Merck Statement on FDA Advisory Committee Meeting for Suvorexant


May 22, 2013 5:28 pm ET

Merck (NYSE: MRK), known as MSD outside the United States and Canada,
today provided the following statement after the conclusion of the
Peripheral and Central Nervous System Drugs Advisory Committee meeting
of the U.S. Food and Drug Administration (FDA) about suvorexant, Merck’s
investigational medicine to treat insomnia.

“We are excited about the potential of suvorexant as a new and different
approach to treating insomnia, a serious condition that affects up to
one-third of the adult population,” said Darryle Schoepp, Ph.D., senior
vice president and head of Neuroscience and Ophthalmology, Merck
Research Laboratories. “Today’s votes and discussion bring us one step
closer to providing physicians with another option to help patients
struggling with insomnia. We look forward to working with the FDA as the
agency continues its review of our application.”

If approved, suvorexant would be the first in a new class of medicines,
called orexin receptor antagonists, for use in patients with insomnia, a
condition characterized by difficulty falling asleep and/or staying
asleep. Suvorexant’s novel mechanism is distinct from current
treatments. Merck researchers developed suvorexant to block the action
of orexins, neurotransmitters in a specific part of the brain that help
to keep a person awake. By temporarily blocking the actions of orexins,
suvorexant helps to facilitate sleep.

The FDA will consider the Committee’s recommendations as it completes
its review of the New Drug Application (NDA) for suvorexant. The FDA is
not bound by the Committee’s guidance, but takes its advice into
consideration when reviewing investigational medicines. Merck
anticipates FDA action on suvorexant in mid-year. 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 typically takes place after FDA approval.

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
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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 (

Pam Eisele, 908-423-5042
Tracy Ogden, 267-305-2301
Carol Ferguson, 908-423-4465
Justin Holko, 908-423-5088

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