Top-line results from Phase III study in
China demonstrate the efficacy and
safety profile of YUPELRI in patients with COPD
PITTSBURGH and DUBLIN, Nov. 13,
2023 /PRNewswire/ -- Viatris Inc. (NASDAQ:
VTRS), a global healthcare company, and Theravance Biopharma, Inc.
(NASDAQ: TBPH) today announced positive results from the YUPELRI®
(revefenacin) Phase III placebo-controlled clinical trial conducted
in China assessing the efficacy
and safety of YUPELRI, a once-daily nebulized long-acting
muscarinic antagonist (LAMA) for the maintenance treatment of
patients with COPD. Top-line results showed that YUPELRI met its
primary efficacy endpoint demonstrating a statistically significant
increase in trough FEV1 (forced expiratory volume in one
second) versus placebo. The results are comparable to those from
studies of the same design used for U.S. registration and provide
support for a regulatory filing in China anticipated to occur in mid-2024.
Top Line Results Highlights:
- A total of 258 patients enrolled with 257 included in safety
and full analysis sets. Both groups were well balanced for baseline
characteristics with 129 treated with YUPELRI and 128 treated with
placebo.
- Study population was moderate to very severe COPD patients with
mean baseline FEV1 approximately 50% predicted.
Approximately two-thirds of patients remained on long-acting beta-2
agonist/inhaled corticosteroids throughout the study.
- Primary efficacy analysis of change from baseline in trough
FEV1 measured 24 hours after the final dose at week 12
detected a mean (95% confidence intervals) treatment difference of
150.9 (104.1, 197.7) mL compared to placebo.
- Safety and tolerability profile assessed by summary of adverse
events consistent with U.S. package insert.
Viatris President Rajiv Malik
said, "We are pleased with the positive top-line results of our
Phase III clinical results for YUPELRI in China. The strength of the data and the
primary endpoint analysis, which is consistent with our U.S.
clinical data, firmly supports a comparable efficacy and safety
profile of YUPELRI. With this data, we look forward to
progressing our regulatory application in China and continue to believe, when approved,
a once-daily nebulized revefenacin product will be an important
therapeutic option for the millions of patients in the region with
COPD."
"Given its novel profile, we and Viatris share a commitment to
make YUPELRI available for as many COPD patients as possible,
particularly those who stand to benefit from nebulized therapy, and
we commend VIATRIS on the execution of this study," said Rick E
Winningham, CEO of Theravance Biopharma. "The consistent lung
function improvement demonstrated in this study supports the use of
LAMA therapy as foundational in a range of patients and we are
encouraged that COPD patients in China may soon have the
opportunity to benefit from a new, valuable treatment option."
It is estimated that COPD affects nearly 100 million individuals
in China1 with approximately 43 percent of
those patients suffering from moderate to very severe forms of the
disease2. COPD is one of the top three causes of
mortality in China, accounting for approximately 910,000
deaths annually3. COPD presents a significant financial
burden to the healthcare system in China, contributing up
to $266 billion in costs annually2.
About the Study
The Phase III study was designed to
compare the efficacy and safety of revefenacin (175mcg) and
double-blind placebo nebulized once-daily in moderate to very
severe COPD patients in China over
a 12-week treatment period.
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
U.S., with their combined sales infrastructure targeting healthcare
professionals who treat COPD patients suitable for YUPELRI. In
2019, the companies announced the expansion of their development
and commercialization agreement for nebulized revefenacin to
include China and certain adjacent territories, which include Hong
Kong SAR, the Macau SAR and Taiwan.
About Viatris
Viatris Inc. (NASDAQ: VTRS) is a
global healthcare company uniquely positioned to bridge the
traditional divide between generics and brands, combining the best
of both to more holistically address healthcare needs globally.
With a mission to empower people worldwide to live healthier at
every stage of life, we provide access at scale. In 2022 alone, we
supplied high-quality medicines to approximately 1 billion patients
around the world. With our exceptionally extensive and diverse
portfolio of medicines, a one-of-a-kind global supply chain
designed to reach more people when and where they need them, and
the scientific expertise to address some of the world's most
enduring health challenges, access takes on deep meaning at
Viatris. We have the ability to touch all of life's moments, from
birth to end of life, acute conditions to chronic diseases. We are
headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at
viatris.com and investor.viatris.com, and connect with us on
Twitter, LinkedIn, Instagram and YouTube.
Viatris Forward Looking Statements
This press release includes statements that constitute
"forward-looking statements." These statements are made pursuant to
the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. Such forward looking statements may include
statements regarding positive results from the YUPELRI®
(revefenacin) Phase III placebo-controlled clinical trial conducted
in China assessing the efficacy
and safety of YUPELRI, a once-daily nebulized long-acting
muscarinic antagonist (LAMA) for the maintenance treatment of
patients with COPD; top-line results showed that YUPELRI met its
primary efficacy endpoint demonstrating a statistically significant
increase in trough FEV1 (forced expiratory volume in one
second) versus placebo; the results are comparable to those from
studies of the same design used for U.S. registration and provide
support for a regulatory filing in China anticipated to occur in mid-2024; the
strength of the data and the primary endpoint analysis, which is
consistent with our U.S. clinical data, firmly supports a
comparable efficacy and safety profile of YUPELRI; and with this
data, we look forward to progressing our regulatory application in
China and continue to believe,
when approved, a once-daily nebulized revefenacin product will be
an important therapeutic option for the millions of patients in the
region with COPD. Because forward-looking statements inherently
involve risks and uncertainties, actual future results may differ
materially from those expressed or implied by such forward-looking
statements. Factors that could cause or contribute to such
differences include, but are not limited to: actions and decisions
of healthcare and pharmaceutical regulators; changes in healthcare
and pharmaceutical laws and regulations in the U.S. and abroad; any
regulatory, legal or other impediments to Viatris' ability to bring
new products to market, including but not limited to "at-risk"
launches; Viatris' or its partners' ability to develop,
manufacture, and commercialize products; the possibility that
Viatris may be unable to realize the intended benefits of, or
achieve the intended goals or outlooks with respect to, its
strategic initiatives; the possibility that Viatris may be unable
to achieve expected benefits, synergies and operating efficiencies
in connection with acquisitions, divestitures, or its global
restructuring program, within the expected timeframe or at all;
impairment charges or other losses related to the divestiture or
sale of businesses or assets; Viatris' failure to achieve expected
or targeted future financial and operating performance and results;
the potential impact of public health outbreaks, epidemics and
pandemics, including the ongoing challenges and uncertainties posed
by COVID-19; the scope, timing and outcome of any ongoing legal
proceedings, and the impact of any such proceedings; any
significant breach of data security or data privacy or disruptions
to our information technology systems; risks associated with
international operations; the ability to protect intellectual
property and preserve intellectual property rights; changes in
third-party relationships; the effect of any changes in Viatris' or
its partners' customer and supplier relationships and customer
purchasing patterns; the impacts of competition; changes in the
economic and financial conditions of Viatris or its partners;
uncertainties and matters beyond the control of management,
including general economic conditions, inflation and exchange
rates; failure to execute stock repurchases consistent with current
expectations; stock price volatility; and the other risks described
in Viatris' filings with the Securities and Exchange Commission
(SEC). Viatris routinely uses its website as a means of disclosing
material information to the public in a broad, non-exclusionary
manner for purposes of the SEC's Regulation Fair Disclosure (Reg
FD). Viatris undertakes no obligation to update these statements
for revisions or changes after the date of this release other than
as required by law.
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 symptom atrophy
patients. Theravance Biopharma is committed to creating/driving
shareholder value. 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.
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. Such forward looking statements may include statements
regarding positive results from the YUPELRI® (revefenacin) Phase
III placebo-controlled clinical trial conducted in China assessing the efficacy and safety of
YUPELRI, a once-daily nebulized long-acting muscarinic antagonist
(LAMA) for the maintenance treatment of patients with COPD;
top-line results showed that YUPELRI met its primary efficacy
endpoint demonstrating a statistically significant increase in
trough FEV1 (forced expiratory volume in one second)
versus placebo; the results are comparable to those from studies of
the same design used for U.S. registration and provide support for
a regulatory filing in China
anticipated to occur in mid-2024; the strength of the data and the
primary endpoint analysis, which is consistent with U.S. clinical
data, firmly supports a comparable efficacy and safety profile of
YUPELRI; and with this data, the partners look forward to
progressing a regulatory application in China and continue to believe, when approved,
a once-daily nebulized revefenacin product will be an important
therapeutic option for the millions of patients in the region with
COPD. These statements are based on the current estimates and
assumptions of management 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 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: actions and
decisions of healthcare and pharmaceutical regulators; changes in
healthcare and pharmaceutical laws and regulations in the U.S. and
abroad; any regulatory, legal or other impediments to our or our
collaboration partner's ability to bring new products to market,
including but not limited to "at-risk" launches; our or our
collaboration partner's ability to develop, manufacture, and
commercialize products; 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 are unsafe, ineffective or not differentiated;
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; 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 Theravance Biopharma and its collaboration partner's to
protect and to enforce its intellectual property rights; 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.
1 C. Wang, J. Xu, L. Yang et al., "Prevalence
and risk factors of chronic obstructive pulmonary disease
in China (the China Pulmonary Health [CPH] study): a
national cross-sectional study," The Lancet, vol. 391, no.
10131, pp. 1706–1717, 2018.
2 Fang L, Gao P, Bao H, et
al., "Chronic obstructive pulmonary disease in China: a
nationwide prevalence study," Lancet Respir Med
2018; 6: 421–430.
3 Yin P, Wang H, Vos T, et al., "A subnational analysis
of mortality and prevalence of COPD in China From 1990 to 2013: Findings from the
global burden of disease study 2013," Chest.
2016;150:1269–1280.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/viatris-and-theravance-biopharma-announce-positive-top-line-results-from-yupelri-revefenacin-phase-iii-trial-in-china-for-the-treatment-of-chronic-obstructive-pulmonary-disease-copd-301985426.html
SOURCE Viatris Inc.