Merck Statement on FDA Advisory Committee Meeting for Suvorexant

  Merck Statement on FDA Advisory Committee Meeting for Suvorexant

Business Wire

WHITEHOUSE STATION, N.J. -- May 22, 2013

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 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. 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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