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, June 16-20.
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 and B)
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.
About ZERBAXA
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 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 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 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, 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 2015
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://zerbaxa.com/pdf/PrescribingInformation.pdf.
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version on businesswire.com: http://www.businesswire.com/news/home/20160615005215/en/
Media:Pamela Eisele, 267-305-3558Robert Consalvo,
908-295-0928Investor:Teri Loxam, 908-740-1986Amy Klug,
908-740-1898
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