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

to see our first pivotal trial culminate with publication of its significant findings in such a prestigious journal," said David Hung, M.D., President and Chief Executive Officer of Medivation. "Currently available therapies treat the symptoms of Alzheimer's disease with only modest effect. The Dimebon study is the first study in which a drug has achieved statistically significant benefits of this breadth, size and duration in a one year, well-controlled trial. These data, coupled with our recently announced positive results in Huntington's disease, suggest that Dimebon could be a novel therapy for the treatment of neurodegenerative diseases. We look forward to the completion of our confirmatory pivotal Phase 3 study of Dimebon in Alzheimer's disease."

About the Pivotal Study

In the trial, 183 patients with mild-to-moderate Alzheimer's disease were randomized to receive Dimebon (20 mg three times a day, administered orally) or placebo for six months. 134 patients continued treatment in a blinded manner for an additional six months (one year total treatment) in the same group to which they were originally randomized; 120 of these patients (90 percent) completed the trial.

Earlier this year, the U.S. Food and Drug Administration (FDA) informed Medivation that this study can be used as one of the pivotal studies required to support the approval of Dimebon to treat mild-to-moderate Alzheimer's disease, as long as a significant proportion of the sites in the confirmatory Phase 3 trial are located in the United States. The Company recently began a confirmatory pivotal Phase 3 trial of Dimebon in Alzheimer's disease known as the CONNECTION study. Patients and caregivers can learn more about the study by visiting http://www.connectionstudy.com or by calling 1-877-888-6386.

About Dimebon

Dimebon is an orally available small molecule that has been shown to inhibit brain cell death in
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SOURCE Medivation, Inc.
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