Merck Highlights Ongoing Commitment to Fighting Infectious Diseases with More Than 30 Data Presentations at ECCMID 2016
April 7, 2016 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 30
scientific data presentations on the company’s established and
investigational infectious disease medicines and vaccines at this year’s
26th European Congress of Clinical Microbiology and Infectious Diseases
(ECCMID), April 9-12 in Amsterdam, Netherlands.
“At Merck, we remain deeply committed to developing anti-infective
therapies to address some of today’s pressing health threats, including
infections caused by antibiotic resistant pathogens,” said Dr. Eliav
Barr, vice president infectious diseases, Merck Research Laboratories.
“We are also proud to continue to collaborate with researchers,
clinicians and other stakeholders worldwide to provide important
surveillance data and to support antimicrobial stewardship.”
Presentations at ECCMID will include new data analyses from two pivotal
Phase 3 clinical trials of bezlotoxumab, Merck’s investigational
compound for the prevention of Clostridium difficile (C. difficile) infection
recurrence in patients on standard-of-care antibiotics for the treatment
of C. difficile infection. Researchers also will present studies
showing 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. For more
information, including a complete list of abstract titles, please visit
the ECCMID website at www.eccmid.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 (ceftolozane and tazobactam) is an antibacterial combination
product for intravenous infusion consisting of the cephalosporin
antibacterial drug ceftolozane sulfate and the beta-lactamase inhibitor
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
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 (ceftolozane
and tazobactam) 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 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,
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.
Doris Li, 908-246-5701
Robert Consalvo, 908-295-0928
Teri Loxam, 908-740-1986
Amy Klug, 908-740-1898