Astellas Announces Marketing Authorisation Application for XTANDI(TM) (enzalutamide) for Chemotherapy-Naïve Metastatic Prostate Cancer

Tokyo (ots/PRNewswire) -

Astellas Pharma Inc. today announces the submission of a
variation to amend the Marketing Authorisation Application for
XTANDI(TM) (enzalutamide) capsules for the treatment of adult men
with metastatic castration-resistant prostate cancer (mCRPC) who are
asymptomatic or mildly symptomatic after failure of androgen
deprivation therapy and in whom chemotherapy is not yet clinically
indicated.Enzalutamide is currently approved in Europe for the
treatment of adult men with mCRPC whose disease has progressed on or
after docetaxel chemotherapy.[i]

This announcement follows presentation of the Phase III data for
the PREVAIL trial at the American Society of Clinical Oncology (ASCO)
2014 Genitourinary (GU) Cancers Symposium in San Francisco on
Thursday, January 30, 2014.[ii]

In the Phase III PREVAIL trial, treatment with enzalutamide showed
a statistically significant overall survival benefit compared with
placebo, with enzalutamide reducing the risk of death by 29%
(HR=0.71; p<0.0001), compared with placebo.[ii] Treatment with
enzalutamide also significantly reduced the risk of radiographic
progression or death by 81% compared with placebo treatment (HR=0.19;
p<0.0001).[ii] Men taking enzalutamide experienced a 17-month delay
in the time to initiation of chemotherapy compared with men taking
placebo (28.0 months versus 10.8 months; HR=0.35; p<0.0001).[ii]The
study also concluded that enzalutamide was generally well tolerated
by patients and met all secondary endpoints.[ii]

Prostate cancer is the most common cancer in men in Europe,
accounting for over 20% of all cancer diagnoses (excluding
non-melanoma skin cancer) and is the third most common cause of
cancer death in Europe.[iii] Up to 40% of men with prostate cancer
develop metastatic disease and a high number of these men eventually
fail androgen deprivation treatment, which is called
castration-resistant prostate cancer (CRPC).[iv]

"Oncology is a growing area of focus for Astellas, and we are
committed to developing and bringing to market medicines which meet
current unmet medical needs," said Dr Ayad Abdulahad, Senior Vice
President, Medical Affairs & Health Economics, Astellas Pharma Europe
Ltd. "We will continue to work with our partner, Medivation, to seek
the necessary European regulatory approval for Xtandi, that will
allow for its use amongst patients who have not received chemotherapy
for their advanced prostate cancer."

About the PREVAIL Trial

The Phase 3 PREVAIL trial is a randomized, double-blind,
placebo-controlled, multi-national trial that enrolled more than
1,700 patients at sites in the United States, Canada, Europe,
Australia, Russia, Israel and Asian countries including Japan. The
trial enrolled patients with chemotherapy-naïve metastatic prostate
cancer whose disease progressed on a luteinizing hormone-releasing
hormone analogue or after bilateral orchiectomy. The co-primary
endpoints of the trial were overall survival and radiographic
progression-free survival. The trial was designed to evaluate
enzalutamide at a dose of 160 mg taken orally once daily versus
placebo.

About XTANDI(TM)

Xtandi is a novel, oral, once-daily androgen receptor signalling
inhibitor. Xtandi directly targets the androgen receptors (AR) and
exerts its effects on all three steps of AR signalling pathway:

- Blocks androgen binding[v]
- Androgen binding induces a conformational change that triggers activation
of the receptor[vi]
- Prevents nuclear translocation[v]
- Transit of the AR to the nucleus is an essential step in AR-mediated gene
regulation[vi]
- Impairs DNA binding[v]
- Binding of the AR to the DNA is essential for modulation of gene
expression[vi]

Xtandi was approved by the FDA on August 31, 2012 and is indicated
for the treatment of adult men with mCRPC who have previously
received docetaxel[vii]

Xtandi is currently licensed in Europe for the treatment of adult
men with mCRPC whose disease has progressed on or after docetaxel
therapy.[i] Marketing authorisation was granted by the European
Commission on June 21, 2013.

In March 2014, Astellas and Medivation submitted a supplemental
new drug application for Xtandi for chemotherapy-naïve advanced
prostate cancer to the US Food and Drug Administration.

Important Safety Information for XTANDI(TM)

For important Safety Information for Xtandi please see the full
Summary of Product Characteristics at:

http://www.medicines.org.uk/emc/medicine/27912/SPC/Xtandi+40mg+sof
t+capsules

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 pharmaceuticals. The organisation is
committed to being 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 http://www.astellas.com/en.

About the Astellas / Medivation Collaboration

In October 2009, Medivation and Astellas entered into a global
agreement to jointly develop and commercialize enzalutamide. The
companies are collaborating on a comprehensive development program
that includes studies to develop enzalutamide across the full
spectrum of advanced prostate cancer as well as advanced breast
cancer. The companies jointly commercialize Xtandi in the United
States and Astellas will have responsibility for manufacturing and
all additional regulatory filings globally, as well as
commercializing Xtandi outside the United States.

i. European Medicines Agency, XTANDI, (enzalutamide) Summary of
Product Characteristics, 2013

ii. Beer T, et al. Enzalutamide Decreases Risk of Death and Delays
Progression in Phase 3 Trial of Men with Metastatic Prostate Cancer.
Presentation ASCO GU 2014

iii. Ferlay J, Shin HR, Bray F et al. Globocan 2008 v2.0, cancer
incidence and mortality worldwide. IARC CancerBase No. 10 [Internet].
Lyon, France: International Agency for Research on Cancer 2010.
Available from: http://globocan.iarc.fr. Last accessed March 2014

iv. Beltran H, Beer TM, Carducci MA et al. New therapies for
castration-resistant prostate cancer: Efficacy and safety. Eur Urol
2011; 60 (2): 279-290

v. Tran C, et al. Development of a second-generation antiandrogen
for treatment of advanced prostate cancer. Science 2009;324:787-790

vi. Hu R, Denmeade SR and Luo J. Molecular processes leading to
aberrant androgen receptor signaling and castration resistance in
prostate cancer. Expert Rev Endocrinol Metab 2010; 5 (5): 753-764

vii. U.S. Food and Drug Administration. Enzalutamide (XTANDI
Capsules). Available from: http://www.fda.gov/drugs/informationondrug
s/approveddrugs/ucm317997.htm. Last accessed March 2014

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

Contact:
Astellas Contacts: Mindy Dooa, Communications Director,
+44(0)7826-912339; Katy Pogson, Red Door Communications,
+44(0)7941-418962;
Medivation Contacts: Anne Bowdidge, Senior Director, Investor
Relations,
+1-(650)218-6900