SOURCE: Medivation, Inc.

Medivation, Inc.

Medivation, Inc.

May 12, 2011 08:10 ET

Medivation and Astellas Announce Upcoming Presentation of Long-Term Efficacy Data From Phase 1-2 Trial of MDV3100 in Advanced Prostate Cancer Patients

Data to Be Presented at American Urological Association Annual Meeting

SAN FRANCISCO, CA and TOKYO--(Marketwire - May 12, 2011) - Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. today announced that long-term efficacy data from the Phase 1-2 trial of MDV3100, a triple-acting oral androgen receptor antagonist, in patients with advanced prostate cancer will be presented in an oral session at the American Urological Association (AUA) Annual Meeting in Washington, D.C.

The abstract (#647) can be accessed at the AUA website at www.aua2011.org. Details of the presentation follow:

Abstract Title: "Phase 1-2 Study of MDV3100 in Pre- and Post-Docetaxel Advanced Prostate Cancer: Long-Term Efficacy Results"

Session: Prostate Cancer: Advanced

Presentation Date/Time: Sunday, May 15, 2011, from 3:30 to 5:30 p.m. ET

Presenter: Celestia S. Higano, M.D., Professor, Medical Oncology Division, University of Washington School of Medicine

Location: Walter E. Washington Convention Center, Washington D.C.

About the Medivation/Astellas Collaboration
In October 2009, Medivation and Astellas entered into a global agreement to jointly develop and commercialize MDV3100. The companies are collaborating on a comprehensive development program that includes studies to develop MDV3100 across the full spectrum of advanced prostate cancer disease states. Subject to receipt of regulatory approval, the companies will jointly commercialize MDV3100 in the U.S. and Astellas will have responsibility for commercializing MDV3100 outside the U.S. Medivation received a $110 million up-front payment upon entering into the collaboration agreement, and is eligible to receive up to $335 million in development milestone payments, up to $320 million in commercial milestone payments, 50% of profits on sales in the U.S., and tiered, double-digit royalties on sales outside the United States.

About MDV3100
MDV3100 is an investigational therapy in clinical development for advanced prostate cancer. In a Phase 1-2 trial in 140 patients with advanced prostate cancer published in The Lancet, encouraging antitumor activity was noted with MDV3100 across endpoints. In preclinical experiments published in Science in April 2009, the triple-acting, oral androgen receptor antagonist provided more compIete suppression of the androgen receptor pathway than bicalutamide, the most commonly used anti-androgen. MDV3100 slows growth and induces cell death in bicalutamide-resistant cancers via three complementary actions - MDV3100 blocks testosterone binding to the androgen receptor, impedes movement of the androgen receptor to the nucleus of prostate cancer cells (nuclear translocation) and inhibits binding to DNA. In the preclinical experiments published in Science, MDV3100 was superior to bicalutamide in each of these three actions.

About Prostate Cancer
Prostate cancer is the second most common non-skin cancer among men in the world and it is the sixth leading cause of cancer death among men worldwide. Patients whose prostate tumors have stopped responding to, or are growing despite the use of, active hormone treatment strategies are considered to have advanced prostate cancer. These patients have a poor prognosis and few
treatment options.

About Medivation
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. Together with its corporate partners Astellas and Pfizer, Medivation currently has investigational drugs in Phase 3 development to treat advanced prostate cancer and mild-to-moderate Alzheimer's disease. For more information, please visit us at www.medivation.com.

About Astellas Pharma Inc.
Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company dedicated to improving the health of people around the world through provision of innovative and reliable pharmaceuticals. Astellas has approximately 16,000 employees worldwide. The organization is committed to becoming a global category leader in Urology, Immunology & Infectious Diseases, Neuroscience, DM complications & Metabolic Diseases and Oncology. For more information on Astellas Pharma Inc., please visit our website at www.astellas.com/en.