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Astellas Pharma Global Development, Inc. Release: Data From PREVAIL Trial Of Enzalutamide In Chemotherapy-Naive Metastatic Prostate Cancer To Be Presented In Late-Breaking Session At ASCO GU Symposium


12/20/2013 11:54:24 AM

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SAN FRANCISCO, CA and NORTHBROOK, IL--(Marketwired - December 19, 2013) - Medivation Inc. (NASDAQ: MDVN) and Astellas Pharma Global Development, Inc. announced that additional data from the Phase 3 PREVAIL trial evaluating enzalutamide in patients with chemotherapy-naïve metastatic prostate cancer will be highlighted in a late-breaking oral presentation at the upcoming American Society of Clinical Oncology (ASCO) 2014 Genitourinary (GU) Cancers Symposium in San Francisco.

Details of the oral presentation are as follows:

Title: Enzalutamide in men with chemotherapy-naïve metastatic prostate cancer (mCRPC): Results of Phase 3 PREVAIL Study

Presenter: Tomasz M. Beer, OHSU Knight Cancer Institute, Oregon Health & Science University

  • Session Detail: Welcome and General Session 1: Integrating Androgen Axis Therapy across the Disease Spectrum
  • Session Date/Time: January 30, 2014 from 7:45 a.m - 9:45 a.m.

Two additional enzalutamide abstracts will be presented during General Poster Sessions:

  • (Abstract #62) Enzalutamide monotherapy: Phase 2 study results in hormone-naïve prostate cancer patients. Presenter: Bertrand Tombal, Université Catholique de Louvain, Cliniques Universitaires Saint-Luc (11:30 a.m. - 1:00 p.m., Thursday, January 30, 2014)
  • (Abstract #247) Enzalutamide in men with prostate cancer resistant to docetaxel and abiraterone. Presenter: Mark Creamer Scholz, Prostate Oncology Specialists (12:00 - 1:30 p.m., Friday, January 31, 2014)

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 metastatic prostate cancer whose disease progressed despite treatment with androgen deprivation therapy and had not yet received chemotherapy. 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. Targeted enrollment was completed in May 2012 and the pre-specified interim analysis was conducted after 516 events (patient deaths).

Enzalutamide Mechanism of Action

Enzalutamide is an androgen receptor 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.

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 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 (greater than or equal to 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 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 Medivation

Medivation, Inc. is a biopharmaceutical company focused on the rapid development of novel small molecule drugs 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

Astellas Pharma Global Development, Inc., located in Northbrook, Illinois, is a member of the Astellas group of companies. 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 being a global category leader in focused areas such as Oncology and Urology, by combining outstanding R&D and marketing capabilities. For more information about Astellas Pharma Inc., please visit our website at www.astellas.com/en.

Note Regarding Forward-Looking Statement - Medivation
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding therapeutic potential of XTANDI. 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, the risk that unanticipated developments could interfere with the commercialization of XTANDI, as well as other risks detailed in Medivation's filings with the Securities and Exchange Commission, including its quarterly report on Form 10-Q for the quarter ended September 30, 2013, filed on November 12, 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 release.


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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