Medivation Plans to Initiate Pivotal Confirmatory Phase 3 Trial of Dimebon(TM) for Alzheimer's Disease in Second Quart...( - Conference Call Today a...),Health

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SAN FRANCISCO, Jan. 28 /PRNewswire-FirstCall/ -- Medivation, Inc. (Nasdaq: MDVN) today announced that, based on its end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), the Company plans to begin a pivotal confirmatory Phase 3 trial of Dimebon(TM) for mild-to-moderate Alzheimer's Disease in the second quarter of 2008.

The FDA informed Medivation that the company's previously completed trial conducted in Russia can be used as one of the two 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.

"We are now a Phase 3 company with clear regulatory guidance on the pivotal trials required to seek marketing approval for Dimebon in the United States," said David T. Hung, M.D., president and chief executive officer of Medivation. "This is a significant step forward for Medivation, and validates our strategy to advance Dimebon directly into a pivotal Phase 3 trial."

The Phase 3 clinical trial will enroll approximately 525 patients with mild-to-moderate Alzheimer's disease at 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 (TID); Dimebon 5 mg TID; and placebo. Patients will be treated for six months and may not be taking any other Alzheimer's disease drugs. The primary endpoints 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).

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