Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical
company engaged in the commercialization and development of
innovative anti-infective agents to treat serious infections,
announced today that its partner, Sunovion Pharmaceuticals Canada
Inc., has received approval from Health Canada to market oral and
intravenous (IV) formulations of XENLETA® (lefamulin) for the
treatment of community-acquired pneumonia (CAP) in adults.
Additional information on the Notice of Compliance from Health
Canada dated July 10, 2020 is available at
Nabriva entered into a license and commercialization agreement
in March 2019 with Sunovion Pharmaceuticals Canada Inc. for XENLETA
in Canada. Sunovion Pharmaceuticals Canada Inc., based in
Mississauga, Ontario, is a wholly-owned direct subsidiary of
Sunovion Pharmaceuticals Inc.
About Nabriva Therapeutics
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).
XENLETA was discovered in Nabriva Therapeutics laboratories
in Vienna, Austria. For more information, please
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 frequently reported adverse reactions are
administration site reactions (7%), diarrhea (7%), nausea (4%),
vomiting (2%), hepatic enzyme elevation (2%), headache (1%),
hypokalemia (1%), and insomnia (1%). Administration site reactions
led to discontinuation in <1%; gastrointestinal disorders were
predominantly associated with the oral formulation and led to
treatment discontinuation in <1%.
INDICATION AND IMPORTANT SAFETY INFORMATION
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
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
IMPORTANT SAFETY INFORMATION
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
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.
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
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
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 the FDA at 1-800-FDA-1088 or
Please see Full Prescribing Information for
Any statements in this press release about future expectations,
plans and prospects for Nabriva Therapeutics, including but not
limited to statements about the potential benefits to Nabriva
Therapeutics under its sales promotion and distribution agreement
with the subsidiaries of Merck & Co. Inc., the potential
benefits to patients of SIVEXTRO and XENLETA, the market
opportunity for SIVEXTRO and XENLETA, the sufficiency of its cash
resources 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 satisfy the conditions under the
distribution agreement to obtain the right to exclusively
distribute and promote SIVEXTRO, including its ability to establish
or secure a commercial infrastructure sufficient to promote and
distribute SIVEXTRO, 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 SEC. 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
may 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.
Nabriva Therapeutics plc
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