DUBLIN and HERTFORDSHIRE,
England and PITTSBURGH,
July 19, 2017 /PRNewswire/
-- Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance
Biopharma") and Mylan N.V. (NASDAQ, TASE: MYL) ("Mylan") today
announced positive results from a 12-month Phase 3 safety study of
revefenacin (TD-4208), an investigational long-acting muscarinic
antagonist (LAMA) and a proposed once-daily, nebulized
bronchodilator in development for the treatment of chronic
obstructive pulmonary disease (COPD). The study of 1,055 patients
with COPD demonstrated that revefenacin was generally
well-tolerated, and no new safety issues were identified. Rates of
adverse events (AEs) and serious adverse events (SAEs) were low and
comparable to those seen in the standard of care treatment arm.
"The data from this 12-month safety study build on our
observations from the previous three-month efficacy studies and
suggest that revefenacin has a favorable safety and tolerability
profile when dosed chronically, either as a standalone therapy or
when taken as an add-on to other COPD therapies including
combinations of ICS and LABA," said Brett
Haumann, MD, Chief Medical Officer at Theravance Biopharma.
"As of today, there are no approved nebulized LAMAs, despite a
significant number of COPD patients needing or preferring nebulized
therapy for the treatment of their disease. Having achieved
positive efficacy and tolerability data in our Phase 3 program, we
and our partner Mylan believe that revefenacin is well positioned
to address this important patient need. We remain on schedule to
submit the NDA in the fourth quarter of 2017, which is the next
step towards our goal of delivering the first once-daily nebulized
bronchodilator to the COPD patient community."
Mylan President Rajiv Malik
commented, "Our revefenacin collaboration with Theravance Biopharma
continues to deliver results at every step along the development
path. We are very pleased with the top-line results from the
12-month safety trial and now feel we have all the data necessary
to support a successful NDA filing. Should revefenacin receive
approval from the FDA, we look forward to introducing this
nebulized LAMA, to ensure the treatment has the greatest possible
impact on the lives of patients with COPD."
The Phase 3 safety study of revefenacin was a randomized,
active-controlled parallel group trial designed to evaluate the
safety and tolerability of two doses of revefenacin (88 mcg or 175
mcg, inhaled once daily via a nebulizer) over a dosing period of 52
weeks, as compared to standard of care. Tiotropium
(Spiriva®), administered via a handheld device, served
as the active comparator standard of care treatment arm in the
study. 50% of patients in the study were using other COPD
therapies, including long-acting beta-agonists (LABA) or
LABA/inhaled corticosteroids (ICS). Data from the trial
demonstrated low rates of AEs and SAEs for both doses of
revefenacin, comparable to tiotropium. Mortality rates were low,
balanced across each arm of the study, and deemed by investigators
as not related to study treatment. The most commonly reported
adverse events were exacerbations, nasopharyngitis, upper
respiratory tract infections, and cough. Rates of COPD
exacerbations were numerically lowest in the 175 mcg arm. The
numerical frequency of anti-muscarinic side effects such as dry
mouth and constipation was lowest in the revefenacin arms.
Theravance Biopharma and Mylan plan to present more detailed
results from the study at upcoming scientific conferences.
The companies previously reported positive results from two
pivotal Phase 3 efficacy studies of revefenacin, which included
more than 1,250 patients with moderate to very severe COPD. In
these studies, revefenacin demonstrated statistically significant
and clinically meaningful improvements over 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. The data from these
studies, combined with the results announced today, will support
the submission of the new drug application (NDA) for revefenacin
with the U.S. Food and Drug Administration (FDA), anticipated in
the fourth quarter of 2017.
Theravance Biopharma and its affiliates have partnered with
Mylan and its affiliates on the development and commercialization
of nebulized revefenacin products for COPD and other respiratory
diseases. The companies are developing revefenacin as a once-daily,
nebulized bronchodilator for the treatment of patients with COPD
that will be compatible with a range of jet nebulizers.
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. Under the terms of the agreement, Theravance
Biopharma is leading the U.S. development program for the
revefenacin inhalation solution product, with all costs related to
the registrational program reimbursed by Mylan up until the
approval of the first new drug application, after which costs will
be shared. Mylan is responsible for ex-U.S. development and
commercialization. Theravance Biopharma is eligible to receive up
to $220 million in development and
sales milestone payments, as well as a profit-sharing arrangement
with Mylan on U.S. sales and double-digit royalties on ex-U.S.
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), and the
rights to nebulized revefenacin in China.
About COPD
COPD is a growing and devastating disease that is the third
leading cause of death in the U.S.1 An estimated 12.7
million American adults are diagnosed with COPD and an almost equal
number are believed to be undiagnosed.2 There were more
than 700,000 hospital discharges related to COPD in the U.S.
reported in 2010. The costs of managing COPD in the U.S. were
estimated to be nearly $50 billion in
2010, including $29.5 billion in
direct healthcare expenditures, $8
billion in indirect morbidity costs and $12.4 billion in indirect mortality
costs.2
About Revefenacin
Revefenacin (TD-4208) is a novel investigational once-daily
nebulized LAMA in Phase 3 development for the treatment of moderate
to very severe COPD. Market research by Theravance Biopharma
indicates approximately 9% of the treated COPD patients in the U.S.
use nebulizers for ongoing maintenance therapy.3 LAMAs
are a cornerstone of maintenance therapy for COPD and, if approved,
revefenacin has the potential to be a best-in-class once-daily
single-agent product for COPD patients who require, or prefer,
nebulized therapy. The product'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.
About Theravance Biopharma
Theravance Biopharma is a diversified biopharmaceutical company
with the core purpose of creating medicines that that help improve
the lives of patients suffering from serious illness.
Our pipeline of internally discovered product candidates
includes potential best-in-class medicines to address the unmet
needs of patients being treated for serious conditions primarily in
the acute care setting. VIBATIV® (telavancin), our first
commercial product, is a once-daily dual-mechanism antibiotic
approved in the U.S., Europe and
certain other countries for certain difficult-to-treat infections.
Revefenacin (TD-4208) is a long-acting muscarinic antagonist (LAMA)
being developed as a potential once-daily, nebulized treatment for
chronic obstructive pulmonary disease (COPD). Our neprilysin (NEP)
inhibitor program is designed to develop selective NEP inhibitors
for the treatment of a range of major cardiovascular and renal
diseases, including acute and chronic heart failure, hypertension
and chronic kidney diseases, such as diabetic nephropathy. Our
research efforts are focused in the areas of inflammation and
immunology, with the goal of designing medicines that provide
targeted drug delivery to tissues in the lung and intestinal tract
in order to maximize patient benefit and minimize risk. The first
program to emerge from this research is designed to develop
intestinally restricted pan-Janus kinase (JAK) inhibitors for the
treatment of a range of inflammatory intestinal diseases.
In addition, we have an economic interest in future payments
that may be made by Glaxo Group Limited or one of its affiliates
(GSK) pursuant to its agreements with Innoviva, Inc. relating to
certain drug development programs, including the Closed Triple (the
combination of fluticasone furoate, umeclidinium, and vilanterol),
currently in development for the treatment of COPD and asthma.
For more information, please visit www.theravance.com.
THERAVANCE®, the Cross/Star logo and
VIBATIV® are registered trademarks of the Theravance
Biopharma group of companies. Trademarks, trade names or service
marks of other companies appearing on this press release are the
property of their respective owners.
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, the potential benefits and mechanisms of action
of the company's product and product candidates, the company's
expectations for product candidates through development, potential
regulatory approval and commercialization (including their
potential as components of combination therapies) and the company's
expectations for product sales. 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 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),the feasibility of undertaking
future clinical trials for our product candidates based on FDA
policies and feedback, 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 and
commercialize product and product candidates, 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 9, 2017 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 approximately 50% of
people being treated for HIV/AIDS in the developing world 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 more than
35,000-strong workforce is dedicated to creating better health for
a better world, one person at a time.
Learn more at Mylan.com.
This press release includes statements that constitute
"forward-looking statements," including with regard to the
anticipated filing of a NDA with FDA for revefenacin in the fourth
quarter of 2017; suggestions that revefenacin has a favorable
safety and tolerability profile; that Theravance Biopharma and
Mylan believe that revefenacin is well positioned to address an
important patient need; Theravance Biopharma and Mylan remaining on
schedule to submit the NDA in the fourth quarter of 2017, which is
the next step towards their goal of delivering the first once-daily
nebulized bronchodilator to the COPD patient community; Theravance
Biopharma and Mylan having all the data necessary to support a
successful NDA filing; Mylan looking forward to introducing the
nebulized LAMA, to ensure the treatment has the greatest possible
impact on the lives of patients with COPD; Theravance Biopharma and
Mylan planning to present results from the study at upcoming
conferences; revefenacin being compatible with a range of jet
nebulizers; revefenacin having the potential to be a best-in-class
once-daily single-agent product for COPD patients who require, or
prefer, nebulized therapy; and the product's stability in both
metered dose inhaler and dry powder device formulations, suggesting
that this LAMA could also serve as a foundation for novel handheld
combination products. These statements are made pursuant to the
safe harbor provisions of the Private Securities Litigation Reform
Act of 1995. Because such 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: success of clinical trials and our or our
partners' ability to execute on new product opportunities; any
regulatory, legal or other impediments to our or our partners'
ability to bring products to market; other risks inherent in
product development; the scope, timing, and outcome of any ongoing
legal proceedings, including government investigations, and the
impact of any such proceedings on our or our partners' businesses;
actions and decisions of healthcare and pharmaceutical regulators,
and changes in healthcare and pharmaceutical laws and regulations,
in the United States and abroad;
the impact of competition; strategies by competitors or other third
parties to delay or prevent product introductions; the effect of
any changes in our or our partners' customer and supplier
relationships and customer purchasing patterns; any other changes
in third-party relationships; changes in the economic and financial
conditions of the businesses of Mylan or its partners;
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
1American Lung Association. "Chronic Obstructive
Pulmonary Disease (COPD)"
http://www.lung.org/lung-health-and-diseases/lung-disease-lookup/copd.
Accessed on September 29, 2016.
2American Lung Association. "Trends in COPD (Chronic
Bronchitis and Emphysema): Morbidity and Mortality"
http://www.lung.org/assets/documents/research/copd-trend-report.pdf.
Accessed on September 29, 2016.
3TBPH market research (N = 160 physicians); Refers to
US COPD patients
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SOURCE Mylan N.V.; Theravance Biopharma, Inc.