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Medivation Reports First Quarter 2009 Financial Results and Provides Corporate Update
Date:5/11/2009

data from a small-scale safety and tolerability trial of Dimebon added to donepezil, which found the combination to be well tolerated.
  • Completed a multicenter, randomized, double-blind, placebo-controlled Phase 1 study to evaluate the safety and tolerability of Dimebon given to Alzheimer's disease patients who currently are on a stable dose and regimen of memantine (Namenda(R)) or memantine plus donepezil. The study showed that these combinations were well tolerated.
  • In addition to the CONNECTION and CONCERT trials and a Phase 3 safety study already underway, we and Pfizer plan to initiate two additional Phase 3 studies in 2009 that will evaluate Dimebon in a total of approximately 1,100 patients with moderate-to-severe Alzheimer's disease.
  • Expect to initiate a Phase 3 trial this year to evaluate Dimebon's potential benefits on cognition in patients with mild-to-moderate Huntington's disease.
  • Presented posters featuring Dimebon at the 61st American Academy of Neurology Annual Meeting in Seattle on April 29 and 30, including a poster entitled "Estimating Disease-Modifying Effects Using a Staggered Start Approach and a Natural History Staggered Start (NHSS) Approach: Preliminary Results from a 12-Month Study of Dimebon and a 6-Month Open-Label Period."
  • Presented a poster at the American Geriatrics Society meeting in Chicago on May 1.

    • MDV3100

    • Received written permission from the U.S. Food and Drug Administration to initiate a pivotal Phase 3 trial of MDV3100 in castration-resistant prostate cancer in men who were previously treated with docetaxel-based chemotherapy; the primary endpoint of this randomized, placebo-controlled, double-blind, multinational trial will be overall survival.
    • Announced publication of an article in the May 8 issue of Science, present
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    SOURCE Medivation, Inc.
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