Full Press Release Details
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.
About the PIFR-2 Study
This 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).
The Company expects to report top-line results in first quarter 2023.
About Theravance Biopharma / Viatris Collaboration
Theravance 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 Company is entitled to low double-digit tiered royalties on ex-US net sales.
About YUPELRI ®
YUPELRI ® (revefenacin) inhalation solution is a once-daily nebulized long-acting muscarinic antagonist (LAMA) approved for the maintenance treatment of COPD in the US. LAMAs are recognized by international COPD treatment guidelines as a cornerstone of maintenance therapy for COPD, regardless of severity of disease. Our market research indicates there is an enduring population of COPD patients in the US that either need or prefer nebulized delivery for maintenance therapy. The stability of revefenacin in both metered dose inhaler and dry powder inhaler ("MDI/DPI") formulations suggests that revefenacin could also serve as a foundation for novel handheld combination products.
Important Safety Information
What is YUPELRI ® ?
Who should not use YUPELRI?
Before using YUPELRI, tell your healthcare provider about all your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. YUPELRI and certain other medicines may interact with each other. This may cause serious side effects.
Especially tell your healthcare provider if you take:
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.
What are the possible side effects with YUPELRI? YUPELRI can cause serious side effects, including:
If you have any of these symptoms, call your healthcare provider right away before taking another dose.
If you have any of these symptoms, stop taking YUPELRI, and call your healthcare provider right away before taking another dose.
Common side effects of YUPELRI include:
Tell your healthcare provider if you get any side effects that bother you or that do not go away. These are not all the possible side effects with YUPELRI. Ask your healthcare provider or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I use YUPELRI?
Read the step by step instructions for using YUPELRI at the end of this Patient Information Leaflet
This summary does not include all the information about YUPELRI and is not meant to take the place of a discussion with your healthcare provider about your treatment.
About Theravance Biopharma
Theravance Biopharma, Inc. is a biopharmaceutical company primarily focused on the discovery, development and commercialization of respiratory medicines. Its core purpose is to create medicines that help improve the lives of patients suffering from respiratory illness.
In pursuit of its purpose, Theravance Biopharma leverages decades of respiratory expertise to discover and develop transformational medicines that make a difference. These efforts have led to the development of FDA-approved YUPELRI ® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Its respiratory pipeline of internally discovered programs is targeted to address significant patient respiratory needs.
Theravance Biopharma has an economic interest in potential future payments from Glaxo Group Limited or one of its affiliates (GSK) pursuant to its agreements with Innoviva, Inc. relating to certain programs, including TRELEGY.
For more information, please visit www.theravance.com .
THERAVANCE BIOPHARMA ® , THERAVANCE ® , and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies (in the US and certain other countries).
YUPELRI ® is a registered trademark of Mylan Specialty L.P., a Viatris Company. Trademarks, trade names or service marks of other companies appearing on this press release are the property of their respective owners.
Forward-Looking Statements
Contact: Gail B. Cohen Corporate Communications / 917-214-6603
SOURCE Theravance Biopharma, Inc.