Medivation and Pfizer : Results from Phase 3 Concert Trial of Dimebon in Alzheimer's Disease

January 17, 2012 - Dimebon Did Not Meet Primary Efficacy Endpoints - Medivation, Inc. (NASDAQ: MDVN) and Pfizer Inc. (NYSE: PFE) announced results from the CONCERT trial, which is a Phase 3 trial that evaluated dimebon (latrepirdine) when added to ongoing treatment with donepezil HCL tablets in patients with mild-to-moderate Alzheimer's disease. Dimebon did not achieve statistically significant results for either of the two co-primary endpoints, the Alzheimer's Disease Assessment Scale — cognitive subscale (ADAS-cog), which measures cognitive ability, or the Alzheimer's Disease Cooperative Study — Activities of Daily Living (ADCS-ADL), which measures self care and daily function.

"We are disappointed in the CONCERT results and the implications for Alzheimer's disease patients and their caregivers," said David Hung, M.D., president and CEO of Medivation. "I would like to extend my sincere thanks to the patients, their physicians and study teams involved in this trial."

Dimebon was generally well tolerated in the study. A full analysis of the results from CONCERT will be conducted and submitted for presentation at an upcoming scientific congress.

Medivation and Pfizer will discontinue development of dimebon for all indications and will terminate the ongoing open label extension study in Alzheimer's disease. The companies also announce that they will terminate their collaboration to co-develop and market dimebon pursuant to the terms of their Collaboration Agreement... Medivation's Press Release - Pfizer's Press Release -

Pfizer and Medivation : Global Agreement to Co-Develop and Market Dimebon for the Treatment of Alzheimer's and Huntington's Diseases

Sep 03, 2008 - Pfizer Inc (NYSE: PFE) and Medivation, Inc.(NASDAQ: MDVN) announced that they have entered into an agreement to develop and commercialize Dimebon, Medivation's investigational drug for treatment of Alzheimer's disease and Huntington's disease. Dimebon currently is being evaluated in an international, confirmatory Phase III trial in patients with mild-to-moderate Alzheimer's disease.
Under the terms of the agreement, Medivation will receive an up-front cash payment of $225 million. Medivation also is eligible to receive payments of up to $500 million upon the attainment of development and regulatory milestones plus additional undisclosed commercial milestone payments. Medivation and Pfizer will collaborate on the Phase III program in Alzheimer's disease, Huntington's disease development and regulatory filings in the United States. The companies will share all U.S. development and commercialization expenses along with U.S. profits/losses on a 60 percent/40 percent basis, with Pfizer assuming the larger share of both expenses and profit/losses. In addition, Medivation will co-promote Dimebon to specialty physicians in the U.S...


... Alzheimer's disease leads to the death of brain cells and the loss of nerve connections in areas of the brain that govern memory, thinking and behavior. Alzheimer's disease gradually destroys a person's memory and ability to learn, reason, make judgments, communicate and carry-out daily activities. No currently marketed Alzheimer's disease drug appears to stop brain cell death and prevent or restore lost nerve connections.
Dimebon is an orally-available, small molecule that has been shown to inhibit brain cell death in preclinical models relevant to Alzheimer's disease and Huntington's disease, making it a potential treatment for these and other neurodegenerative conditions. Based on preclinical data generated to date, Dimebon appears to improve the function of mitochondria, the energy generators in cells that play a vital role in governing brain cell health, growth and overall function. Dimebon also has been shown to stimulate the outgrowth of nerves from brain cells, or neurites, a process that is believed to play an important role in restoring or generating new brain cell connections... Medivation's Press Release - Pfizer's Press Release -

Medivation : Publication in The Lancet of Dimebon Pivotal Trial Results in Alzheimer's Disease

July 17, 2008 - Dimebon Improved the Clinical Course of Alzheimer's Disease; Patients Experienced Statistically Significant Improvements in Memory and Thinking, Activities of Daily Living, Behavior and Overall Function - Medivation, Inc. (Nasdaq: MDVN) announced publication of the results of its first Alzheimer's disease pivotal clinical trial of the investigational drug Dimebon in the July 19, 2008 issue of The Lancet. In this double-blind, placebo-controlled trial, patients with mild-to-moderate Alzheimer's disease treated with Dimebon experienced statistically significant improvements compared to placebo in all the key aspects of the disease: memory and thinking, activities of daily living, behavior and overall function.

After both six months and a full year of treatment, Dimebon-treated patients were significantly better than placebo-treated patients on all key aspects of the disease. The benefit on the primary endpoint, the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) at six months, was highly significant... Medivation's Press Release -

Medivation : Dimebon Improves Significantly Thinking and Memory in Alzheimer's Disease Patients Over One Year

April 17, 2008 - Medivation, Inc. (Nasdaq: MDVN) announced that Alzheimer's patients treated with the investigational drug Dimebon(TM) showed improvement in the key aspects of cognitive function over a one-year period compared with placebo. The improvement occurred in not only memory and language, but also in more complex functions such as awareness of time and place, and praxis -- the process of getting an idea and initiating and completing a new motor task. These clinical results were generated during a pivotal trial of Dimebon in patients with mild-to-moderate Alzheimer's disease (AD)... Medivation's Press Release -

Medivation, Pivotal Confirmatory Phase 3 Trial of Dimebon(TM) for Alzheimer's Disease in Second Quarter of 2008

Jan. 28, 2008 - Medivation, Inc. (Nasdaq: MDVN) 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... Medivation's Press Release -