DUBLIN and HERTFORDSHIRE, England and PITTSBURGH, June 14,
2019 /PRNewswire/ -- Theravance Biopharma Ireland
Limited, a subsidiary of Theravance Biopharma, Inc. (NASDAQ: TBPH)
("Theravance Biopharma") and Mylan N.V. (NASDAQ: MYL) ("Mylan")
today announced the expansion of the companies' current development
and commercialization agreement for nebulized revefenacin to
include China and certain adjacent territories. Revefenacin,
marketed as YUPELRI® in the U.S., is a long-acting
muscarinic antagonist (LAMA), which is the first and only
once-daily, nebulized bronchodilator approved for the treatment of
chronic obstructive pulmonary disease (COPD) in the U.S.
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.
In 2015, Theravance Biopharma and Mylan, and their affiliates,
established a strategic collaboration to develop and commercialize
nebulized revefenacin products for COPD and other respiratory
diseases in all global markets with the exception of China and
adjacent territories. Under terms of the new agreement,
Theravance Biopharma has granted Mylan exclusive development and
commercialization rights to nebulized revefenacin in China and adjacent territories, which include
Hong Kong SAR, the Macau SAR and Taiwan. In exchange, Theravance Biopharma will
receive an upfront payment of $18.5
million and will be eligible to receive additional potential
development and sales milestones totaling $54 million together with tiered royalties on net
sales of nebulized revefenacin, if approved. Mylan will be
responsible for all aspects of development and commercialization in
the partnered regions, including pre- and post-launch activities
and product registration and all associated costs.
"We are pleased to expand our ongoing revefenacin development
and commercialization collaboration with Mylan to include China, as
we believe that this novel compound has the therapeutic profile to
provide key benefits to the country's large and underserved COPD
patient population. Our companies share the belief that revefenacin
can play a critical role in COPD treatment, particularly for those
patients who require or prefer nebulized therapy," said Rick E
Winningham, chairman and chief executive officer of Theravance
Biopharma, Inc. "Mylan is a global leader in nebulized
respiratory therapies and has been a valued and trusted partner
since we entered our original collaboration in 2015. Based on
its deep experience with nebulized revefenacin, Mylan is well
positioned to efficiently guide the compound through the
development and regulatory approval process in China, as well as maximize its commercial
potential in the partnered regions."
Mylan President Rajiv Malik said:
"Mylan has had a long-term, strategic focus on its growing presence
in China, one of the world's
largest pharmaceutical markets. Our expanded partnership on
revefenacin represents a natural next step, and together with
Theravance Biopharma we look forward to making a meaningful
difference for the millions of patients living with COPD in
China. Through our continued
investment in a comprehensive portfolio of products across the
value chain, our deep understanding of the evolving Chinese
healthcare landscape, our scientific excellence and innovation, and
our industry-leading pipeline, we look forward to continue meeting
unmet needs for patients in China
and the world over."
About Theravance Biopharma and Mylan Strategic
Collaboration
Theravance Biopharma and Mylan N.V. and their respective
affiliates have established a strategic collaboration to develop
and commercialize nebulized revefenacin products for COPD and other
respiratory diseases. Theravance Biopharma is eligible to receive
up to $259 million in development and
sales milestone payments, as well as a profit-sharing arrangement
with Mylan on US sales and double-digit royalties on ex-US sales.
Additionally, Theravance Biopharma retains worldwide rights to
revefenacin delivered through other dosage forms, such as a metered
dose inhaler or dry powder inhaler (MDI/DPI).
About Revefenacin
Revefenacin inhalation solution, marketed as YUPELRI in the US,
is a novel once-daily nebulized LAMA that is approved for the
maintenance treatment of COPD in the US. LAMAs are a cornerstone of
maintenance therapy for COPD and revefenacin is positioned as a
first-in-class once-daily single-agent bronchodilator product for
COPD patients who require, or prefer, nebulized therapy.
Revefenacin's stability in both metered dose inhaler and dry powder
device formulations suggest that this LAMA could also serve as
a foundation for novel handheld combination products.
In two replicate pivotal Phase 3 efficacy studies conducted in
the US, revefenacin demonstrated statistically significant and
clinically meaningful improvements as compared to placebo in trough
forced expiratory volume in one second
(FEV1) and in overall treatment effect on
trough FEV1 (OTE FEV1) after 12 weeks of
dosing.4 Revefenacin had comparable rates of
adverse events (AEs) to placebo, low rates of serious adverse
events (SAEs), and no clinically meaningful differences in blood
parameters or electrocardiogram (ECG) data, across all treatment
groups (active and placebo). As previously reported, the most
commonly reported adverse events, across both trials and across all
treatment groups, were cough, nasopharyngitis, upper respiratory
tract infection, headache, and back pain. Additionally, a 12-month
Phase 3 open-label safety study versus tiotropium did not identify
any new safety issues. Rates of AEs and SAEs in the study were low
and comparable to those seen in the tiotropium treatment arm.
YUPELRI is a registered trademark of Mylan N.V.
About Theravance Biopharma
Theravance
Biopharma, Inc. ("Theravance Biopharma") is a diversified
biopharmaceutical company primarily focused on the discovery,
development and commercialization of organ-selective medicines. Our
purpose is to create transformational medicines to improve the
lives of patients suffering from serious illnesses. Our research is
focused in the areas of inflammation and immunology.
In pursuit of our purpose, we apply insights and innovation at
each stage of our business and utilize our internal capabilities
and those of partners around the world. We apply organ-selective
expertise to biologically compelling targets to discover and
develop medicines designed to treat underserved localized diseases
and to limit systemic exposure, in order to maximize patient
benefit and minimize risk. These efforts leverage years of
experience in developing lung-selective medicines to treat
respiratory disease, including FDA-approved YUPELRI®
(revefenacin) inhalation solution indicated for the maintenance
treatment of patients with chronic obstructive pulmonary disease
(COPD). Our pipeline of internally discovered programs is targeted
to address significant patient needs.
We have an economic interest in potential future payments from
Glaxo Group or one of its affiliates (GSK) pursuant to its
agreements with Innoviva, Inc. relating to certain programs,
including TRELEGY ELLIPTA.
For more information, please visit www.theravance.com.
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 and the Private Securities
Litigation Reform Act of 1995. Examples of such statements include
statements relating to: the Company's strategies, plans and
objectives, the Company's regulatory strategies and timing of
clinical studies (including the data therefrom), the potential
characteristics, benefits and mechanisms of action of the Company's
product and product candidates, and the Company's expectations for
product candidates through development and potential regulatory
approval and commercialization (including their potential as
components of combination therapies and their differentiation from
other products or potential products). These statements are based
on the current estimates and assumptions of the management of
Theravance Biopharma as of the date of the 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: 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 are unsafe or ineffective (including when our product
candidates are studied in combination with other compounds), risks
that product candidates do not obtain approval from regulatory
authorities, the feasibility of undertaking future clinical trials
for our product candidates based on policies and feedback from
regulatory authorities, 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.
Other risks affecting Theravance Biopharma are described under the
heading "Risk Factors" contained in Theravance Biopharma's Form
10-Q filed with the Securities and Exchange Commission (SEC) on
May 10, 2019 and Theravance
Biopharma's other filings 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.
About Mylan
Mylan is a global pharmaceutical
company committed to setting new standards in healthcare. Working
together around the world to provide 7 billion people access to
high quality medicine, we innovate to satisfy unmet needs; make
reliability and service excellence a habit; do what's right, not
what's easy; and impact the future through passionate global
leadership. We offer a growing portfolio of more than 7,500
marketed products around the world, including antiretroviral
therapies on which more than 40% of people being treated for
HIV/AIDS globally depend. We market our products in more than 165
countries and territories. We are one of the world's largest
producers of active pharmaceutical ingredients. Every member of our
approximately 35,000-strong workforce is dedicated to creating
better health for a better world, one person at a time. Learn more
at Mylan.com. We routinely post information that may be
important to investors on our website
at investor.mylan.com.
This press release includes statements that constitute
"forward-looking statements," including with regard to the outcome
of clinical trials. These statements are made pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act
of 1995. Because forward-looking statements inherently involve
risks and uncertainties, actual future results may differ
materially from those expressed or implied by such
statements. Factors that could cause or contribute to such
differences include, but are not limited to any changes in,
interruptions to, or difficulties with Mylan's or its partners'
ability to develop, manufacture, and commercialize products; the
effect of any changes in Mylan's or its partners' customer and
supplier relationships and customer purchasing patterns; other
changes in third-party relationships; the impact of competition;
changes in the economic and financial conditions of the businesses
of Mylan or its partners; the scope, timing, and outcome of any
ongoing legal proceedings and the impact of any such proceedings on
Mylan's or its partners' business; any regulatory, legal, or other
impediments to Mylan's or its partners' ability to bring products
to market; actions and decisions of healthcare and pharmaceutical
regulators, and changes in healthcare and pharmaceutical laws and
regulations, in the United States
and abroad; Mylan's and its partners' ability to protect
intellectual property and preserve intellectual property rights;
risks associated with international operations; other uncertainties
and matters beyond the control of management; and the other risks
detailed in Mylan's filings with the Securities and Exchange
Commission. Mylan undertakes no obligation to update these
statements for revisions or changes after the date of this
release.
References
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.
4 "Clinically meaningful" is defined by industry
established Minimal Clinically Important Difference (MCID) for lung
function (100 mL improvement in FEV1).
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SOURCE Mylan N.V.