FDA: Schering-Plough’s Sugammadex, or Bridion®, is “Non-Approvable”! — Ouch!

Despite an EU approval just a couple of days ago — the US FDA has declared the Schering anesthesia drug Bridion^®, or sugammadex, not approvable. I’ll have much more shortly (including a shiny original graphic — DONE! — see at right), but here is the Marketwatch story. Off 9 now 7.5 percent in NASDAQ pre-market trading (small volumes, though, to be fair). Wow.

[I'm tempted to say "told ya' so" -- with my earlier prediction for FDA approval of sugammadex coming in 2009 -- but I won't. He~He!]

It seems the FDA wants additional data on allergic reactions — and while that doesn’t directly point to concerns about efficacy — it does portend a rather substantial additional delay. As I mentioned last night — it seems deficient data sets out of Schering are an emerging theme — first from two Congressional Committee Chairs, now FDA. So much for that “bump” to Schering EPS in 2008 — or even 2009(?). That would-be $600 million market just became about $200 million, for the foreseeable future. Said another way, the 2.4 cents in EPS pick-up I posited two days ago just became one shiny penny. Just one cent of EPS, for the foreseeable future. Ouch.