At the outset, let me be clear: this is in no way intended as any criticism of current New Merck management. They are simply trying to make lemonade, from some old legacy Schering-Plough lemons.
No, the fault lies with the moon-eyed leadership of legacy Schering-Plough, for drinking too much of its own lemonade. [Although, I suppose to be fair, some small fault should lie with the former legacy Merck Chairman and CEO, for believing “Fast” Fred Hassan’s snake-oil pitches, as the diligence was conducted — on the Schering-Plough yard sale. But only a small portion.]
In any event, what was hailed as Fred Hassan’s lead star for the years 2008-2009, is just now — almost five years later — ready to seek US market approval.
Sales of Bridion® have limped along at an immaterial level in the EU, ever since it was approved in July 2008. Without full US reimbursement, and a strong case for its clearly-additive benefits — in US surgical suites — I predict this will never be a material drug franchise for New Merck.
Once again, this is likely just finishing off the last bit of spend — on what may be a half-billion dollars of previously-sunk costs at legacy Schering-Plough. If New Merck can recoup some of that with a US market approval, that is the likely best case rationale — for today’s announcement.
From Whitehouse Station, this morning, then:
. . . .Sugammadex sodium injection is the company’s investigational agent for the reversal of neuromuscular blockade (NMB) induced by rocuronium or vecuronium (neuromuscular blocking agents). NMB is used in anesthesiology to induce muscle relaxation during surgery. Sugammadex is designed to work by inactivating rocuronium or vecuronium molecules directly by encapsulation. If approved, it would be the first in a new class of medicines in the U.S. known as selective relaxant binding agents to be used in the surgical setting.
In 2008, the FDA did not approve the original NDA for sugammadex sodium injection, requesting additional data related to hypersensitivity (allergic) reactions and coagulation (bleeding) events. Merck submitted this requested data within the NDA resubmission, which the FDA has now deemed complete for review. . . .
Just the same, I’d look for Mr. Frazier to remark upon the FDA filing at tonight’s JP Morgan conference in San Francisco. We will keep you posted.