Publicado 22/10/2013 12:59
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Medivation and Astellas Announce the Phase 3 PREVAIL Trial of XTANDI▼(TM) (Enzalutamide) Meets Both Co-Primary Endpoints

Astellas Pharma Europe Ltd., located in the UK, is the European headquarters 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 pharmaceuticals. The organisation's focus is to deliver outstanding R&D and marketing to continue growing in the world pharmaceutical market. Astellas Pharma Europe Ltd. is responsible for 21 affiliate offices located across Europe, the Middle East and Africa, an R&D site and three manufacturing plants. The company employs approximately 4,350 staff across these regions. For more information about Astellas Pharma Europe, please visit http://www.astellas.eu.

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 http://www.astellas.com/en.

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 http://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 (formerly MDV3100).The companies are collaborating on a comprehensive development programme that includes studies to develop enzalutamide across the full spectrum of advanced prostate cancer. The companies are jointly commercialising enzalutamide in the United States and Astellas will have responsibility for commercialising enzalutamide outside the U.S, pending further regulatory authorisation. To date, enzalutamide has been filed in Japan, Switzerland and Brazil, and has received authorisation in the US, Canada and the EU.

References

i. Data on file: IDMC correspondence

ii. Tran C, Ouk S, Clegg NJ et al. Development of a second-generation antiandrogen for treatment of advanced prostate cancer. Science 2009; 324 (5928): 787-790

iii. European Medicines Agency, Xtandi (enzalutamide) Summary of Product Characteristics, 2013

iv. http://clinicaltrials.gov/ct2/show/NCT01.... Last accessed 21.10.13

        
        Job number: ENZ/13/0093/EU
        Date of preparation: October 2013

CONTACT: Contact: Mindy Dooa. Astellas Pharma Europe Ltd,Mindy.Dooa@eu.astellas.com, +44-(0)7826-912339

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