Merck Statement on FDA Advisory Committee Meeting About Sugammadex Sodium Injection

Tuesday, July 16, 2013 12:01 pm EDT

Dateline:

WHITEHOUSE STATION, N.J.

Public Company Information:

NYSE:
MRK
"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"

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--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, programs and partnerships. For more information, visit www.merck.com 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.

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