DUBLIN and HERTFORDSHIRE, England and PITTSBURGH, Oct. 20,
2016 /PRNewswire/ -- Theravance Biopharma, Inc.
(NASDAQ: TBPH) ("Theravance Biopharma") and Mylan N.V. (NASDAQ,
TASE: MYL) ("Mylan") today announced positive results from two
replicate Phase 3 efficacy studies of revefenacin (TD-4208), an
investigational long-acting muscarinic antagonist (LAMA) and the
first once-daily, nebulized bronchodilator in development for the
treatment of chronic obstructive pulmonary disease (COPD). Top-line
results across more than 1,250 moderate to very severe COPD
patients confirmed that both Phase 3 studies met their primary
efficacy endpoint, demonstrating statistically significant
improvements over placebo in trough forced expiratory volume in one
second (FEV1) after 12 weeks of dosing for each of the
revefenacin doses studied (88 mcg once daily and 175 mcg once
daily).
The trials demonstrated statistically and clinically relevant
increases in trough FEV1 after 12 weeks of once-daily
dosing. The improvements in trough FEV1 compared to
placebo for the intent-to-treat population across both studies were
118 mL and 145 mL for 88 mcg and 175 mcg, respectively. In
pre-specified pooled analyses, revefenacin produced increases in
trough FEV1 in the subgroup (38%) of patients using
background long-acting beta agonist (LABA) containing therapies and
in the subgroup of patients who were not using concomitant LABA
therapy. The improvements in FEV1 for the LABA subgroup
were 92 mL and 135 mL for 88 mcg and 175 mcg, respectively, and for
the non-LABA subgroup were 131 mL and 150 mL for 88 mcg and 175
mcg, respectively.
The studies also demonstrated that the 88 mcg and 175 mcg doses
of revefenacin were generally well-tolerated, with comparable rates
of adverse events and serious adverse events across all treatment
groups (active and placebo). The most commonly reported adverse
events, across both trials and across all treatment groups were
exacerbations, cough, dyspnea and headache. There were no reports
of blurred vision, narrow-angle glaucoma or worsening of urinary
retention, all of which are commonly reported adverse events for
this class of medication, and in addition, reports of dry mouth
were <0.5% in the revefenacin treatment arms.
Theravance Biopharma and Mylan plan to present more detailed
data from the two efficacy studies at upcoming scientific
conferences.
"We are extremely pleased with the outcome of these pivotal
Phase 3 efficacy studies. The impressive improvements in
FEV1 have exceeded our expectations, particularly when
one considers that in nearly 40% of the patients we added
revefenacin to their existing LABA or LABA/ICS therapy. These data
confirm that revefenacin has the potential to offer meaningful
benefits to patients with moderate to very severe COPD," said
Brett Haumann, MD, Chief Medical
Officer at Theravance Biopharma. "As the first once-daily nebulized
bronchodilator of any class in late-stage development, combined
with its compatibility with any standard jet nebulizer, revefenacin
is uniquely positioned to address a key unmet need in the treatment
of COPD. We look forward to completing our ongoing Phase 3 safety
trial in 2017, with the goal of filing an NDA by the end of
2017."
Mylan President Rajiv Malik
commented, "The positive results from these Phase 3 studies
represent another exciting milestone in Mylan's robust global
respiratory pipeline. We are very pleased with our collaboration
with Theravance Biopharma and their work advancing this important
program, and we look forward to continuing to work together to
bring this product to market. We believe Mylan's strong experience
with nebulized products and experienced salesforce in the
respiratory segment, which has been further enhanced through our
Meda transaction, will help ensure this product's success if
approved."
Revefenacin is being developed as the first once-daily,
nebulized bronchodilator for the treatment of patients with COPD
and will be compatible with a range of jet nebulizers. The Phase 3
efficacy studies were replicate, randomized, double-blind,
placebo-controlled, parallel-group trials designed to provide
pivotal efficacy data for once-daily revefenacin over a dosing
period of twelve weeks. The replicate studies enrolled a combined
total over 1,250 patients in the U.S. across a range of disease
severity from moderate to very severe COPD and allowed for the
concomitant use of long-acting beta agonist (LABA) and/or
long-acting beta agonist/inhaled corticosteroid (LABA/ICS) products
in a significant proportion (38%) of the studied population. Study
investigators tested two doses (88 mcg and 175 mcg) of revefenacin
inhalation solution or matched placebo administered once daily via
a standard jet nebulizer in moderate to very severe COPD
patients.
In addition to the two efficacy trials, the revefenacin Phase 3
program includes an ongoing twelve-month, open-label, active
comparator safety study in more than 1,050 patients, which is
expected to be completed in 2017. Together, the three studies
enrolled approximately 2,300 patients. Should outcomes from the
safety study be supportive, Theravance Biopharma expects to file a
new drug application (NDA) for revefenacin with the United States
Food and Drug Administration (FDA) by the end of 2017. Theravance
Biopharma and its affiliates have partnered with Mylan N.V. and its
affiliates on the development and commercialization of nebulized
revefenacin products for COPD and other respiratory diseases.
Conference Call Today at 8:00 am
ET
Theravance Biopharma will hold a conference call and webcast
presentation today at 8:00 am ET to
discuss the results of the Phase 3 efficacy studies of revefenacin
and provide a brief business update. To participate in the live
call by telephone, please dial (855) 296-9648 from the U.S., or
(920) 663-6266 for international callers, using the confirmation
code 1078310. To listen to the conference call live via the
internet please visit Theravance Biopharma's website at
www.theravance.com, under the Investor Relations section,
Presentations and Events. To listen to the live call please go to
Theravance Biopharma's website 15 minutes prior to its start to
register, download, and install any necessary audio software.
A replay of the conference call will be available on Theravance
Biopharma's website through November 20,
2016. An audio replay will also be available through
8:00 am ET on October 27, 2016 by dialing (855) 859-2056 from
the U.S., or (404) 537-3406 for international callers, using the
confirmation code 1078310.
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 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 make a difference
in 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, MEDICINES THAT MAKE
A DIFFERENCE® 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 and the conference call will
contain 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 August 9,
2016 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 2,700 generic and branded pharmaceuticals,
including antiretroviral therapies on which approximately 50% of
people being treated for HIV/AIDS worldwide depend. We market our
products in more than 165 countries and territories. Our global
R&D and manufacturing platform includes more than 50
facilities, and we are one of the world's largest producers of
active pharmaceutical ingredients. Every member of our more than
40,000-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 revefenacin
having the potential to offer meaningful benefits to patients with
moderate to very severe COPD; revefenacin being uniquely positioned
to address a key unmet need in the treatment of COPD; goals and
expectations to complete the ongoing Phase 3 safety trial in 2017
and submit an NDA regulatory filing in the U.S. by the end of 2017;
and Mylan's belief that its strong experience with nebulized
products and experienced salesforce in the respiratory segment will
help ensure revefenacin's success if approved. 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 ability to execute on new product
opportunities; any regulatory, legal or other impediments to our
ability to bring our 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 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.
Contact Information:
Theravance Biopharma
Renee Gala
Chief Financial Officer
650-808-4045
investor.relations@theravance.com
Tim Brons
Vida Strategic Partners (media)
646-319-8981
tbrons@vidasp.com
Mylan
Nina Devlin (Media)
724.514.1968
Kris King (Investors)
724.514.1813
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.
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.
Accessed on September 29, 2016.
3TBPH market research (N = 160 physicians); Refers to
US COPD patients
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SOURCE Theravance Biopharma, Inc.