Medivation and Astellas Announce Phase 3 Study of Enzalutamide in Men With High-Risk, Hormone-Sensitive, Non-Metastatic Prostate Cancer That Has Recurred Following Definitive Local Therapy

SAN FRANCISCO, CA and NORTHBROOK, IL--(Marketwired - Oct 30, 2014) - Medivation Inc. (NASDAQ: MDVN) and Astellas today announced plans to initiate a global Phase 3 clinical trial that will evaluate the efficacy and safety of enzalutamide in patients with high-risk, hormone-sensitive, non-metastatic prostate cancer that has biochemically recurred (rising prostate-specific antigen [PSA] level) following definitive local therapy with radical prostatectomy and/or radiation therapy. Currently there is no prescription medicine specifically approved in the United States for these patients.

"It is estimated that approximately one third of men in the United States experience a rising PSA, also known as biochemical recurrence, after localized therapy for the treatment of prostate cancer¹," said Lynn Seely, M.D., chief medical officer of Medivation, Inc. "This trial will determine if enzalutamide can delay the development of metastatic prostate cancer in high-risk men with a rapidly rising PSA. The initiation of this trial in collaboration with our partner Astellas showcases our mutual commitment to continue exploring the potential of enzalutamide in areas of significant unmet medical need."

"Following enzalutamide's continued positive impact on overall survival and progression-free survival versus placebo in metastatic castration-resistant prostate cancer, we are looking forward to continuing to explore the medicine's potential impact on patients at earlier stages of the disease," said Sef Kurstjens, M.D., Ph.D., chief medical officer of Astellas Pharma Inc. and president of Astellas Pharma Global Development, Inc.

About the Phase 3 study
The Phase 3 randomized, multi-national trial will be conducted at approximately 160 sites and is designed to enroll approximately 1,860 hormone-sensitive, non-metastatic men with biochemical recurrence following prostatectomy and/or radiation therapy that are at high risk for morbidity and mortality from prostate cancer. Patients will be randomized into three separate groups: enzalutamide plus leuprolide acetate, enzalutamide monotherapy, or placebo plus leuprolide acetate. Treatment with enzalutamide monotherapy will be open-label. Treatment with enzalutamide and placebo will be double-blind in combination with open-label leuprolide acetate.