- Conference Call Today at 4:30 p.m. Eastern Time -

SAN FRANCISCO, May 11 /PRNewswire-FirstCall/ -- Medivation, Inc. (Nasdaq: MDVN) today reported on its corporate progress and financial results for the first quarter ended March 31, 2009.

'We continue to make significant progress with both of our product candidates -- Dimebon in patients with Alzheimer's and Huntington's diseases and MDV3100 in patients with prostate cancer. Having received written permission from the FDA to initiate a pivotal Phase 3 trial of MDV3100 in castration-resistant prostate cancer, we are on track to be in Phase 3 testing in all of our clinical programs this year,' said David Hung, M.D., president and chief executive officer of Medivation. 'We expect to achieve a significant milestone in June - completion of enrollment in our six-month, confirmatory, pivotal Phase 3 CONNECTION trial in mild-to-moderate Alzheimer's disease. And as part of our plan to support a broad and differentiated label for Dimebon in Alzheimer's disease, we are pleased to have initiated the Phase 3 CONCERT trial of Dimebon in combination with donepezil (Aricept(R)), and intend to begin two additional Phase 3 trials in moderate-to-severe Alzheimer's disease patients this year.'

Recent Highlights and Accomplishments

Dimebon

• Expect to complete patient enrollment in CONNECTION, a confirmatory, pivotal Phase 3 trial in patients with mild-to-moderate Alzheimer's disease, in June.
• Initiated the Phase 3 CONCERT trial in patients with mild-to-moderate Alzheimer's disease; the 12-month clinical trial is designed to evaluate the efficacy of Dimebon when added to ongoing treatment with donepezil (Aricept(R)), the leading Alzheimer's disease medication worldwide, and builds on data from a small-scale safety and tolerability trial of Dimebon added to donepezil, which found the combination to be well tolerated.
• Completed a multicenter, randomized, double-blind, placebo-controlled Phase 1 study to evaluate the safety and tolerability of Dimebon given to Alzheimer's disease patients who currently are on a stable dose and regimen of memantine (Namenda(R)) or memantine plus donepezil. The study showed that these combinations were well tolerated.
• In addition to the CONNECTION and CONCERT trials and a Phase 3 safety study already underway, we and Pfizer plan to initiate two additional Phase 3 studies in 2009 that will evaluate Dimebon in a total of approximately 1,100 patients with moderate-to-severe Alzheimer's disease.
• Expect to initiate a Phase 3 trial this year to evaluate Dimebon's potential benefits on cognition in patients with mild-to-moderate Huntington's disease.
• Presented posters featuring Dimebon at the 61st American Academy of Neurology Annual Meeting in Seattle on April 29 and 30, including a poster entitled 'Estimating Disease-Modifying Effects Using a Staggered Start Approach and a Natural History Staggered Start (NHSS) Approach: Preliminary Results from a 12-Month Study of Dimebon and a 6-Month Open-Label Period.'
• Presented a poster at the American Geriatrics Society meeting in Chicago on May 1.

MDV3100

• Received written permission from the U.S. Food and Drug Administration to initiate a pivotal Phase 3 trial of MDV3100 in castration-resistant prostate cancer in men who were previously treated with docetaxel-based chemotherapy; the primary endpoint of this randomized, placebo-controlled, double-blind, multinational trial will be overall survival.
• Announced publication of an article in the May 8 issue of Science, presenting the discovery, novel mechanism of action and potent anti-androgen properties of MDV3100.
• Conducted a podium presentation featuring MDV3100 at the 2009 American Urological Association Annual Meeting in Chicago on April 26.
• Received acceptance by the American Society of Clinical Oncology (ASCO) of an abstract, entitled 'Antitumor activity of MDV3100 in a Phase 1-2 study of castration-resistant prostate cancer (CRPC),' for oral presentation at the 2009 ASCO Annual Meeting on May 30 at 4:15 p.m. Eastern Time.
• MDV3100 abstract selected by ASCO for inclusion in the Best of ASCO(R) program, an educational initiative covering highlights from the ASCO Annual Meeting to increase global access to cutting-edge science.