SAN FRANCISCO, Oct. 22 /PRNewswire-FirstCall/ -- Medivation, Inc. (Nasdaq: MDVN) today announced that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act for its collaboration with Pfizer Inc. expired on October 20, 2008. Under the collaboration, Medivation and Pfizer have agreed to jointly develop and commercialize Dimebon for the treatment of Alzheimer's disease and Huntington's disease. Expiration of the waiting period triggers an up-front payment to Medivation of $225 million.
Under the terms of the collaboration agreement with Pfizer, 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 3 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. Pfizer will have responsibility for development, regulatory and commercialization outside the U.S. and will pay Medivation tiered royalties on commercial sales outside of the U.S.
Results from the first pivotal trial of Dimebon in Alzheimer's disease showed that patients treated with Dimebon experienced statistically significant improvements compared to placebo in key aspects of the disease -- memory and thinking, activities of daily living, behavior and overall function. Dimebon's benefit over placebo continued to increase throughout the 12-month treatment period. At the end of 12 months, Dimebon-treated patients were on average functioning as well or better than they had been at the start of the study on each of 5 clinical endpoints. These results were published in the July 19, 2008, edition of The Lancet.
In July 2008, Medivation announced positive safety and efficacy results from its Phase 2 trial of Dimebon in Huntington's disease. Dimebon appeared to be well tolerated and showed statistically significant benefit versus placebo in cognition as measured by the Mini-Mental State Examination, a secondary endpoint in the study.
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. The Company's current clinical development program includes a pivotal and confirmatory Phase 3 trial of Dimebon in Alzheimer's disease and a Phase 1-2 clinical trial of MDV3100 in patients with castration-resistant (also known as hormone-refractory) prostate cancer. Medivation recently announced that it plans to continue further development of Dimebon in patients with mild-to-moderate Huntington's disease based on the positive results seen in its Phase 2 trial. In September 2008, Medivation entered into a global agreement with Pfizer Inc to develop and commercialize Dimebon for the treatment of Alzheimer's and Huntington's diseases. For more information, please visit us at http://www.medivation.com.
|SOURCE Medivation, Inc.|
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