Merck (NYSE: MRK), known as MSD outside the United States and Canada,
today announced that researchers will provide 40 scientific data
presentations on the company’s established and investigational
infectious disease medicines and vaccines at ID Week 2017 in San Diego
from Oct. 4-8. Antimicrobial research remains an important area of focus
at Merck, with ongoing clinical studies in antibiotic, antiviral and
antifungal medicines; adult and pediatric vaccines; and medicines for
HIV and HCV.
“At Merck, we remain deeply committed to developing medicines and
vaccines that help to 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 antimicrobial
Presentations at ID Week 2017 will include new data analyses 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).
Results from a Phase 3 study of V212, Merck’s investigational vaccine
for herpes zoster, in autologous HSCT recipients will be discussed
during an oral presentation at the meeting.
Researchers also will present real-world susceptibility and clinical use
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 in vitro data 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 ID Week 2017 include:
A Mortality Analysis of the Cytomegalovirus (CMV) Infection Letermovir
Prophylaxis Trial in CMV-Seropositive Recipients of Allogeneic
Hematopoietic Cell Transplantation (HCT), P. Ljungman (Poster 1029,
12:30 - 2:00 p.m. PT, Friday, Oct.6, Hall CD)
Cost of Hematopoietic Stem Cell Transplant and Cytomegalovirus Related
Complications in a Large Inpatient Claims Database, J. Schelfhout
(Poster 2436, 12:30 - 2:00 p.m. PT, Saturday, Oct.7, Hall CD)
Immunogenicity of Inactivated Varicella Zoster Vaccine (ZVIN) in
Autologous Hematopoietic Stem Cell Transplant (auto-HSCT) Recipients,
M. Boeckh (Oral Abstract 1818, 10:45 a.m. PT, Saturday, Oct.7, Room:
ZERBAXA (ceftolozane and tazobactam)
Real World Analysis of Prescribing Patterns and Susceptibility of
Ceftolozane/tazobactam (C/T) Treatment using an Electronic Medical
Record (EMR) Database in the United States, J. Pogue (Poster 797,
12:30 - 2:00 p.m. PT, Thursday, Oct.5, Hall CD)
Real World Evaluation of Ceftolozane/tazobactam Use and Clinical
Outcomes at an Academic Medical Center in Las Vegas, K. Leuthner
(Poster 828, 12:30 - 2:00 p.m. PT, Thursday, Oct.5, Hall CD)
Antimicrobial Activity of Ceftolozane-Tazobactam Tested against
Contemporary (2012-2016) Enterobacteriaceae and Pseudomonas
aeruginosa Isolates by US Census Division, D. Shortridge (Poster
1216, 12:30 - 2:00 p.m. PT, Friday, Oct.6, Hall CD)
Activity of Ceftolozane-Tazobactam Against Global Pseudomonas
Aeruginosa Isolates: SMART 2016, S. Lob (Poster 1244, 12:30 - 2:00
p.m. PT, Friday, Oct.6, Hall CD)
For more information, including a complete list of presentation titles,
please visit the
ID week 2017 website at www.IDWeek.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 eight 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 creatinine clearance (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
(ceftolozane and tazobactam) 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.
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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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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