Key Developments For Medivation, Inc.
Medivation, Inc. (MDVN.O) (Consolidated Issue listed on NASDAQ Global Market)
Pfizer And Medivation, Inc. Initiate Two Phase 3 Trials Of Dimebon In Patients With Moderate-To-Severe Alzheimer`s Disease
Pfizer and Medivation, Inc. announced the initiation of CONTACT and CONSTELLATION, two Phase 3 trials of the investigational drug dimebon (latrepirdine) in patients with moderate-to-severe Alzheimer`s disease (AD). The CONTACT study will assess as primary endpoints the potential benefits of adding dimebon to ongoing treatment with donepezil HCI tablets, the leading AD medication worldwide, on neuropsychiatric symptoms and activities of daily living. The CONSTELLATION study will evaluate as primary endpoints the effects of adding dimebon to memantine HCI, another standard of care, on cognition, memory and activities of daily living.
Astellas Pharma Inc. and Medivation, Inc. Enter Into Worldwide Agreement To Co-Develop and Co-Commercialize MDV3100 For Treatment Of Prostate Cancer
Astellas Pharma Inc. and Medivation, Inc. announced that they have entered into a global agreement to develop and commercialize MDV3100, Medivation's investigational drug for the treatment of prostate cancer. MDV3100 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, Medivation will receive an up-front cash payment of $110 million. Medivation is also 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. The companies 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, the companies will jointly commercialize MDV3100 in the U.S. The companies 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 Medivation tiered double-digit royalties on ex-U.S. sales.
Medivation, Inc. Announces Initiation of Phase III Clinical Trial of MDV3100 in Advanced Prostate Cancer
Medivation, Inc. announced the treatment of the first patient in a Phase III clinical trial of the investigational drug MDV3100 in advanced prostate cancer. Known as AFFIRM, the trial will evaluate the androgen receptor antagonist MDV3100 in men with castration-resistant prostate cancer who were previously treated with docetaxel-based chemotherapy. The randomized, placebo-controlled, double-blind, multi-national AFFIRM trial is expected to enroll approximately 1,200 patients at sites in the United States, Canada, Europe, South America, Australia and South Africa. The primary endpoint of the trial is overall survival; secondary endpoints include progression-free survival, safety and tolerability. This trial will evaluate MDV3100 at a dose of 160 mg taken orally once daily versus placebo.
Pfizer and Medivation, Inc. Initiate Phase 3 Trial Of Dimebon In Patients With Huntington Disease; Granted Orphan Drug Designation To Dimebon For Treatment Of Huntington Disease
Pfizer and Medivation, Inc. announced the initiation of a Phase 3 trial of the investigational drug dimebon (latrepirdine) in patients with Huntington disease. The international safety and efficacy trial, known as HORIZON, is designed to evaluate the potential benefits of dimebon on cognition (thinking and memory) in patients with Huntington disease. The companies also announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to dimebon for the treatment of Huntington disease. Orphan drug designation entitles Pfizer and Medivation to a seven-year period of marketing exclusivity in the United States for dimebon if it is approved by the FDA for the treatment of Huntington disease.
Medivation, Inc.'s Alzheimer's Drug Boosts Toxic Protein-Reuters
Reuters reported that Medivation, Inc.'s experimental Alzheimer's drug, significantly raised levels of a toxic protein in the brains of mice, yet has been shown to delay thinking problems in human dementia patients, U.S. researchers said. The study raises new questions about how the drug works and new worries about drugs meant to remove telltale clumps of a protein called beta amyloid from the brain as a way to reverse Alzheimer's disease. Researchers are not sure whether amyloid is a cause or a symptom of Alzheimer's but, either way, getting rid of it had appeared to be a good thing.
