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July 1, 2013 7:00 am ET

Merck (NYSE: MRK), known as MSD outside the United States and Canada,
announced today that the company has received a Complete Response Letter
from the U.S. Food and Drug Administration (FDA) regarding the New Drug
Application for suvorexant, Merck’s investigational medicine for the
treatment of insomnia.

In the Complete Response Letter, the FDA advised Merck that:

• the efficacy of suvorexant has been established at doses of 10 mg to
  40 mg in elderly and non-elderly adult patients;
• 10 mg should be the starting dose for most patients, and must be
  available before suvorexant can be approved;
• 15 mg and 20 mg doses would be appropriate in patients in whom the 10
  mg dose is well-tolerated but not effective; and,
• for patients taking concomitant moderate CYP3A4 inhibitors, a 5 mg
  dose would be necessary.

In addition, the FDA determined that the safety data do not support the
approval of suvorexant 30 mg and 40 mg.

“We will evaluate the requests outlined in the Complete Response Letter,
and expect thereafter to work expeditiously with the FDA to make
suvorexant available as a new treatment option for patients suffering
from insomnia,” said Roger M. Perlmutter, M.D., Ph.D., president, Merck
Research Laboratories.

Based on initial review of the letter, Merck has determined that
additional clinical studies of suvorexant 10 mg will not be necessary.
However, manufacturing studies will be required to advance the 10 mg
dosage form. Merck will discuss with the FDA whether additional studies
will be required to support the 5 mg dose.

As previously disclosed, both FDA approval and a separate scheduling
determination by the U.S. Drug Enforcement Administration are required
before Merck can introduce suvorexant in the United States.

Insomnia is a condition characterized by difficulty falling asleep
and/or staying asleep. Today, insomnia affects up to a third of adults
and there is a clear need for additional treatment options.

If approved, suvorexant would be the first in a new class of medicines,
called orexin receptor antagonists, for use in patients with insomnia.
Suvorexant’s novel mechanism is distinct from current treatments. Merck
researchers developed suvorexant to facilitate sleep by blocking the
action of orexins, which are neurotransmitters in the brain that help to
keep a person awake.

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
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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. These statements are based
upon the current beliefs and expectations of Merck’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; Merck’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 Merck’s patents and other protections
for innovative products; and the exposure to litigation, including
patent 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 2012 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
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