Monday, June 11, 2012 - 01:00

Investigational, phase III treatment made available for metastatic prostate cancer patients post-chemotherapy with no alternative treatment options available.

Staines, England, Monday 11th June, 2012

The investigational therapy enzalutamide – proposed INN* (MDV3100) – is now available across Europe through a Named Patient Programme, supported by Astellas Pharma Europe Ltd., Astellas Pharma Global Development and Medivation, Inc.

* International Nonproprietary Names for Pharmaceutical Substances (INN)

A Named Patient Programme is a compassionate use programme that provides controlled access to investigational medicines prior to their regulatory approval or launch. They are designed to support early access to treatments that have demonstrated positive resultsduring clinical trials for patients who have no alternative treatment options available to them. Enzalutamide, a novel, oral androgen-receptor signalling inhibitor,1 will be available to men with metastatic castrate-resistant prostate cancer previously treated with docetaxelchemotherapy who meet the eligibility criteria and whose physician determines that there is no other suitable therapy. Regulatory submission for enzalutamide has been filed in the US and is underway for Europe, based on the results of the phase III AFFIRM study which was halted early by the Independent Data Monitoring Committee overseeing the study due to the positive benefits seen.

Healthcare professionals can find further information by contacting Clinigen Customer Services (call +44 (0) 128 494 340, e-mail customer.services@clinigengroup.com).

Contact 

Sarah Mckinnon 
Clark Red Health 
Sarah.mclark@redconsultancy.com 
0207 025 6414 / 0771 331 3158 

Mindy Dooa
Astellas Pharma Europe Ltd. 
Mindy.Dooa@astellas.com 

Notes to Editors 

About Prostate Cancer 

Prostate cancer is the most frequently diagnosed cancer in the male population,2 with some 2.6 million new cases diagnosed each year in Europe alone.3 Prostate cancer generally affects men over 50 years of age.4 

Prostate cancer growth is primarily driven by androgen receptor (AR) signalling within the cancer cell.5 In advanced prostate cancer (APC), the cancer may continue to progress and metastasize to other parts of the body despite prior surgery, radiation therapy and conventional hormone or chemotherapy-based treatments.6 

When APC progresses despite treatment with androgen-deprivation therapy (ADT), it can be defined as castration-resistant prostate cancer (CRPC). It is thought that AR signalling continues to be an important driver of cancer growth and proliferation in CRPC.1,5 

Patients with CRPC currently have few treatment options. There is an unmet need in this area for new compounds that target the cancer differently and which may provide alternative therapeutic options for patients at this late stage of their disease.

About Enzalutamide-proposed INN* (MDV3100) 

Enzalutamide is an oral, once-daily investigational agent that is an androgen receptor signaling inhibitor.1,8 Enzalutamide is not yet approved for use. 

Enzalutamide inhibits androgen receptor signaling in three distinct ways: it inhibits 1) testosterone binding to androgen receptors; 2) nuclear translocation of androgen receptors; and 3) DNA binding and activation by androgen receptors.1,8 

In the phase III AFFIRM trial, enzalutamide was generally well tolerated. Common side effects observed more frequently in enzalutamide as compared with placebo-treated patients included fatigue, diarrhea and hot flush. Seizure was reported in < 1% of enzalutamidetreated patients. Serious adverse events, adverse events causing patients to stop treatment, and adverse events causing death all were lower in the enzalutamide group than in the placebo group.1 

About Astellas Pharma Europe 

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 and reliable pharmaceuticals. The organisation is committed to becoming a global company by combining outstanding R&D and marketing capabilities and continuing to grow 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 4,200 staff across these regions. For more information about Astellas Pharma Europe, please visit www.astellas.eu. 

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 caregivers. For more information, please visit us at 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. Subject to receipt of regulatory approval, the companies will jointly commercialise enzalutamide in the United States and Astellas will have responsibility for commercialising enzalutamide outside the U.S. 

About the Named Patient Programme 

The enzalutamide EU Named Patient Programme will be available across Europe, provided under the local country regulations for the supply of unlicensed medicines. The programme will be launched to patients in the 27 member countries of the European Union, in addition to Norway and Switzerland on Friday 1 June 2012. 

About Clinigen 

Clinigen is a specialty global pharmaceuticals and services business dedicated to serving patients, the medical community and the healthcare industry. They will manage the programme on behalf of Astellas and Medivation. Clinigen has experience in implementing Named Patient and Compassionate Use Programmes around the world. 

References 

1. Scher H I. et al, MDV3100, an Androgen Receptor Signaling Inhibitor (ARSI), Improves Overall Survival in Patients With Prostate Cancer Post Docetaxel; Results From the Phase 3 Affirm Study. Presented at SCO-GU, 02 February 2012 

2. Beltran H. et al, Collaborative Review – Prostate Cancer New Therapies for Castration-Resistant Prostate Cancer: Efficacy and Safety, European Urology 2011; 60(2):279-290 
3. Montzka K, Heidenreich A. Castration-Resistant Prostate Cancer: Definition, Biology, and Novel Therapeutic Intervention Strategies. AoU 2010 
4. McMillan Cancer Support – Prostate Cancer – Cancer Information. Available at: http://www.macmillan.org.uk/Cancerinformation/Cancertypes/Prostate/About... Last accessed March 2012 
5. Lonergan P E, Tindall D J, Androgen receptor signalling in prostate cancer development and progression, J Carcinog 2011;10:20 
6. Nieto M, Finn S, Prostate Cancer: re-focusing on Androgen receptor signalling, Int. Journal Cell Biology 2007;39(9):1562-8 
7. Yap T A, et al. The changing therapeutic landscape of castration-resistant prostate cancer, Nat. Rev. Clin. Oncol 2011;8(10):597-610 
8. Scher H I. et al, Antitumour activity of MDV3100 in castration-resistant prostate cancer: a phase 1–2 study. The Lancet 2010;375(9724):1437-46 

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