Tuesday, December 2, 2008

Schering to Conduct Additional Safety Trials on Sugammadex -- in 2009 -- thus FDA Approval Not Likely Before 2012

[UPDATED -- 12.03.08 @ 9 AM EST: Reuters is now carrying my story -- with nearly the same narrative elements: ". . . .Just last week, Schering-Plough touted the drug as one of five "stars" of its research pipeline at a meeting with investors. . . ." -- Cool!

And earlier, that gentleman at Pharmalot, Ed Silverman, had hat-tipped mine -- for his story on it.]

Man -- this stuff just writes itself. . . .

Well, the mystery of the missing Schering Investor FAQs has been solved, tonight.

A new "Investor FAQs" file, dated today, was just uploaded. It hasn't been filed with the SEC, yet. Look for that, tomorrow.

So, what's the [all-too-predictably-buried] headline, here -- out of Kenilworth, after-hours?

A newly-FDA-requested SAFETY study, for Sugammadex. Yep. Y A W N. Another delay in any future US market approval for Sugammadex -- even though CEO Hassan was touting it, just last week (11.24.08), at the Schering R&D Day web-cast (image of that slide coming here below):

On November 24, 2008, Fred Hassan said Schering was "working through" the issue of getting Sugammadex approved by FDA. This is a very big setback. A multi-year setback, in all likelihood.

Strangely, the November 14, 2008 FAQ-file just re-appeared. Quoting from today's file, now:

. . . .The company has an ongoing dialogue with the FDA regarding sugammadex and recently met with the FDA. In order to address issues which primarily related to hypersensitivity/allergic reactions, the Company plans to conduct an allergy sensitivity trial in healthy volunteers that will include repeat exposure to sugammadex. The study protocol is being developed, and the Company anticipates conducting the trial in 2009. . . .

Repeat exposures to sugammadex -- that, in turn, will require multiple courses of general anesthesia -- that means these volunteers must have multiple surgical procedures, or at least get multiple generals. That alone could take years, to reach a statistically-meaningful number of multiple surgery/multiple general anesthesia patient-volunteers.

So much for Schering's fifth "star", eh?


T said...

Your predictions are probably way off.

Considering the planned trial is in healthy volunteers, it's definitely not going to involve multiple surgeries. It's unlikely (from an ethical point of view) it will even incorporate multiple GAs. You can run a multiple-dose allergy study with... well... multiple doses of the drug.

Could be quick and easy, and could take a matter of months to commence and run.

Condor said...

Well that's a definte "maybe", T.

I think it significant that Seamus Fernandez is now predicting NO FDA filing before 2010, here. This, no approval prior to 2012 looks like a safe bet, from where I sit.

Care to take a truly friendly wager?

Of course, you could just recruit 500 or so very-healthy college kids, pay them to be pit under, then be brought out with the aid of sugammadex -- and get to an "n" that way --but what real scientific world-benefit would that data set actually entail? Would FDA approve, on such a data set?

With an Obama-appointee at FDA, I'd put the odds as pretty small. . . But that's what males it an attractive wager-- to each of us!


Condor said...

Excuse all the typos -- darn iPhone!

Anonymous said...

I don't know. It really depends how long it will take to enroll and conduct the study,.

The review period for a major response like this is 6 months. So the FDA won't be the rate limiting step. The time frame really depends on the size, ease of recruitment, availability of sites etc..

Even if they get started with the FPI (first person in) in Jan 09 and say take 15 months until (LPO), with the write up it might be possible to submit mid-'10 and get an approval by beginning of '11.

That said it's going to depend on those other factors which we don't have a good handle on. Plus recruiting for a safety study in healthy volunteers might make recruiting more difficult than usual with an informed consent that essentially says: We're going to put you under general anesthesia and then wake you up with a drug to see whether you have an anaphylactic reaction to it that might kill you, but we can always try to slice open your throat and put you on a respirator or restart your heart if the worse should happen.



Condor said...

Yeah what Salmon wrote. Heh!

Anonymous said...

P.S. I forgot as a NME there will be a required advisory committee meeting. The FDA will need some time to prepare the background materials for the AC so even if they finish the review by month 4, have the AC meeting by month 6, then they'll still need to finish up negotiating labeling. So this might add a couple of months to the FDA timeline until they issue a letter.

All said, it's possible to have an approval in 2011, although I wouldn't be surprised if it's not til 2012. Plus this assumes no more problems. Overall I would be afraid to make any bets.

Scott said...

Why would study participants ever need to be "put out" to receive multiple doses of sugammadex for an allergic reaction / hypersensitvity study? This should be able to easily be done on awake volunteers. As a mmater of fact the information from awake volunteers would be more valuable, I would think.

Condor said...

I appear here tonight, solely to note that Merck will see an FDA approval no earlier than June of 2015 now. 2015. Not 2011. Not 2012. Not 2013 or 14. 2015?!

I hate being right -- in this instance.

Poor trial design (Hassan led), poor legal/regulatory strategy in then EVP & GC Sabatino's law department. . . and eight years later. . . it is still months away from US market launch.

Pathetic. Namaste, just the same.