Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical
company engaged in the commercialization and development of
innovative anti-infective agents to treat serious infections,
announced the publication of a study entitled, A Multicenter
Evaluation of the U.S. Prevalence and Regional Variation in
Macrolide Resistant S. pneumoniae from Blood or Respiratory
Cultures among Adult Patients (Abstract #5523), online in the
proceedings of 30th European Congress on Clinical Microbiology and
Infectious Diseases (ECCMID).
This study assessed 3,510 patients with a positive S. pneumoniae
blood or respiratory culture in the ambulatory and inpatient
setting at 329 hospitals across nine U.S. Census geographic regions
over 12 months ending 3Q2019 to determine the prevalence and rates
of macrolide resistance in S. pneumoniae. Macrolide resistance was
observed in 47.3 percent of S. pneumoniae obtained from respiratory
cultures, and 29.6 percent from blood cultures. Higher rates of
macrolide resistance were seen among ambulatory patients (45.3
percent) as compared with inpatients (37.8 percent). While the
overall rate of macrolide resistance was 39.5 percent, regional
variation occurred, ranging from 13.9 percent in the Mountain
region to 54.2 percent in the West North Central region,
demonstrating the importance of local epidemiology data to inform
selection of empiric therapy for patients with community-acquired
bacterial pneumonia (CABP).
“These results are a stark reminder of the urgent need for
innovative antibacterial agents with a new mechanism of action to
address the growing public health threat of antibiotic resistance,”
said Jennifer Schranz, MD, Chief Medical Officer at Nabriva. “S.
pneumoniae has been designated as a serious threat by the CDC, and
the high rates of macrolide resistant S. pneumoniae from
respiratory and blood isolates throughout the United States
highlight the urgent need for timely epidemiology information to be
readily available so that physicians can make evidence-based
decisions about empiric antibiotic therapy for patients with
CABP.”
S. pneumoniae is the leading cause of community-acquired
bacterial pneumonia (CABP), a lung infection and the most common
type of pneumonia that occurs outside of hospitals or other health
care facilities. In its 2019 Antibiotic Threats Report, the Centers
for Disease Control and Prevention (CDC) designated
macrolide-resistant S. pneumoniae as a “Serious Threat” to
patients. According to the CDC, S. pneumoniae causes 900,000
infections and 3,600 deaths annually. Joint guidelines issued by
the Infectious Disease Society of America and the American Thoracic
Society (IDSA/ATS) for the treatment of CABP recommend
macrolide antibiotics only be used in geographical regions
where outpatient macrolide resistance is less than 25 percent.
“The high rate of macrolide resistant S. pneumoniae in this
epidemiologic study is concerning to me,” says Dr. Julio Ramirez,
M.D., FACP, Professor of Medicine and Chief, Division of Infectious
disease at the University of Louisville, Kentucky. “Clinicians must
take local resistance rates into consideration as well as assess
risk factors for poor outcomes, such as being elderly or having
co-morbidities, prior to selecting empiric antimicrobial
therapy.”
XENLETA™ is a first-in-class systemic pleuromutilin antibiotic
for the intravenous (IV) and oral treatment of CABP in adults.
XENLETA offers an effective and well tolerated empiric monotherapy
for CABP with a treatment duration as short as five days and the
potential to address the limitations of existing agents.
XENLETA has a novel mechanism of action that targets a binding
site on bacteria that is different from existing antibiotics. It
has been shown to result in no cross resistance to other antibiotic
classes commonly prescribed for CABP and a low potential for the
development of resistance. XENLETA is also convenient for patients
being treated in the hospital, transitioning treatment out of the
hospital or initiating treatment in the community.
About Nabriva Therapeutics plc
Nabriva Therapeutics is a biopharmaceutical company engaged in
the commercialization and development of innovative anti-infective
agents to treat serious infections. Nabriva Therapeutics received
U.S. Food and Drug Administration approval for XENLETA (lefamulin
injection, lefamulin tablets), the first systemic pleuromutilin
antibiotic for community-acquired bacterial pneumonia (CABP).
Nabriva Therapeutics is also developing CONTEPO™ (fosfomycin) for
injection, a potential first-in-class epoxide antibiotic for
complicated urinary tract infections (cUTI), including acute
pyelonephritis. For more information, please visit
www.nabriva.com.
About XENLETA
XENLETA (lefamulin) is a first-in-class semi-synthetic
pleuromutilin antibiotic for systemic administration in humans
discovered and developed by the Nabriva Therapeutics team. It is
designed to inhibit the synthesis of bacterial protein, which is
required for bacteria to grow. XENLETA’s binding occurs with high
affinity, high specificity and at molecular sites that are
different than other antibiotic classes. Efficacy of XENLETA was
demonstrated in two multicenter, multinational, double-blind,
double-dummy, non-inferiority trials assessing a total of 1,289
patients with CABP. In these trials, XENLETA was compared
with moxifloxacin and in one trial, moxifloxacin with and without
linezolid. Patients who received XENLETA had similar rates of
efficacy as those taking moxifloxacin alone or moxifloxacin plus
linezolid. The most common adverse reactions associated with
XENLETA included diarrhea, nausea, reactions at the injection site,
elevated liver enzymes, and vomiting. For more information, please
visit www.xenleta.com.
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION
XENLETA is a pleuromutilin antibacterial indicated for the
treatment of adults with community-acquired bacterial pneumonia
(CABP) caused by the following susceptible microorganisms:
Streptococcus pneumoniae, Staphylococcus aureus
(methicillin-susceptible isolates), Haemophilus influenzae,
Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila
pneumoniae.
USAGE
To reduce the development of drug-resistant bacteria and
maintain the effectiveness of XENLETA and other antibacterial
drugs, XENLETA should be used only to treat or prevent infections
that are proven or strongly suspected to be caused by susceptible
bacteria.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
XENLETA is contraindicated in patients with known
hypersensitivity to XENLETA or pleuromutilins.
XENLETA tablets are contraindicated for use with CYP3A4
substrates that prolong the QT interval.
WARNINGS AND PRECAUTIONS
XENLETA has the potential to prolong the QT interval. Avoid
XENLETA in patients with known QT prolongation, ventricular
arrhythmias, and patients receiving drugs that may prolong the QT
interval.
Based on animal studies, XENLETA may cause fetal harm. Advise
females of reproductive potential of the potential risk to the
fetus and to use effective contraception.
Clostridium difficile-associated diarrhea (CDAD) has been
reported with nearly all systemic antibacterial agents, including
XENLETA, with severity ranging from mild diarrhea to fatal colitis.
Evaluate if diarrhea occurs.
ADVERSE REACTIONS
The most common adverse reactions (≥2%) for (a) XENLETA
Injection are administration site reactions, hepatic enzyme
elevation, nausea, hypokalemia, insomnia, and headache and (b)
XENLETA Tablets are diarrhea, nausea, vomiting, and hepatic enzyme
elevation.
USE IN SPECIFIC POPULATIONS
In patients with severe hepatic impairment, reduce the dosage of
XENLETA Injection to 150 mg infused over 60 minutes every 24 hours.
XENLETA Tablets are not recommended in patients with moderate or
severe hepatic impairment due to insufficient information to
provide dosing recommendations.
Avoid XENLETA Injection and Tablets with concomitant strong or
moderate CYP3A or P-gp inducers. Monitor for reduced efficacy of
XENLETA.
Avoid XENLETA Tablets with strong CYP3A or P-gp inhibitors.
Monitor for adverse reactions of sensitive CYP3A substrates
administered with XENLETA Tablets.
XENLETA has not been studied in pregnant women. Verify pregnancy
status in females prior to initiating XENLETA and advise females to
use contraception during treatment and for 2 days after the final
dose. Lactating women should pump and discard milk for the duration
of treatment with XENLETA and for 2 days after the final dose.
To report SUSPECTED ADVERSE REACTIONS, or administration during
pregnancy, contact Nabriva Therapeutics US, Inc. at 1-855-5NABRIVA
or FDA at 1-800-FDA-1088 or
https://www.fda.gov/safety/medwatch.
Please see Full Prescribing Information for
XENLETA.
Forward-Looking Statements
Any statements in this press release about future expectations,
plans and prospects for Nabriva Therapeutics, including but not
limited to statements about its ability to successfully launch and
commercialize XENLETA for the treatment of CABP, including the
availability of and ease of access to XENLETA through major U.S.
specialty distributors, marketing exclusivity and patent protection
for XENLETA, the development of CONTEPO for cUTI, the clinical
utility of XENLETA for CABP and of CONTEPO for cUTI, plans for and
timing of the review of regulatory filings for CONTEPO, efforts to
bring CONTEPO to market, the market opportunity for and the
potential market acceptance of XENLETA for CABP and CONTEPO for
cUTI, the development of XENLETA and CONTEPO for additional
indications, the development of additional formulations of XENLETA
and CONTEPO, plans for making lefamulin available in China, plans
to pursue research and development of other product candidates,
expectations regarding the ability of customers to satisfy demand
for XENLETA with their existing inventory, the sufficiency of
Nabriva Therapeutics’ existing cash resources and its expectations
regarding anticipated revenues from product sales and how far into
the future its existing cash resources will fund its ongoing
operations and other statements containing the words “anticipate,”
“believe,” “estimate,” “expect,” “intend,” “may,” “plan,”
“predict,” “project,” “target,” “potential,” “likely,” “will,”
“would,” “could,” “should,” “continue,” and similar expressions,
constitute forward-looking statements within the meaning of The
Private Securities Litigation Reform Act of 1995. Actual results
may differ materially from those indicated by such forward-looking
statements as a result of various important factors, including:
Nabriva Therapeutics’ ability to successfully implement its
commercialization plans for XENLETA and whether market demand for
XENLETA is consistent with its expectations, Nabriva Therapeutics’
ability to build and maintain a sales force for XENLETA, the
content and timing of decisions made by the U.S. Food and Drug
Administration and other regulatory authorities, the uncertainties
inherent in the initiation and conduct of clinical trials,
availability and timing of data from clinical trials, whether
results of early clinical trials or studies in different disease
indications will be indicative of the results of ongoing or future
trials, uncertainties associated with regulatory review of clinical
trials and applications for marketing approvals, the availability
or commercial potential of CONTEPO for the treatment of cUTI, the
ability to retain and hire key personnel, the availability of
adequate additional financing on acceptable terms or at all and
such other important factors as are set forth in Nabriva
Therapeutics’ annual and quarterly reports and other filings on
file with the U.S. Securities and Exchange Commission. In addition,
the forward-looking statements included in this press release
represent Nabriva Therapeutics’ views as of the date of this press
release. Nabriva Therapeutics anticipates that subsequent events
and developments will cause its views to change. However, while
Nabriva Therapeutics may elect to update these forward-looking
statements at some point in the future, it specifically disclaims
any obligation to do so. These forward-looking statements should
not be relied upon as representing Nabriva Therapeutics’ views as
of any date subsequent to the date of this press release.
CONTACTS:
For InvestorsGary SenderNabriva Therapeutics
plcir@nabriva.com
For MediaMike BeyerSam Brown
Inc.mikebeyer@sambrown.com312-961-2502
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