Friday, March 15, 2013

Legacy S-P's Bridion® Delayed. Again. And Again. And Again.

I've been reporting on the highly-likely -- and later, actual -- delays related to legacy Schering-Plough's Bridion® drug candidate, in providing the data required to secure US FDA approval, since at least December of 2008. Today's FDA news brings yet another. Yawn.

[Bridion has turned out to be only a very modest performer, for new Merck, selling about $260 million in 75 countries, other than the US, in 2012. It was once the first among Ex-CEO "Fast" Fred Hassan's Five Stars in late 2008, though.]

Per Reuters, then -- do go read it all:

. . . .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 drugmaker said.

Merck acquired the product, called sugammadex, through its merger in 2009 with Schering-Plough Corp. The product has faced numerous regulatory delays. . . .

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. . . .
So, all in -- that's at least five years of delays, here. We will keep you posted, but I'd not expect FDA communication before December of 2013, now. Either way, it is not material to New Merck's nearly $50 billion in annual revenue. And so it goes.

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