Merck Announces FDA Acceptance of New Drug Application for Suvorexant, an Investigational Insomnia Medicine

  Merck Announces FDA Acceptance of New Drug Application for Suvorexant, an
  Investigational Insomnia Medicine

Business Wire

WHITEHOUSE STATION, N.J. -- November 08, 2012

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today
announced that the New Drug Application (NDA) for suvorexant, the company's
investigational insomnia medicine, has been accepted for standard review by
the U.S. Food and Drug Administration (FDA). Suvorexant will be evaluated by
the Controlled Substance Staff of the FDA during NDA review. If approved by
the FDA,suvorexant will become available after a schedule assessment and
determination has been completed by the U.S. Drug Enforcement Administration,
which routinely occurs after FDA approval. The company is continuing with
plans to seek approval for suvorexant in other countries around the world.

The NDA for suvorexant was based on data from a broad clinical development
program, including: two pivotal, three-month efficacy trials that evaluated
the ability of suvorexant to help patients fall asleep and stay asleep; a
12-month study, followed by a two-month discontinuation phase, that was
designed to assess the safety of suvorexant, while also evaluating its longer
term efficacy and the impact of stopping treatment; and two next-day driving
studies that provided an assessment of residual effects following evening use
of suvorexant.

"The discovery and development of innovative medicines that help patients is
our goal at Merck, and insomnia is a common disorder where patients are
seeking new treatments," said Darryle D. Schoepp, Ph.D., senior vice president
and franchise head, Neuroscience and Ophthalmology, Merck Research
Laboratories. "Suvorexant is a novel mechanism for the treatment of insomnia,
and the filing of suvorexant is an example of Merck's commitment to patients
and to scientific excellence."

Merck researchers developed suvorexant to target and block orexins, chemical
messengers that help to keep you awake. By temporarily blocking the actions of
orexins, suvorexant helps to facilitate sleep. If approved, suvorexant would
be the first in a new class of medicines, called orexin receptor antagonists,
for use in patients with difficulty falling or staying asleep.

About Merck

Today's Merck is a global healthcare 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 consumer care 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

This news release includes “forward-looking statements” within the meaning of
the safe harbor provisions of the United States Private Securities Litigation
Reform Act of 1995. Such statements may include, but are not limited to,
statements about the benefits of the merger between Merck and Schering-Plough,
including future financial and operating results, the combined company’s
plans, objectives, expectations and intentions and other statements that are
not historical facts. Such statements are based upon the current beliefs and
expectations of Merck’s management and are subject to significant risks and
uncertainties. Actual results may differ from those set forth in the
forward-looking statements.

The following factors, among others, could cause actual results to differ from
those set forth in the forward-looking statements: the possibility that all of
the expected synergies from the merger of Merck and Schering-Plough will not
be realized, or will not be realized within the expected time period; the
impact of pharmaceutical industry regulation and health care legislation in
the United States and internationally; Merck’s ability to accurately predict
future market conditions; dependence on the effectiveness of Merck’s patents
and other protections for innovative products; and the exposure to litigation
and/or regulatory actions.

Merck 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 Merck’s 2011
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).

Contact:

Merck
Media:
Pam Eisele, 908-423-5042
or
Lesley Brown, 267-305-3545
or
Investors:
Carol Ferguson, 908-423-4465
 
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