Medivation recognizes the importance of collaborations to maximize the global potential of our product candidates.In September 2008, Medivation announced a global development and commercialization agreement with Pfizer Inc for dimebon (latrepirdine), an investigational drug for the treatment of Alzheimer's and Huntington diseases. Under the terms of the agreement, we received an up-front cash payment of $225 million and are eligible to receive payments of up to $500 million upon the attainment of development and regulatory milestones plus additional undisclosed commercial milestone payments. We will collaborate on the Phase 3 program in Alzheimer's disease and Huntington disease, and regulatory filings in the United States. We 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, we have the option to co-promote dimebon to specialty physicians in the U.S. Pfizer has responsibility for development, regulatory and commercialization outside the U.S. and will pay us tiered royalties on commercial sales outside of the U.S. In October 2009, Medivation announced a global agreement with Astellas Pharma Inc. to develop and commercialize MDV3100, our investigational drug for the treatment of prostate cancer that is currently being evaluated in the Phase 3 AFFIRM clinical trial in men with castration-resistant prostate cancer who were previously treated with docetaxel-based chemotherapy. Under the terms of the agreement, we received an up-front cash payment of $110 million and are eligible to receive payments of up to $335 million upon the attainment of development and regulatory milestones plus up to an additional $320 million in commercial milestone payments. We will collaborate on a comprehensive development program that will include additional studies to develop MDV3100 for both late- and early-stage prostate cancer. Subject to receipt of regulatory approval, we will jointly commercialize MDV3100 in the U.S. We will share equally all U.S. development costs, commercialization costs, and profits. Astellas will have responsibility for developing and commercializing MDV3100 outside the U.S. and will pay us tiered double-digit royalties on ex-U.S. sales. |
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