USA-based Medivation (NASDAQ: MDVN) and global drugs behemoth Pfizer (NYSE: PFE) have finally decided to discontinue the development of Dimebon also known as latrepirdine, for all indications and will terminate the ongoing open label extension study in Alzheimer’s disease.
The companies announced results from the CONCERT trial, which is a Phase III trial that evaluated Dimebon when added to ongoing treatment with Donepezil HCL tablets in patients with mild-to-moderate Alzheimer’s
The CONCERT trial was a 12-month global randomized, double-blind, placebo-controlled trial that enrolled 1,003 patients with mild to moderate AD. Patients receiving a stable dose of Donepezil for at least 4 months were randomly assigned to 1 of 3 treatment groups: Dimebon, 20 mg 3 times per day; Dimebon, 5 mg 3 times per day; or placebo.
“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.” He added.
Pfizer acquired rights to Dimebon in 2008, under an agreement with Medivation, whereby the latter received an up-front cash payment of $225 million and was also eligible to receive payments of up to $500 million on the attainment of development and regulatory milestones plus additional undisclosed commercial milestones. The drug was once touted not only stopping but also possibly reversing the degenerative disease, and as having a $1.5 billion to $5 billion a year sales potential.
A full analysis of the results from CONCERT will be conducted and submitted for presentation at an upcoming scientific congress.
Medivation, Inc. is a biopharmaceutical company focused on the rapid development of novel small molecule drugs to treat serious diseases for which there are limited treatment options. Medivation aims to transform the treatment of these diseases and offer hope to critically ill patients and their caregivers. Together with its corporate partner Astellas, Medivation currently has its investigational drug MDV3100 in Phase 3 development to treat advanced prostate cancer. For more information, please visit www.medivation.com.