SAN FRANCISCO, July 17 Medivation, Inc.(Nasdaq: MDVN) today announced publication of the results of its firstAlzheimer's disease pivotal clinical trial of the investigational drug Dimebonin the July 19, 2008 issue of The Lancet. In this double-blind,placebo-controlled trial, patients with mild-to-moderate Alzheimer's diseasetreated with Dimebon experienced statistically significant improvementscompared to placebo in all the key aspects of the disease: memory andthinking, activities of daily living, behavior and overall function.
After both six months and a full year of treatment, Dimebon-treatedpatients were significantly better than placebo-treated patients on all keyaspects of the disease. The benefit on the primary endpoint, the Alzheimer'sDisease Assessment Scale-cognitive subscale (ADAS-cog) at six months, washighly significant (p<0.0001). Patients treated with Dimebon were alsosignificantly improved at six months over baseline on all measures (p=0.005 onADAS-cog). Dimebon's benefit over placebo continued to increase throughoutthe 12-month treatment period. At the end of 12 months, Dimebon-treatedpatients preserved their starting level of function on each measure ofAlzheimer's disease.
"In this study, Dimebon improved the clinical course of Alzheimer'sdisease, which is important given that the natural course is progressivedeterioration over time," said Rachelle Doody, M.D., Ph.D., lead author andthe Effie Marie Cain Chair in Alzheimer's Disease Research at the Alzheimer'sDisease and Memory Disorders Center, Baylor College of Medicine in Houston."There is a clear need for new treatments that can add value and enduringbenefit to the treatment of Alzheimer's disease. The results of this trialsuggest that, if the findings are replicated, Dimebon could advanceAlzheimer's treatment, offering more hope for patients and their caregivers."
Dimebon was well-tolerated throughout the trial. There was no differencebetween the Dimebon and placebo groups in the number of patients with adverseevents, and the most common side effects seen were dry mouth (18 percentversus 1 percent for placebo) and depressed mood/depression (15 percent versus5 percent for placebo). Importantly, fewer patients treated with Dimebon hadserious adverse events than did patients on placebo at the end of the study (3percent versus 12 percent; p=0.03).
Additional analyses of the Dimebon pivotal study data presented at recentmedical conferences showed that Dimebon's impact extended to caregivers.Behavioral improvements in Dimebon-treated patients resulted in a significantdecrease in caregiver distress at six months and at one year compared to thedistress of caregivers of placebo-treated patients. Further, after sixmonths, caregivers of Dimebon-treated patients saved approximately one hourper day assisting patients with activities of daily living compared tocaregivers of placebo-treated patients.
"The magnitude, consistency and duration of the beneficial effects ofDimebon demonstrated in this trial are striking," said Paul Aisen, M.D.,Director, Alzheimer's Disease Cooperative Study (ADCS) and Professor in theDepartment of Neurosciences, University of California, San Diego (UCSD). "Inaddition, the drug has been well-tolerated to date and, if the safety profileis replicated in the ongoing international trial, it will be a substantialadvance for this patient population prone to drug side effects."
"We are pleased to see our first pivotal trial culminate with publicationof its significant findings in such a prestigious journal," said David Hung,M.D., President and Chief Executive Officer of Medivation. "Currentlyavailable therapies treat the symptoms of Alzheimer's disease with only modesteffect. The Dimebon study is the first study in which a drug has achievedstatistically significant benefits of this breadth, size and duration in a oneyear, well-co