Astellas and Medivation Announce Submission of Application for Marketing
Approval of Enzalutamide, an Oral Androgen Receptor Inhibitor, in Japan
TOKYO & SAN FRANCISCO -- May 24, 2013
Astellas Pharma Inc. (TOKYO: 4503) and Medivation, Inc. (NASDAQ: MDVN) today
announced that Astellas has submitted an application for marketing approval of
enzalutamide (generic name) to the Ministry of Health, Labour and Welfare in
Japan for the treatment of prostate cancer.
Enzalutamide is a novel, once-daily, oral androgen receptor signaling
inhibitor. It inhibits multiple steps in the androgen receptor signaling
pathway, which has been shown to decrease cancer cell growth and can induce
cancer cell death (apoptosis).
This filing application is based mainly on results obtained from the global
Phase 3 trial (the AFFIRM trial)* and a Phase 1-2 trial conducted in Japan.**
* A multi-country, double-blind, placebo-controlled study in patients with
advanced castration-resistant prostate cancer who had previously undergone
** An open-label, study. Phase 1 enrolled patients with advanced
castration-resistant prostate cancer and Phase 2 enrolled patients with
advanced castration-resistant prostate cancer who had received docetaxel
XTANDI^® (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
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.
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
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, 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 www.medivation.com.
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. 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 quarterly report on Form 10-Q for the three months ended March
31, 2013, filed on May 10, 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 press
Photos/Multimedia Gallery Available:
Patrick Machado, (415) 829-4101
Chief Business & Financial Officer
Anne Bowdidge, (650) 218-6900
Senior Director, Investor Relations
Astellas Pharma Inc.
Toshiyuki Ishii, +81-3-3244-3201
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