Nabriva Therapeutics plc (NASDAQ: NBRV) announced today that the
Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has adopted a positive opinion
recommending approval of XENLETA (lefamulin) for the treatment of
community-acquired pneumonia (CAP) in adults when it is considered
inappropriate to use antibacterial agents that are commonly
recommended for the initial treatment of CAP or when these have
failed. The CHMP opinion will be reviewed by the European
Commission (EC), which has the authority to approve medicines for
all 28 countries of the European Union, Norway, Iceland, and
Liechtenstein. A regulatory decision is anticipated during the
second half of 2020.
“Today’s announcement brings us one step closer to the first
approval of a new class of antibiotics for patients with
community-acquired pneumonia in Europe in almost 20 years,” said
Jennifer Schranz, MD, Chief Medical Officer of Nabriva. “XENLETA
has a novel mechanism of action and provides an urgently needed
short course, empiric monotherapy treatment alternative for adult
patients with CAP. We look forward to the European Commission’s
decision and the opportunity to bring this important medicine to
patients.”
The CHMP recommendation for marketing authorization is based on
efficacy data from the Lefamulin Evaluation Against Pneumonia
(LEAP) 1 and LEAP 2 studies and a safety database of 1,242 study
participants.
In the two Phase 3 clinical trials, the EMA co-primary endpoint
was the Investigator Assessment of Clinical Response (IACR) at Test
of Cure (TOC) in both the clinically evaluable (CE) and modified
intent-to-treat (mITT) populations. Both studies established
XENLETA to be non-inferior to the standard-of-care moxifloxacin in
the treatment of adults with CAP independently and when the pooled
data were analyzed across PORT scores of II-V. In the pooled
analysis, the IACR success rate at TOC in the modified
Intent-to-Treat (mITT) population was 85 percent in the XENLETA
group and 87.1 percent in the moxifloxacin group (treatment
difference ‑2.2 percent; 95 percent confidence interval (CI): ‑5.9,
1.6), and 88.5 percent in the lefamulin group and 91.8 percent in
the moxifloxacin group (treatment difference ‑3.3 percent; 95
percent CI: ‑6.8, 0.1) in the Clinically Evaluable population. In
these trials, lefamulin was generally well-tolerated. The
most frequently reported adverse reactions are administration site
reactions, diarrhea, nausea, vomiting, hepatic enzyme elevation,
headache, hypokalemia, and insomnia.
The European Commission will review the CHMP recommendation and
typically delivers its final decision in approximately two months.
The U.S. Food and Drug Administration (FDA) approved XENLETA in
August 2019 for the treatment of adult patients with
community-acquired bacterial pneumonia (CABP).
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 frequently reported adverse reactions are
administration site reactions (7%), diarrhea (7%), nausea (4%),
vomiting (2%), hepatic enzyme elevation (2%), headache (1%),
hypokalaemia (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%.
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 the potential outcome of and timing of
a decision by the European Commission with respect to regulatory
approval for XENLETA in Europe, Nabriva Therapeutics’ 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
European Commission, 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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