Medivation Initiates Second Pivotal Phase 3 Trial of Dimebon(TM) in Patients With Alzheimer...( - Dimebon Showed Statistically Sign...),Health

- Dimebon Showed Statistically Significant Benefit Versus Placebo on All

Key Efficacy Endpoints in First Pivotal Trial -

SAN FRANCISCO, June 9 /PRNewswire-FirstCall/ -- Medivation, Inc. (Nasdaq: MDVN) today announced it has initiated dosing of patients in its second pivotal Phase 3 trial of the investigational drug Dimebon(TM) in patients with mild-to-moderate Alzheimer's disease (AD). The international, double-blind, placebo-controlled safety and efficacy study of oral Dimebon is known as the CONNECTION study.

"We saw very encouraging results in our first pivotal trial, in which Dimebon demonstrated statistically significant improvements over placebo on all five efficacy endpoints at both six months and at one year. We look forward to confirming the efficacy and safety of Dimebon in the CONNECTION study," said Lynn Seely, M.D., Chief Medical Officer of Medivation. "The initiation of this study brings us a major step closer to our goal of obtaining regulatory approval for Dimebon. We are working to bring this investigational drug to market as quickly as possible to address the unmet medical need in Alzheimer's disease and bring hope to patients and caregivers."

The U.S. Food and Drug Administration (FDA) has informed Medivation that the CONNECTION study together with the previously completed pivotal trial can be used 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 CONNECTION study are located in the United States. Medivation expects to complete the CONNECTION study and apply for U.S. and European marketing approval in 2010.

Design of CONNECTION Study

The CONNECTION study will enroll approximately 525 p
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