- 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.
______________ 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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Investors Argot Partners (212) 600-1902
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