Merck Statement on FDA Advisory Committee Meeting About Sugammadex Sodium Injection

  Merck Statement on FDA Advisory Committee Meeting About Sugammadex Sodium
  Injection

Business Wire

WHITEHOUSE STATION, N.J. -- July 16, 2013

Merck (NYSE: MRK), known as MSD outside the United States and Canada,
confirmed today that the U.S. Food and Drug Administration (FDA) has cancelled
Thursday’s discussion of sugammadex at the Anesthetic and Analgesic Drug
Products Advisory Committee (AADPAC). Sugammadex sodium injection is Merck’s
investigational medicine for the reversal of neuromuscular blockade (NMB)
induced by rocuronium or vecuronium.

The FDA advised Merck that the agency needs additional time to assess the
results of the FDA’s recently completed inspection of a clinical trial site.
The site was one of four sites that conducted the hypersensitivity study
previously requested by the agency. Merck is engaged in discussions with the
FDA to identify the steps necessary to enable the agency to complete its
review.

“Merck believes that sugammadex is an important treatment option for an unmet
medical need in anesthesia, and we will work with the FDA on the next steps to
bring this innovation forward to patients in the United States,” said David
Michelson, M.D., head of global clinical development for neuroscience, Merck
Research Laboratories.

Sugammadex is marketed in 40 countries other than the U.S., and more than five
million vials of sugammadex have been sold as of March 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,
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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).

Contact:

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