Astellas and Medivation Announce Initiation of Phase 2 Clinical Trial Comparing MDV3100 With Bicalutamide in Advanced Prostate Cancer

LONDON, STAINES, England and SAN FRANCISCO, March 30, 2011
(ots/PRNewswire) -- Astellas Pharma Europe Ltd. and Medivation, Inc.
today announced treatment of the first patient in the TERRAIN trial,
a Phase 2 comparison of the investigational drug MDV3100, a
triple-acting, oral androgen receptor antagonist, with bicalutamide,
a commonly used non-steroidal anti-androgen, for the treatment of
advanced prostate cancer in patients who have progressed while on
LHRH analogue therapy or following surgical castration.

"Given the novel mechanism of MDV3100, this study has the
potential to answer fundamental clinical questions about continued
androgen receptor signalling in patients with progressive prostate
cancer despite castrate levels of testosterone," said Professor Axel
Heidenreich, Principal Investigator of the TERRAIN trial, from
Universitätsklinikum der RWTH in Aachen, Germany, "We look forward to
the results of this important trial."

The TERRAIN Phase 2 trial is expected to enroll approximately 370
patients in Europe and North America. The primary endpoint of the
trial is progression-free survival.

"MDV3100 has been shown in preclinical studies to provide more
complete suppression of the androgen receptor signalling pathway than
existing anti-androgens and the TERRAIN study provides the
opportunity to investigate this finding further in a clinical
setting," said Lynn Seely, M.D., Chief Medical Officer of Medivation.
"MDV3100 is currently in Phase 3 testing for advanced prostate
cancer, but our goal is to determine if MDV3100 can benefit men with
prostate cancer earlier in the course of the disease."

"This is the first of two Phase 2 trials in earlier-stage disease
that we and our partner Medivation will initiate this year to
evaluate the potential benefit of MDV3100 in a broad spectrum of
prostate cancer patients," said Steven Ryder, M.D., President,
Astellas Pharma Global Development. "The second of our new Phase 2
trials will study MDV3100 in an even earlier-stage population -
hormone naïve prostate cancer patients who are indicated for androgen
deprivation therapy. We expect to begin that trial in the first half
of this year."

MDV3100 Phase 3 Clinical Development Programme

In addition to the TERRAIN trial, MDV3100 is currently being
evaluated in two global Phase 3 studies in patients with advanced
prostate cancer.

The randomised, double-blind, placebo-controlled Phase 3 AFFIRM
trial completed enrollment in November 2010. This trial of 1,199
patients with advanced prostate cancer who were previously treated
with docetaxel-based chemotherapy is evaluating 160 mg/day of MDV3100
versus placebo. The primary endpoint is overall survival.

A second Phase 3 clinical trial of MDV3100 in advanced prostate
cancer, the PREVAIL trial, is currently enrolling patients. This
randomised, double-blind, placebo-controlled, multi-national trial of
approximately 1,700 men with advanced prostate cancer who have not
yet received chemotherapy is evaluating MDV3100 at a dose of 160 mg
taken orally once daily plus standard of care versus placebo plus
standard of care. The co-primary endpoints of the trial are overall
survival and progression-free survival.

About the Medivation/Astellas Collaboration

In October 2009, Medivation and Astellas entered into a global
agreement to jointly develop and commercialise MDV3100. The companies
are collaborating on a comprehensive development programme that
includes studies to develop MDV3100 across the full spectrum of
advanced prostate cancer disease states. Subject to receipt of
regulatory approval, the companies will jointly commercialise MDV3100
in the U.S. and Astellas will have responsibility for commercialising
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 United States.

About MDV3100

MDV3100 is an investigational therapy in clinical development for
advanced prostate cancer. In a Phase 1-2 trial in 140 patients with
advanced prostate cancer published in The Lancet in April 2010,
encouraging anti-tumour activity was noted with MDV3100 across
endpoints. In preclinical experiments published in Science in April
2009, the triple-acting, oral androgen receptor antagonist provided
more complete suppression of the androgen receptor pathway than
bicalutamide, the most commonly used anti-androgen. MDV3100 slows
growth and induces cell death in bicalutamide-resistant cancers 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. In the preclinical experiments published in
Science, MDV3100 was superior to bicalutamide in each of these three
actions.

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 tumours 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.

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 MDV3100, the planned initiation of additional clinical
trials and the continued effectiveness of, and continuing
collaborative activities under, Medivation's collaboration agreements
with Pfizer and 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 annual report on
Form 10-K for the year ended December 31, 2010, filed on March 16,
2011 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.

About Astellas Pharma Europe Ltd.

Astellas Pharma Europe Ltd., located in the UK, is a European
subsidiary of Tokyo-based Astellas Pharma Inc. Astellas is a
pharmaceutical company dedicated to improving the health of people
around the world through the provision of innovative and reliable
pharmaceuticals. The organisation is committed to becoming a global
company by combining outstanding R&D and marketing capabilities and
continuing to grow in the world pharmaceutical market. Astellas
Pharma Europe Ltd. is responsible for 21 affiliate offices located
across Europe, the Middle East and Africa, an R&D site and three
manufacturing plants. The company employs approximately 3,900 staff
across these regions. For more information about Astellas Pharma
Europe, please visit http://www.astellas.eu.

About Medivation, Inc.

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 Astellas and Pfizer, 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.

http://www.astellas.eu

http://www.medivation.com

ots Originaltext: Astellas Pharma Europe Limited
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Contacts for inquiries or additional information: Astellas
PharmaEurope Ltd., Corporate Communications, Mindy Dooa, Tel:
+44(0)1784-419408;Medivation, Inc., Chief Business Officer, Patrick
Machado, Tel:+1-415-829-4101