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September 3, 2008
By: Tim Wright
Editor-in-Chief, Contract Pharma
Pfizer and Medivation, Inc. 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 studied in a confirmatory Phase III trial in patients with mild-to-moderate Alzheimer’s disease. Under the terms of the agreement, Medivation will receive an upfront cash payment of $225 million and is eligible to receive as much as $500 million based on development and regulatory milestones, as well as additional commercial milestone payments. The two companies will collaborate on the Phase III program and regulatory filings in the U.S. and will share all U.S. development and commercialization expenses along with profits/losses on a 60%/40% (Pfizer/ Medivation) basis. In addition, Medivation will co-promote Dimebon to specialty physicians in the U.S. Pfizer will have responsibility for development, regulatory and commercialization outside the U.S. and will pay Medivation royalties on commercial sales outside of the U.S. The agreement is subject to approval under the Hart-Scott-Rodino Antitrust Improvements Act. 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, 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.
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