Medivation Plans To Initiate Pivotal Confirmatory Phase 3 Trial Of Dimebon(TM) For Alzheimer's Disease In Second Quarter Of 2008

Medivation, Inc.
(Nasdaq: MDVN) announced that, based on its end-of-Phase 2 meeting
with the U.S. Food and Drug Administration (FDA), the Company plans to
begin a pivotal confirmatory Phase 3 trial of Dimebon(TM) for
mild-to-moderate Alzheimer's Disease in the second quarter of 2008.


The FDA informed Medivation that the company's previously completed
trial conducted in Russia can be used as one of the two pivotal studies
required to support the approval of Dimebon to treat mild-to-moderate
Alzheimer's disease, as long as a significant proportion of the sites in
the confirmatory Phase 3 trial are located in the United States.



"We are now a Phase 3 company with clear regulatory guidance on the
pivotal trials required to seek marketing approval for Dimebon in the
United States," said David T. Hung, M.D., president and chief executive
officer of Medivation. "This is a significant step forward for Medivation,
and validates our strategy to advance Dimebon directly into a pivotal Phase
3 trial."



The Phase 3 clinical trial will enroll approximately 525 patients with
mild-to-moderate Alzheimer's disease at sites in the United States, Europe
and South America. Patients will be randomized to one of three treatment
groups: Dimebon 20 mg three times per day (TID); Dimebon 5 mg TID; and
placebo. Patients will be treated for six months and may not be taking any
other Alzheimer's disease drugs. The primary endpoints are the Alzheimer's
Disease Assessment Scale - cognitive subscale (ADAS-cog) and the
Clinician's Interview-Based Impression of Change plus caregiver interview
(CIBIC-plus).



In the previously completed trial Dimebon-treated patients were
significantly improved over placebo patients on both the ADAS-cog and
CIBIC-plus, with p values of less than 0.0001. This level of statistical
significance is several times better than what is required to obtain
marketing approval.



"We changed as little as possible in the design of the Phase 3 trial
given the highly statistically significant results of our previous trial,"
said Lynn Seely, M.D., chief medical officer of Medivation. "The primary
endpoints, duration of treatment and patient inclusion and exclusion
criteria are all substantially identical to the previous trial. The primary
differences are that the Phase 3 trial will be global and will test two
doses of Dimebon -- the dose studied in the previous trial plus a lower
dose to address the regulatory recommendation that minimum effective dose
be explored in the development of investigational drugs."



Medivation expects to complete the pivotal confirmatory Phase 3 trial
and apply for marketing approval in 2010.


About Medivation



Medivation, Inc. is a biopharmaceutical company with small molecule
drugs in clinical development to treat three large, unmet medical needs --
Alzheimer's disease, Huntington's disease and hormone-refractory prostate
cancer. For more information, please go to medivation.



This press release contains forward-looking statements, which are made
pursuant to the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements involve risks and
uncertainties that could cause actual results to differ significantly from
those projected. You are cautioned not to place undue reliance on the
forward-looking statements, which speak only as of the date of this
release. None of the Company's product candidates has been approved for
sale, significant additional animal and human testing is required in order
to seek marketing approval for any of its product candidates, and
Medivation cannot assure you that marketing approval can be obtained for
any of its product candidates. Furthermore, as is typically the case at
this stage of the regulatory review process, the FDA has not yet performed
an in-depth review of Medivation's preclinical and clinical data, so its
views remain subject to change. Medivation's filings with the Securities
and Exchange Commission, including its Annual Report on Form 10-KSB for the
year ended December 31, 2006, include information about additional factors
that could affect the Company's financial and operating results.


Medivation, Inc

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