Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical
company engaged in the commercialization and development of
innovative anti-infective agents to treat serious infections, today
announced the oral formulation of XENLETA® (lefamulin) is now
available in a 10-count oral pack in the U.S. through major
specialty distributors.
XENLETA is the first oral and IV treatment in the pleuromutilin
class of antibiotics. XENLETA has in vitro activity and
demonstrated clinical efficacy against the most common pathogens
that cause community-acquired bacterial pneumonia (CABP). XENLETA
has a novel mechanism of action that targets a binding site on
bacterial cells that is different from existing antibiotics,
resulting in a low propensity for the development of resistance, as
well as a lack of cross-resistance with antibiotic classes commonly
used for the treatment of CABP.
“This new package size offers pharmacies an option to expand
product availability in a cost-effective way to service their local
patients and physicians by providing patients a convenient package
that contains a complete 5-day course of oral treatment for CABP,”
said Ted Schroeder, Chief Executive Officer of Nabriva
Therapeutics. “Our community-based sales force is excited to
communicate the availability of the 10-count oral pack – or ‘X’
pack to their target customers.”
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
IndicationXENLETA 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.
UsageTo 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
CONTRAINDICATIONSXENLETA 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 PRECAUTIONSXENLETA 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.
Clostridioides 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 REACTIONSThe 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 POPULATIONSIn 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 www.fda.gov/medwatch.
Please see Full Prescribing Information for XENLETA at
www.XENLETA.com.
About Nabriva Therapeutics plcNabriva
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. Nabriva entered into an exclusive agreement with
subsidiaries of Merck & Co. Inc., Kenilworth, N.J., USA to
market, sell and distribute SIVEXTRO® (tedizolid phosphate) in the
United States and certain of its territories.
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 commercialize XENLETA
for the treatment of CABP, including the managed care coverage for
XENLETA, the distribution and promotion of SIVEXTRO for the
treatment of ABSSSI, the development of CONTEPO for Complicated
Urinary Tract Infections (cUTI), the expansion of its commercial
sales force, the clinical utility of XENLETA for CABP, SIVEXTRO for
ABSSSI and of CONTEPO for cUTI, the impact on gross sales revenue
from the recognition of SIVEXTRO sales in its results of
operations, the impact of macro events on sales of SIVEXTRO and
XENLETA, plans for and timing of the review of regulatory filings
for XENLETA and CONTEPO, efforts to bring CONTEPO to market, the
market opportunity for and the potential market acceptance of
XENLETA for CABP, SIVEXTRO for ABSSSI 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 the European Union,
Canada and China, the timing for and receipt of milestone and
royalty payments under its license agreement with Sumitomo
Pharmaceuticals (Suzhou), plans to pursue research and development
of other product candidates, plans to pursue business development
initiatives, expectations regarding the ability of customers to
satisfy demand for XENLETA with their existing inventory,
expectations regarding the impact of the interruptions resulting
from COVID-19 on its business, 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 SIVEXTRO and whether market
demand for XENLETA and SIVEXTRO is consistent with its
expectations, Nabriva Therapeutics’ ability to build and maintain a
sales force for XENLETA and SIVEXTRO, 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 extent of business interruptions resulting from the
infection causing the COVID-19 outbreak or similar public health
crises, 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 InvestorsKim AndersonNabriva Therapeutics
plcir@nabriva.com
For MediaAndrea
GreifOgilvyandrea.greif@ogilvy.com914-772-3027
Nabriva Therapeutics (NASDAQ:NBRV)
Historical Stock Chart
From Mar 2024 to Apr 2024
Nabriva Therapeutics (NASDAQ:NBRV)
Historical Stock Chart
From Apr 2023 to Apr 2024