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Medivation's Dimebon(TM) Significantly Improved Daily Function in Alzheimer's Disease Patients, Resulting in Reduced Need for Caregiver Assistance
Date:4/15/2008

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Dimebon Showed Statistically Significant Benefit Versus Placebo on All Key Efficacy Endpoints

Medivation previously announced efficacy and safety results from the pivotal, 12-month, double-blind, placebo-controlled trial of Dimebon in 183 patients with mild-to-moderate AD. Dimebon improved the clinical course of Alzheimer's disease patients by causing statistically significant improvements over placebo in each of the five primary aspects of the disease -- memory, thinking, activities of daily living, behavior and overall clinical function. Significant gains over placebo were evident after as little as 12 weeks of treatment, and were maintained after both six months and a full year of treatment. In addition, after six months of treatment, Dimebon patients were significantly better on all five disease aspects than they were at the beginning of the study. The real-world impact of these data was evaluated by independent assessment, including caregiver interviews, which confirmed improvement or stabilization in 81 percent of Dimebon-treated patients after six months of treatment. Importantly, Dimebon's overall benefit compared to placebo continued to increase over time, and was larger at one year than at six months.

Dimebon was well-tolerated throughout the entire one-year treatment period. The majority of adverse events were mild, with dry mouth (18.0 percent Dimebon, 1.1 percent placebo) and depressed mood the most common events. There were significantly fewer serious adverse events in the Dimebon group than in the placebo group at one year.

Medivation is planning to initiate a second, confirmatory pivotal Phase 3 trial of Dimebon in mild-to-moderate AD in the second quarter of 2008 with the goal of completing the trial and applying for U.S. and European marketing approval in 2010. The Company is also evaluating Dimebon in an ongoing Phase 2 clinical trial in mild-to-moderate Huntington's disease. Dimebon is an orally-available small
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SOURCE Medivation, Inc.
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