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 agreed to an extension of its exclusive agreement
with subsidiaries of Merck & Co. Inc., Kenilworth, N.J., USA
(“Merck”), known as MSD outside the United States and Canada, to
promote and distribute SIVEXTRO® (tedizolid phosphate) in the
United States through December 31, 2026. 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.
Nabriva has been marketing and distributing SIVEXTRO in the
United States and certain of its territories as part of an
exclusive agreement executed in July 2020 with Merck. Under the
initial term of the agreement, Nabriva was solely responsible for
marketing, sales, and distribution of SIVEXTRO in the United States
through December 31, 2023. The amendment extends the agreement to
December 31, 2026. The term of the agreement can be further
extended by an additional three-year period, subject to mutual
agreement.
Ted Schroeder, Chief Executive Officer of Nabriva, commented,
“We are excited to announce the extension of our agreement with
Merck to promote and distribute SIVEXTRO for at least an additional
three years. This is a testament to our successful and
collaborative relationship with Merck, and our strong commercial
performance with SIVEXTRO. We look forward to building upon this
momentum and expect SIVEXTRO be a significant contributor to the
continued long-term growth of Nabriva.”
About SIVEXTRO® (tedizolid phosphate)
SIVEXTRO was approved by the U.S. Food and Drug Administration
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. To reduce the development of drug-resistant
bacteria and maintain the effectiveness of SIVEXTRO and other
antibacterial drugs, SIVEXTRO should be used only to treat ABSSSI
that are proven or strongly suspected to be caused by susceptible
bacteria. When culture and susceptibility information are
available, they should be considered in selecting or modifying
antibacterial therapy. In the absence of such data, local
epidemiology and susceptibility patterns may contribute to the
empiric selection of therapy.
MRSA has been categorized by the U.S. Centers for Disease
Control and Prevention (CDC) as a serious public health threat.
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.
Please see Prescribing Information for SIVEXTRO® (tedizolid
phosphate) at
http://www.sivextro.com/pdf/01-crt-uspi-mk1986-mf-ar-new-manuf-site.pdf
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 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. 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 the [sales, promotion and distribution]
agreement with the subsidiaries of Merck & Co. Inc.,
Kenilworth, NJ, USA, the potential benefits to patients of SIVEXTRO
and XENLETA, the market opportunity for SIVEXTRO and XENLETA, the
impact on Nabriva Therapeutics’ reported revenue from anticipated
sales of SIVEXTRO, 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 maintain commercial resources 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.
Please see Prescribing Information for SIVEXTRO® (tedizolid
phosphate) at
http://www.sivextro.com/pdf/01-crt-uspi-mk1986-mf-ar-new-manuf-site.pdf
CONTACTS:
For InvestorsKim AndersonNabriva Therapeutics
plcir@nabriva.com
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