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Berger & Montague Announces Class Action Lawsuit Against Elan Corporation
Date:10/29/2008

made the results appear random, rather than drug-related.

(c) For nearly a year into the 18-month trial, AAB-001 and placebo patients were both losing cognition at the same rate. The lower rate in the drug-treated patients came about only because placebo patients suffered a steep loss of cognition at the end of the study. An effective drug would be expected to manifest its effect at an earlier stage in time.

(d) The non-gene carrier placebo patients loss cognition at the rate of 11 points on the scale used to measure cognition, compared with a 7 point loss of cognition by placebo patients in a much larger trial recorded publicly, and lower rates in other 18-month trials, which suggests that the condition of the placebo patients may have been more severe than the norm in such trials.

(e) The baseline score for the Mini Mental State Examination score for non-carrier placebo patients was 1.6 points lower than the score for the AAB-001 patients, a statistically significant difference. Thus, the condition of the placebo patients was worse than that of the AAB-001 patients at the state of the study, which indicated a likelihood that the placebo patients would deteriorate more rapidly than those treated with the drug.

(f) Twelve patients in the study treated with AAB-001 developed a potentially dangerous accumulation of fluid in the brain known as vasogenic edema. All of these cases resolved favorably, however, this condition was detected only by subjecting patients to numerous MRI scans. In the real world, Alzheimer's patients would not be monitored this closely, so that vasogenic edema remains an issue with respect to the drug. The condition was found in patients receiving the high dose of the drug, indicating that the high dose was unlikely to be a dose that could receive regulatory approval.

When these facts were revealed on July 29, 2008, the market price of Elan ADSs fell from a closing price of $33.75 on July 29th, to a closing pr
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SOURCE Berger & Montague, P.C.
Copyright©2008 PR Newswire.
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