Full Press Release Details
Theravance Biopharma Announces Results from
the Phase 4 YUPELRI PIFR-2 Study in Patients with Severe to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
DUBLIN- January 5, 2024 - Theravance Biopharma,
Inc. (NASDAQ: TBPH) today announced results from the Phase 4 PIFR-2 study of YUPELRI (revefenacin) inhalation solution,
the only once-daily, nebulized long-acting muscarinic antagonist (LAMA) approved in the U.S. for maintenance treatment of COPD.
The PIFR-2 study aimed to demonstrate greater improvement in lung
function for YUPELRI delivered via standard jet nebulizer compared to Spiriva (tiotropium) delivered via a dry powder
inhaler (Spiriva HandiHaler ) in adults with severe to very severe COPD and suboptimal peak inspiratory
Chief Executive Officer Rick E Winningham said: "While the
primary endpoint in the Phase 4 PIFR-2 study was not met, YUPELRI demonstrated an efficacy and safety profile consistent with its performance
in other clinical studies. We appreciate the growth opportunities that lie ahead for YUPELRI, which is an important option for COPD maintenance
care, and look forward to sharing additional details from PIFR-2 in the future, following additional data analyses."
About the PIFR-2 Study
The Phase 4 PIFR-2 Study (NCT05165485) is
a randomized, double-blind, parallel-group study, comparing improvements in lung function in adults with severe to very severe COPD (FEV1
<50% of predicted) and suboptimal PIFR (<55 L/min) 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).
YUPELRI is approved in the U.S. for the maintenance treatment of patients with COPD; Spiriva HandiHaler is approved in the U.S. for the
long-term, once-daily, maintenance treatment of bronchospasm associated with COPD, and for reducing COPD exacerbations.
YUPELRI (revefenacin) inhalation solution is a once-daily
nebulized long-acting muscarinic antagonist (LAMA) approved for the maintenance treatment of COPD in the U.S. 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 U.S. 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
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.
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 in the FDA-approved
Prescribing Information and 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.'s focus is to deliver Medicines that
Make a Difference in people's lives. In pursuit of its purpose, Theravance Biopharma leverages decades of expertise,
which has led to the development of FDA-approved YUPELRI (revefenacin) inhalation solution indicated for the maintenance
treatment of patients with chronic obstructive pulmonary disease (COPD). Ampreloxetine, its late-stage investigational norepinephrine
reuptake inhibitor in development for symptomatic neurogenic orthostatic hypotension, has the potential to be a first in class therapy
effective in treating a constellation of cardinal symptoms in multiple system atrophy patients. The Company is committed to creating/driving
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 U.S. 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.
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.
Theravance Biopharma Forward-Looking Statements
This press release contains certain "forward-looking"
statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements
relating to goals, plans, objectives, expectations and future events. Theravance Biopharma intends such forward-looking statements to
be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934,
as amended, and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to: future
YUPELRI sales and sales growth, timing of additional details from PIFR-2, and the ability to provide value to shareholders, the Company's
regulatory strategies and timing of clinical studies, and possible safety, efficacy or differentiation of our investigational therapy.
These statements are based on the current estimates and assumptions of the management of Theravance Biopharma as of the date of this
press release and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual
results of Theravance Biopharma to be materially different from those reflected in the forward-looking statements. Important factors
that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks
related to: whether the milestone thresholds can be achieved, delays or difficulties in commencing, enrolling or completing clinical
studies, the potential that results from clinical or non-clinical studies indicate the Company's product candidates or product
are unsafe, ineffective or not differentiated, risks of decisions from regulatory authorities that are unfavorable to the Company, dependence
on third parties to conduct clinical studies, delays or failure to achieve and maintain regulatory approvals for product candidates,
risks of collaborating with or relying on third parties to discover, develop, manufacture and commercialize products, and risks associated
with establishing and maintaining sales, marketing and distribution capabilities with appropriate technical expertise and supporting
infrastructure, ability to retain key personnel, the ability of the Company to protect and to enforce its intellectual property rights,
volatility and fluctuations in the trading price and volume of the Company's shares, and general economic and market conditions.
Other risks affecting Theravance Biopharma are in the Company's Form 10-Q filed with the SEC on November 9, 2023, and other periodic
reports filed with the SEC. In addition to the risks described above and in Theravance Biopharma's filings with the SEC, other
unknown or unpredictable factors also could affect Theravance Biopharma's results. No forward-looking statements can be guaranteed,
and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these
forward-looking statements. Theravance Biopharma assumes no obligation to update its forward-looking statements on account of new information,
future events or otherwise, except as required by law.
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