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Biotech / Medical : Regeneron Pharmaceuticals -- Ignore unavailable to you. Want to Upgrade?

To: Icebrg who wrote (881)	10/8/2003 11:47:55 AM
From: Biomaven	Read Replies (3) \| Respond to of 3557

They made the point in the CC that they had been constrained by fiscal concerns and drug supply concerns from running a decent-sized trial. Those constraints are now in the past. I believe them that they could have gotten statistical significance with a bigger trial. But there is still a concern here in terms of effect size. These numbers are a long way from Enbrel and other TNF-inhibitors, but nevertheless they are still possibly better than Kineret levels and will likely exceed it if they can bump the dose a little. (Note that Kineret is by daily injection, so a weekly dose would be a substantial advantage). Here are the Kineret numbers at 3 months by way of comparison (Study 1 from their label, patients on concomitant MTX - numbers without DMARDs are similar): ACR 20: 24% PBO vs. 34% drug ACR50: 6% vs 13% ACR70: 0% vs 3% Here are the REGN numbers from this trial: ACR 20: 30.9% PBO vs. 46% drug ACR50: 9.1% vs 20% ACR70: 3.6% vs 12% Note also that the REGN 12% ACR70 response is actually better than Remicade and not much worse than Enbrel (15%). But of course note that comparisons across trials are always dangerous. Peter