Medivation and Astellas Provide Update on PREVAIL
Companies Announce Phase 3 PREVAIL Interim Analysis Expected to Occur
SAN FRANCISCO, CA and TOKYO -- (Marketwire) -- 04/01/13 --
Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. (TSE: 4503)
today announced that the companies have established an updated
interim analysis plan for the PREVAIL trial, a global Phase 3
clinical trial evaluating XTANDI(R) (enzalutamide) capsules in men
with metastatic castration-resistant prostate cancer (mCRPC) who have
not yet received chemotherapy. The planned interim analysis for the
PREVAIL trial is expected to occur in 2013. In addition, the
protocol-specified number of radiographic progression-free survival
(PFS) events has been exceeded, and the primary PFS analysis will
occur at the time of the interim analysis for overall survival.
Medivation is conducting this study under its agreement with
"As we did with our AFFIRM trial, we have evaluated recent industry
data announced in the prostate cancer disease area and updated our
analysis plan for the PREVAIL trial," said Lynn Seely, M.D., chief
medical officer of Medivation, Inc. "We've shared our updated plan
with the U.S. Food and Drug Administration who are in agreement with
our approach. We plan to conduct the PREVAIL interim analysis in
The randomized, double-blind, placebo-controlled, multi-national
Phase 3 PREVAIL trial met its enrollment goals in May 2012 at sites
in the United States, Canada, Europe, Australia, Russia, Israel and
Asian countries including Japan. The PREVAIL trial includes 1,717
patients who have progressed following treatment with a luteinizing
hormone releasing hormone (LHRH) analog drug only, as well as
patients who have progressed following treatment with both an LHRH
analog drug and an anti-androgen drug. The study co-primary endpoints
are radiographic progression-free survival and overall survival;
secondary endpoints include time to first skeletal-related event and
time to initiation of chemotherapy. The trial is designed to evaluate
enzalutamide at a dose of 160 mg taken orally once daily plus
standard of care versus placebo plus standard of care.
XTANDI(R) (enzalutamide) capsules is an oral, once-daily androgen
receptor inhibitor. XTANDI
was approved by the FDA on August 31, 2012
for the treatment of metastatic castration-resistant prostate cancer
for patients who have previously received docetaxel (chemotherapy). A
Marketing Authorization Application for XTANDI is currently under
review by the European Medicines Agency (EMA).
Important Safety Information for XTANDI
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.
Warning and Precautions - In the randomized phase 3 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.
Drug Interactions - XTANDI is a strong CYP3A4 inducer and a moderate
CYP2C9 and CYP2C19 inducer in humans. 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. 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
For Full Prescribing Information, please visit www.XtandiHCP.com.
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
Astellas Pharma US, Inc., located in Northbrook, Illinois, is a U.S.
affiliate 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
pharmaceutical products. The organization is committed to becoming a
global category leader in oncology, and has several oncology products
on the market and compounds in development. Astellas is proud to be
an award recipient of the CEO Gold Standard Accreditation from the
CEO Roundtable on Cancer. For more information on Astellas Pharma
Inc., please visit our website at www.astellas.us.
This press release contains forward-looking statements that are made
pursuant to the safe harbor provisions of the federal securities
laws, including statements regarding the potential timing of analyses
of data from the PREVAIL trial. 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, those 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, 2012, filed on February 28,
2013 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
Chief Business & Financial Officer
Senior Director, Investor Relations
Sam Brown, Inc (media for both companies)
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