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September 11, 2018 5:45 am ET

Company Plans to Submit Supplemental New Drug Applications in the US and EU

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck & Co., Inc. (NYSE: MRK), known as MSD outside the United States
and Canada, today announced that the pivotal Phase 3 clinical study
evaluating the company’s antibiotic ZERBAXA^® (ceftolozane and
tazobactam) at an investigational dose for the treatment of adult
patients with either ventilated hospital-acquired bacterial pneumonia
(HABP) or ventilator-associated bacterial pneumonia (VABP) met the
pre-specified primary endpoints, demonstrating non-inferiority to
meropenem, the active comparator, in Day 28 all-cause mortality and in
clinical cure rate at the test-of-cure visit. In the U.S., ZERBAXA is
currently indicated in adult patients for the treatment of complicated
urinary tract infections, including pyelonephritis, caused by certain
Gram-negative microorganisms, and is indicated, in combination with
metronidazole, in adult patients for the treatment of complicated
intra-abdominal infections caused by certain Gram-negative and
Gram-positive microorganisms.

Based on these results, Merck plans to submit supplemental new drug
applications to the U.S. Food and Drug Administration (FDA) and European
Medicines Agency (EMA) seeking regulatory approval of ZERBAXA for this
potential new indication. The company plans to submit results from the
study for presentation at a future scientific conference.

“HABP and VABP are serious and life-threatening hospital related
pulmonary infections, especially in patients with severe underlying
medical conditions,” said Dr. Roy Baynes, senior vice president, head of
global clinical development and chief medical officer, Merck Research
Laboratories. “The results from the ASPECT-NP study demonstrate the
potential role of ZERBAXA for the treatment of patients with HABP and
VABP.”

About the ASPECT-NP study

This prospective, randomized, double-blind, multicenter,
non-inferiority, Phase 3 study assessed the safety and efficacy of
ZERBAXA compared with meropenem in 726 adult patients diagnosed with
either ventilated HABP or VABP requiring intravenous antibiotic therapy.
In the study, ZERBAXA was administered in an investigational 3g dose
compared with meropenem 1g, each given intravenously every eight hours
for 8 to 14 days, or for 14 days for Pseudomonas aeruginosa
infection. Meropenem is an approved broad-spectrum injectable antibiotic
widely used to treat serious infections.

Additional details about the study can be found online at https://www.clinicaltrials.gov/ct2/show/NCT02070757.

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 1.5g (ceftolozane 1g and tazobactam 0.5g) 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 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.

Merck’s commitment to infectious diseases

For more than 100 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, antiviral
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 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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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 2017 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 & Co., Inc.
Media:
Pam Eisele, 267-305-3558
Robert Consalvo, 908-295-0928
or
Investors:
Michael DeCarbo, 908-740-1807