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Medivation Announces Publication in The Lancet of Dimebon Pivotal Trial Results in Alzheimer's Disease
Date:7/17/2008

the Alzheimer's Disease and Memory Disorders Center, Baylor College of Medicine in Houston. "There is a clear need for new treatments that can add value and enduring benefit to the treatment of Alzheimer's disease. The results of this trial suggest that, if the findings are replicated, Dimebon could advance Alzheimer's treatment, offering more hope for patients and their caregivers."

Dimebon was well-tolerated throughout the trial. There was no difference between the Dimebon and placebo groups in the number of patients with adverse events, and the most common side effects seen were dry mouth (18 percent versus 1 percent for placebo) and depressed mood/depression (15 percent versus 5 percent for placebo). Importantly, fewer patients treated with Dimebon had serious adverse events than did patients on placebo at the end of the study (3 percent versus 12 percent; p=0.03).

Additional analyses of the Dimebon pivotal study data presented at recent medical conferences showed that Dimebon's impact extended to caregivers. Behavioral improvements in Dimebon-treated patients resulted in a significant decrease in caregiver distress at six months and at one year compared to the distress of caregivers of placebo-treated patients. Further, after six months, caregivers of Dimebon-treated patients saved approximately one hour per day assisting patients with activities of daily living compared to caregivers of placebo-treated patients.

"The magnitude, consistency and duration of the beneficial effects of Dimebon demonstrated in this trial are striking," said Paul Aisen, M.D., Director, Alzheimer's Disease Cooperative Study (ADCS) and Professor in the Department of Neurosciences, University of California, San Diego (UCSD). "In addition, the drug has been well-tolerated to date and, if the safety profile is replicated in the ongoing international trial, it will be a substantial advance for this patient population prone to drug side effects."

"We are pleased
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SOURCE Medivation, Inc.
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