Friday, July 31, 2009

Asenapine Chronicles: WSJ Finally Discovers the Full FDA Background Materials. . . .

Well, better late than never, I guess. Jennifer Corbett Dooren, for The Wall Street Journal, has apparently found the 1,067 page PDF we've been blogging about for the last few days:

. . . .An FDA memo released in advance of the meeting said the data in support of Saphris' short-term efficacy, or effectiveness, in treating schizophrenia "are not overwhelming for this drug. . . ."

[And earlier, she wrote:]

If approved, Saphris would compete with other top-selling antipsychotic drugs like AstraZeneca's Seroquel . . . and Eli Lilly's top-selling drug Zyprexa. . . .

If nothing else, one would get the sense from The Wall Street Journal article that this is a market already crowded with best-selling, entrenched franchise names. And that -- coupled with the lukewarm-at-best official PDAC remarks -- may explain why Schering-Plough's stock actually fell into negative territory (even though it had gapped higher, at the NYSE open), after the PDAC vote news was released. For the last three NYSE Schering-Plough trading sessions, more than double the usual daily volume has crossed the tape. The smart money may be moving -- and moving, away (SGP topped the WSJ's "selling on strength" list, yesterday). We shall see. Overnight, Reuters quoted a BMO Capital analyst, thus:
. . . .BMO Capital Markets analyst Robert Hazlett boosted his sales estimates for the drug following the panel's positive vote, saying he expects Saphris to earn $25 million in 2009, $125 million in 2010 and $200 million in 2011. . . .

Only $200 million by the end of 2011. That would confirm my "already-crowded space" theory, on the drug.

Now, I guess, it is in the hands of the full Commission.


Anonymous said...

Thanks for the Haida Salmon. I tend to picture myself like this:

but alone.

Well, maybe with a condor flying above.


Condor said...

Ironic -- I almost chose that very same photo, last night -- but I decided it was too small to render well.

Tak a look above, now -- it is derived from some line-art.

Namaste, with gratitude. . . .

Anonymous said...

I don't think the WSJ has really found the true background yet.

I believe that statement about underwhelming efficacy was upfront and is actually a set up.

Every AC meeting I've been to FDA sets up questions or issues for the AC to address. In this case they made the AC focus on schizophrenia study 023 and why the 5 mg worked and the 10 mg didn't. This distracts from the real issues, i.e. hepatotox, cardiac tox, and the higher baseline and low placebo response in study 004.

As expected the clinicians, who don't know statistics said well if the 5 mg dose works it must work (especially since the 5 mg dose in study 004 works. NOT. Whereas the statistician, the expert, said he didn't believe the 5 mg dose hadn't been shown to work in study 023 and they never even discussed 004.

I'd like you to photoshop the YMRS quintile graph from page 761 and pages 791 and 792 in two separate blog posts and I'll explain the nuances of each one separately.

Anonymous said...

Only $200 million. This was a drug that predicted to have $2 billion in sales. Was the supposedly the #1 drug in potential sales of the 5 late stage compounds behind the purchase of Organon (I believe suggamadex was supposed to be #2 at $500 mil).

And was supposedly the driving force behind the $41 billion sale to Merck.

Now considering the net on these sales I wonder how many years of sales it will take to pay off the EMT's severence packages.