Nabriva Therapeutics plc (NASDAQ: NBRV) announced today that the
European Commission (EC) has issued a legally binding decision for
approval of the marketing authorization application for XENLETA™
(lefamulin) for the treatment of community-acquired pneumonia (CAP)
in adults following a review by the European Medicines Agency
(EMA). The EMA approval of XENLETA in CAP patients when it is
considered inappropriate to use antibacterial agents that are
commonly recommended for initial treatment or when these agents
have failed paves the way for the launch of XENLETA across Europe.
The U.S. Food and Drug Administration (FDA) approved XENLETA for
the treatment of adult patients with community-acquired bacterial
pneumonia (CABP) in August 2019.
“The marketing authorization of XENLETA provides an important
step forward for patients with CAP, offering the first new
antibiotic class approved by the EMA in nearly two decades,” said
Ted Schroeder, chief executive officer of Nabriva Therapeutics.
“XENLETA has a novel mechanism of action, with targeted in vitro
activity against the most common pathogens associated with CAP, and
a low propensity for the development of resistance. Along with its
short course, monotherapy regimen, and availability of both
intravenous (IV) and oral formulations, XENLETA offers an important
empiric treatment option for adult patients with CAP aligned with
the core principles of antimicrobial stewardship. We believe the
approval of XENLETA is a significant advancement in the fight
against antimicrobial resistance and we are excited to bring this
critically needed medicine to patients throughout Europe.”
The EMA approval 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 European Medicines Agency’s 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 were administration site reactions, diarrhea, nausea,
vomiting, hepatic enzyme elevation, headache, hypokalemia and
insomnia.
About CAP
Approximately three to four million cases of pneumonia occur
annually in the EU (Gibson et al, 2013). Data from the Global
Burden of Disease 2015 Study reported that lower respiratory tract
infections, including pneumonia, were the third most common cause
of death worldwide and the most common cause of infectious death
globally, claiming three million lives annually (GBD, 2016; WHO,
2018). The impact on morbidity and mortality associated with
community-acquired pneumonia is magnified in older patients, where
data have shown that mortality is associated with advancing age
(Welte et al, 2012; Cillóniz et al, 2013; Ochoa-Gondar et al,
2008). Approximately 90 percent of deaths due to pneumonia occur in
people over 65 years old (EC, 2009a).
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). 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.
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 were
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% of patients; gastrointestinal
disorders were predominantly associated with the oral formulation
and led to treatment discontinuation in <1% of patients.
For more information about Xenleta please refer to the
Summary of Product Characteristics [SmPc] at:
https://www.ema.europa.eu/en/medicines/human/summaries-opinion/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 Nabriva Therapeutics’ ability to
successfully launch and commercialize XENLETA for the treatment of
CABP or CAP, including the availability of and ease of access to
XENLETA in Europe and 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 or CAP and CONTEPO for cUTI, the
development of XENLETA and CONTEPO for additional indications, the
development of additional formulations of XENLETA and CONTEPO,
plans to pursue research and development of other product
candidates, 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 Investors
Gary Sender
Nabriva Therapeutics plc
ir@nabriva.com
For Media
Mike Beyer
Sam Brown Inc.
mikebeyer@sambrown.com
312-961-2502
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