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

To: Ian@SI who wrote (381)	11/10/2003 1:23:21 PM
From: Ian@SI	Respond to of 824

Now attempting to post remainder of PR... Alexion Announces Results of Phase III PRIMO-CABG Trial Presented At the American Heart Association's Scientific Sessions 2003 ... In further analyses, it appeared that the observed effects of pexelizumab in the PRIMO-CABG study may have been more pronounced in patients with a greater number of pre-specified risk factors at study entry. In this group of approximately 2,000 patients, Death / MI at Day 30 was reduced with statistical significance from 16.3% with placebo to 11.7% with pexelizumab (relative reduction 28%, p=0.003). Further analyses of subpopulations will be completed, and are expected to be presented at a subsequent cardiovascular scientific conference. The pexelizumab regimen appeared to be safe and well tolerated, with the most common serious adverse events observed being post-operative wound infection, pneumonia, respiratory failure, and pleural effusion. The most common adverse events observed were atrial fibrillation, anemia, nausea, and post-operative pain. Serious and common adverse event rates appeared to be similar between placebo and pexelizumab in the study population. "Pexelizumab statistically significantly reduced perioperative heart attack and all pre-specified measures of myocardial damage in this trial, and we are extremely pleased with the overall activity profile the drug provided in this large patient population," said Leonard Bell, M.D., Chief Executive Officer of Alexion. "As we had announced in August, while our objective to achieve statistical significance in the primary endpoint was not met, and although this trial alone may not provide a basis for us to seek approval, additional pre-specified analyses of the study have provided us with encouraging clinical information. This information supports our hypothesis that the terminal complement inhibitor pexelizumab would reduce myocardial infarction, that myocardial infarction would strongly predict mortality, and that the drug would have a beneficial effect on clinical morbidity and mortality. We continue to focus our regulatory strategy on ensuring the best and most timely development path forward for the potential success of pexelizumab." Conference Call Information Alexion will host a conference call/web cast to discuss matters mentioned in this release. The call is scheduled for Monday, November 10th at 3:00 p.m., Eastern Standard Time. To participate in this call, dial 913-981-5509, confirmation code 232605 shortly before 3:00 p.m. A replay of the call will be available for a limited period following the call, beginning 6:00 p.m., Eastern Time. The replay number is 719-457-0820, confirmation code 232605. The web cast can be accessed at alexionpharm.com. [snip]