Medivation Completes Enrollment In Phase-III Alzheimer’s Trial

Medivation has completed patient enrollment in the six-month, confirmatory, pivotal Phase-III trial of the investigational drug dimebon, in patients with mild-to-moderate Alzheimer’s disease.

The pivotal Phase-III study enrolled 598 patients. The study will evaluate the effect of dimebon on the Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-cog) and the Clinician’s Interview-Based Impression of Change plus caregiver interview (CIBIC-plus).

Lynn Seely, CMO of Medivation, said: Completion of patient enrollment in this second pivotal trial moves us closer to our goal of submitting a marketing application to the FDA and bringing dimebon to market for the many Alzheimer’s patients suffering from this devastating disease.

We are gratified by the strong interest in this trial as indicated by our exceeding the enrollment goal. Together with our partner Pfizer, we are executing a comprehensive clinical plan to support an NDA filing, currently targeted for 2011, with a broad and differentiated label for dimebon in Alzheimer’s disease. We are also conducting a Phase 3 safety study, which will provide us and Pfizer the opportunity to seek marketing approval earlier if results of the Connection study confirm our previously completed first pivotal study, which was published in the Lancet last year, he added.