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Biotech / Medical : Alexion Pharmaceuticals, Inc. (ALXN) -- Ignore unavailable to you. Want to Upgrade?

To: Ian@SI who wrote (379)	11/10/2003 1:15:36 PM
From: Ian@SI	Read Replies (1) \| Respond to of 824

Alexion Announces Results of Phase III PRIMO-CABG Trial Presented At the American Heart Association's Scientific Sessions 2003 CHESHIRE, Conn., Nov. 10 /PRNewswire-FirstCall/ -- Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) announced today that Edward D. Verrier, M.D., William K. Edmark Professor and Chief of Cardiothoracic Surgery at the University of Washington, presented the Phase III trial results of the investigational drug pexelizumab in patients undergoing coronary artery bypass graft ("CABG") surgery with cardiopulmonary bypass - "Pexelizumab for Reduction in Infarction and Mortality in Coronary Artery Bypass Graft Surgery," or PRIMO-CABG. The results were presented today at the Late Breaking Clinical Trials Session of the American Heart Association Scientific Sessions in Orlando, Florida. Alexion conducted the PRIMO-CABG trial together with Procter & Gamble Pharmaceuticals, and initially described top-line observations of the trial in a press release dated August 4, 2003. Alexion will host a conference call and web cast today at 3:00 p.m. EST to discuss the matters mentioned in this release. The total Intent-to-Treat population (n=3,099) consisted of patients undergoing CABG-alone (n=2,746) and patients who had CABG together with cardiac valve surgery (n=353). The primary endpoint in this trial was the incidence of death or myocardial infarction ("Death/MI") at post-operative Day 30 in the subpopulation of study patients who had only CABG surgery (n=2,746). The incidence of Death/MI, the primary endpoint, was reduced by 18% (11.8% placebo vs. 9.8% pexelizumab, p=0.069). Although the primary endpoint was not met with statistical significance, pexelizumab did achieve statistically significant reductions in the same Death/MI endpoint in each additional secondary analysis: * Day 30 in the overall Intent to Treat population (18% relative reduction; placebo 14.0%, pexelizumab 11.5%; p=0.030) * Day 4 in the overall Intent to Treat population (24% relative reduction; placebo 11.9%, pexelizumab 9.1%; p=0.008) * Day 4 in the CABG-only subpopulation (26% relative reduction; placebo 10.0%, pexelizumab 7.4%; p=0.014) Additionally, pexelizumab achieved statistically significant reductions in the following Myocardial Infarction (MI) secondary analyses: * Day 30 in the overall Intent to Treat population (18% relative reduction; placebo 12.0%, pexelizumab 9.8%; p=0.042) * Day 30 in the CABG-only subpopulation (22% relative reduction; placebo 10.3%, pexelizumab 8.1%; p=0.036) * Day 4 in the overall Intent to Treat population (24% relative reduction; placebo 11.1%, pexelizumab 8.4%; p=0.010) * Day 4 in the CABG-only subpopulation (27% relative reduction; placebo 9.3%, pexelizumab 6.7%; p=0.012) [snip]

To: Ian@SI who wrote (379)	11/10/2003 1:48:56 PM
From: rkrw	Read Replies (2) \| Respond to of 824

I'd guess the probably not-so-prospectively defined secondary endpoints of death at 4 and 30 days were much closer to random than the .096 at 90 days. I tried to reverse calculate what possible death outcomes were and came up with 4 Day: 9 drug, 10 Placebo 30 Day: 27 Drug, 30 Placebo 90 Day: 56 Drug, 74 Placebo If I remember correctly for the phase II the gap in death at 90 days had narrowed slightly from 30 days. Hate to say it, but I don't think they're going to get approval without a second, larger phase III. If so, that could push approval back to at least 2007 imo.