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Merck Receives Complete Response Letter for Investigational Medicine Sugammadex Sodium Injection



  Merck Receives Complete Response Letter for Investigational Medicine
  Sugammadex Sodium Injection

Business Wire

WHITEHOUSE STATION, N.J. -- September 23, 2013

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) for the resubmission of the New Drug
Application for sugammadex sodium injection, Merck’s investigational medicine
for the reversal of neuromuscular blockade induced by rocuronium or
vecuronium.

The FDA’s letter raised concerns about operational aspects of a
hypersensitivity study that the agency had requested in 2008. Merck is
evaluating the Complete Response Letter and expects to be able to determine a
path forward in the very near future.

“We believe sugammadex is an important innovation, and will work closely with
the FDA to bring this product to hospitals, surgeons, anesthesia professionals
and patients in the United States,” said David Michelson, M.D., head of global
neuroscience clinical development, Merck Research Laboratories.

As previously disclosed, the FDA cancelled the discussion of sugammadex at the
July 18th Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC).
At that time, the FDA advised Merck that the agency needed additional time to
assess the results of the agency’s recently completed inspection of a clinical
trial site conducting the hypersensitivity study.

Neuromuscular blockade is used in anesthesiology to induce muscle relaxation
during surgery. Sugammadex is designed to work by inactivating rocuronium or
vecuronium, two neuromuscular blocking agents, directly by encapsulation. If
approved, sugammadex would be the first in a new class of medicines, known as
selective relaxant binding agents, to be used in the U.S. Sugammadex is
currently marketed in more than 50 countries other than the U.S., and more
than 5 million vials have been sold as of June 2013.

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.

Merck 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).

Contact:

Media:
Pam Eisele, 908-423-5042
or
Sarra Herzog, 908-423-6154
or
Investors:
Carol Ferguson, 908-423-4465
or
Justin Holko, 908-423-5088
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