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
bacteria.”
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
important medicines.”
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
infectious diseases.
About ZERBAXA
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
tazobactam)
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
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
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 healthcare through
far-reaching policies, programs and partnerships. For more information,
visit www.merck.com
and connect with us on Twitter,
Facebook
and YouTube.
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 2014 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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