DUBLIN and HERTFORDSHIRE, England and PITTSBURGH, Jan. 29,
2018 /PRNewswire/ -- Theravance Biopharma, Inc.
(NASDAQ: TBPH) ("Theravance Biopharma") and Mylan N.V. (NASDAQ,
TASE: MYL) ("Mylan") today announced that the U.S. Food and Drug
Administration (FDA) has accepted for review the companies'
recently submitted New Drug Application (NDA) for revefenacin
(TD-4208), an investigational long-acting muscarinic antagonist
(LAMA). If approved, revefenacin would be the first once-daily,
nebulized bronchodilator for the treatment of chronic obstructive
pulmonary disease (COPD). The FDA has assigned a Prescription Drug
User Fee Act (PDUFA) target action date of November 13, 2018, and indicated that it does not
currently plan to convene an advisory committee meeting to discuss
the NDA.
"The acceptance of our NDA moves us closer to providing COPD
patients with access to once-daily, nebulized LAMA therapy. With
positive results in our Phase 3 program, we believe that
revefenacin is well positioned to fill this important need," said
Rick E Winningham, chairman and chief executive officer of
Theravance Biopharma. "I commend the team at Theravance
Biopharma and Mylan for producing a high quality submission, and we
look forward to working with the FDA in its review of our
application."
"Today, patients with moderate to severe COPD do not have access
to a nebulized LAMA as a treatment option yet. We believe
revefenacin, when approved, represents an important advancement in
respiratory care by offering a convenient once-daily option for
patients, and further strengthens Mylan's robust and growing
respiratory portfolio," said Mylan President Rajiv Malik. "We are extremely pleased that the
revefenacin NDA has been accepted for FDA review, as it
demonstrates the success of our collaboration with Theravance
Biopharma, our collective expertise in complex products and the
quality of the revefenacin development program."
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 Nearly 15.7 million
Americans (6.4%) report that they have been diagnosed with COPD and
more 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 under FDA review 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. 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.
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, 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), 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, manufacture
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 November 8, 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 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 target
action date; that, if approved, revefenacin would be the first
once-daily, nebulized bronchodilator for the treatment of COPD;
that the acceptance of the NDA moves us closer to providing COPD
patients with access to once-daily, nebulized LAMA therapy; that
with positive results in the Phase 3 program, we believe that
revefenacin is well positioned to fill this important need. We
believe revefenacin, when approved, represents an important
advancement in respiratory care by offering a convenient once-daily
option for patients, and further strengthens Mylan's robust and
growing respiratory portfolio; and that revefenacin's acceptance by
FDA demonstrates the success of Mylan's collaboration with
Theravance Biopharma, our collective expertise in complex products
and the quality of the revefenacin development program. 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.
Contact Information:
Theravance Biopharma
Alexander Dobbin
Head of Investor Relations
650-808-4045
investor.relations@theravance.com
Tim Brons
Vida Strategic Partners (media)
646-319-8981
tbrons@vidasp.com
Mylan
Christine Dusek (Media)
724.514.1968
Melissa Trombetta (Investor
Relations)
724.514.1813
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 Center for Disease Control, COPD
https://www.cdc.gov/copd/index.html. Accessed on January 3, 2018.
4 TBPH market research (N = 160 physicians); Refers
to US COPD patients
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SOURCE Theravance Biopharma, Inc.