Nabriva Therapeutics Receives Complete Response Letter from FDA on NDA for CONTEPO™ (fosfomycin) for injection
June 19 2020 - 8:52PM
Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical
company engaged in the commercialization and development of
innovative anti-infective agents to treat serious infections,
announced today that it received a Complete Response Letter (CRL)
from the U.S. Food and Drug Administration (FDA) for the New Drug
Application (NDA) resubmission seeking marketing approval of
CONTEPO (fosfomycin) for injection for the treatment of complicated
urinary tract infections (cUTI), including acute
pyelonephritis.
Although Nabriva’s European contract manufacturing partners were
prepared for regulatory authority inspections, the CRL cites
observations at our manufacturing partners that could not be
resolved due to FDA’s inability to conduct onsite inspections
because of travel restrictions. In general, previously identified
product quality and facility inspection related observations at our
contract manufacturing partners are required to be satisfactorily
resolved before the NDA may be approved. The FDA did not
request any new clinical data and did not raise any other concerns
with regard to the safety or efficacy of CONTEPO in the CRL.
Nabriva plans to request a Type A meeting with the FDA to discuss
appropriate next steps and the FDA’s plans for completing foreign
facility inspections. CONTEPO has been granted Qualified
Infectious Disease Product (QIDP) and Fast Track designations by
the FDA for the treatment of serious infections, including
cUTI.
Complicated Urinary Tract Infection
Complicated urinary tract infections represent a serious
infection in patients with underlying functional or structural
abnormality of the urinary tract or in the presence of
catheterization, and includes patients with acute pyelonephritis,
regardless of underlying abnormalities of the urinary tract. An
estimated three million cases of Gram-negative cUTIs are treated in
the U.S. hospital setting annually, where approximately 40 percent
of cases are suspected to be caused by resistant strains.
Ineffectively managed cUTIs can lead to increased treatment failure
rates, which in turn, can result in prolonged hospital stays,
recurrence, re-hospitalization, and mortality – each of which poses
a substantial resource and economic burden on the healthcare and
payer systems.
Among the causes of cUTI is Enterobacteriaceae, which is a
multi-drug resistance (MDR) strain of Gram-negative bacteria.
Enterobacteriaceae produces extended spectrum beta-lactamases
(ESBL), a chemical that can cause some antibiotics to be
ineffective in treating bacterial infections such as cUTI. As a
result, cUTI poses a serious and rapidly emerging health threat for
hospitalized patients, especially those in intensive care
units.
About CONTEPO
CONTEPO (fosfomycin) for injection 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 extended spectrum β-lactamase
(ESBL)-producing Enterobacteriaceae. IV fosfomycin has been
approved for a number of indications and utilized for over 45 years
outside the U.S. to treat a variety of infections, including cUTIs
and other serious bacterial infections.
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 (cUTIs), including acute
pyelonephritis. For more information, please visit
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 Nabriva Therapeutics’ plans for further
interactions with the FDA, 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 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 resolve the matters set forth in the
Complete Response Letter it received from the FDA in connection
with its NDA resubmission 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, 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
extent of business interruptions resulting from the infection
causing the COVID-19 outbreak or similar public health crises, 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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