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

SAN FRANCISCO, Aug. 5 /PRNewswire-FirstCall/ -- Medivation, Inc. (Nasdaq: MDVN) today reported on its corporate progress and financial results for the second quarter ended June 30, 2009.

"In the past several months, we completed enrollment in our confirmatory, pivotal Phase 3 CONNECTION trial of dimebon (latrepirdine*) in Alzheimer's disease; initiated the pivotal Phase 3 HORIZON trial of dimebon in Huntington disease; reported important clinical data from both our dimebon and MDV3100 development programs; and raised $62.4 million to further solidify our financial foundation," said David Hung, M.D., president and chief executive officer of Medivation. "We remain focused on executing our milestones, including initiating three additional Phase 3 trials before year end: two dimebon trials in moderate-to-severe Alzheimer's patients and a trial of MDV3100 in advanced prostate cancer."

Recent Accomplishments and Near-Term Milestones

Dimebon (latrepirdine)

• Completed patient enrollment in CONNECTION, a confirmatory, pivotal Phase 3 trial in patients with mild-to-moderate Alzheimer's disease.
• Continued patient enrollment in the Phase 3 CONCERT trial, a 12-month clinical trial in patients with mild-to-moderate Alzheimer's disease that is designed to evaluate the efficacy of dimebon when added to ongoing treatment with donepezil (Aricept(R)), the leading Alzheimer's disease medication worldwide.
• Continued enrollment in a placebo-controlled Phase 3 safety study in 750 Alzheimer's disease patients on a variety of background anti-dementia drugs. The purpose of the safety study is to generate a sufficient safety database to provide the option for an earlier-than-planned filing of the initial marketing application should Medivation and Pfizer elect to pursue that option.
• On track to initiate two additional Phase 3 trials this year that will evaluate dimebon in a total of approximately 1,100 patients with moderate-to-severe Alzheimer's disease.
• Presented at the Alzheimer's Association 2009 International Conference on Alzheimer's Disease (ICAD) positive safety and tolerability data from a Phase 1 trial showing that dimebon was well tolerated when used in combination with donepezil in patients with mild-to-moderate Alzheimer's disease.
• Initiated HORIZON, a six-month, double-blind, placebo-controlled Phase 3 trial to evaluate dimebon's potential benefits on cognition in patients with Huntington disease.
• Received orphan drug designation for dimebon from the U.S. Food and Drug Administration for the treatment of Huntington disease.
  

*Latrepirdine is the proposed generic (nonproprietary) name for dimebon.

MDV3100

• Reported at the American Society of Clinical Oncology (ASCO) Annual Meeting positive new efficacy data from a Phase 1-2 study in patients with castration-resistant prostate cancer (CRPC), confirming previously reported results that MDV3100 consistently demonstrated anti-tumor activity in both chemotherapy-naive and post-chemotherapy CRPC patients across dose levels and endpoints, as evaluated by reductions in prostate specific antigen levels, radiographic findings and circulating tumor cell counts.
• Completed analysis of the full data set from the Phase 1-2 trial and concluded that the anti-tumor effects were similar between doses of 150 and 240 mg/day, while the lower dose group was better tolerated (Grade 3 fatigue of nine percent at 240 mg/day versus none at 150 mg/day). No seizures have been reported at either dose.
• On track to initiate this year AFFIRM, a randomized, placebo-controlled, double-blind Phase 3 survival trial, which will evaluate 160 mg/day of MDV3100 in men with CRPC who were previously treated with docetaxel-based chemotherapy.
  

Corporate

• Successfully raised net proceeds of $62.4 million in a public offering of the Company's common stock.
  

Second Quarter 2009 Financial Results

Revenue for the second quarter of 2009 was $16.3 million, consisting of partial recognition of the non-refundable up-front payment of $225.0 million received from Pfizer in October 2008. The up-front payment was recorded as deferred revenue upon receipt and is being recognized on a straight-line basis over the estimated performance period of the Company's obligations under its collaboration agreement with Pfizer, which the Company presently expects to complete in the first quarter of 2012.

Total operating expenses for the three months ended June 30, 2009, were $24.2 million, compared with total operating expenses of $18.7 million for the same period in 2008. These figures included non-cash stock-based compensation expense of $2.5 million in the quarter ended June 30, 2009, compared with $2.1 million for the same period in 2008.

For the six months ended June 30, 2009, total operating expenses were $46.2 million, compared with total operating expenses of $34.6 million for the same period in 2008.