Merck (NYSE: MRK), known as MSD outside the United States and
Canada, today announced that researchers are scheduled to provide
more than 25 scientific data presentations on the company’s
established and investigational infectious disease medicines at
this year’s 27th European Congress of Clinical Microbiology and
Infectious Diseases (ECCMID), April 22-25 in Vienna, Austria.
“Infectious diseases remain one of the great public health
threats in the world today. At Merck, we have never wavered in our
commitment to invest in developing anti-infective therapies that
prevent and treat serious infectious diseases,” said Dr. Nicholas
Kartsonis, vice president, infectious disease clinical research,
Merck Research Laboratories. “We also continue to collaborate with
researchers, clinicians and other stakeholders worldwide to
advocate for responsible use of these important medicines.”
Presentations at ECCMID 2017 will include topline data from the
pivotal Phase 3 clinical study of letermovir, Merck’s
investigational antiviral medicine for prevention of
cytomegalovirus (CMV) infection or disease in adult
CMV-seropositive recipients of an allogeneic hematopoietic stem
cell transplant (HSCT).
Researchers also will present “real-world use” data as well as
data on the in vitro activity of ZERBAXA® 1.5 g (ceftolozane 1 g
and tazobactam 0.5 g). ZERBAXA is indicated for the treatment of
adults with complicated urinary tract infections (cUTI), including
pyelonephritis, and in combination with metronidazole, complicated
intra-abdominal infections (cIAI) caused by designated susceptible
Gram-negative and Gram-positive bacteria.
Other studies to be presented include data on the in vitro
activity of relebactam, Merck’s investigational beta-lactamase
inhibitor, in combination with imipenem/cilastatin (an approved
carbapenem antibiotic), collected as part of the SMART (Study for
Monitoring Antimicrobial Resistance Trends) surveillance program.
SMART was initiated by Merck in 2002 to monitor the in vitro
susceptibility of clinical isolates to several commonly used
antibiotics in different regions of the world to monitor changing
trends in antibiotic susceptibility. Bacterial samples have been
collected and characterized from patients with intra-abdominal,
urinary tract and lower-respiratory tract infections.
Select data presentations at ECCMID 2017 include:
Letermovir
- Safety and tolerability of letermovir
prophylaxis of cytomegalovirus (CMV) infection in adult
CMV-seropositive recipients of allogeneic hematopoietic cell
transplantation (ALLO-HCT), R. Chemaly (Oral Presentation, Abstract
No. 2800, 11:42 - 11:52 a.m., Monday, April 24, Exhibit Hall
H)
ZERBAXA (ceftolozane and tazobactam)
- Ceftolozane/tazobactam (C/T)
prescribing patterns in hospitalized patients: A multicenter
evaluation, J. Pogue (Abstract No. 7013, 8:45 a.m. - 3:30 p.m.,
Saturday, April 22, ePoster Viewing Area)
- Antimicrobial activity of
ceftolozane/tazobactam tested against contemporary (2014-2016) P.
aeruginosa isolates from hospitalized patients with bloodstream
infections and pneumonia in European medical centres, D. Shortridge
(Abstract No. 1577, 12:30 -1:30 p.m., Monday, April 24, Paper
Poster Area)
- Antimicrobial activity of
ceftolozane/tazobactam tested against contemporary (2014-2016)
Gram-negative organisms collected from European medical centres, D.
Shortridge (Abstract No. 1607, 12:30 - 1:30 p.m., Monday, April 24,
Paper Poster Area)
- Antimicrobial activity of
ceftolozane/tazobactam tested against contemporary (2014-2016)
Gram-negative organisms collected from Latin American medical
centres, L. Duncan (Abstract No. 2739, 12:30 - 1:30 p.m., Monday,
April 24, Paper Poster Area)
Imipenem/Relebactam
- Determining resistance mechanisms in
Pseudomonas aeruginosa clinical isolates that demonstrate altered
susceptibility profiles to beta-lactam-relebactam (REL) versus
beta-lactam-avibactam (AVI) combinations, M. Barnes (Abstract No.
5165, 3:30 - 4:30 p.m., Saturday, April 22, Paper Poster Area)
- Activity of imipenem-relebactam against
Enterobacteriaceae and Pseudomonas aeruginosa from respiratory
tract infections in Europe, SMART 2015, V. Di Lorenzo (Abstract No.
1340, 12:30 - 1:30 p.m., Monday, April 24, Paper Poster Area)
- Global perspective on imipenem
non-susceptible Pseudomonas aeruginosa isolates collected as part
of the SMART surveillance programme, 2015, K. Kazmierczak (Abstract
No. 1462, 12:30 - 1:30 p.m., Monday, April 24, Paper Poster
Area)
- Relebactam (REL) in combination with
imipenem (IMI) activity against KPC-producing Enterobacteriaceae,
K. Papp-Wallace (Abstract No. 2629, 12:30 - 1:30 p.m., Monday,
April 24, Paper Poster Area)
For more information, including a complete list of presentation
titles, please visit the ECCMID website at www.eccmid.org.
Merck’s commitment to infectious diseases
For more than 80 years, Merck has contributed to the discovery
and development of novel medicines and vaccines to combat
infectious diseases. In addition to a combined portfolio of
antibiotic and antifungal medicines, vaccines, and medicines for
HIV and HCV, Merck has multiple programs that span discovery
through late-stage development. Merck currently has nine compounds
in Phase 2/Phase 3 clinical trials for the potential treatment or
prevention of infectious diseases.
About ZERBAXA
ZERBAXA (ceftolozane and tazobactam) is an antibacterial
combination product for intravenous infusion consisting of the
cephalosporin antibacterial drug ceftolozane sulfate and the
beta-lactamase inhibitor tazobactam sodium.
ZERBAXA is approved in the United States and is indicated in
adult patients for the treatment of complicated urinary tract
infections (cUTI), including pyelonephritis, caused by the
following Gram-negative microorganisms: Escherichia coli,
Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas
aeruginosa. ZERBAXA used in combination with metronidazole is
indicated in adult patients for the treatment of complicated
intra-abdominal infections (cIAI) caused by the following
Gram-negative and Gram-positive microorganisms: Enterobacter
cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella
pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Bacteroides
fragilis, Streptococcus anginosus, Streptococcus constellatus, and
Streptococcus salivarius.
To reduce the development of drug-resistant bacteria and
maintain the effectiveness of ZERBAXA and other antibacterial
drugs, ZERBAXA should be used only to treat infections 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.
Important Safety Information about ZERBAXA
Patients with renal impairment: Decreased efficacy of
ZERBAXA has been observed in patients with baseline CrCl of 30 to
≤50 mL/min. In a clinical trial, patients with cIAIs with CrCl
>50 mL/min had a clinical cure rate of 85.2% when treated with
ZERBAXA plus metronidazole vs. 87.9% when treated with meropenem.
In the same trial, patients with CrCl 30 to ≤50 mL/min had a
clinical cure rate of 47.8% when treated with ZERBAXA (ceftolozane
and tazobactam) plus metronidazole vs. 69.2% when treated with
meropenem. A similar trend was also seen in the cUTI trial. Monitor
CrCl at least daily in patients with changing renal function and
adjust the dose of ZERBAXA accordingly.
Hypersensitivity: ZERBAXA is contraindicated in patients
with known serious hypersensitivity to ceftolozane/tazobactam,
piperacillin/tazobactam, or other members of the beta-lactam class.
Serious and occasionally fatal hypersensitivity (anaphylactic)
reactions have been reported in patients receiving beta-lactam
antibacterials. Before initiating therapy with ZERBAXA, make
careful inquiry about previous hypersensitivity reactions to
cephalosporins, penicillins, or other beta-lactams. If an
anaphylactic reaction to ZERBAXA occurs, discontinue use and
institute appropriate therapy.
Clostridium difficile–associated diarrhea (CDAD),
ranging from mild diarrhea to fatal colitis, has been reported with
nearly all systemic antibacterial agents, including ZERBAXA.
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 confirmed, antibacterial use not
directed against C. difficile should be discontinued, if
possible.
Development of drug-resistant bacteria: Prescribing
ZERBAXA in the absence of a proven or strongly suspected bacterial
infection 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
occurring in ≥5% of patients were headache (5.8%) in the cUTI
trial, and nausea (7.9%), diarrhea (6.2%) and pyrexia (5.6%) in the
cIAI trial.
About Merck
For more than a century, Merck, a leading global
biopharmaceutical company known as MSD outside of the United States
and Canada, has been inventing for life, bringing forward medicines
and vaccines for many of the world’s most challenging diseases.
Through our prescription medicines, vaccines, biologic therapies
and animal health products, we work with customers and operate in
more than 140 countries to deliver innovative health solutions. We
also demonstrate our commitment to increasing access to health care
through far-reaching policies, programs and partnerships. Today,
Merck continues to be at the forefront of research to advance the
prevention and treatment of diseases that threaten people and
communities around the world - including cancer, cardio-metabolic
diseases, emerging animal diseases, Alzheimer’s disease and
infectious diseases including HIV and Ebola. For more information,
visit www.merck.com and connect with us on Twitter, Facebook,
YouTube and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J.,
USA (the “company”) includes “forward-looking statements” within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These statements are
based upon the current beliefs and expectations of the company’s
management and are subject to significant risks and uncertainties.
There can be no guarantees with respect to pipeline products that
the products will receive the necessary regulatory approvals or
that they will prove to be commercially successful. If underlying
assumptions prove inaccurate or risks or uncertainties materialize,
actual results may differ materially from those set forth in the
forward-looking statements.
Risks and uncertainties include but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of pharmaceutical industry regulation and health care
legislation in the United States and internationally; global trends
toward health care cost containment; technological advances, new
products and patents attained by competitors; challenges inherent
in new product development, including obtaining regulatory
approval; the company’s ability to accurately predict future market
conditions; manufacturing difficulties or delays; financial
instability of international economies and sovereign risk;
dependence on the effectiveness of the company’s patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in the company’s 2016
Annual Report on Form 10-K and the company’s other filings with the
Securities and Exchange Commission (SEC) available at the SEC’s
Internet site (www.sec.gov).
Please see Prescribing Information for ZERBAXA (ceftolozane
and tazobactam) at
http://www.merck.com/product/usa/pi_circulars/z/zerbaxa/zerbaxa_pi.pdf
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