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Medivation Initiates Second Pivotal Phase 3 Trial of Dimebon(TM) in Patients With Alzheimer's Disease
Date:6/9/2008

atients with mild-to-moderate Alzheimer's disease at approximately 100 sites in the United States, Europe and South America. Patients will be randomized to one of three treatment groups: Dimebon 20 mg three times per day, Dimebon 5 mg three times per day or placebo. Patients may not be taking any other Alzheimer's disease drugs during the trial. After completing six months of treatment, all patients -- including those randomized to placebo -- will be offered the opportunity to receive Dimebon in an extension trial until marketing authorization.

The primary endpoints of the trial are the Alzheimer's Disease Assessment Scale -- cognitive subscale (ADAS-cog) and the Clinician's Interview-Based Impression of Change plus caregiver interview (CIBIC-plus). These are the two endpoints that have been accepted by the FDA to support registration of all approved drugs for Alzheimer's disease.

"Currently available therapies for Alzheimer's disease have modest effects, for the most part," said Pierre Tariot, M.D., Director, Memory Disorders Center, Banner Alzheimer's Institute. "There is an urgent need for new treatments for a disease with such devastating effects on the quality of life of patients and their caregivers. Dimebon represents an innovative form of therapy that may have the potential to ameliorate symptoms and possibly improve the course of Alzheimer's disease. It is crucial that it be fully assessed as rapidly as possible."

For more information on the CONNECTION study, please visit http://www.connectionstudy.com or call 1-877-888-MDVN (1-877-888-6386).

Results of First Pivotal Phase 3 Trial

Medivation previously announced results from its first pivotal trial of Dimebon in 183 patients with mild-to-moderate Alzheimer's disease, which showed that Dimebon improved the clinical course of Alzheimer's disease by demonstrating statistically significant improvements over placebo in
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SOURCE Medivation, Inc.
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