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Biotech / Medical : IDPH--Positive preliminary results for pivotal trial of ID -- Ignore unavailable to you. Want to Upgrade?


To: Howard Hoffman who wrote (1389)12/4/1997 1:56:00 AM
From: Roger Cranwill  Read Replies (1) | Respond to of 1762
 
My concern about dropping CE9.1 is losing time-IDEC was on-track for marketing 9.1 about the same time as Immunex's arthritis drug-dropping 9.1 puts them of the other side of the curve in a market that will be unbelievably profitable (pardon my capitalism). Roger



To: Howard Hoffman who wrote (1389)12/5/1997 10:53:00 PM
From: I. Luttichuys  Read Replies (1) | Respond to of 1762
 
Howard... the thing to watch are the CD4 cells...
This has been a traditional problem with these kinds of therapies and this is why CE9.1 is out. During the earlier trials, I believe CD4 counts were relatively preserved but, in more extended trials, the counts fell and, CE9.1 was pretty much finished. I do not know exactly why this problem appeared only in subsequent trials. It may be something which was done differently during scale-up etc... hard to say but, anyway, you will notice IDEC makes it a point in the recent announcement to point out that CD4 cell populations were not disturbed. Will things stay that way... I don't know.
The reason Rituxan was a non-event was because the approval was widely anticipated. No one in my circles doubted it's approval for even a minute... for over a year, at least... everyone knew it would pass. The FDA worked very closely with IDEC on this one... it's not passing would have been an embarassment.
BENNETT



To: Howard Hoffman who wrote (1389)12/6/1997 3:11:00 AM
From: I. Luttichuys  Read Replies (2) | Respond to of 1762
 
I should add, Howard, that the cautious line would be to view SK's backing of the second generation anti-body as only marginally meaningful.
I only say this because, at one time, SK backed the failed CE9.1 version as well. If something goes wrong with this one, they'll dump it too.
Also, the decision to go onto phase II, while good news, doesn't make it any different than it's predecessor either.
I don't mean to be a drag at all. I've been in this stock for years. It's just that, what we have here at most, is another crack at the RA market. It's nice to get that chance but, so far, the trail looks just like CE9.1 which, as far as I know, showed only transient, if any, CD4 depletion in earlier trials. It wasn't until later that such problems showed up with sufficient severity to justify scuttling the trials. The very same course could occur here... then again, maybe not.
BENNETT