Merck Highlights Ongoing Commitment to Fighting Infectious Diseases with More than 30 Data Presentations at ASM Microbe 2016
June 15, 2016 7:30 am ET
Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced that researchers are scheduled to provide more than 30
scientific data presentations on the company’s established and
investigational infectious disease medicines and vaccines at the
American Society for Microbiology’s ASM Microbe 2016 meeting in Boston,
Researchers will present results of a Phase 2 clinical trial of
relebactam, the company’s investigational beta-lactamase inhibitor, in
combination with imipenem/cilastatin (an approved carbapenem
antibiotic), in patients with complicated urinary tract infections,
including those caused by antibiotic-resistant pathogens.
Among other presentations, researchers also will present studies showing
updated data from the Phase 3 trials and updated data on the in vitro activity
of ZERBAXA® (ceftolozane and tazobactam) 1.5 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.
Select data presentations at ASM Microbe include:
Relebactam + Imipenem/Cilastatin
Phase 2 Study of Relebactam (REL) + Imipenem/Cilastatin (IMI) vs. IMI
Alone in Subjects with Complicated Urinary Tract Infection (cUTI), M.
Sims (Poster No. 472, 12:30 – 2:30 p.m., Monday, June 20, Exhibit
Halls A and B)
In Vitro Activity of Imipenem-Relebactam (MK-7655) against
Enterobacteriaceae and Pseudomonas aeruginosa from the United
States – SMART 2015, M. Hackel (Poster No. 340, 12:45 p.m. – 2:45
p.m., Saturday, June 18, Exhibit Halls A and B)
Activity of Imipenem-Relebactam (MK-7655) against Enterobacteriaceae
and Pseudomonas aeruginosa from Europe – SMART 2015, M. Hackel
(Poster No. 337, 12:45 – 2:45 p.m., Saturday, June 18, Exhibit Halls A
ZERBAXA (ceftolozane and tazobactam)
Activity of Ceftolozane-Tazobactam (TOL/TAZ) against Drug-Resistant
Gram-Negative Pathogens Collected from USA Medical Centers in 2015, M.
Huband (Poster No. 430, 12:30 – 2:30 p.m., Monday, June 20, Exhibit
Halls A and B)
In Vitro Activity of Ceftolozane-Tazobactam against Pseudomonas
aeruginosa and Enterobacteriaceae Isolates Collected from Medical
Centers in the USA in 2015, M. Huband (Poster No. 431, 12:30 – 2:30
p.m., Monday, June 20, Exhibit Halls A and B)
Analysis of Diabetes Patients with Complicated Intra-Abdominal
Infection or Complicated Urinary Tract Infection in Phase 3 Trials of
Ceftolozane/Tazobactam, M. Popejoy (Poster No. 430, 12:30 – 2:30 p.m.,
Friday, June 17, Exhibit Halls A and B)
For more information, including a complete list of presentation titles,
please visit the ASM Microbe website at www.asmmicrobe.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 10 compounds in Phase 2/Phase 3 clinical trials for
the potential treatment or prevention of infectious diseases.
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 (ceftolozane and tazobactam) 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
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 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 125 years, Merck has been a global health care leader working to
help the world be well. Merck is known as MSD outside the United States
and Canada. 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.
For more information, visit www.merck.com
and connect with us on Twitter,
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“company”) includes “forward-looking statements” within the meaning of
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Please see Prescribing Information for ZERBAXA (ceftolozane and
Pamela Eisele, 267-305-3558
Robert Consalvo, 908-295-0928
Teri Loxam, 908-740-1986
Amy Klug, 908-740-1898