Salmon Surfaces, Sporting Some Salient Solvay Suspicions

Salmon is on point, again, here -- with a few additional, and entirely fascinating potential Solvay connections (as follow-up -- on my earlier post, detailing Abbott's purchase of Solvay):

. . . .There are other similarities.

Schering Plough -- Saphris/Asenapine: an antipsychotic whose approval was delayed.

Solvay -- bifeprunox -- an antipsychotic whose approval was delayed. (Nonapprovable -- but then again Vanda's iloperidone was nonapprovable and then was approved later).

See this, which quotes [FDA's] Bob Temple, apparently referring to the nonapproval of bifeprunox -- as it wasn't as effective as the active comparator.

But low and behold, iloperidone has since been approved, due to an about face by Tom Laughren and Bob Temple on the acceptability of the exact same studies which they previously said didn't support approval of iloperidone. (See my previous comments -- Just place "Salmon" in the Blogger Search-Box, at the top of this page.)

Press reports and quotes on websites from Spring of 2008 indicate Solvay was working on the deficiencies. (Notice the quotes from Esser the ex-CEO of Wyeth that was copromoting bifeprunox and the CEO of Novartis which was developing iloperidone until Titan/Vanda took it over.)

Also slightly after this, Janet Woodcock indicated that there would be delays in approvals, but the problems would go away in time.

And FDA would be shifting safety from pre-approval to post-marketing evaluation. (Hmmm) This seems almost as if she's talking about asenapine and iloperidone.

This also seems to coincide with the delays in the approvals for asenapine and iloperidone.

More recently Lundbeck and Solvay seem to have dropped the maintenance study approach with bifeprunox.

But then who knows what will happen to bifeprunox under Abbott.

Perhaps it will be resurrected just like iloperidone without the need for additional studies.

Remember drugs have a strange way of coming back to life (just click the image, at right, for proof of this, re Asenapine/Saphris). Just like vampires in the old movies they never really die. For if they were really dead the companies would say so and then FDA could release the data. Now considering the slide on bifeprunox in the asenapine background package and other information that can be gleaned from public information and from comparing it to public info on structurally similar drugs such as iloperidone and ziprasidone. I'd say that I could come up with be some pretty interesting information just as I was able to make inferences about asenapine from Lilly's olanzapine and from AZ's quetiapine data.

-- Salmon

September 30, 2009 6:22 PM

As ever, my sincere thanks go to the erstwhile Salmon, for the immense "value-added", here!