall B + C

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 infect other body sites, such as the urinary tract and the skin.1 Acinetobacter is considered a global threat in the healthcare setting due in part to its ability to acquire multidrug resistance.² 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.²

The Centers for Disease Control and Prevention (CDC) has identified carbapenem-resistant micro-organisms as an urgent threat.³ Globally, Acinetobacter baumannii was among the top six leading pathogens for deaths associated with resistance in 2019.⁴ Carbapenem-resistant Acinetobacter is considered a Priority 1 pathogen by the World Health Organization (WHO).⁵

In the U.S., there are more than 40,000 cases of Acinetobacter each year and approximately bout 40 percent of those are carbapenem-resistant.^6,7 Globally, there are about a million cases each year of Acinetobacter, and about two-thirds of those are carbapenem-resistant Acinetobacter baumannii.6 More than 300,000 global deaths annually are associated with carbapenem-resistant Acinetobacter.⁴

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^® INDICATION & USAGE

Indication

XACDURO^® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use is indicated in adults for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii- calcoaceticus complex.

Limitations of Use

XACDURO is not indicated for the treatment of HABP/VABP caused by pathogens other than susceptible isolates of Acinetobacter baumannii-calcoaceticus complex.

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of XACDURO and other antibacterial drugs, XACDURO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

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 beta-lactam 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 >10% of patients treated with XACDURO were liver test abnormalities (19%), diarrhea (17%), anemia (13%), and hypokalemia (12%).

To report SUSPECTED ADVERSE REACTIONS, contact Innoviva Specialty Therapeutics, Inc. at 1-800-651-3861 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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

XERAVA^® Important Safety Information

Indications and Usage

XERAVA is indicated for the treatment of complicated intra-abdominal infections (cIAI) caused by susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii, Enterobacter cloacae, Klebsiella oxytoca, Enterococcus faecalis, Enterococcus faecium, Staphylococcus aureus, Streptococcus anginosus group, Clostridium perfringens, Bacteroides species, and Parabacteroides distasonis in patients 18 years or older.

Limitations of Use

XERAVA is not indicated for the treatment of complicated urinary tract infections (cUTI).

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of XERAVA and other antibacterial drugs, XERAVA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

XERAVA is contraindicated for use in patients with known hypersensitivity to eravacycline, tetracycline-class antibacterial drugs, or to any of the excipients. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with XERAVA.

The use of XERAVA during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia. The use of XERAVA during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth.

Clostridium 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. The most common adverse reactions observed in clinical trials (incidence ≥3%) were infusion site reactions (7.7%), nausea (6.5%), and vomiting (3.7%).

XERAVA is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti-anabolic action which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with XERAVA. Discontinue XERAVA if any of these adverse reactions are suspected.

To report SUSPECTED ADVERSE REACTIONS, contact Innoviva Specialty Therapeutics, Inc., at 1-833-7-XERAVA (1-833-793-7282) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Please see Full Prescribing Information for XERAVA.

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.

References

¹ Ballouz T, Aridi J, Afif C, et al. (2017) Risk Factors, Clinical Presentation, and Outcome of Acinetobacter baumannii Bacteremia. Front. Cell. Infect. Microbiol. 7:156. doi: 10.3389/fcimb.2017.00156

² Kyriakidis I, Vasileiou E, Pana ZD, Tragiannidis A. Acinetobacter baumannii Antibiotic Resistance Mechanisms. Pathogens. 2021 Mar 19;10(3):373. doi: 10.3390/pathogens10030373. PMID: 33808905; PMCID: PMC8003822.

³ 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. Accessed: August 7, 2023

⁴ 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

⁵ 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. Accessed: August 7, 2023

⁶ Spellberg B, Rex JH. The Value of Single-Pathogen Antibacterial Agents. National Review Drug Discovery. 2013 Dec;12(12):963. doi: 10.1038/nrd3957-c1. Epub 2013 Nov 15.

⁷ Gupta V, Ye G, Olesky M, Lawrence K, Murray J, Yu K. National prevalence estimates for resistant Enterobacteriaceae and Acinetobacter species in hospitalized patients in the United States. Int J Infect Dis. 2019 Aug;85:203-211. doi: 10.1016/j.ijid.2019.06.017. Epub 2019 Jun 20. PMID: 31229615.

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