Merck (NYSE: MRK), known as MSD outside the United States and
Canada, today announced that researchers will provide more than 30
scientific data presentations on the company’s established and
investigational infectious disease medicines and vaccines at ID
Week 2016 in New Orleans from Oct. 26-30.
Researchers will present posters showing surveillance, clinical
and updated data on the in vitro activity of ZERBAXA® (ceftolozane
and tazobactam). 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.
Presentations for ZOSTAVAX® (Zoster Vaccine Live) will include a
review of post-marketing safety reports after ten years of use
worldwide, as well as an oral presentation from an ongoing
real-world observational effectiveness study against post-herpetic
neuralgia (PHN). ZOSTAVAX is a live attenuated virus vaccine
indicated for prevention of herpes zoster (shingles) in individuals
50 years of age and older. ZOSTAVAX is not indicated for the
treatment of zoster or postherpetic neuralgia. ZOSTAVAX should not
be used for prevention of primary varicella infection (Chickenpox).
ZOSTAVAX was initially approved in May 2006 and subsequently
licensed in more than 50 countries.
“For decades, Merck has played a significant role in vaccine and
antimicrobial research and development,” said Dr. Eliav Barr,
senior vice president, global clinical development, infectious
diseases and vaccines, Merck Research Laboratories. “Today, Merck
is one of only a few large pharmaceutical companies to sustain a
focus on developing anti-infective therapies and vaccines to
address some of today’s pressing health threats.”
Select data presentations at ID Week 2016 include:
ZERBAXA (ceftolozane and tazobactam)
- Activity of Ceftolozane/Tazobactam and
Comparators Tested against Carbapenem Non-susceptible Pseudomonas
aeruginosa isolates from USA hospitals (Castanheira et al.) Poster
Abstract Session #1823: Antibacterial Susceptibility Surveillance,
Saturday, Oct. 29, Room: Poster Hall
- Ceftolozane/Tazobactam Activity Tested
against Bacterial Bloodstream Isolates from Multiple Infection
Sources (Duncan et al.), Poster Abstract Session #1824:
Antibacterial Susceptibility Surveillance, Saturday, Oct. 29, Room:
Poster Hall
- Pharmacokinetics and Safety of
Ceftolozane/Tazobactam in Adolescents and Young Children with
Proven or Suspected Gram-negative Infection (Larson et al.) Poster
Abstract Session #1965: Antimicrobial Pharmacokinetics and
Pharmacodynamics, Saturday, Oct. 29, Room: Poster Hall
- The Importance of Postmarking
Surveillance in the Identification of Early Safety Signals of
Medication Errors in Patients Receiving a New Combination
Antibiotic (Marr et al.) Poster Abstract Session #1801:
Antibacterial Safety, Saturday, Oct. 29, Room: Poster Hall
ZOSTAVAX (Zoster Vaccine Live)
- Effectiveness of Live Zoster Vaccine in
Preventing Postherpetic Neuralgia (PHN) (Baxter et al.), Oral
Abstract Session #128: Newer and Older Vaccines in Older Adults,
Thursday, Oct. 27, 11:00 a.m. CT, Room: 388-390
- Zoster Vaccine Live: A Review of Nearly
10 Years of Post-marketing Experience (Willis et al.), Poster
Abstract Session #714: Vaccines, Thursday, Oct. 27, Room: Poster
Hall
- VZV Cell-Mediated Immunity 3 Years
After The Administration Of Zoster Vaccine To Septuagenarians and
Octogenarians Immunized 10 Years Previously (Weinberg et.al),
Session: Poster Abstract Session #715: Vaccines, Thursday, Oct. 27,
Room: Poster Hall
For more information, including a complete list of presentation
titles, please visit the ID Week 2016 website at
http://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 10 compounds in
Phase 2/Phase 3 clinical trials for the potential treatment or
prevention of infectious diseases.
About ZERBAXA (ceftolozane and tazobactam)
ZERBAXA 1.5g (ceftolozane 1g and tazobactam 0.5g) is an
antibacterial combination product for intravenous infusion
consisting of the cephalosporin-class 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
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 (ceftolozane and tazobactam)
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 ZOSTAVAX (Zoster Vaccine Live)
ZOSTAVAX is a live attenuated virus vaccine indicated for
prevention of herpes zoster (shingles) in individuals 50 years of
age and older. ZOSTAVAX is not indicated for the treatment of
zoster or postherpetic neuralgia. ZOSTAVAX should not be used for
prevention of primary varicella infection (Chickenpox).
Select Safety Information about ZOSTAVAX
Vaccination with ZOSTAVAX does not result in protection of all
vaccine recipients.
ZOSTAVAX is contraindicated in: persons with a history of
anaphylactic or anaphylactoid reaction to gelatin, neomycin, or any
other component of the vaccine; persons with a history of primary
or acquired immunodeficiencies; persons on immunosuppressive
therapy; pregnant women or women of childbearing age.
A reduced immune response to ZOSTAVAX was observed in
individuals who received concurrent administration of PNEUMOVAX®23
(Pneumococcal Vaccine Polyvalent) and ZOSTAVAX compared with
individuals who received these vaccines 4 weeks apart. Consider
administration of the two vaccines separated by at least 4
weeks.
Serious vaccine-related adverse reactions that have occurred
following vaccination with ZOSTAVAX include asthma exacerbation and
polymyalgia rheumatica. Other serious adverse events reported
following vaccination with ZOSTAVAX include cardiovascular events
(congestive heart failure, pulmonary edema). Common adverse
reactions occurring in ≥1% of vaccinated individuals during
clinical trials include injection-site reactions (erythema,
pain/tenderness, swelling, hematoma, pruritus, warmth) and
headache.
Transmission of vaccine virus may occur between vaccinees and
susceptible contacts.
Deferral should be considered in acute illness (for example, in
the presence of fever) or in patients with active untreated
tuberculosis.
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.
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
https://www.merck.com/product/usa/pi_circulars/z/zerbaxa/zerbaxa_pi.pdf.
Please see Prescribing Information for ZOSTAVAX (zoster
vaccine live) at
http://www.merck.com/product/usa/pi_circulars/z/zostavax/zostavax_pi2.pdf
and Patient Information for ZOSTAVAX at
http://www.merck.com/product/usa/pi_circulars/z/zostavax/zostavax_ppi.pdf.
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MerckMedia:Pamela Eisele, 267-305-3558Robert Consalvo,
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