Merck Highlights Ongoing Commitment to Fighting Infectious Diseases with More than 30 Data Presentations at ID Week 2016

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October 26, 2016 7:00 am ET

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

.



Merck
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or
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