Nabriva Therapeutics Completes Submission of New Drug Application to U.S. Food and Drug Administration for Intravenous CONTEP...
November 01 2018 - 7:00AM
Nabriva Therapeutics plc (NASDAQ: NBRV), a clinical-stage
biopharmaceutical company engaged in the research and development
of innovative anti-infective agents to treat serious infections,
announced it has submitted a New Drug Application (NDA) to the U.S.
Food and Drug Administration (FDA) to seek marketing approval for
its investigational intravenous antibiotic, CONTEPO™ (fosfomycin
for injection) to treat complicated urinary tract infections
(cUTIs), including acute pyelonephritis. CONTEPO has been granted
Qualified Infectious Disease Product (QIDP) and Fast Track
designations by the FDA for the treatment of several serious
infections, including cUTI, which enables Priority Review of the
NDA, following acceptance.
“A significant medical need remains in the
United States for new treatments for complicated urinary tract
infections as serious Gram-negative infections caused by
extended-spectrum beta-lactamase (ESBLs) producing
Enterobacteriaceae, as well as other multi-drug resistant
pathogens, continue to be a significant challenge for healthcare
providers leading to treatment failure, infection recurrence,
re-hospitalizations, and higher rates of morbidity and mortality,”
said Dr. Jennifer Schranz, chief medical officer of Nabriva
Therapeutics. “Therapies with a new mechanism of action are
desperately needed to address this growing public health threat.
This NDA submission represents a substantial achievement for our
company. We are truly grateful to the patients,
investigators, and the entire team for their commitment to
advancing CONTEPO to this important milestone. We look forward to
working with the FDA during the review process with the goal of
bringing CONTEPO, a potentially first-in-class intravenous
antibiotic, to clinicians and patients.”
The NDA submission is utilizing the 505(b)(2)
regulatory pathway and is supported by a robust data package,
including a pivotal Phase 2/3 clinical trial (known as ZEUS™),
which met its primary endpoint of statistical non-inferiority to
piperacillin/tazobactam in patients with cUTI, including acute
pyelonephritis.
About cUTIsUrinary tract
infections (UTIs) are a significant health problem in both the
community- and hospital-based treatment settings. It is estimated
that 150 million UTIs occur yearly worldwide, accounting for $6
billion in health care expenditures, according to the American
Urological Association. Patients who fail to respond to an initial
course of antibiotics can go on to develop a cUTI, which occurs
when the bacteria are embedded in the bladder wall where they can
multiply more slowly and are much harder to address with
antibiotics. In most cases, cUTIs occur following treatment for a
normal UTI because antibiotics were given too late, for too short a
period of time, at too low of a dose course or the wrong antibiotic
was used and did not provide adequate spectrum of coverage. An
estimated three million cases of cUTIs are treated in the hospital
setting in the United States each year for Gram-negative
infections. Enterobacteriaceae are the most common pathogens
causing cUTIs and, currently, widespread antibiotic resistance
limits the effective treatment options for cUTI. Ineffectively
managed cUTI can lead to increased treatment failure rates,
recurrence of infection, increased re-hospitalization, and
increased morbidity and mortality.
About CONTEPO™CONTEPO™
(fosfomycin for injection, previously referred to as ZTI-01 and
ZOLYD) is a novel, potentially first-in-class in the United States,
intravenous investigational antibiotic with a broad spectrum of
Gram-negative and Gram-positive activity, including activity
against most contemporary multi-drug resistant (MDR) strains such
as ESBL-producing Enterobacteriaceae. Intravenous (I.V.) fosfomycin
has been approved for a number of indications and utilized for over
45 years in Europe to treat a variety of infections, including
cUTIs and other serious bacterial infections. CONTEPO utilizes a
new dosing approach, originally developed by Zavante (which Nabriva
Therapeutics acquired), to optimize its pharmacokinetics and
pharmacodynamics. Nabriva Therapeutics believes these attributes,
along with the positive clinical experience worldwide, support
CONTEPO as a first-line treatment for cUTIs, including acute
pyelonephritis, suspected to be caused by MDR pathogens. At least
20 percent of cUTIs are caused by MDR bacteria and limited
treatment options are available in the U.S. In addition,
non-clinical data have shown that CONTEPO acts in combination with
certain other antibiotics to improve bacterial killing.
About Nabriva Therapeutics
plcNabriva Therapeutics is a clinical-stage
biopharmaceutical company engaged in the research and development
of innovative anti-infective agents to treat serious infections.
Nabriva Therapeutics has two product candidates that are in late
stage development: lefamulin, under development to potentially be
the first pleuromutilin antibiotic available for I.V. and oral
administration in humans, and CONTEPO, a potential first-in-class
in the United States I.V. antibiotic. Nabriva Therapeutics is
developing both I.V. and oral formulations of lefamulin for the
treatment of community-acquired bacterial pneumonia (CABP) and
CONTEPO I.V. for cUTIs, including acute pyelonephritis. Nabriva
Therapeutics may potentially develop lefamulin and CONTEPO for
additional indications. 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 the development of Nabriva Therapeutics’
product candidates, such as the future development or
commercialization of lefamulin and CONTEPO, conduct and timelines
of clinical trials, 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
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, 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: 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 moderate to severe 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 MEDIABenjamin Navon W2O Group
bnavon@w2ogroup.com 617-337-4166
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