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Biotech / Medical : Elan Corporation, plc (ELN) -- Ignore unavailable to you. Want to Upgrade?

To: Qualified Opinion who wrote (4410)	5/26/2003 8:52:41 AM
From: Icebrg	Read Replies (1) \| Respond to of 10345

Rob I am not quite sure what you mean when you refer to "that way". My original point was that it is perhaps not very useful to compare phase II trial results for Remicade and Antegren to judge each drugs chance of success in the marketplace (provided Antegren gains approval). There are a couple of reasons for this. As Remicade and Antegren work in completely different ways it is even possible that the two drugs will complement each other. That it never will become a matter of either/or, but rather "how much of each". To use Remicade phase II results may not be very useful. I have not looked into any details, but it is at least very possible that several different trials were run to find the best balance between safety and efficacy (that is at least the way a company like J&J should have handled this matter). To gain the best information on how Remicade works for patients with Crohn's, it is better to look for the phase III results. These were run with a higher number of participants and under what the company considered ideal conditions. This is where the true character of Remicade should manifest itself. As for the Antegren phase II trials, it appears as if the phase II trial was underpowered (didn't even reach its primary endpoints) and there was a mismatch in the randomization. (Most probably there was no randomization done with regard to what additional medicines these patients were taking). What conclusions can one draw from such a trial? As more patients in the placebo group were on supportive medication this may actually be a positive factor for Antegren, but it points to the difficulties the company may run into when designing the clinical study. The end result will anyhow be, that we may be restricted in the conclusions we can draw from this trial. It looks promising, but that's about it. The presence of shall we call it supportive care is however also a problem if one attempts to compare the Remicade results with what was achieved with Antegren. For the results to be comparable, it would be necessary for the patients in both the Remicade and Antegren trials to have been drawn from the same pool of participants. They should be equally sick and they should to the same extent be taking the same supportive medication. Results from say patients who are not so severely sick and who don't take any medication might differ very much from very sick persons who are already medicating heavily. To make things even worse, the combination effect of say a 5-ASA like drug and Remicade might be very different from the one of 5-ASA and Antegren. Most probably the combination of 5-ASA and Antegren will give a better result as both 5-ASA and Remicade are both directly anti-inflammatory. It may however also be the other way around. I trust you get the idea. Erik