Merck Statement on FDA Advisory Committee Meeting for BRIDION® (sugammadex), Investigational Agent for the Reversal of Neuromuscular Blockade (NMB) Induced by Rocuronium or Vecuronium

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today issued the following statement after the conclusion of a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee of the U.S. Food and Drug Administration (FDA) to discuss BRIDION® (sugammadex). BRIDION is the proposed trade name for Merck’s investigational agent for the reversal of neuromuscular blockade (NMB) induced by rocuronium or vecuronium.

“We believe that BRIDION has the potential to offer anesthesia professionals an important new option to reverse neuromuscular blockade in the surgical setting,” said Dr. David Michelson, head of global clinical development for neuroscience, Merck Research Laboratories. “Today’s discussion is one step in the regulatory process, and we look forward to working with the FDA as it completes the review of our New Drug Application for BRIDION.”

The FDA is not bound by the committee’s guidance but takes its advice into consideration when reviewing investigational medicines. The Prescription Drug User Fee Act (PDUFA) action date for the FDA’s review of BRIDION is Dec. 19, 2015.

If approved, BRIDION would be the first in a new class of medicines, known as selective relaxant binding agents, to be used in the U.S.

About Merck

Today’s Merck is a global health care 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 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 health care 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 of Merck & Co., Inc., Kenilworth, NJ, USA

This news release of Merck & Co., Inc., Kenilworth, NJ, USA (the “company”) 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 the company’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 healthcare legislation in the United States and internationally; global trends toward healthcare cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’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 the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company 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 the company’s 2014 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).

View source version on businesswire.com: http://www.businesswire.com/news/home/20151106005937/en/