Nabriva Therapeutics Announces Submission of Marketing Authorization Application for Lefamulin to Treat Community-Acquired Pn...
May 08 2019 - 7:00AM
Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical
company engaged in the development of innovative anti-infective
agents to treat serious infections, announced that the Company’s
marketing authorization application (MAA) for both 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, has been submitted to the European Medicines
Agency (EMA). If approved, Nabriva intends to work with a
commercial partner to make lefamulin available to patients in the
EU.
The MAA filing is supported by two pivotal,
Phase 3 clinical trials (known as LEAP 1 and LEAP 2) that evaluated
the safety and efficacy of IV and oral lefamulin compared to
moxifloxacin in the treatment of adults with CAP. LEAP 1 was
designed with the option to switch from IV to oral administration,
while LEAP 2 was designed as a short course, 5-day, oral only
treatment with lefamulin. In both LEAP 1 and LEAP 2,
lefamulin was demonstrated to be non-inferior to moxifloxacin, and
met both the EMA and U.S. Food and Drug Administration (FDA)
primary and secondary efficacy endpoints for the treatment of
CAP. Lefamulin was also shown to be generally well-tolerated
when administered either orally or intravenously.
“The MAA filing for lefamulin represents another major milestone
for Nabriva as we continue to make significant progress toward our
commitment of addressing the urgent and unmet medical need for
novel anti-infective agents for patients with serious infections,”
said Dr. Jennifer Schranz, chief medical officer of Nabriva
Therapeutics. “The spread of bacterial resistance and the growing
recognition of certain adverse effects associated with guideline
concordant treatment options has significantly complicated
selection of empiric antibiotic therapy for patients with
CAP. Effective alternative monotherapy options with a novel
mechanism of action are urgently needed to address this growing
unmet medical need.”
About CABPBased on Nabriva
Therapeutics’ combined analysis of the U.S. Centers for Disease
Control and Prevention’s 2007 National Ambulatory Medical Care
Survey, the National Hospital Ambulatory Medical Care Survey and
2013 data from the Healthcare Cost and Utilization Project, Nabriva
Therapeutics estimates that more than five million adults are
treated annually for community-acquired bacterial pneumonia (CABP)
in the United States. Additionally, based on 2013 data from the
Healthcare Cost and Utilization Project, Nabriva Therapeutics
estimates that approximately three million of these adult CABP
patients are diagnosed in an in-patient hospital and/or emergency
department setting, where most are then treated with in-patient IV
and oral antibiotics or out-patient oral antibiotics prescribed for
use following hospital discharge or release.
About LefamulinLefamulin 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 CABP 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 five to six million adults in the United
States diagnosed with CABP each year.
About Nabriva Therapeutics
plcNabriva 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 StatementsAny
statements in this press release about future expectations, plans
and prospects for Nabriva Therapeutics, including but not limited
to statements about Nabriva Therapeutics’ plans for further
interactions with the FDA and EMA; 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, plans to enter into arrangements with third
parties to commercialize lefamulin in Europe, if approved; the
market opportunity for and the potential market acceptance of
lefamulin for CABP and CONTEPO for cUTI, the potential benefits
under its license agreements with Sinovant Sciences, Ltd. and
Sunovion Pharmaceutics Canada, Inc., 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’ ability to resolve the matters set forth in the
Complete Response Letter it received from the FDA in connection
with its NDA for CONTEPO (fosfomycin) for injection; 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 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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