DUBLIN and HERTFORDSHIRE, England and PITTSBURGH, May 17,
2017 /PRNewswire/ -- Theravance Biopharma, Inc.
(NASDAQ: TBPH) ("Theravance Biopharma") and Mylan N.V. (NASDAQ,
TASE: MYL) ("Mylan") today announced that data from several studies
of revefenacin (TD-4208) will be presented at the American Thoracic
Society (ATS) International Conference, which is being held in
Washington, D.C., May 19-24, 2017. Revefenacin is 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).
Presented findings will include a detailed review of the
positive efficacy results and the safety data from two replicate
completed pivotal Phase 3 studies of revefenacin, following the
initial announcement of top-line results from the trials in
October 2016. Additionally,
researchers will present results of an analysis of the prevalence
of COPD patients with low peak inspiratory flow rate (PIFR) who
were enrolled in the ongoing 12-month, Phase 3 safety study of
revefenacin, which is expected to be completed in mid-2017.
Details of the revefenacin poster
presentations at 2017 ATS are as
follows:
Poster
#P365:
|
Safety and
Tolerability of Revefenacin, a Novel Once-Daily Nebulized
Long-Acting Muscarinic Antagonist: Results of Two 12-Week,
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase
3 Trials in Participants with Moderate to Very Severe Chronic
Obstructive Pulmonary Disease
|
|
|
|
Monday, May 22, 2017,
9:15 a.m. Eastern
|
|
Session: Long Acting
Bronchodilator Therapy in COPD I
|
|
|
Poster
#P1090:
|
Efficacy of
Revefenacin, a Novel Once-Daily Nebulized Long-Acting Muscarinic
Antagonist: Results of Two 12-Week, Randomized, Double-Blind,
Placebo-Controlled, Parallel-Group Phase 3 Trials in Participants
with Moderate to Very Severe Chronic Obstructive Pulmonary
Disease
|
|
|
|
Tuesday, May 23,
2017, 9:15 a.m. Eastern
|
|
Session: Long Acting
Bronchodilator Therapy in COPD II
|
|
|
Poster #P1271:
|
Prevalence and
Characteristics of Patients with COPD and Low Peak Inspiratory Flow
Rate Recruited in a Phase 3 Development Program for Revefenacin, a
Nebulized Once-Daily Long-Acting Muscarinic Antagonist
|
|
|
|
Tuesday, May 23,
2017, 9:15 a.m. Eastern
|
|
Session: Advancing
Understanding of Obstructive Lung Disease: Medications and
Mechanisms of Delivery
|
|
|
Poster
#P1219:
|
Pharmacological
Studies with Revefenacin (TD-4208) in Rat Isolated Trachea and
Human Isolated Bronchus: Animal to Human Translation of Potent and
Long Acting Muscarinic Receptor Antagonistic Properties in Airway
Tissues
|
|
|
|
Tuesday, May 23,
2017, 9:15 a.m. Eastern
|
|
Session: Advances in
Translational COPD
|
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 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 would provide a once-daily option 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 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 gastrointestinal
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 the conference
call 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 market a
growing portfolio of approximately 7,500 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 clinical
studies, potential products and the possibility 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 and our partners'
ability to execute on new product opportunities; any regulatory,
legal or other impediments to our ability to bring our and our
partners' 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' business; 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 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; 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 American Lung Association. "Chronic Obstructive
Pulmonary Disease (COPD)"
http://www.lung.org/lung-health-and-diseases/lung-disease-lookup/copd.
2 American Lung Association. "Trends in COPD (Chronic
Bronchitis and Emphysema): Morbidity and Mortality"
http://www.lung.org/assets/documents/research/copd-trend-report.pdf.
3 TBPH market research (N = 160 physicians); Refers
to US COPD patients
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visit:http://www.prnewswire.com/news-releases/theravance-biopharma-and-mylan-to-present-additional-data-for-revefenacin-td-4208-in-several-presentations-at-2017-ats-300459191.html
SOURCE Mylan N.V.; Theravance Biopharma, Inc.