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Medivation Reports Fourth Quarter and Year-End 2008 Financial Results and Provides Corporate Update
Date:3/16/2009

we and Pfizer elect to pursue that option.
  • Plan to initiate enrollment next month in our Phase 3 CONCERT trial, a 12-month safety and efficacy study evaluating Dimebon in combination with donepezil (Aricept(R)) in approximately 1,000 patients with mild-to-moderate Alzheimer's disease.
  • 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.
  • Huntington's Disease

    • Held an end-of-Phase 2 meeting at which the U.S. Food and Drug Administration (FDA) informed us that we could begin a Phase 3 trial of Dimebon in patients with Huntington's disease using the Mini-Mental State Examination (MMSE) and the Clinician's Interview-based Impression of Change, plus caregiver input (CIBIC-plus) as co-primary endpoints. Discussions with the European regulators are ongoing. We expect to begin this study in 2009.
    • Presented the data from the Phase 2 trial of Dimebon in Huntington's disease patients at the 9th International Conference on Alzheimer's and Parkinson's Diseases (AD/PD) held last week. Results showed Dimebon to be well tolerated and to significantly improve cognition as measured by the MMSE.

    Mechanism of Action (MOA)

    • Presented new data at various medical conferences, including the recent AD/PD conference, that provide additional evidence that Dimebon potentially stabilizes and improves mitochondrial function in a way that prevents neuron death and dysfunction, a mechanism thought to be distinct from currently available Alzheimer's disease medications.
    • At AD/PD, we presented new research from the Karolinska Institutet, which quantified the impact of Dimebon on mitochondrial function. Responses were seen on mitochondria
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