Nov. 4, 2009 (PR Newswire) -- SAN FRANCISCO, Nov. 4 /PRNewswire-FirstCall/ -- Medivation, Inc. (Nasdaq: MDVN) today reported on its corporate progress and financial results for the third quarter ended September 30, 2009.

"With the signing of our agreement for MDV3100 with Astellas last week, we now have a first-class partner with a global reach, leading commercial presence in the urology space, and strategic focus on oncology. This achievement marks our second major collaboration in just over a year's time, bringing us significant resources which allow us to drive our product candidates forward, while still maintaining substantial ownership of our dimebon and MDV3100 programs. We and Astellas are committed to advancing development of this novel androgen receptor antagonist as quickly as possible for a broad spectrum of prostate cancer disease states," said David Hung, M.D., president and chief executive officer of Medivation. "We also made important progress with dimebon and now have seven pivotal trials in our broad clinical development program in both Alzheimer's and Huntington diseases in various stages of activity. We have reported results from our first pivotal trial, we expect data in the first half of next year from our second confirmatory pivotal trial, and five other pivotal trials are ongoing."

Recent Accomplishments and Near-Term Milestones

Dimebon (latrepirdine*)

--  On track to announce top-line results from CONNECTION, a confirmatory,
pivotal Phase 3 trial in patients with mild-to-moderate Alzheimer's
disease, in the first half of 2010.
--  Completed patient enrollment in a placebo-controlled Phase 3 safety
study in 750 Alzheimer's disease patients on a variety of background
anti-dementia drugs.
--  Initiated patient enrollment in CONSTELLATION, a six-month, randomized,
double-blind, placebo-controlled Phase 3 trial in approximately 570
patients with moderate-to-severe Alzheimer's disease that will evaluate
as primary endpoints the effects of adding dimebon to Namenda®, a
standard of care Alzheimer's disease medicine, on cognitive and
behavioral symptoms.
--  Initiated patient enrollment in CONTACT, a six-month, randomized,
double-blind, placebo-controlled Phase 3 trial in approximately 600
patients with moderate-to-severe Alzheimer's disease that will assess as
primary endpoints the potential benefits of adding dimebon to ongoing
treatment with Aricept®, the leading Alzheimer's medication worldwide,
on neuropsychiatric symptoms and activities of daily living. This study
is the first pivotal Alzheimer's disease study to use the
Neuropsychiatric Inventory (NPI) scale as a co-primary endpoint.
--  Continued patient enrollment in CONCERT, a 12-month Phase 3 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 Aricept.

--  Continued patient enrollment in HORIZON, a six-month, double-blind,
placebo-controlled Phase 3 trial that is evaluating dimebon's potential
benefits on cognition in patients with Huntington disease.

*Latrepirdine is the proposed generic name for dimebon.

MDV3100

--  Entered into a global collaboration agreement with Astellas Pharma Inc.
to develop and commercialize MDV3100 for the treatment of prostate
cancer. Under the terms of the agreement, Medivation has received an
up-front cash payment of $110 million and 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.

--  Initiated AFFIRM, a randomized, placebo-controlled, double-blind Phase 3
survival trial that is evaluating 160 mg/day of MDV3100 in men with
castration-resistant prostate cancer who were previously treated with
docetaxel-based chemotherapy.

Corporate

    --  Appointed Hank Mansbach, M.D., a neurologist with more than 10 years of
industry experience, as vice president, medical affairs.

Third Quarter 2009 Financial Results

Revenue for the third 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 September 30, 2009, were $27.6 million, compared with total operating expenses of $20.6 million for the same period in 2008.