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Theravance Biopharma, Inc. Announces Enrollment of First Patient in YUPELRI® Phase 4 Study
DUBLIN, Jan. 10, 2022 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ: TBPH) today announced enrollment of the
About this update from Theravance Biopharma, Inc.
[{"type":"text","content":"DUBLIN, Jan. 10, 2022 /PRNewswire/ -- Theravance Biopharma, Inc. (\"Theravance Biopharma\" or the \"Company\") (NASDAQ: TBPH) today announced enrollment of the first patient in a Phase 4 study of YUPELRI® (revefenacin) inhalation solution, the first and only once-daily, nebulized bronchodilator approved in the US for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Success in this study is intended to capture more of YUPELRI's addressable market and further strengthen its competitive advantage.\n\n \n \n \n \n \n \n\n \n\"YUPELRI, discovered and developed by Theravance, is one of the key pillars of value creation for the go-forward organization. We, and our partner Viatris, believe we have just scratched the surface of YUPELRI's contribution to the COPD community,\" said Rick E Winningham, Chief Executive Officer. \"The enrollment of the first patient in the Phase 4 PIFR-2 study demonstrates, through continued investment in controlled clinical studies, our commitment to provide healthcare professionals with the evidence needed to design personalized treatment plans in order to make better informed decisions for their COPD patients.\" \nAbout the PIFR-2 Study\nThis study (NCT05165485) is a randomized, double-blind, parallel-group study, comparing improvements in lung function in adults with severe to very severe COPD and suboptimal inspiratory flow rate following once-daily treatment over 12 weeks with either YUPELRI (revefenacin) inhalation solution delivered via standard jet nebulizer or SPIRIVA® (tiotropium) delivered via a dry powder inhaler (Spiriva® HandiHaler®) (n=366).\nThe Company expects to report top-line results in first quarter 2023.\nAbout Theravance Biopharma / Viatris Collaboration\nTheravance Biopharma and Viatris Inc. and their respective affiliates have established a strategic collaboration to develop and commercialize nebulized revefenacin products for COPD and other respiratory diseases. Theravance Biopharma and Viatris co-promote YUPELRI® (revefenacin) in the US, with their combined sales infrastructure targeting healthcare professionals who treat COPD patients suitable for YUPELRI. The Company is entitled to a share of US profits and losses (65% to Viatris; 35% to Theravance Biopharma) received in connection with commercialization of YUPELRI® (revefenacin), and the Co...