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January 27, 2016 8:30 am ET

FDA Grants Priority Review with Target Action Date of July 23, 2016

Marketing Authorization Application Also Filed with the European Medicines Agency

Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced that the U.S. Food and Drug Administration (FDA) has
accepted for review the Biologics License Application (BLA) for
bezlotoxumab, an investigational antitoxin for prevention of Clostridium
difficile (C. difficile) infection recurrence. The FDA
granted Priority Review for bezlotoxumab, with a Prescription Drug User
Fee Act (PDUFA) action date of July 23, 2016.

The company also has filed a marketing authorization application for
bezlotoxumab with the European Medicines Agency (EMA) that is currently
under review.

“Recurrence is a major challenge with C. difficile infection, one
of the most common healthcare-associated infections in U.S. hospitals,”
said Dr. Roy Baynes, senior vice president of clinical development,
Merck Research Laboratories. “Currently, there are no therapies approved
for the prevention of C. difficile infection recurrence. As part
of Merck’s commitment to the fight against infectious diseases, we look
forward to continuing to work with the FDA and EMA to bring forward this
novel medicine for appropriate patients.”

The application for bezlotoxumab is based in part on data from the
pivotal MODIFY
I and MODIFY II clinical trials. Data from these trials were
previously presented at the Interscience Conference of Antimicrobial
Agents and Chemotherapy (ICAAC) and International Congress of
Chemotherapy and Infection (ICC) 2015 joint meeting.

About bezlotoxumab

Bezlotoxumab is an investigational antitoxin given in conjunction with
standard of care antibiotics that are used in the treatment of C.
difficile infection. It is not an antibiotic. Bezlotoxumab is
designed to neutralize C. difficile toxin B, a toxin that can
damage the gut wall and cause inflammation, leading to C. difficile-associated
diarrhea.

About Merck

Today’s Merck is 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, NJ, 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:
Pamela Eisele, 267-305-3558
Robert Consalvo, 908-236-1127
or
Investors:
Teri Loxam, 908-740-1986
Amy Klug, 908-740-1898