New Data Presented at ESMO 2016 Further Demonstrates XTANDITM▼ (enzalutamide) Significantly Improves Time to PSA Progression in Advanced Prostate Cancer, Compared with Placebo

Astellas Pharma Europe Ltd., a subsidiary of Tokyo-based Astellas Pharma Inc. (TSE:4503), today announced the presentation of new data that reaffirms the role of XTANDI^TM▼ (enzalutamide) in extending time to prostate specific antigen (PSA) progression in men with advanced prostate cancer. The data presented today at the European Society for Medical Oncology Congress (ESMO), held in Copenhagen, Denmark, from 7-11 October, confirms the efficacy of enzalutamide vs placebo in Asian men.

Data from a study examining the efficacy and safety of enzalutamide versus placebo in 409 Asian patients from China, South Korea, Taiwan and Hong Kong with asymptomatic/mildly symptomatic progressive advanced prostate cancer following androgen deprivation therapy (ADT) found that enzalutamide significantly improved time to PSA progression, compared with placebo (7.46 months vs 2.86 months, respectively (HR* 0.36; 95% CI 0.27**, 0.5; P<0.0001)).¹ PSA blood tests are used to monitor the progression of prostate cancer.²

Secondary end points included overall survival, defined as time from randomisation to death from any cause, and radiographic progression free survival (rPFS) defined as the time from randomisation to radiographic progression or death from any cause.^a Although the median overall survival was not yet reached at the time of the data cut-off in either treatment arm, enzalutamide significantly reduced the risk of death (HR 0.35; 95% CI 0.17, 0.70; p=0.0021). At data cut-off, enzalutamide significantly reduced the risk of rPFS events with 19.6% (41/209) of patients receiving enzalutamide and 36% (72/200) of patients in the placebo arm experiencing a rPFS event – i.e, spreading of the cancer. While slightly more patients treated with enzalutamide reported at least one treatment-emergent adverse event, enzalutamide was generally well tolerated in the trial.¹ These results are consistent with data from the pivotal PREVAIL trial, which considered a patient population with similar clinical characteristics. In the PREVAIL trial, enzalutamide was found to increase the median overall survival in asymptomatic or mildly symptomatic patients with advanced prostate cancer who had not received chemotherapy, compared with placebo.³

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^aWithin 168 days of treatment discontinuation, whichever occurred first, assessed during the screening, at day 57, 113, 169 and 253 and every subsequent 12 weeks.

Dr Simon Chowdhury, Consultant Medical Oncologist, Guy's and St Thomas' NHS Foundation Trust, “The findings presented today show that enzalutamide can increase the time to PSA progression - an important marker used to monitor disease progression in prostate cancer - compared with placebo, in Asian men. Historically there has been a lack of studies considering this group of men and so these results provide reassurance of enzalutamide’s efficacy and tolerability across the broad population that we tend to see across Europe.”

An additional five abstracts focusing on enzalutamide were also presented today, adding further to the body of data supporting the safety and efficacy profile of enzalutamide as a treatment option for advanced prostate cancer.

-Ends-

*Hazard ratio
**Confidence interval

Dr Simon Chowdhury was approached by Astellas Pharma Europe Ltd. to provide a quote for inclusion in this press release.

Notes to Editors

Enzalutamide data presentation details:

• Ye D, Ahn H, Pu Y-S, et al. Efficacy and safety of enzalutamide (ENZ) vs placebo (PL) in chemotherapy-naïve patients (pts) with progressive metastatic castration-resistant prostate cancer (mCRPC) following androgen deprivation therapy (ADT): an Asian multinational study. Poster 760P; 9 Oct 2016 (Sun); 13:00-14:00; Hall E
• Chowdhury S, Shore N, Saad f, et al. Fatigue in men with metastatic castration-resistant prostate cancer treated with enzalutamide: data from randomised clinical trials. Poster 739P; 9 Oct 2016 (Sun);13:00-14:00;Hall E
• Heidenreich A, Shore N, Villers A, et al. Prognostic factors in men with metastatic castration-resistant prostate cancer (mCRPC) treated with enzalutamide (ENZA) or bicalutamide (BIC) in TERRAIN. Poster 759P; 9 Oct 2016 (Sun); 13:00-14:00; Hall E
• Bryce A, Alumkal J, Armstrong A, et al. A post hoc analysis of radiographic progression with nonrising prostate-specific antigen in patients with metastatic castration-resistant prostate cancer (mCRPC) in the PREVAIL study. Poster 760P; 9 Oct 2016 (Sun); 13:00-14:00; Hall E
• Stenzl A, Krivoshik A, Baron B, et al. Efficacy and safety of enzalutamide plus androgen deprivation therapy vs placebo plus androgen deprivation therapy in men with metastatic hormone-sensitive prostate cancer: the ongoing ARCHES trial. Poster 767TiP;9 Oct 2016 (Sun);13:00-14:00; Hall E
• Miller K, Mulders P, Freedland S, et al. EMBARK: A phase 3, randomized, efficacy and safety study of enzalutamide plus leuprolide, enzalutamide monotherapy and placebo plus leuprolide in men with high-risk nonmetastatic prostate cancer progressing after definitive therapy. Poster 770TiP; 9 Oct 2016 (Sun); 13:00-14:00; Hall E

About PREVAIL

PREVAIL was a Phase 3, randomised, double-blind, placebo-controlled trial of enzalutamide versus placebo in patients with mCRPC who had not received chemotherapy.³

About AFFIRM

AFFIRM was a Phase 3, randomised, double-blind, placebo-controlled study of enzalutamide in patients with mCRPC who had previously been treated with docetaxel-based chemotherapy.⁴

About TERRAIN

TERRAIN was a Phase 2, randomised, double-blind, efficacy and safety study of enzalutamide vs. bicalutamide in patients with mCRPC.⁵

About STRIVE

STRIVE was a Phase 2, randomised, double-blind, efficacy and safety study of enzalutamide versus bicalutamide in patients with nonmetastatic or metastatic CRPC.⁶

About XTANDI ^™ (enzalutamide)

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

• Blocks androgen binding⁷
  • Androgen binding induces a conformational change that triggers activation of the receptor⁸
• Prevents nuclear translocation⁷
  • Translocation of the AR to the nucleus is an essential step in AR-mediated gene regulation⁸
• Impairs DNA binding⁷
  • Binding of the AR to the DNA is essential for modulation of gene expression⁸

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.⁹ Enzalutamide is also approved in Europe for the treatment of adult men with mCRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.⁹

Important Safety Information for XTANDI ^™ (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 Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. We focus on Urology, Oncology, Immunology, Nephrology and Neuroscience as prioritised therapeutic areas while advancing new therapeutic areas and discovery research leveraging new technologies/modalities. We are also creating new value by combining internal capabilities and external expertise in the medical/healthcare business. Astellas is on the forefront of healthcare change to turn innovative science into value for patients.

About Astellas Pharma Europe Ltd.

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.

About the Medivation/Astellas Collaboration

In October 2009, Medivation (NASDAQ: MDVN) and Astellas (TSE: 4503) 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.

References
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¹Ye D, Ahn H, Pu Y-S, et al. Efficacy and safety of enzalutamide (ENZ) vs placebo (PL) in chemotherapy-naïve patients (pts) with progressive metastatic castration-resistant prostate cancer (mCRPC) following androgen deprivation therapy (ADT): an Asian multinational study. Poster 760P; 9 Oct 2016 (Sun); 13:00-14:00; Hall E

²Cancer Research UK. Prostate Cancer Tests. Available at: http://www.cancerresearchuk.org/about-cancer/type/prostate-cancer/diagnosis/prostate-cancer-tests. [Accessed October 2016]

³Beer TM, Armstrong AJ, Rathkopf DE, et al. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med 2014; 371:424-433

⁴Scher HI, Fizazi K, Saad F, et al. Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy. N Eng J Med 2012; 367:1187-1197

⁵Shore ND, Chowdhury S, Villers A, et al. Efficacy and safety of enzalutamide versus bicalutamide for patients with metastatic prostate cancer (TERRAIN): a randomised, double-blind, phase 2 study. Lancet Onc 2016; 17(2):p153–163

⁶Penson DF, Armstrong AJ, Concepcion R, et al. Enzalutamide Versus Bicalutamide in Castration-Resistant Prostate Cancer: The STRIVE Trial. J Clin Oncol 2016; 34(18): 2098-2106

⁷Tran C, et al. Development of a second-generation antiandrogen for treatment of advanced prostate cancer. Science 2009; 324:787-790

⁸Hu 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

⁹European Medicines Agency. XTANDI (enzalutamide). Summary of Product Characteristics, 2016

ENZ/16/0026/APEL
October 2016

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