Medivation and Astellas Initiate Phase 3 Study of Enzalutamide in Non-Metastatic Castration-Resistant Prostate Cancer

Medivation and Astellas Initiate Phase 3 Study of Enzalutamide in Non-Metastatic Castration-Resistant Prostate Cancer 
SAN FRANCISCO, CA and TOKYO, JAPAN -- (Marketwired) -- 12/03/13 -- 
Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. (TOKYO:
4503) announced enrollment of the first patient in a global Phase 3
clinical trial, known as PROSPER, which will evaluate the safety and
efficacy of enzalutamide in patients with non-metastatic (often
referred to as M0) castration-resistant prostate cancer (CRPC).
Currently no prescription medicine is specifically approved for the
treatment of patients with non-metastatic CRPC in the United States. 
"PROSPER targets an important patient population as we and Astellas
look to advance the development of enzalutamide further upstream in
the prostate cancer treatment paradigm," said David Hung, M.D.,
president and chief executive officer of Medivation, Inc. "The
initiation of this trial underscores our commitment to develop
enzalutamide as a potential treatment for those touched by this
The Phase 3 randomized, double-blind, placebo-controlled,
multi-national trial plans to enroll approximately 1,500 patients
with non-metastatic castration-resistant prostate cancer at sites in
the United States, Canada, Europe, South America and the Asia Pacific
region. PROSPER will enroll a high-risk subgroup of patients with
prostate cancer who are progressing despite androgen deprivation
therapy, but who are asymptomatic with no prior or present evidence
of metastatic disease. The primary endpoint of the trial is
metastasis-free survival. The trial will evaluate enzalutamide at a
dose of 160 mg to be taken orally once daily versus placebo, plus
androgen deprivation therapy. Information about patient eligibility
and enrollment can be obtained by calling the PROSPER hotline
toll-free at 855-977-3825. For more information on the PROSPER trial
go to 
About Enzalutamide  
Enzalutamide is an androgen receptor inhibitor that acts on different
steps in the androgen receptor signaling pathway. Enzalutamide has
been shown to competitively inhibit androgen binding to androgen
receptors, and inhibit androgen receptor nuclear translocation and
interaction with DNA.  
About XTANDI(R) (enzal
utamide) capsules 
 XTANDI was approved by the
U.S. Food and Drug Administration on August 31, 2012 and is indicated
for the treatment of patients with metastatic castration-resistant
prostate cancer (mCRPC) who have previously received docetaxel. 
Important Safety Information for XTANDI from the approved prescribing
Contraindications- XTANDI can cause fetal harm when administered to a
pregnant woman based on its mechanism of action. XTANDI is not
indicated for use in women. XTANDI is contraindicated in women who
are or may become pregnant. 
Warnings and Precautions- In the randomized clinical trial, seizure
occurred in 0.9% of patients on XTANDI. No patients on the placebo
arm experienced seizure. Patients experiencing a seizure were
permanently discontinued from therapy. All seizures resolved.
Patients with a history of seizure, taking medications known to
decrease the seizure threshold, or with other risk factors for
seizure were excluded from the clinical trial. Because of the risk of
seizure associated with XTANDI use, patients should be advised of the
risk of engaging in any activity where sudden loss of consciousness
could cause serious harm to themselves or others. 
Adverse Reactions- The most common adverse drug reactions ( ≥
5%) reported in patients receiving XTANDI in the randomized clinical
trial were asthenia/fatigue, back pain, diarrhea, arthralgia, hot
flush, peripheral edema, musculoskeletal pain, headache, upper
respiratory infection, muscular weakness, dizziness, insomnia, lower
respiratory infection, spinal cord compression and cauda equina
syndrome, hematuria, paresthesia, anxiety, and hypertension. Grade
1-4 neutropenia occurred in 15% of XTANDI patients (1% Grade 3-4) and
in 6% on placebo (no Grade 3-4). Grade 1-4 elevations in bilirubin
occurred in 3% of XTANDI patients and 2% on placebo. One percent of
XTANDI patients compared to 0.3% on placebo died from infections or
sepsis. Falls or injuries related to falls occurred in 4.6% of XTANDI
patients vs 1.3% on placebo. Falls were not associated with loss of
consciousness or seizure. Fall-related injuries were more severe in
XTANDI patients and included non-pathologic fractures, joint
injuries, and hematomas. Grade 1 or 2 hallucinations occurred in 1.6%
of XTANDI patients and 0.3% on placebo, with the majority on
opioid-containing medications at the time of the event. 
Drug Interactions- Effect of Other Drugs on XTANDI: Administration of
strong CYP2C8 inhibitors can increase the plasma exposure to XTANDI.
Co-administration of XTANDI with strong CYP2C8 inhibitors should be
avoided if possible. If co-administration of XTANDI cannot be
avoided, reduce the dose of XTANDI. Co-administration of XTANDI with
strong or moderate CYP3A4 and CYP2C8 inducers can alter the plasma
exposure of XTANDI and should be avoided if possible. 
Effect of XTANDI on Other Drugs: XTANDI is a strong CYP3A4 inducer
and a moderate CYP2C9 and CYP2C19 inducer in humans. Avoid CYP3A4,
CYP2C9 and CYP2C19 substrates with a narrow therapeutic index, as
XTANDI may decrease the plasma exposures of these drugs. If XTANDI is
co-administered with warfarin (CYP2C9 substrate), conduct additional
INR monitoring. 
For Full Prescribing Information for XTANDI (enzalutamide) capsules,
please visit 
About Medivation 
 Medivation, Inc. is a biopharmaceutical company
focused on the rapid development of novel therapies 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 families. For more information,
please visit us at 
About Astellas 
 Astellas Pharma Inc. is a pharmaceutical company
dedicated to improving the health of people around the world through
provision of innovative and reliable pharmaceuticals. The
organization is committed to becoming a global category leader in
Oncology and Urology, and has several oncology compounds in
development in addition to enzalutamide. For more information on
Astellas Pharma Inc., please visit our website at  
Note Regarding Forward-Looking Statement - Medivation
 This press
release contains forward-looking statements, including statements
regarding the continued clinical development of enzalutamide and
potential future progress related thereto, the therapeutic potential
of enzalutamide in non-metastatic prostate cancer, our strategy, and
the continued effectiveness of, and continuing collaborative
activities and benefits 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 the 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, the risk that positive
results seen in our clinical trials may not be predictive of the
results of our ongoing or planned clinical trials, difficulties or
delays in enrolling and retaining patients in Medivation's clinical
trials, Medivation's dependence on the efforts of and funding by
Astellas for the development of enzalutamide, the achievement of
development, regulatory and commercial milestones under Medivation's
collaboration agreement with Astellas, the manufacturing of
Medivation's product candidates, the industry and competitive market,
the adequacy of Medivation's financial resources, unanticipated
expenditures or liabilities, Medivation's outstanding convertible
senior notes, 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, 2013, filed with the SEC on November 12, 2013. 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
Medivation Contacts: 
Patrick Machado 
Chief Business & Financial Officer 
(415) 829-4101  
Anne Bowdidge 
Senior Director, Investor Relations 
(650) 218-6900  
Astellas Contacts:
Jenny Kite
Corporate Communications
(224) 205-5405 
Mike Beyer
Sam Brown, Inc (media for both companies)
(773) 463-4211 
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