UPDATED 10.27.08 — Do go read Part Three of the Continuing Asenapine Chronicles. Follow the link.
In comments, earlier, Salmon laid out some fascinating inferences from the Schering Asenapine press release of yesterday. They deserve a much-wider audience — thanks, Salmon!
Do take a look:
. . . .Asenapine was filed over a year ago. It should have been approved already, yet nothing has been announced. When you have an add-on a study like this — with no news on an approval and safety data to come out at a later time — it points to major safety issues with a drug.
Since structurally similar compounds with major safety issues are marketed i.e., Zyprexa and even Clozapine with restricted access, this points to potentially huge safety issues. [Is this] another study carefully-designed with exclusion of certain subjects (e.g. bipolar) that may be intended to dilute out and obfuscate serious adverse effects[?]. . . .
[Later. . . . Do click on the image, at right, to view full size.] For what it’s worth — this study appears to be the same as the one the results were reported on, towards the end of last May or early June. If that’s the case, then SP should have already had more than enough time to complete their analysis of safety data and to submit the results during the present review cycle. If there is a safety issue especially in bipolar this study would dilute the overall incidence rates.
I looked at SP’s press release, and it was a 6 month placebo controlled study in 700 people at doses of 5 mg and 10 mg with only about 380 people on asenapine with some sort of run-in period — that made no sense — and may indicate they were screening out people (e.g., who switched meds from an active control during acute treatment), and either lost efficacy, or then had toxicities on asenapine.
If half the people on asenapine received 5 mg and half 10 mg then only about 165 people got the higher dose. Based on this, you can’t even be guaranteed to see even a single case of a serious dose related toxicity [if that outcome were to occur] in 1% of people. Plus, this says nothing of cumulative toxicites, that show up after 6 months. Since there’s no active comparator (the most obvious would be Zyprexa) you can’t even tell if it’s less safe than Zyprexa — which is likely also intentional.
Overall, things look very fishy.
Quite well-reasoned, and yes, indeed, they do. . . . Again, thanks for taking the time to share your expertise, and practiced perspective, here, Salmon!
Even later (in commentary, below), Salmon has this to offer:
There are other things that are suspicious about this program. For example this drug has been in development for decades. It simply doesn’t take that long to do 4 – 6 week acute efficacy studies in an illness that’s common and for which it’s easy to show efficacy. (Preclinical prior to human studies only takes 2-3 years max.)This suggests that there were either safety or efficacy problems(or both) noted a long long time ago.
Pfizer also dropped codevelopment of the compound which was proposed to bring in over $2 billion/year.
The fact that we haven’t heard anything in the last 2 – 3 months when we expect to hear at least something and we’ve got additional bad news with Vytorin during the same timeframe suggests that SP doesn’t want to release any more bad news at the same time and drive the stock price even lower. (Looks like withholding of material facts to me.)
Plus maybe you can comment on this, but it this were such a great drug why wouldn’t Azko Nobel simply take Organon public like they planned rather than sell it outright to SP. Looks like AN simply took the money and washed their hands of a dud with problems.
October 24, 2008 4:27 PM
[My thoughts on Salmon’s last paragraph, immediately above, are now in these comment-streams.]
Subsequently, an anonymous commenter just offered an echoing concern — and an excellent observation:
I agree with Salmon. There is something ‘amiss’ here.
Why did Pfizer pass on this? You could say Azko didn’t move on their own as they wanted to rid themselves of pharmaceuticals — to concentrate more on chemicals. But Pfizer passing. . . . must be something wrong.
October 24, 2008 5:57 PM