Medivation and Astellas Complete Enrollment in Phase 3 AFFIRM trial of MDV3100 in Advanced Prostate Cancer

San Francisco and Tokyo, November 30 (ots/PRNewswire) -
Medivation, Inc. and Astellas Pharma Inc. today announced that
patient enrollment was completed on November 15, 2010 in the Phase 3
AFFIRM study of the investigational drug MDV3100, a novel,
triple-acting oral androgen receptor antagonist, in patients with
advanced prostate cancer who have previously been treated with
chemotherapy.

"There has been a lot of positive news for advanced prostate
cancer patients over this past year, and the completion of patient
enrollment in AFFIRM is yet another significant achievement in the
development of new therapies to treat this devastating disease," said
Lynn Seely, M.D., chief medical officer of Medivation.

"While AFFIRM is focused on patients with the most advanced stage
of disease, earlier stage prostate cancer patients are also in need
of new treatment options," said Steve Ryder, MD, president, Astellas
Pharma Global Development."The first step in our expanded development
of MDV3100 into earlier stage patients is our ongoing Phase 3 PREVAIL
trial, in which we are studying advanced prostate cancer patients who
are chemotherapy naïve. In addition, Medivation and Astellas plan to
initiate two Phase 2 trials in earlier stage prostate cancer early
next year."

The randomized, double-blind, placebo-controlled Phase 3 AFFIRM
study enrolled 1,199 patients. The trial is evaluating 160 mg/day of
MDV3100 versus placebo. The primary endpoint is overall survival, and
secondary endpoints include progression-free survival, safety and
tolerability. The AFFIRM study is being conducted at sites in the
United States, Canada, Europe, Australia, South America and South
Africa.

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 for both early-stage and advanced
prostate cancer. 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 U.S.

About MDV3100

MDV3100 is an investigational therapy in clinical development for
advanced prostate cancer. The novel, triple-acting, oral androgen
receptor antagonist has been shown to slow growth and induces cell
death in bicalutamide-resistant cell-lines 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. Preclinical data comparing MDV3100 and bicalutamide in each of
these three actions was published in Science in April 2009.

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 Pfizer and Astellas, Medivation currently has
investigational drugs in Phase 3 development to treat advanced
prostate cancer, mild-to-moderate Alzheimer's disease and Huntington
disease. For more information, please visit us at
http://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
http://www.astellas.com/en.

This press release contains forward-looking statements, including
statements regarding the continued clinical development of
Medivation's product candidates, the therapeutic and commercial
potential of Medivation's product candidates, the planned initiation
of additional clinical trials and the continued effectiveness of, and
continuing collaborative activities under, Medivation's collaboration
agreement with Astellas, which are made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
Any statements contained in this press release that are not
statements of historical fact may be deemed to be forward-looking
statements. Forward-looking statements involve risks and
uncertainties that could cause Medivation's actual results to differ
significantly from those projected, including, without limitation,
risks related to progress, timing and results of Medivation's
clinical trials, including the risk that adverse clinical trial
results could alone or together with other factors result in the
delay or discontinuation of some or all of Medivation's product
development activities, enrollment of patients in Medivation's
clinical trials, partnering of Medivation's product candidates,
including Medivation's dependence on the efforts of and funding by
Astellas for the development of MDV3100, the achievement of
development, regulatory and commercial milestones under Medivation's
collaboration agreements, the manufacturing of Medivation's product
candidates, the adequacy of Medivation's financial resources,
unanticipated expenditures or liabilities, intellectual property
matters, and other risks detailed in Medivation's filings with the
Securities and Exchange Commission, including its quarterly report on
Form 10-Q for the quarter ended September 30, 2010, filed on November
5, 2010 with the SEC. You are cautioned not to place undue reliance
on the forward-looking statements, which speak only as of the date of
this release. Medivation disclaims any obligation or undertaking to
update or revise any forward-looking statements contained in this
press release.

Contacts:
Medivation, Inc. Red Door Communications Astellas
Patrick Machado Arran Attridge Mindy Dooa
Chief Business Officer
+1(415)829-4101 +44-208-392-8040 +44-1784-419-408

ots Originaltext: Astellas Pharma Inc. and Medivation, Inc.
Im Internet recherchierbar: http://www.presseportal.de

Contact:
CONTACT: Medivation, Inc. Patrick Machado, Chief Business
Officer,+1(415)829-4101, Red Door Communications, Arran Attridge,
+44-208-392-8040,Astellas, Mindy Dooa, +44-1784-419-408