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Medivation Announces Presentation of New Subset Analyses From,Dimebon Phase 2 Alzheimer's Disease Trial at American Academy of,Neurology Annual Meeting

behavior. These endpoints were the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog), the Clinician's Interview-Based Impression of Change with a caregiver interview (CIBIC-plus), the Alzheimer's Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL), the Neuropsychiatric Inventory (NPI) and the Mini Mental State Exam (MMSE), the first two of which have been used by the U.S. Food and Drug Administration to register all drugs previously approved to treat mild-to-moderate Alzheimer's disease. The study was conducted at multiple sites in Russia. Patients received oral Dimebon, 20 mg three times a day (60 mg/day), or placebo.

Previously announced results from the six-month study showed that, overall, Dimebon-treated patients demonstrated significant improvement versus placebo on the primary endpoint of ADAS-cog (p<0.0001) and the key secondary endpoint of CIBIC-plus (p<0.0001). Dimebon-treated patients also significantly outperformed the placebo-treated patients (p<0.01) on the three additional secondary endpoints: the ADCS-ADL, the NPI and the MMSE.

Dimebon was well tolerated in this study. Dry mouth, which occurred in 13.5 percent of Dimebon-treated patients, was the only gastrointestinal side effect that occurred with an incidence higher than three percent. Fewer Dimebon-treated patients experienced serious adverse events than placebo- treated patients (2.2 percent versus 7.4 percent, respectively). A higher percentage of Dimebon-treated patients than placebo-treated patients completed the trial (87.6 percent and 81.9 percent, respectively), for an overall trial completion rate of 84.7 percent.

Teleconference/Webcast Details

Medivation will hold a teleconference tomorrow, Friday, May 4, at 9:00 a.m. Eastern time with Dr. Hung, Dr. Seely and Dr. Doody to discuss the data and answer questions. To participate in the live call by telephone, please dial 800-289-0485 from the U.S. or 913-981-5518 internationally.
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