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September 18, 2015 2:00 pm ET

Company Initiates Pivotal Phase 3 Studies Evaluating Relebactam in Combination with Imipenem/Cilastatin for Treatment of Serious Bacterial Infections

Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced that a Phase 2 study of relebactam, the company’s
investigational beta-lactamase inhibitor for the treatment, in
combination with imipenem/cilastatin (an approved carbapenem
antibiotic), of complicated intra-abdominal infections, met its primary
endpoint, and that Merck is now initiating pivotal Phase 3 studies. In
the Phase 2 study, relebactam in combination with imipenem/cilastatin
demonstrated noninferiority in the percentage of microbiologically
evaluable patients with favorable clinical response at the end of
intravenous therapy compared to imipenem/cilastatin alone. The addition
of relebactam is designed to restore activity of imipenem against
certain imipenem-resistant strains of Gram-negative bacteria, including Pseudomonas
aeruginosa and Klebsiella pneumoniae carbapenemase
(KPC)-producing Enterobacteriaceae.

The results were presented at the Interscience Conference of
Antimicrobial Agents and Chemotherapy (ICAAC) and International Congress
of Chemotherapy and Infection (ICC) joint meeting in San Diego, Sept.
17-21.

“New medicines are urgently needed to address the growing threat of
antibiotic-resistant bacteria,” said Dr. Nicholas Kartsonis, associate
vice president, infectious disease clinical research, Merck Research
Laboratories. “We look forward to advancing our Phase 3 clinical program
evaluating relebactam, in combination with imipenem/cilastatin, for use
in the treatment of several complicated Gram-negative bacterial
infections, and to continue to build on Merck’s commitment to infectious
diseases.”

In this multicenter, double-blind Phase 2 study, 351 adult patients with
complicated intra-abdominal infections, most commonly complicated
appendicitis (53%) and complicated cholecystitis (17%), were randomized
to receive either relebactam 250mg, relebactam 125mg or placebo, each
given intravenously in combination with imipenem/cilastatin 500mg every
six hours for 4 to 14 days. The percentage of microbiologically
evaluable patients with favorable clinical response at the end of
intravenous therapy, the primary efficacy endpoint, was similar across
treatment groups: relebactam 250mg (96.3%) (n=83), relebactam 125mg
(98.8%) (n=87) and placebo (95.2%) (n=85).

Safety analysis focused on adverse events occurring while on intravenous
study therapy or during the 14 days following the end of therapy. The
most common adverse events (nausea, diarrhea and vomiting) occurred at
similar rates across treatment groups: relebactam 250mg (6.8%, 6.0%,
6.0%), relebactam 125mg (7.8%, 6.0%, 7.8%) and placebo (7.0%, 4.4%,
2.6%), respectively.

Phase 3 Clinical Program of Imipenem/Cilastatin/Relebactam Initiated

Based in part on the results of this Phase 2 study, Merck is planning to
initiate two pivotal Phase 3 clinical studies of relebactam with
imipenem/cilastatin given as a fixed-dose combination. A study comparing
imipenem/cilastatin/relebactam to colistimethate sodium in combination
with imipenem/cilastatin for the treatment of imipenem-resistant
bacterial infections, including those caused by P. aeruginosa and
KPC-producing organisms, is currently recruiting patients. Infections
evaluated in this study are hospital-acquired bacterial pneumonia,
ventilator-associated bacterial pneumonia, complicated intra-abdominal
infections and complicated urinary tract infections. (www.ClinicalTrials.gov
Identifier: NCT02452047)

A second Phase 3 study, which will initiate later this year, will
compare treatment with the fixed-dose combination of
imipenem/cilastatin/relebactam to piperacillin/tazobactam in patients
with hospital-acquired and ventilator-associated bacterial pneumonia. (www.ClinicalTrials.gov
Identifier: NCT02493764)

About Relebactam

Relebactam is an investigational intravenous, class A and C,
beta-lactamase inhibitor currently being evaluated in combination with
imipenem/cilastatin for the treatment of certain complicated
Gram-negative bacterial infections. In preclinical studies, relebactam
administered in combination with imipenem demonstrated antibacterial
activity against a broad range of Gram-negative and
beta-lactam-resistant pathogens. The U.S. Food and Drug Administration
(FDA) has designated this combination as a Qualified Infectious Disease
Product (QIDP) with designated Fast Track status for the treatment of
hospital-acquired bacterial pneumonia, ventilator-associated bacterial
pneumonia, complicated intra-abdominal infections and complicated
urinary tract infections.

About Merck

Today’s Merck is a global healthcare leader working to help the world be
well. Merck is known as MSD outside of 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 healthcare through
far-reaching policies, programs and partnerships. For more information,
visit www.merck.com
and connect with us on Twitter,
Facebook
and YouTube.

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 2014 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).

Merck
Media:
Doris Li, (908) 246-5701
Ian McConnell, (973) 901-5722
or
Investor:
Teri Loxam, (908) 740-1986
Justin Holko, (908) 740-1879