Category Archives: FDA Wall Street Journal Online Schering Plough NDA ANDA

It is usually unwise to complain about the FDA, for the record, in your company’s name, in the Wall Street Journal

. . . . but, in the case of Schering-Plough, and CEO Fred Hassan — that rule doesn’t really apply, inasmuch as Schering has so very little good-will left to lose with the FDA. Mr. Hassan certainly has seen his credibility tarnished — with the FDA, various states attorneys’ general (NY, CT and OR, at least), the DoJ, the SEC, and at least two investigatory arms of Committees of Congress, as well.

So Hassan fires the long guns, this morning, at FDA ($, subs. req’d.). . . . and misses the target altogether:

. . . .Over the past 16 months, Schering-Plough Corp. Chief Executive Fred Hassan and his top scientists have pulled the plug on two drug-development projects — one for obesity and the other for cholesterol — that had the potential to produce big sellers. And they’re considering scrapping a third [VLA 4]. . . .

. . . .”What will it take to get a new drug approved?” asks Mr. Hassan. “The point is, we don’t know. . . .”

Well, that doesn’t exactly inspire confidence, does it?

Moreover, to suggest pulling the plug on already-filed NDAs or ANDAs — due primarily to excessive levels of regulation — is puzzling. Isn’t this supposed to be a core competency — navigating FDA back-waters — of any credible pharmaceutical company? I think so. Apparently, Mr. Hassan doesn’t. Odd.

His remarks ought to make the shareholders very happy (not). I am sure they are glad they spent all that money — just for Mr. Hassan to say, effectively, “UM. . . never mind“. doubly odd. Such a maneuver would decrease Schering’s pipeline when it desperately needs new products — and when we’ve all been told that it has one of the best pipelines in all of pharma. Could that have been a less-than-complete truth? What piece of news — very likely negative — about Schering — is this interview, preemptively granted by Mr. Hassan, designed to draw the bee’s sting away from?

Should Hassan decide to pull VLA 4 (a candidate-drug to treat multiple sclerosis, and to be taken orally — an injected version, developed by another company, now under review at FDA, has been linked to brain infections), it will save some (mostly nominal) expense-burn-rate, though — to be fair.

Sugammadex’s delay is also highlighted — presumably as a result of remarks made by Hassan, or other Schering spokespeople — in the Wall Street Journal article — so it could be year-end 2008, or later, before that drug is approved in the US. [Earlier, stock analysts’ models expected revenue from that drug in the third quarter of 2008. That seems impossible, now.]

Blaming the federal government because the CEO chooses to pursue what have turned out to be unsuitable drug candidates (for FDA approval) is transparently unbecoming — it is simply an attempted blame-shift.

Et tu, Fred?

I guess his strategem is “what do we have (left) to lose?” Not really a reason to inspire new investment positions in Schering-Plough, eh? The traders, over on the NYSE, this morning, agree with me, I gather — Schering stock is once-again now falling.