Merck Highlights Its Commitment to Infectious Disease with 40 Presentations of Data at ICAAC/ICC 2015
September 16, 2015 6:30 am ET
Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced that more than 40 presentations of data on a number of
Merck’s investigational and established infectious disease products are
scheduled for the upcoming Interscience Conference of Antimicrobial
Agents and Chemotherapy (ICAAC) and International Congress of
Chemotherapy and Infection (ICC) joint meeting in San Diego, Sept. 17-21.
“At Merck we continue to advance a broad portfolio of investigational
infectious disease medicines,” said Dr. Eliav Barr, vice president
infectious diseases, Merck Research Laboratories. “We look forward to
presenting data at ICAAC/ICC with a focus on our antibacterial
candidates designed to address serious infections such as C. difficile
and the increasing threats presented by resistant Gram-negative
The presentations will include results from two pivotal Phase 3 clinical
studies of bezlotoxumab (alone and in combination with actoxumab), an
investigational antitoxin for the prevention of Clostridium difficile
(C. difficile) infection recurrence in patients on standard C.
difficile antibiotic treatment; data from several studies of ZERBAXA™
(ceftolozane and tazobactam), which is indicated for the treatment of
complicated urinary tract infections (cUTI) and complicated
intra-abdominal infections (cIAI); and Phase 2 clinical data evaluating
relebactam, the company’s investigational beta-lactamase inhibitor, for
the treatment of cIAI. For more information, including a complete list
of abstract titles, please visit the ICAAC website at www.icaac.org.
“Merck is one of a few large pharmaceutical companies that have remained
deeply committed to developing novel anti-infective therapies,” said Dr.
Julie Gerberding, executive vice president, strategic communications,
global public policy and population health, Merck. “Today, with
increasing concerns about the rise of antimicrobial resistance, we
continue to advocate for appropriate and responsible use of these
Dr. Gerberding, along with other global infectious disease leaders, is
scheduled to deliver remarks at the ICAAC Antimicrobial Research Award
and Lecture on Saturday, Sept. 19, at 1:30 p.m. PDT.
Merck’s commitment to infectious disease
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 25 ongoing Phase 2/Phase 3 clinical trials
evaluating several candidates for the prevention or treatment of
ZERBAXA (ceftolozane and tazobactam) for injection (1.5 g) 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 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.
Today’s Merck is a global healthcare leader working to help the world be
well. Merck is known as MSD outside of the United States and Canada.
Through our prescription medicines, vaccines, biologic therapies and
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Please see Prescribing Information for ZERBAXA (ceftolozane and
tazobactam) at http://zerbaxa.com/pdf/PrescribingInformation.pdf.
Doris Li, 908-246-5701
Ian McConnell, 973-901-5722
Teri Loxam, 908-740-1986
Justin Holko, 908-740-1879