WALTHAM - 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 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
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.
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).
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.
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.
Contact:
Tel: (212) 600-1902
Email: Innoviva@argotpartners.com
INNOVIVA, INC. 
