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 the Centers for Medicare & Medicaid
Services (CMS) has granted a new technology add-on payment (NTAP)
for XENLETA (lefamulin) for injection when administered in the
hospital inpatient setting. XENLETA is a pleuromutilin
antibacterial indicated for the treatment of adults with
community-acquired bacterial pneumonia (CABP). Both the IV and oral
formulations of XENLETA were granted Qualified Infectious Disease
Product (QIDP) and Fast Track designation by the FDA.
Beginning on October 1, 2020, CMS will provide an additional
maximum payment of $1,275.75 for XENLETA when used in the inpatient
hospital setting for fiscal year 2021. The U.S. Food and Drug
Administration (FDA) approved the IV and oral versions of XENLETA
for the treatment of adult patients with CABP in August 2019.
Nabriva also announced today that CMS has granted an NTAP for
CONTEPO (fosfomycin), making CONTEPO the first QIDP to be granted
conditional NTAP approval prior to receiving FDA approval. CONTEPO
was granted QIDP and Fast Track Designation by the FDA for the
treatment of complicated urinary tract infections (cUTI), including
acute pyelonephritis. If CONTEPO receives FDA approval prior to
July 1, 2021, the maximum add-on payment for a case involving the
administration of CONTEPO is $2,343.75 for fiscal year 2021, which
would become effective beginning in the first quarter after FDA
approval is granted.
The NTAP will provide hospitals with a payment on top of the
standard-of-care Diagnostic Related Group (DRG) reimbursement. This
additional payment is provided to offset some of the costs of new
drugs and devices when certain criteria are met. For the fiscal
year 2021, add-on payments for QIDPs are limited to the lesser of
75 percent of the average cost of the product, or 75 percent of the
amount by which the costs of the case exceeds the standard DRG
payment. NTAP designation lasts no more than three years for a
specific indication.
“The NTAP designation highlights the potential of XENLETA and
CONTEPO to address the urgent need for novel, first-in-class
antibiotics for patients fighting drug-resistant infections,” said
Ted Schroeder, Chief Executive Officer of Nabriva Therapeutics.
“Importantly, the decision to grant conditional NTAP approval to
CONTEPO is unprecedented and we believe should enable more rapid
access to this innovative antimicrobial following FDA approval. We
applaud CMS for taking the initial policy steps that will enable
patients in need to be prescribed innovative antibacterial agents
and help reverse the consequences of antimicrobial resistance.”
The NTAP program for antimicrobial resistance (AMR) is intended
to encourage the use of new medical technologies in the hospital
inpatient setting and help reduce barriers to antibiotic
innovation.
About XENLETA
XENLETA (lefamulin) is a first-in-class semi-synthetic
pleuromutilin antibiotic 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. XENLETA’s binding occurs with high
affinity, high specificity and at molecular sites that are
different than other antibiotic classes. Efficacy of XENLETA was
demonstrated in two multicenter, multinational, double-blind,
double-dummy, non-inferiority trials assessing a total of 1,289
patients with CABP. In these trials, XENLETA was compared with
moxifloxacin and in one trial, moxifloxacin with and without
linezolid. Patients who received XENLETA had similar rates of
efficacy as those taking moxifloxacin alone or moxifloxacin plus
linezolid. The most common adverse reactions associated with
XENLETA include diarrhea, nausea, reactions at the injection site,
elevated liver enzymes, and vomiting.
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. Nabriva entered into an exclusive agreement with
subsidiaries of Merck & Co. Inc., Kenilworth, N.J., USA to
market, sell and distribute SIVEXTRO® (tedizolid phosphate) in the
United States and certain of its territories. For more information,
please visit www.nabriva.com.
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION
XENLETA is a pleuromutilin antibacterial indicated for the
treatment of adults with community-acquired bacterial pneumonia
(CABP) caused by the following susceptible microorganisms:
Streptococcus pneumoniae, Staphylococcus aureus
(methicillin-susceptible isolates), Haemophilus influenzae,
Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila
pneumoniae.
USAGE
To reduce the development of drug-resistant bacteria and
maintain the effectiveness of XENLETA and other antibacterial
drugs, XENLETA should be used only to treat or prevent infections
that are proven or strongly suspected to be caused by susceptible
bacteria.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
XENLETA is contraindicated in patients with known
hypersensitivity to XENLETA or pleuromutilins.
XENLETA tablets are contraindicated for use with CYP3A4
substrates that prolong the QT interval.
WARNINGS AND PRECAUTIONS
XENLETA has the potential to prolong the QT interval. Avoid
XENLETA in patients with known QT prolongation, ventricular
arrhythmias, and patients receiving drugs that may prolong the QT
interval.
Based on animal studies, XENLETA may cause fetal harm. Advise
females of reproductive potential of the potential risk to the
fetus and to use effective contraception.
Clostridium difficile-associated diarrhea (CDAD) has been
reported with nearly all systemic antibacterial agents, including
XENLETA, with severity ranging from mild diarrhea to fatal colitis.
Evaluate if diarrhea occurs.
ADVERSE REACTIONS
The most common adverse reactions (≥2%) for (a) XENLETA
Injection are administration site reactions, hepatic enzyme
elevation, nausea, hypokalemia, insomnia, and headache and (b)
XENLETA Tablets are diarrhea, nausea, vomiting, and hepatic enzyme
elevation.
USE IN SPECIFIC POPULATIONS
In patients with severe hepatic impairment, reduce the dosage of
XENLETA Injection to 150 mg infused over 60 minutes every 24 hours.
XENLETA Tablets are not recommended in patients with moderate or
severe hepatic impairment due to insufficient information to
provide dosing recommendations.
Avoid XENLETA Injection and Tablets with concomitant strong or
moderate CYP3A or P-gp inducers.
Monitor for reduced efficacy of XENLETA.
Avoid XENLETA Tablets with strong CYP3A or P-gp inhibitors.
Monitor for adverse reactions of sensitive CYP3A substrates
administered with XENLETA Tablets.
XENLETA has not been studied in pregnant women. Verify pregnancy
status in females prior to initiating XENLETA and advise females to
use contraception during treatment and for 2 days after the final
dose. Lactating women should pump and discard milk for the duration
of treatment with XENLETA and for 2 days after the final dose.
To report SUSPECTED ADVERSE REACTIONS, or administration during
pregnancy, contact Nabriva Therapeutics US, Inc. at 1-855-5NABRIVA
or the FDA at 1-800-FDA-1088 or
https://www.fda.gov/safety/medwatch.
Please see Full Prescribing Information for XENLETA. For more
information, please see: www.xenleta.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 its ability to successfully launch and
commercialize XENLETA for the treatment of CABP, including the
availability of and ease of access to XENLETA through major U.S.
specialty distributors, marketing exclusivity and patent protection
for XENLETA, the distribution and promotion of SIVEXTRO for the
treatment of ABSSSI, the development of CONTEPO for Complicated
Urinary Tract Infections (cUTI), the ability to secure and deploy a
commercial sales force, 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, SIVEXTRO for ABSSSI and CONTEPO for cUTI, the
development of XENLETA and CONTEPO for additional indications, the
development of additional formulations of XENLETA and CONTEPO,
plans for making lefamulin available in the European Union, Canada
and China, plans to pursue research and development of other
product candidates, expectations regarding the ability of customers
to satisfy demand for XENLETA with their existing inventory,
expectations regarding the impact of the interruptions resulting
from COVID-19 on its business, 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 successfully implement its
commercialization plans for XENLETA and SIVEXTRO and whether market
demand for XENLETA and SIVEXTRO is consistent with its
expectations, Nabriva Therapeutics’ ability to build and maintain a
sales force for XENLETA and SIVEXTRO, 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 SenderNabriva Therapeutics plcir@nabriva.com
For Media
Mike BeyerSam Brown
Inc.mikebeyer@sambrown.com 312-961-2502
Nabriva Therapeutics (NASDAQ:NBRV)
Historical Stock Chart
From Aug 2024 to Sep 2024
Nabriva Therapeutics (NASDAQ:NBRV)
Historical Stock Chart
From Sep 2023 to Sep 2024