Dimebon(TM) for Alzheimer's

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"Given the safety and significant efficacy data generated in our recently completed Phase 2 trial in Alzheimer's disease, we believe that aggressive development of Dimebon is clearly merited," said David Hung, M.D., president and chief executive officer of Medivation. "We, therefore, are pleased to announce a comprehensive clinical development program that we believe puts us on-track to apply for marketing approval in Alzheimer's disease in 2010. "

To support these target submission dates, Medivation intends to conduct global Phase 3 development programs in Alzheimer's disease and Huntington's disease beginning in 2008. For 2007, Dimebon development will focus on completing efficacy studies in both Alzheimer's diseases, and preparing for global Phase 3 studies. Key Dimebon development activities in 2007 include:

-- Completing Alzheimer's disease one-year Phase 2 efficacy trial (Russia);

-- Conducting Phase 1 clinical trial (U.S.);

-- Conducting Alzheimer's disease Phase 2 dose finding clinical trial (U.S.);

-- Manufacturing Dimebon for use in global Phase 3 clinical trials.

"Because of Dimebon's long history of commercial use in Russia, we had the unusual opportunity to proceed directly to a large efficacy study with the same duration of treatment and clinical endpoints used by the U.S. Food and Drug Administration (FDA) to approve drugs for mild to moderate Alzheimer's disease," explained Lynn Seely, M.D., chief medical officer of Medivation. "Taking this approach provided us with risk-reducing data on the safety and efficacy of Dimebon in Alzheimer's patients sooner than would have been possible under a more traditional drug development pathway. Moving forward, we will complete standard regulatory requirements before starting Phase 3 in Alzheimer's disease."