Astellas Announces Marketing Approval in Japan for XTANDI® (enzalutamide) Capsules, an Advanced Prostate Cancer Treatment

  Astellas Announces Marketing Approval in Japan for XTANDI® (enzalutamide)
               Capsules, an Advanced Prostate Cancer Treatment

PR Newswire

TOKYO, March 24, 2014

TOKYO, March 24, 2014 /PRNewswire/ --Astellas Pharma Inc. (TSE: 4503) today
announced that Astellas has obtained marketing approval of their oral androgen
receptor signaling inhibitor, XTANDI^® capsules 40mg (development code:
MDV3100; generic name: enzalutamide) for the treatment of patients with
castration-resistant prostate cancer in Japan. Astellas filed the application
for approval in Japan in May 2013.

XTANDI is a once-daily, oral androgen receptor signaling 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.

XTANDI (product name in Europe and the US: XTANDI^®), which is being jointly
developed and commercialized with US-based company, Medivation Inc. (NASDAQ
MDVN), was approved in August 2012 in the U.S. and in June 2013 in Europe for
the treatment of metastatic castration-resistant prostate cancer (mCRPC) in
patients who have previously received docetaxel (chemotherapy).

Upon receiving this marketing authorization in Japan, Astellas will provide
Medivation with a $15 million milestone payment.

Summary of Approval

Brand name:       XTANDI^® Capsules 40mg
Generic name:       Enzalutamide
Indication:  Castration-resistant prostate cancer

Precautions regarding indication:

1.The efficacy and safety of the drug have not been established in patients
    with prostate cancer who have not received chemotherapy.
2.Appropriate patients shall be selected by physicians who are well aware of
    the details of the "clinical results" and who have sufficient
    understanding of the efficacy and safety of the drug.

About XTANDI® (enzalutamide) capsules

XTANDI was approved by the FDA 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 U.S. prescribing
information)

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 versus
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 www.XtandiHCP.com.

About the Medivation/Astellas 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.

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 organization 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 www.astellas.com/en.

SOURCE Astellas Pharma Inc.

Website: http://www.astellas.com/en
Contact: Jenny Kite, 224-205-5405, jenny.kite@astellas.com
 
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