DUBLIN, HERTFORDSHIRE, England and PITTSBURGH, Sept. 14,
2015 /PRNewswire/ -- Theravance Biopharma, Inc.
(NASDAQ: TBPH) ("Theravance Biopharma") and Mylan N.V. (NASDAQ:
MYL) ("Mylan") today announced the initiation of a Phase 3 program
for revefenacin (TD-4208), an investigational long-acting
muscarinic antagonist (LAMA) in development for the treatment of
chronic obstructive pulmonary disease (COPD). The Phase 3
program, designed to support the registration of the product in the
U.S., includes two replicate three-month efficacy studies and a
single 12-month safety study.
"Despite the fact that once-daily LAMAs are the first-line
therapy for patients with moderate-to-severe COPD, there still are
no nebulized LAMA treatments available today. This unmet need is
significant when one considers that approximately 9% of COPD
patients in the U.S. currently use nebulizers for ongoing
maintenance therapy, and a total of 41% of U.S. COPD patients use
nebulizers for bronchodilator therapyat some time during the course
of their disease,"1 said Brett
Haumann, MD, Senior Vice President, Clinical Development at
Theravance Biopharma. "Based on data that we've generated to
date, we believe that revefenacin possesses the product profile
that could uniquely and effectively address this market need. We
look forward to conducting this Phase 3 program in collaboration
with our partner Mylan to generate the data required to support a
regulatory filing for the product."
"The initiation of this Phase 3 program is an important
milestone for Mylan as we continue to further build out our global
respiratory pipeline. Revefenacin is highly complementary to our
currently marketed nebulized COPD product, Perforomist®
Inhalation Solution, as well as other respiratory products in our
pipeline. We are excited by the potential to offer healthcare
professionals, and ultimately patients, an even more robust
respiratory portfolio if revefenacin is approved," said Mylan
President Rajiv Malik. "Theravance
Biopharma has done an excellent job advancing revefenacin to this
stage of development and we look forward to contributing our
expertise and leadership in the area of nebulized respiratory
therapy as we work together to bring this important product to
market."
The revefenacin development program includes two Phase 3
efficacy studies and one Phase 3 safety study, examining 2 doses
(88 mcg and 175 mcg) of revefenacin inhalation solution
administered once-daily via nebulizer in moderate to severe
patients with COPD. The Phase 3 efficacy studies are replicate,
randomized, double-blind, placebo-controlled, parallel-group trials
designed to provide pivotal efficacy and safety data for once-daily
revefenacin over a dosing period of 12 weeks, with a primary
endpoint of trough forced expiratory volume in one second
(FEV1) on day 85. The Phase 3 safety study is an
open-label, active comparator study of 12 months duration.
Together, the three studies will enroll approximately 2,300
patients. Theravance Biopharma expects the results to be
available from the two efficacy studies in 2016, with the results
of the safety study available in 2017. More information about the
trials is available at www.clinicaltrials.gov.
About Theravance Biopharma and Mylan
Partnership
Theravance Biopharma and Mylan N.V. and its
affiliates have partnered 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.2 An estimated 12.7 million American adults are
diagnosed with COPD and an almost equal number are believed to be
undiagnosed.3 There were more than 700,000 hospital
discharges 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.3
About Revefenacin
Revefenacin (TD-4208), is a
novel investigational LAMA in development for the treatment of
COPD. Theravance Biopharma has completed a successful Phase 2b
program with revefenacin, administered once-daily via nebulizer for
up to 28 days in a moderate-to-severe COPD population. Market
research by Theravance Biopharma indicates approximately 9% of the
treated COPD patients in the U.S. use nebulizers for ongoing
maintenance therapy.1 LAMAs are a cornerstone of
maintenance therapy for COPD, but are only available in handheld
devices that may not be suitable for every patient. 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
The mission of
Theravance Biopharma (NASDAQ: TBPH) is to create value from a
unique and diverse set of assets: an approved product; a
development pipeline of late-stage assets; and a productive
research platform designed for long-term growth.
Our pipeline of internally discovered product candidates
includes potential best-in-class opportunities in underserved
markets in the acute care setting, representing multiple
opportunities for value creation. 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 an
investigational long-acting muscarinic antagonist (LAMA) being
developed as a potential once-daily, nebulized treatment for COPD.
Axelopran (TD-1211) is an investigational potential once-daily,
oral treatment for opioid-induced constipation (OIC). Our
earlier-stage clinical assets represent novel approaches for
potentially treating diseases of the lung and gastrointestinal
tract and infectious disease. In addition, we have an economic
interest in future payments that may be made by GlaxoSmithKline plc
pursuant to its agreements with Theravance, Inc. relating to
certain drug development programs, including the combination of
fluticasone furoate, umeclidinium and vilanterol (the "Closed
Triple").
With our successful drug discovery and development track record,
commercial infrastructure, experienced management team and
efficient corporate structure, we believe that we are well
positioned to create value for our shareholders and make a
difference in the lives of patients.
For more information, please visit www.theravance.com.
THERAVANCE®, the Cross/Star logo, MEDICINES THAT MAKE
A DIFFERENCE® and VIBATIV® are registered
trademarks of the Theravance Biopharma group of companies.
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 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 and results of clinical studies,
the potential benefits and mechanisms of action of the Company's
product and product candidates and the Company's expectations for
product candidates through development and commercialization. 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, 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 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 expertise and supporting infrastructure. Other risks
affecting Theravance Biopharma are described under the heading
"Risk Factors" contained in Theravance Biopharma's Quarterly Report
on Form 10-Q filed with the Securities and Exchange Commission
(SEC) on August 13, 2015. In addition
to the risks described above and in Theravance Biopharma's other
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 around 1,400 generic
pharmaceuticals and several brand medications. In addition, we
offer a wide range of antiretroviral therapies, upon which nearly
50% of HIV/AIDS patients in developing countries depend. We also
operate one of the largest active pharmaceutical ingredient
manufacturers and currently market products in about 145 countries
and territories. Our workforce of approximately 30,000 people is
dedicated to creating better health for a better world, one person
at a time. Learn more at mylan.com.
Perforomist® is a registered trademark of Mylan
Specialty L.P.
This press release includes statements that constitute
"forward-looking statements," including with regard to the Phase 3
program and included studies, product, pipeline and portfolio
development and potential, approvals and sales of products and the
company's strategy, future growth and performance. 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: the impacts of
competition; changes in economic and financial conditions of the
company's business; strategies by competitors or other third
parties to delay or prevent product introductions; actions taken by
regulatory or governmental agencies with respect to our or our
competitors' current or future products; success of clinical trials
and our ability to execute on new product opportunities; other
risks inherent in product development and legal and regulatory
processes; changes in third-party relationships uncertainties and
matters beyond the control of management; and the other risks
detailed in the company's filings with the Securities and Exchange
Commission. The company undertakes no obligation to update these
statements for revisions or changes after the date of this
release.
References
- Market research conducted by Theravance Biopharma, Inc.
- American Lung Association. "Chronic Obstructive Pulmonary
Disease (COPD) Fact Sheet."
http://www.lung.org/lung-disease/copd/resources/facts-figures/COPD-Fact-Sheet.html.
Accessed on January 26, 2015.
- American Thoracic Society. "Center for Patients & Families:
The Basics of Lung Disease/Lung Disease 101 Fact Sheet."
http://patients.thoracic.org/?page_id=8. Accessed on January 26, 2015.
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SOURCE Mylan N.V.