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    4503   JP3942400007

ASTELLAS PHARMA INC.

(4503)
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Astellas Pharma : ' XTANDI (enzalutamide) Approved by European Commission for Men with Metastatic Hormone-Sensitive Prostate Cancer

05/05/2021 | 07:38am EDT

TOKYO - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., 'Astellas') announced that the European Commission (EC) has approved an additional indication for the oral once-daily therapy XTANDI (enzalutamide) for adult men with metastatic hormone-sensitive prostate cancer (mHSPC, also known as metastatic castration-sensitive prostate cancer or mCSPC). Men diagnosed with mHSPC tend to have a poor prognosis, with a median survival of approximately 3-4 years,1 underscoring the need for new treatment options.

With this indication, enzalutamide is now the only oral treatment approved by the EC to treat three distinct types of advanced prostate cancer - non-metastatic and metastatic castration-resistant prostate cancer (CRPC) and mHSPC.2 The EC approval is based on results from the pivotal Phase 3 ARCHES trial which evaluated enzalutamide in men with mHSPC.3

'Metastatic hormone-sensitive prostate cancer patients have limited options and, unfortunately, there is a poor prognosis for many men,' said Andrew Armstrong, M.D., Professor of Medicine, Surgery, Pharmacology and Cancer Biology, Director of Research in the Duke Cancer Institute's Center for Prostate and Urologic Cancers and lead investigator of ARCHES. 'The research supporting this approval provides clinical evidence showing how enzalutamide can help improve outcomes for men with mHSPC, which gives healthcare professionals in Europe the option to offer the treatment across the advanced prostate cancer disease continuum.'

Data from the ARCHES trial showed enzalutamide plus androgen deprivation therapy (ADT) significantly reduced the risk of radiographic progression or death by 61% versus placebo plus ADT in men with mHSPC (n=1,150; hazard ratio [HR]=0.39 [95% confidence interval (CI): 0.30-0.50]; P

(C) 2021 Electronic News Publishing, source ENP Newswire

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Financials
Sales 2022 1 324 B 12 073 M 12 073 M
Net income 2022 193 B 1 760 M 1 760 M
Net cash 2022 478 B 4 354 M 4 354 M
P/E ratio 2022 16,5x
Yield 2022 2,79%
Capitalization 3 324 B 30 343 M 30 309 M
EV / Sales 2022 2,15x
EV / Sales 2023 1,89x
Nbr of Employees 15 455
Free-Float 99,0%
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Number of Analysts 14
Last Close Price 1 794,00 JPY
Average target price 2 455,38 JPY
Spread / Average Target 36,9%
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Managers and Directors
Kenji Yasukawa President, CEO & Representative Director
Yoshihiko Hatanaka Chairman
Yoshitsugu Shitaka Chief Scientific Officer
Fumiaki Sakurai Head-Business Administration & Compliance
Mamoru Sekiyama Independent Outside Director
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