Wilder,
Looks like the Dow Jones reporter has the same impression as you - No Safety issues raised. I'm no longer certain whether or not Side Effects were even discussed during the call.
Ian
+++++++++++++++++++++
Alexion: No Safety Issues Came From Pexelizumab Trial
DOW JONES NEWSWIRES
By Hollister H. Hovey
Of DOW JONES NEWSWIRES
NEW YORK -- Alexion Pharmaceuticals Inc. (ALXN) Chief Executive Leonard Bell said there's a "pretty remote possibility" that the Food and Drug Administration will say its first drug is not approvable, even though it failed to meet its primary endpoint in a large Phase III clinical trial.
The more likely scenario for the drug, called pexelizumab and studied in patients undergoing coronary artery bypass graft surgery, will be that the FDA might ask the company to run another Phase III trial or that the data from earlier trials and a secondary-endpoint analysis of the recent trial is enough for approval.
Investors aren't pleased, though, sending the stock down 21.7%, or $3.47, to $12.53 on volume of 1.6 million shares, compared with the 154,786 that cross the tape on an average full trading day.
The company plans to discuss the data with its marketing partner Procter & Gamble Pharmaceuticals, the drug unit of Procter & Gamble Co. (PG), and the FDA.
If the agency asks the company to run another clinical trial, P&G would share the costs 50-50, Bell said.
The news, released late Monday, didn't include the actual data from the Phase III trial. That will be made public at the annual meeting of the American Heart Association in Orlando this November.
The company did say the drug failed to meet its primary endpoint of reducing the incidence of death or heart attacks within 30 days of a patient undergoing coronary artery bypass graft surgery without a valve operation.
However, the company did test the drug on sicker patients who had to undergo procedure and valve surgery. When including those patients, the study did satisfy statistical requirements in cutting down on heart attacks and death, but that was only a secondary endpoint.
The data was reviewed by data safety monitoring board which brought up no specific issues from the trial, Bell said.
Alexion's President and Operating Chief David W. Keiser said that at this time the company, which is years away from profitability, should have a burn rate similar to the past year.
The company has $210 million in cash, he said.
In the nine months ended April 30, the company posted a loss of $62.9 million.
-By Hollister H. Hovey, Dow Jones Newswires |
