Nabriva Therapeutics Announces European Medicines Agency (EMA) Validation of Marketing Authorization Application for Lefamuli...
June 24 2019 - 4:01PM
Nabriva Therapeutics plc (NASDAQ: NBRV), a clinical-stage
biopharmaceutical company engaged in the development of innovative
anti-infective agents to treat serious infections, today announced
that the European Medicines Agency (EMA) has determined that the
Company’s Marketing Authorization Application (MAA) for the
intravenous (IV) and oral formulations of lefamulin, a potentially
first-in-class, semi-synthetic pleuromutilin antibiotic for the
treatment of community-acquired pneumonia (CAP) in adults 18 years
of age and older, is valid. Validation of the MAA confirms that the
submission is sufficiently complete to begin the formal review
process and an opinion of the EMA Committee for Medicinal Products
for Human Use (CHMP) is anticipated in the next 12 to 15 months.
The EMA’s review of the application will follow the
centralized marketing authorization procedure. If approved by the
EMA, lefamulin will receive marketing authorization in all 28
member states of the European Union (EU), as well as in Norway,
Liechtenstein and Iceland. If approved, Nabriva intends to work
with a commercial partner to make lefamulin available to patients
in the EU.
“We are grateful for the EMA’s quick validation of
our MAA submission and look forward to working with the EMA during
the MAA review process. We are committed to providing
European patients with CAP the potential option of short course
treatment with IV or oral lefamulin” said Jennifer Schranz, M.D.,
Chief Medical Officer of Nabriva Therapeutics.”
Nabriva also has a New Drug Applications for
lefamulin under review by the U.S. Food and Drug Administration
(FDA) with an assigned Prescription Drug User Fee Act (PDUFA)
action date of August 19, 2019 for both the IV and oral
formulations of lefamulin for the treatment of community-acquired
bacterial pneumonia (CABP).
About CAP
Approximately 3 to 4 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 3 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% of deaths due to pneumonia occur in people
over 65 years old (EC, 2009a).
About Lefamulin
Lefamulin is a semi-synthetic pleuromutilin
antibiotic with potential to be first-in-class 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.
Lefamulin’s binding occurs with high affinity, high specificity and
at molecular sites that are different than other antibiotic
classes. Based on results from its two global, Phase 3
clinical trials, Nabriva Therapeutics believes lefamulin is
well-positioned for use as a first-line monotherapy for the
treatment of CAP due to its novel mechanism of action, targeted
spectrum of activity, resistance profile, achievement of
substantial drug concentration in lung tissue and fluid,
availability of oral and IV formulations and a generally
well-tolerated safety profile. Nabriva Therapeutics believes
lefamulin represents a potentially important new treatment option
for the approximately 3 to 4 million adults in the European Union
and five to six million adults in the United States diagnosed with
CABP each year.
About Nabriva Therapeutics plc
Nabriva Therapeutics is a biopharmaceutical company
engaged in the development of innovative anti-infective agents to
treat serious infections. Nabriva Therapeutics has two product
candidates that are in late stage development: lefamulin,
potentially the first systemic pleuromutilin antibiotic for CABP
and CONTEPO (fosfomycin) for injection, a potential first-in-class
epoxide antibiotic in the United States for complicated urinary
tract infections (cUTIs) including acute pyelonephritis (AP). For
more information, please visit https://www.nabriva.com.
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 timing of and
outcome of the EMA’s review of the MAA for lefamulin, the ability
of Nabriva Therapeutics to identify and engage a commercial partner
in the EU; the development of Nabriva Therapeutics’ product
candidates, such as the future development or commercialization of
lefamulin and CONTEPO, the clinical utility of lefamulin for CABP
and of CONTEPO for cUTI, plans for and timing of the review of
regulatory filings, efforts to bring lefamulin and CONTEPO to
market, the market opportunity for and the potential market
acceptance of lefamulin for CABP and CONTEPO for cUTI, the
potential benefits under its license agreement with Sinovant
Sciences, the development of lefamulin and CONTEPO for additional
indications, the development of additional formulations of
lefamulin and CONTEPO, plans to pursue research and development of
other product candidates, its ability to achieve any of the
specified regulatory or performance milestones under its loan
agreement with Hercules Capital, the sufficiency of Nabriva
Therapeutics’ existing 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’ reliance
on third-party manufacturers to manufacture the clinical and
commercial supply of its product candidates and the ability of such
third parties to comply with applicable regulatory requirements;
the content and timing of decisions made by the U.S. Food and Drug
Administration, the EMA and other regulatory authorities, Nabriva
Therapeutics’ ability to realize the anticipated benefits,
synergies and growth prospects of its acquisition of Zavante
Therapeutics, 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, whether results of ZEUS will
be indicative of results for any ongoing or future clinical trials
and studies of CONTEPO, uncertainties associated with regulatory
review of clinical trials and applications for marketing approvals,
the availability or commercial potential of product candidates
including lefamulin for use as a first-line empiric monotherapy for
the treatment of CABP and CONTEPO for the treatment of cUTI, the
ability to retain and hire key personnel, the sufficiency of cash
resources and need for additional financing 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 InvestorsDave GarrettNabriva
Therapeutics plcdavid.garrett@nabriva.com 610-816-6657
For MediaMike BeyerSam Brown Inc.
mikebeyer@sambrown.com312-961-2502
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