Merck Highlights Ongoing Commitment to Fighting Infectious Diseases With More than 20 Data Presentations at ASM Microbe 2017
May 30, 2017 7:00 am ET
Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced that researchers are scheduled to provide more than 20
scientific data presentations on the company’s established and
investigational infectious disease medicines at the American Society for
Microbiology’s ASM Microbe 2017 meeting in New Orleans, June 1-5.
“At Merck, we remain deeply committed to developing medicines and
vaccines that prevent and treat serious infectious diseases to help
address some of the most pressing public health threats in the world
today,” said Dr. Joan Butterton, executive director and section head for
antibacterials/CMV, infectious disease clinical research, Merck Research
Laboratories. “We also continue to collaborate with researchers,
clinicians and other stakeholders worldwide to provide important
surveillance data and to advocate for responsible use of
Presentations at ASM Microbe 2017 will include new analyses of data from
the pivotal Phase 3 clinical study of letermovir, Merck’s
investigational antiviral medicine for prophylaxis 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 susceptibility data as well as
data on the in vitro activity of ZERBAXA. ZERBAXA® 1.5
g (ceftolozane 1 g and tazobactam 0.5 g) 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 ASM Microbe 2017 include:
Exposure-Response Analysis of Letermovir (LET) Following Oral and IV
Administration in Allogeneic Hematopoietic Cell Transplantation (HCT)
Patients, M. Prohn Oral Presentation 4, 11:30 – 11:45 a.m., Monday,
June 5, Room 217)
Population Pharmacokinetcs (POPPK) of Letermovir (LET) Following Oral
and IV Administration in Allogeneic Hematopoietic Cell Transplantation
(HCT) Recipients, A. Viberg (Poster 376, 12:15 – 2:15 p.m. Sunday,
June 4, Exhibit Hall D)
Balanced Diversity of CMV DNA Sequences in a Clinical Study of
Letermovir (MK-8228), C. M. Douglas (Poster 380, 12:15 – 2:15 p.m.
Sunday, June 4, Exhibit Hall D)
ZERBAXA (ceftolozane and tazobactam)
Antimicrobial Activity of Ceftolozane/Tazobactam Tested against
Contemporary (2014-2016) Pseudomonas aeruginosa Isolates from
US Hospitals, D. Shortridge (Poster 50, 12:45 – 2:45 p.m., Friday,
June 2, Exhibit Hall D)
Susceptibility of Ceftolozane/Tazobactam (C/T) to Pseudomonas
aeruginosa Clinical Isolates in Hospitalized Patients: A
Multicenter Evaluation, J. M. Pogue (Poster 75, 12:45 – 2:45 p.m.,
Friday, June 2, Exhibit Hall D)
Susceptibility of Ceftolozane/Tazobactam against Isolates Collected
from Intensive Care Unit (ICU) Patients in US Hospitals from
2014-2016, D. Shortridge (Poster 76, 12:45 – 2:45 p.m., Friday, June
2, Exhibit Hall D)
Global Surveillance: Susceptibility of Ceftolozane/Tazbactam against Pseudomonas
aeruginosa, Klebsiella spp. and Escherichia coli
Isolates Collected in Asia Pacific, North and Latin America, and
Europe from 2011-2016, D. Shortridge (Poster 29, 12:15 – 2:15 p.m.,
Saturday, June 3, Exhibit Hall D)
In Vitro Activity of Imipenem-Relebactam (MK-7655) against Enterobacteriaceae
from United States ICU and Non-ICU Wards – SMART 2015-2016, R. Badal
(Poster 44, 12:45 – 2:45 p.m., Friday, June 2, Exhibit Hall D)
In Vitro Activity of Imipenem-Relebactam (MK-7655) against Enterobacteriaceae
and Pseudomonas aeruginosa from Latin America – SMART 2015, R.
Badal (Poster 45, 12:45 – 2:45 p.m., Friday, June 2, Exhibit Hall D)
In Vitro Activity of Imipenem-Relebactam (MK-7655) against P.
aeruginosa from United States ICU and Non-ICU Wards – SMART
2015-2016, R. Badal (Poster 49, 12:45 – 2:45 p.m., Friday, June 2,
Exhibit Hall D)
For more information, including a complete list of presentation titles,
please visit the ASM Microbe 2017 website at www.ASM.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 (ceftolozane and tazobactam)
ZERBAXA 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 (ceftolozane and
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 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
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.
–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.
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,
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Please see Prescribing Information for ZERBAXA (ceftolozane and
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