* FDA needs more time to analyze data -Merck
* Merck says no new safety concerns cited by FDA
* Shares down 0.7 percent
By Ransdell Pierson
March 15 The U.S. Food and Drug Administration
will not complete its review of Merck & Co's
experimental medicine to reverse the effects of anesthesia until
the second half of 2013, representing a three-month delay, the
Merck acquired the product, called sugammadex, through its
merger in 2009 with Schering-Plough Corp. The product has faced
numerous regulatory delays but is deemed by many analysts and
doctors to be one of the biggest advances in anesthesia in
The FDA in 2008 said it could not approve sugammadex until
Merck provided more clinical trial data related to allergic
reactions and blood clots, possible side effects of the drug.
Merck early this year said it had completed the necessary trials
and that the FDA had accepted the company's resubmitted
marketing application for the drug.
Merck spokeswoman Pam Eisele on Friday said the FDA, in
notifying the drugmaker about the expected delay in making a
decision on the drug, did not cite any new safety issues.
"We've maintained regular meetings and discussions with the
FDA, with a commitment to making sugammadex available in the
United States," she said.
Sugammadex is already sold in 75 countries under the brand
name Bridion and had 2012 global sales of $261 million. That
makes it a modest-sized product for Merck, the second-largest
Cowen and Co has projected global annual sales for the drug
of $575 million by 2016, if it is approved in the United States.
It would be the first in a new class of medicines in the
United States known as selective relaxant binding agents. It is
designed to inactivate the effects of two widely used anesthesia
drugs, rocuronium and vecuronium, and thereby help patients
recover far more quickly from anesthesia.
Merck shares were down 0.7 percent at $43.97 on Friday
morning on the New York Stock Exchange.