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July 21, 2016 3:30 pm ET

Merck (NYSE: MRK), known as MSD outside the United States and Canada,
today said that the U.S. Food and Drug Administration (FDA) has
requested the submission of new data and analyses from the MODIFY I and
MODIFY II clinical trials previously submitted to the pending Biologics
Licensing Application (BLA) for bezlotoxumab, an investigational agent
for prevention of Clostridium difficile (C. difficile)
infection recurrence. The additional data and analyses constitute a
major amendment to the BLA, resulting in an extension of the
Prescription Drug User Fee Act (PDUFA) goal date by three months. The
new goal date will be Oct. 23, 2016.

The FDA granted Priority Review designation to the bezlotoxumab BLA,
with an original PDUFA goal date of July 23, 2016. On June 9, the
Antimicrobial Drugs Advisory Committee of the FDA voted 10-to-5, with
one abstention, in support of bezlotoxumab as showing substantial
evidence of efficacy and safety in preventing the recurrence of C.
difficile infection.

Merck looks forward to continuing to work with the FDA on the review of
the bezlotoxumab BLA.

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
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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 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).

Merck
Media:
Pamela Eisele, 267-305-3558
Robert Consalvo, 908-236-1127
or
Investors:
Teri Loxam, 908-740-1986
Amy Klug, 908-740-1898