By Dow Jones Business News, March 15, 2013, 11:21:00 AM EDT
--Merck now expects FDA to complete review of postsurgical drug in second half of year
--Sugammadex is available outside U.S. but FDA rejected it in 2008
--FDA is reviewing additional data submitted by Merck
(Adds analyst's comment in 3rd paragraph; additional details and background throughout.)
By Peter Loftus
Merck & Co. ( MRK ) said the U.S. Food and Drug Administration has extended by three months its review of the company's
application to market a new postsurgical drug.
Merck now expects the agency to complete its review of the drug, sugammadex, in the second half of this year. Merck
previously said in January it expected the FDA to complete the review by midyear.
Three-month extensions by FDA are relatively common, and don't necessarily indicate the chances of regulatory
approval, said ISI Group analyst Mark Schoenebaum.
Sugammadex was designed to reverse the effects of muscle-relaxation agents used in surgery. The Whitehouse Station,
N.J., company acquired the drug with its 2009 takeover of Schering-Plough.
The FDA had rejected Schering-Plough's original application for sugammadex in 2008, despite a positive recommendation
from a panel of outside advisers to the agency. The FDA asked for additional information about allergic reactions and
bleeding events, which Merck later submitted.
Sugammadex is already approved for sale in many countries outside the U.S., marketed under the brand Bridion. World-
wide sales were $261 million for 2012. J.P. Morgan estimated sales will grow to $979 million in 2020.
Merck is hoping for regulatory approval of several new drugs to help replace sales lost to generic competition for
older drugs such as the asthma and allergy treatment Singulair, which lost U.S. patent protection last year. The company
recently named a new research-and-development chief.
The company's R&D efforts have hit some setbacks, including a delay in the planned regulatory submission of an
experimental osteoporosis drug, odanacatib, and the recent termination of development of the cholesterol drug Tredaptive
after a study showed it provided no significant benefit to patients.
Merck shares declined 0.6% to $44 in recent trading.
Write to Peter Loftus at email@example.com
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