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 stewardship.”
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:
Letermovir
- 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)
Merck Vaccines
- 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: 07AB)
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
tazobactam)
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.
About Merck
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,
visit www.merck.com and connect with us on Twitter, Facebook,
Instagram, 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 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
View source
version on businesswire.com: http://www.businesswire.com/news/home/20171004005680/en/
MerckMedia:Pamela Eisele, 267-305-3558orRobert Consalvo,
908-295-0928orSkip Irvine, 215-652-6059orInvestors:Amy Klug,
908-740-1898
Merck (NYSE:MRK)
Historical Stock Chart
From Mar 2024 to Apr 2024
Merck (NYSE:MRK)
Historical Stock Chart
From Apr 2023 to Apr 2024