Enzalutamide Data to Be Presented at ASCO GU Symposium

Enzalutamide Data to Be Presented at ASCO GU Symposium 
SAN FRANCISCO, CA and TOKYO -- (Marketwire) -- 01/30/13 -- 
Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. (TSE: 4503)
today announced that six abstracts related to enzalutamide research
will be presented on Thursday, February 14 at the American Society of
Clinical Oncology (ASCO) 2013 Genitourinary (GU) Cancers Symposium in
Orlando, Florida.  
Oral Abstract Session A from 2:03-2:15pm ET: 


 
--  (Abstract #6) Impact of on-study corticosteroid use on efficacy and
    safety in the Phase 3 AFFIRM study of enzalutamide, an androgen
    receptor inhibitor. Presenter: Howard I. Scher - Sidney Kimmel Center
    for Prostate and Urologic Cancers, Memorial Sloan-Kettering Cancer
    Center

  
General Poster Session A from 11:45am-1:15pm ET and again from
5:05-6:35pm ET: 


 
--  (Abstract #18) Enzalutamide monotherapy: Phase 2 study results in
    hormone-naive prostate cancer patients. Presenter: Bertrand
    Tombal - Universite Catholique de Louvain, Cliniques
    Universitaires Saint-Luc
--  (Abstract #63): Enzalutamide in combination with docetaxel in men with
    prostate cancer (PC): Preliminary results from a phase 1 study.
    Presenter: Mark T. Fleming - Virginia Oncology Associates
--  (Abstract #16) Improved outcomes in elderly patients with metastatic
    castration-resistant prostate cancer (mCRPC) treated with the androgen
    receptor inhibitor enzalutamide: Results from the Phase 3 AFFIRM
    trial. Presenter: Cora N. Sternberg - San Camillo and Forlanini
    Hospital
--  (Abstract #17) Effect of enzalutamide on health-related quality of
    life (HRQoL) in men with metastatic castration-resistant prostate
    cancer (mCRPC) following docetaxel-based therapy: Results from the
    AFFIRM study. Presenter: Kurt Miller -
    Charite-Universitaetsmedizin Berlin
--  (Abstract #20) Long-term responders to enzalutamide during the phase 3
    AFFIRM trial: Baseline characteristics and efficacy outcomes.
    Presenter: Mark T. Fleming - Virginia Oncology Associates

  
About XTANDI(R)  
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 prost
ate 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).  
The efficacy and safety of XTANDI were assessed in the randomized,
placebo-controlled, global phase 3 AFFIRM clinical trial. A total of
1,199 patients with mCRPC who had previously received docetaxel were
randomized 2:1 to receive either XTANDI orally at a dose of 160 mg
once daily (N = 800) or placebo (N = 399). 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. The primary endpoint of the trial was OS. 
XTANDI-treated patients had a statistically-significant improvement
in median OS compared to the placebo group: 18.4 months in the XTANDI
group versus 13.6 months in the placebo group (P < 0.0001). XTANDI
provided a 37% reduction in risk of death compared to placebo (hazard
ratio = 0.631). Seizure occurred in 0.9% of patients on XTANDI and 0%
of the placebo-treated patients. The most common adverse reactions
(&#8805; 5%) are 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 3
and higher adverse reactions were reported among 47% of
XTANDI-treated patients and 53% of placebo-treated patients.  
The recommended dose of XTANDI is 160 mg (four 40 mg capsules)
administered orally once daily. XTANDI can be taken with or without
food and does not require concomitant steroid (e.g., prednisone) use.
In the phase 3 clinical trial, 48% of XTANDI patients and 46% of
patients in the placebo arm were treated with glucocorticoids. 
XTANDI Mechanism of Action  
XTANDI (enzalutamide) is an androgen receptor inhibitor that acts on
different steps in the androgen receptor signaling pathway. XTANDI
has been shown to competitively inhibit androgen binding to androgen
receptors, inhibit androgen receptor nuclear translocation and
interaction with DNA. A major metabolite, N-desmethyl enzalutamide,
exhibited similar in vitro activity to XTANDI. XTANDI decreased
proliferation and induced cell death of prostate cancer cells in
vitro, and decreased tumor volume in a mouse prostate cancer
xenograft model.  
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 (&#8805;
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
INR monitoring.  
For Full Prescribing Information, please visit www.XtandiHCP.com. 
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 www.medivation.com.  
About Astellas Pharma Inc.
 Astellas Pharma Inc. is a pharmaceutical
company dedicated to improving the health of people around the world
through provision of innovative and reliable pha
rmaceuticals. The
organization is committed to becoming a global category leader in
oncology, and has several oncology compounds in development in
addition to XTANDI. For more information on Astellas Pharma Inc.,
please visit our website at www.astellas.com/en.  
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) 204-5405 
Mike Beyer
Sam Brown, Inc (media for both companies)
(773) 463-4211  
 
 
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