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,
today announced that the Company will webcast its Analyst &
Investor Day being held from 8:30 a.m. to 11:30 a.m. ET on January
23, 2019 in New York City.
The event will feature a discussion with leading
clinicians and researchers who will address current and potential
new treatments for community-acquired bacterial pneumonia (CABP)and
complicated urinary tract infections (cUTIs). Nabriva management
will also discuss the commercial strategy for the company’s
investigational antibiotics, lefamulin and CONTEPO™, followed by a
panel Q&A.
Lefamulin and CONTEPO are potential
first-in-class antibiotics in the United States. Both products have
New Drug Applications (NDAs) under review by the Food and Drug
Administration (FDA). Additionally, both lefamulin and
CONTEPO were granted Qualified Infectious Disease Product and Fast
Track designation by the FDA, enabling the potential Priority
Review of the applications.
The live webcast and slide presentation may be
accessed by visiting the "Investors" section of the Company’s web
site under the "Events and Presentations" tab
at http://investors.nabriva.com. A replay of the webcast will
be available following the event for 90 days.
Featured sessions and speakers include:
“Community-Acquired Bacterial Pneumonia: Can Lefamulin
Help Address the Significant Clinical and Economic
Burden?” Thomas Lodise, Pharm.D., Ph.D.Professor, Pharmacy
PracticeAlbany College of Pharmacy and Health Sciences
“Novel Antibiotics: The ID Pharmacists Perspective on
Meeting an Urgent Unmet Medical Need” Kevin Garey, PharmD,
MSProfessor and ChairUniversity of Houston College of PharmacyDept
of Pharmacy Practice and Translational Research
“IV Fosfomycin – Real World Evidence from Outside the
United States” Matteo Bassetti, MD PhDHead, Infectious
Diseases ClinicAssociate Professor of Infectious DiseasesHead
Post-graduate School of Infectious and Tropical Diseases,
University of UdineDepartment of Medicine University of Udine and
Santa Maria Misericordia University Hospital, Udine-ITChairperson,
ESCMID Study Group for Infections in Critically Ill Patients-
ESGCIP
“Emergency Physician’s Perspective on Lefamulin Use in
the Emergency Room” Philip Giordano MD, FACEPChief,
Corporate Research OperationsOrlando HealthVice ChairmanDepartment
of Emergency MedicineOrlando Regional Medical Center
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 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 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 with complicated urinary tract
infections (cUTIs), which includes acute pyelonephritis (kidney
infection), have pyuria and bacteria in their urine, in association
with features such as fever, chills, malaise or flank/back pain, in
the setting of a functional or anatomical abnormality of the
urinary tract or a history of catheterization. Patients who fail to
respond to an initial course of antibiotics may develop a cUTI,
which occurs when the bacteria are embedded in the bladder wall or
ascend to the kidneys, 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, 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 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 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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