Astellas Pharma Europe Ltd. and Medivation, Inc.

New Enzalutamide Data to Be Presented in Late Breaking News Plenary Session at European Association of Urology Congress

Chertsey, England (ots/PRNewswire) - Astellas Pharma Europe Ltd. and Medivation, Inc. announced that two enzalutamide abstracts will be presented at the annual European Association of Urology (EAU) Congress on March 24, 2015 in Madrid, Spain.

(Logo: http://photos.prnewswire.com/prnh/20140522/689211 )

(Logo: http://photos.prnewswire.com/prnh/20150319/735705 )

The following abstracts will be presented during a late-breaking news plenary session:

Title: Enzalutamide in men with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC): Final overall survival analysis of the phase 3 PREVAIL study

Presenter: Bertrand Tombal, M.D., Ph.D., professor and chairman, Department of Urology, Universite catholique de Louvain, Cliniques universitaires Saint-Luc, Brussels, Belgium

- Session Date/Time: Tuesday, March 24, 10:20 AM - 10:30 AM CEST
- Location: eURO Auditorium
 

Title: A randomized, double-blind, phase 2, efficacy and safety study of enzalutamide vs. bicalutamide in metastatic castration-resistant prostate cancer: TERRAIN trial

Presenter: Axel Heidenreich, M.D., Ph.D., professor and director, Department of Urology, University hospital, Aachen, Germany

- Session Date/Time: Tuesday, March 24, 10:35 AM - 10:45 AM CEST
- Location: eURO Auditorium
 

About the PREVAIL Trial[1]

The Phase 3 PREVAIL trial, a randomised, double-blind, placebo-controlled, multi-national trial, enrolled 1,717 patients at sites in the United States, Canada, Europe, Australia, Russia, Israel and Asia, including Japan. The trial enrolled patients with chemotherapy-naïve metastatic prostate cancer, who were asymptomatic or mildly symptomatic and whose disease progressed on androgen deprivation therapy (i.e., a luteinising hormone-releasing hormone (LHRH) therapy 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 the TERRAIN Trial

The Phase 2 TERRAIN trial enrolled 375 patients in North America and Europe. The trial enrolled patients with metastatic prostate cancer whose disease progressed despite treatment with a LHRH analogue therapy or following surgical castration. The primary endpoint of the trial was progression-free survival, defined as time from randomisation to centrally confirmed radiographic progression, skeletal related event, initiation of new anti-neoplastic therapy or death, whichever occurs first. The trial was designed to evaluate enzalutamide at a dose of 160 mg taken once daily versus bicalutamide at a dose of 50 mg taken once daily, the approved dose in combination with a LHRH analogue.

About XTANDI(TM) (enzalutamide)

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

- Blocks androgen binding[2]
     - Androgen binding induces a conformational change that triggers activation
     of the receptor[3]
- Prevents nuclear translocation[2]
     - Transit of the AR to the nucleus is an essential step in AR-mediated gene
     regulation[3]
- Impairs DNA binding[2]
     - Binding of the AR to the DNA is essential for modulation of gene
     expression[3]
 

Enzalutamide was first approved by the European Commission in June 2013 for the treatment of adult men with mCRPC whose disease has progressed on or after docetaxel therapy.[4] Enzalutamide is now approved in Europe for the treatment of adult men with metastatic castration-resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.[4]

Important Safety Information for XTANDI(TM) (enzalutamide)

For important Safety Information for enzalutamide please see the full Summary of Product Characteristics at: http://www.medicines.org.uk/emc/medicine/27912/SPC/Xtandi+40mg+soft+capsules.

About Astellas

Astellas Pharma Europe Ltd. operates in 40 countries across Europe, the Middle East and Africa, and is the regional business 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 pharmaceuticals. The organisation's focus is to deliver outstanding R&D and marketing to continue growing in the world pharmaceutical market. Astellas' presence in Europe also includes an R&D site and three manufacturing plants. The company employs approximately 4,350 staff across these countries. For more information about Astellas Pharma Europe Ltd., please visit http://www.astellas.eu.

About Medivation Inc.

Medivation, Inc. is a biopharmaceutical company focused on the rapid development of medically innovative 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 http://www.medivation.com [http://C:\Users\am00400106\AppData\Local\Microsoft\Windows\Temporary InternetFiles\Content.Outlook\VV66ANWY\www.medivation.com] .

About the Medivation/Astellas Collaboration

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

1. Beer TM, et al. Enzalutamide in Metastatic Prostate Cancer before Chemotherapy. N Engl J Med 2014; DOI: 10.1056/NEJMoa1405095

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

3. 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

4. European Medicines Agency. XTANDI (enzalutamide). Summary of Product Characteristics, 2015


Photo: 
http://photos.prnewswire.com/prnh/20140522/689211



http://photos.prnewswire.com/prnh/20150319/735705
 

Contact:

Astellas Contact
Mindy Dooa
Senior Director, Corporate Communications
+44(0)7826-912-339
Mindy.Dooa@astellas.com
Medivation Contacts
Rick Bierly
Chief Financial Officer
+1(415)543-3470
Anne Bowdidge
Senior Director, Investor Relations
+1(650)218-6900



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