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    4503   JP3942400007

ASTELLAS PHARMA INC.

(4503)
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The U.S. Food and Drug Administration Approves Astellas Pharma Inc.'s Supplemental New Drug Application for Prograf for the Prevention of Organ Rejection in Adult and Pediatric Lung Transplant Recipients

07/20/2021 | 06:11pm EDT

Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for PROGRAF® (tacrolimus) for the prevention of organ rejection in adult and pediatric lung transplant recipients. The sNDA submission was based on Real World Evidence (RWE) generated from a retrospective observational study of data from the U.S. Scientific Registry of Transplant Recipients (SRTR), which captures data on all transplants performed in the U.S. The study analyzed outcomes based on discharge immunosuppression treatment regimens in recipients of a primary lung transplant between 1999 and 2017 who were alive at the time of discharge. In adult (n=15,478) and pediatric (n=450) patients receiving tacrolimus immediate-release (IR) products in combination with mycophenolate mofetil (MMF), the one-year graft survival estimates from time of discharge were 90.9% (adult) and 91.7% (pediatric). In adult (n=4,263) and pediatric (n=72) patients receiving tacrolimus IR in combination with azathioprine (AZA), the one-year graft survival estimates from time of discharge were 90.8% (adult) and 84.7% (pediatric). The number of lung transplants performed annually increased from 724 in 1999 to 2,248 in 2017, and in recent years, over 85.5% of lung transplant recipients are treated with tacrolimus, MMF and steroids. Based on the SRTR study results, published clinical trials and postmarketing reports, the safety profile for lung transplant patients treated with PROGRAF is consistent with the safety profile in liver, kidney and heart transplant patients treated with PROGRAF. The primary adverse reactions described include renal dysfunction, infection, diabetes, gastrointestinal disturbances (e.g., diarrhea), hypertension, and neurological events (e.g., tremor). As expected, lung transplant patients have a higher incidence of pulmonary complications (e.g., pneumonia, bronchiolitis obliterans syndrome) than other solid organ transplant patients, which is in part due to the underlying disease and to the nature of the transplanted organ. The FDA granted Orphan Drug Designation (ODD) to PROGRAF for the prevention of rejection after lung transplant in September 2019. PROGRAF, which was discovered and developed by Astellas, is currently marketed in approximately 100 countries/areas and has greatly contributed to medical transplantation globally as a first-line immunosuppressant for organ transplantation. PROGRAF® was initially approved by the FDA in 1994. PROGRAF® is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, heart or lung transplants, in combination with other immunosuppressants.


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Financials
Sales 2022 1 325 B 11 963 M 11 963 M
Net income 2022 194 B 1 756 M 1 756 M
Net cash 2022 478 B 4 312 M 4 312 M
P/E ratio 2022 18,0x
Yield 2022 2,63%
Capitalization 3 525 B 31 844 M 31 831 M
EV / Sales 2022 2,30x
EV / Sales 2023 1,94x
Nbr of Employees 15 455
Free-Float 98,9%
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Number of Analysts 13
Last Close Price 1 902,50 JPY
Average target price 2 451,54 JPY
Spread / Average Target 28,9%
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Managers and Directors
Kenji Yasukawa President, CEO & Representative Director
Naoki Okamura CFO, Representative Director & Vice President
Yoshihiko Hatanaka Chairman
Yoshitsugu Shitaka Chief Scientific Officer
Fumiaki Sakurai Head-Business Administration & Compliance
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