Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical
company engaged in the commercialization and development of
innovative anti-infective agents to treat serious infections, today
announced that it has 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. SIVEXTRO is an
oxazolidinone-class antibacterial indicated in adults and pediatric
patients 12 years of age and older for the treatment of acute
bacterial skin and skin structure infections (ABSSSI) caused by
certain susceptible Gram-positive microorganisms.
Ted Schroeder, Chief Executive Officer of Nabriva, commented,
“We are excited to be selected by Merck & Co. Inc., Kenilworth,
N.J., USA as their exclusive commercialization and distribution
partner for SIVEXTRO in the U.S. This transaction is aligned
with our corporate strategy to add revenue generating products to
our business that benefit patients and create value for
shareholders. SIVEXTRO is an excellent fit in our portfolio, with a
highly complementary customer base, creating synergies and scale
with our commercial team.”
Patrick Magri, Merck & Co. Inc., Kenilworth, N.J., USA’s
Senior Vice President, Hospital & Specialty Business stated,
“For more than 80 years, Merck has contributed to the discovery and
development of novel medicines to combat infectious diseases, and
we continue that commitment today by driving innovation in the
antibacterial marketplace. We are pleased to enter into this
arrangement which provides Nabriva with the rights to market, sell
and distribute SIVEXTRO in the United States.”
Under the terms of the agreement, Nabriva will procure SIVEXTRO
from Merck & Co. Inc., Kenilworth, N.J., USA and be responsible
for marketing, sales, and distribution of SIVEXTRO in the U.S.
through December 31, 2023, with renewable three-year
extensions.
Additionally, Nabriva has engaged Amplity Health, a leading
pharmaceutical contract commercial organization, to provide
community-based commercial and sales services for SIVEXTRO and
XENLETA® in the U.S.
“Our new partnership with Amplity Heath provides us the
opportunity to build a flexible and scalable commercial
infrastructure that enables us to optimize the uptake of both
SIVEXTRO and XENLETA, while mitigating potential risks associated
with the evolving COVID-19 pandemic. Amplity has the experience and
depth to effectively educate prescribers about the appropriate use
of both of these important antibiotics. We look forward to
educating clinicians about the differentiating attributes of both
products and bringing these important treatment options to
patients,” said Mr. Schroeder.
About Acute Skin, Skin Structure and Soft Tissue
Infections (ABSSSI)
Acute bacterial skin and skin structure infections (ABSSSIs) are
common and often require antibiotic treatment. According to the
U.S. Food and Drug Administration (FDA), these infections can be
uncomplicated – simple abscesses, cellulitis or wound infections
mainly caused by the two most common Gram-positive pathogens,
Staphylococcus aureus and Streptococcus pyogenes. They can also be
complicated either involving deeper soft tissue or requiring
surgery – such as ulcers, burns and major abscesses or involving a
significant underlying disease state. ABSSSIs are at least 75
cm2.
About SIVEXTRO® (tedizolid phosphate)
SIVEXTRO was approved by the FDA in 2014. It is indicated in
adults and pediatric patients 12 years of age and older for the
treatment of acute bacterial skin and skin structure infections
(ABSSSI) caused by susceptible isolates of the following
Gram-positive microorganisms: Staphylococcus aureus (including
methicillin-resistant (MRSA) and methicillin-susceptible (MSSA)
isolates), Streptococcus pyogenes, Streptococcus agalactiae,
Streptococcus anginosus group (including Streptococcus anginosus,
Streptococcus intermedius and Streptococcus constellatus), and
Enterococcus faecalis. MRSA has been categorized by the U.S.
Centers for Disease Control and Prevention (CDC) as a serious
public health threat.1 SIVEXTRO 200 mg is administered once daily
orally or as an intravenous (IV) infusion over one hour for six
days.
Selected Important Safety Information for
SIVEXTRO
Patients with neutropenia: The safety and
efficacy of SIVEXTRO in patients with neutropenia (neutrophil
counts <1000 cells/mm³) have not been adequately evaluated. In
an animal model of infection, the antibacterial activity of
SIVEXTRO was reduced in the absence of
granulocytes. Alternative therapies should be considered when
treating patients with neutropenia.
Clostridioides difficile–associated
diarrhea (CDAD), ranging from mild diarrhea to fatal
colitis, has been reported with nearly all systemic
antibacterial agents, including SIVEXTRO. Evaluate
all patients who present with diarrhea following antibacterial
drug use. Careful medical history is necessary because CDAD
has been reported to occur more than two months after the
administration of antibacterial agents. If CDAD is suspected
or confirmed, antibacterial use not directed against
C. difficile should be discontinued, if possible.
Development of drug-resistant bacteria:
Prescribing SIVEXTRO in the absence of a proven or strongly
suspected bacterial infection or prophylactic indication is
unlikely to provide benefit to the patient and increases the risk
of the development of drug-resistant bacteria.
Adverse reactions: The most common adverse
reactions (≥ 2%) in adults for SIVEXTRO are nausea (7%),
headache (5%), diarrhea (4%), vomiting (3%), and dizziness
(2%).
In adult patients receiving SIVEXTRO intravenously, infusion- or
injection-related adverse reactions including but not limited
to: phlebitis, injection- or infusion-site pain or swelling,
injection-site reaction, erythema, or induration, and
infusion-related reaction occurred (4%).
The most common adverse reactions (>2%) in pediatric patients
12 years of age and older are phlebitis (3%) and increased
hepatic transaminases (3%).
Drug interactions with BCRP substrates:
SIVEXTRO (when administered orally) can increase the plasma
concentrations of orally administered Breast Cancer Resistance
Protein (BCRP) substrates and the potential for adverse
reactions. Monitor for adverse reactions related to the concomitant
BCRP substrates if coadministration cannot be avoided.
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 (cUTI), including acute
pyelonephritis.
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 the potential benefits to Nabriva
Therapeutics under its sales promotion and distribution agreement
with the subsidiaries of Merck & Co. Inc., the potential
benefits to patients of SIVEXTRO and XENLETA, the market
opportunity for SIVEXTRO and XENLETA, the sufficiency of its 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 satisfy the conditions under the
distribution agreement to obtain the right to exclusively
distribute and promote SIVEXTRO, including its ability to establish
or secure a commercial infrastructure sufficient to promote and
distribute SIVEXTRO, 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 SEC. 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
may 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
Please see Prescribing Information for SIVEXTRO® (tedizolid
phosphate) at
https://www.merck.com/product/usa/pi_circulars/s/sivextro/sivextro_pi.pdf
1 CDC’s Antibiotic Resistance Threats
in the United States (2019 AR Threats Report) accessed 6/2/2020
https://www.cdc.gov/drugresistance/biggest-threats.html#mrsa
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