DUBLIN and HERTFORDSHIRE, England and PITTSBURGH, Nov. 13,
2017 /PRNewswire/ -- Theravance Biopharma, Inc.
(NASDAQ: TBPH) ("Theravance Biopharma") and Mylan N.V. (NASDAQ,
TASE: MYL) ("Mylan") today announced the submission of a New Drug
Application (NDA) to the U.S. Food and Drug Administration (FDA)
for revefenacin (TD-4208), an investigational long-acting
muscarinic antagonist (LAMA) as a once-daily, nebulized
bronchodilator in development for the treatment of chronic
obstructive pulmonary disease (COPD). The NDA is supported by the
companies' Phase 3 program for revefenacin, which consisted of two
replicate pivotal Phase 3 efficacy studies and a 12-month,
open-label, active comparator safety study.
"This submission represents a key step in our efforts to bring
the first once-daily nebulized LAMA to the COPD patient community.
While a significant number of COPD patients require or prefer
nebulized therapy, these same patients currently have no access to
a nebulized LAMA, broadly considered the cornerstone of COPD
maintenance therapy," said Brett
Haumann, MD, Chief Medical Officer at Theravance Biopharma.
"We are pleased with the comprehensive data package that was
generated through our Phase 3 efficacy and safety studies and look
forward to the FDA's review of our NDA."
"We are proud of our collaboration with Theravance Biopharma
over the past two years on the development of revefenacin and the
quality of our NDA submitted to the FDA," said Mylan President
Rajiv Malik. "If approved, this
product will further strengthen Mylan's expertise in nebulized
respiratory therapies and bolster our commercial presence in the
respiratory space. We look forward to our continued work with
Theravance Biopharma and the FDA as we progress to final
approval."
Theravance Biopharma and Mylan previously reported that in two
replicate pivotal Phase 3 efficacy studies, 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.1 Both doses of 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 exacerbations, cough,
dyspnea and headache. Additionally, the companies have previously
announced positive results from the 12-month Phase 3 safety study,
which did not identify new safety issues. Rates of AEs and SAEs in
the study were low and comparable to those seen in the standard of
care treatment arm.
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 US 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-US 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 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), 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 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.3
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.4 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 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 Trelegy Ellipta (the
combination of fluticasone furoate, umeclidinium, and vilanterol in
a single ELLIPTA® inhaler, previously referred to as the
Closed Triple), currently approved in the US for the treatment of
appropriate COPD patients and in development for the treatment of
COPD in several other countries. The product is also currently in
development for the treatment of 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 August 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 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 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. 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 the NDA submission for revefenacin to the FDA; the NDA
submission for revefenacin being a significant milestone in Mylan's
efforts to bring to market a once-daily nebulized LAMA treatment
option for adults with COPD; that if approved, this product will
further strengthen Mylan's expertise in nebulized respiratory
therapies and bolster its commercial presence in the respiratory
space; and that Mylan looks forward to our continued work with
Theravance and the FDA as we progress to final approval. 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
1 "Clinically meaningful" is defined by industry
established Minimal Clinically Important Difference (MCID) for lung
function (100 ml improvement in FEV1).
2 American Lung Association. "Chronic Obstructive
Pulmonary Disease (COPD)"
http://www.lung.org/lung-health-and-diseases/lung-disease-lookup/copd.
Accessed on September 29, 2016.
3 American 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.
4 TBPH market research (N = 160 physicians); Refers
to US COPD patients
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SOURCE Mylan N.V.