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April 19, 2017 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 25
scientific data presentations on the company’s established and
investigational infectious disease medicines at this year’s 27th
European Congress of Clinical Microbiology and Infectious Diseases
(ECCMID), April 22-25 in Vienna, Austria.

“Infectious diseases remain one of the great public health threats in
the world today. At Merck, we have never wavered in our commitment to
invest in developing anti-infective therapies that prevent and treat
serious infectious diseases,” said Dr. Nicholas Kartsonis, vice
president, infectious disease clinical research, Merck Research
Laboratories. “We also continue to collaborate with researchers,
clinicians and other stakeholders worldwide to advocate for responsible
use of these important medicines.”

Presentations at ECCMID 2017 will include topline data from the pivotal
Phase 3 clinical study of letermovir, Merck’s investigational antiviral
medicine for prevention of cytomegalovirus (CMV) infection or disease in
adult CMV-seropositive recipients of an allogeneic hematopoietic stem
cell transplant (HSCT).

Researchers also will present “real-world use” data as well as data on
the in vitro activity of ZERBAXA^® 1.5 g (ceftolozane 1
g and tazobactam 0.5 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.

Other studies to be presented include data on the in vitro
activity of relebactam, Merck’s investigational beta-lactamase
inhibitor, in combination with imipenem/cilastatin (an approved
carbapenem antibiotic), 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 ECCMID 2017 include:

Letermovir

• Safety and tolerability of letermovir prophylaxis of cytomegalovirus
  (CMV) infection in adult CMV-seropositive recipients of allogeneic
  hematopoietic cell transplantation (ALLO-HCT), R. Chemaly (Oral
  Presentation, Abstract No. 2800, 11:42 – 11:52 a.m., Monday, April 24,
  Exhibit Hall H)

ZERBAXA (ceftolozane and tazobactam)

• Ceftolozane/tazobactam (C/T) prescribing patterns in hospitalized
  patients: A multicenter evaluation, J. Pogue (Abstract No. 7013, 8:45
  a.m. – 3:30 p.m., Saturday, April 22, ePoster Viewing Area)
• Antimicrobial activity of ceftolozane/tazobactam tested against
  contemporary (2014-2016) P. aeruginosa isolates from
  hospitalized patients with bloodstream infections and pneumonia in
  European medical centres, D. Shortridge (Abstract No. 1577, 12:30
  -1:30 p.m., Monday, April 24, Paper Poster Area)
• Antimicrobial activity of ceftolozane/tazobactam tested against
  contemporary (2014-2016) Gram-negative organisms collected from
  European medical centres, D. Shortridge (Abstract No. 1607, 12:30 –
  1:30 p.m., Monday, April 24, Paper Poster Area)
• Antimicrobial activity of ceftolozane/tazobactam tested against
  contemporary (2014-2016) Gram-negative organisms collected from Latin
  American medical centres, L. Duncan (Abstract No. 2739, 12:30 – 1:30
  p.m., Monday, April 24, Paper Poster Area)

Imipenem/Relebactam

• Determining resistance mechanisms in Pseudomonas aeruginosa
  clinical isolates that demonstrate altered susceptibility profiles to
  beta-lactam-relebactam (REL) versus beta-lactam-avibactam (AVI)
  combinations, M. Barnes (Abstract No. 5165, 3:30 – 4:30 p.m.,
  Saturday, April 22, Paper Poster Area)
• Activity of imipenem-relebactam against Enterobacteriaceae and Pseudomonas
  aeruginosa from respiratory tract infections in Europe, SMART
  2015, V. Di Lorenzo (Abstract No. 1340, 12:30 – 1:30 p.m., Monday,
  April 24, Paper Poster Area)
• Global perspective on imipenem non-susceptible Pseudomonas
  aeruginosa isolates collected as part of the SMART surveillance
  programme, 2015, K. Kazmierczak (Abstract No. 1462, 12:30 – 1:30 p.m.,
  Monday, April 24, Paper Poster Area)
• Relebactam (REL) in combination with imipenem (IMI) activity against
  KPC-producing Enterobacteriaceae, K. Papp-Wallace (Abstract No. 2629,
  12:30 – 1:30 p.m., Monday, April 24, Paper Poster Area)

For more information, including a complete list of presentation 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 nine compounds in Phase 2/Phase 3 clinical trials
for the potential treatment or prevention of infectious diseases.

About ZERBAXA

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
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 (ceftolozane and tazobactam) 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,
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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

Merck
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