DUBLIN and HERTFORDSHIRE,
England and PITTSBURGH, Oct. 21,
2019 /PRNewswire/ -- Theravance Biopharma, Inc.
(NASDAQ: TBPH) ("Theravance Biopharma") and Mylan
N.V. (NASDAQ: MYL) ("Mylan") today announced that data
from studies of YUPELRI® (revefenacin) inhalation
solution will be presented at CHEST 2019, the annual meeting of the
American College of Chest Physicians, on Oct. 22 in New Orleans,
LA. Data will include results from a phase 3b trial on YUPELRI when given before or combined
with Perforomist® (formoterol fumarate) inhalation
solution via nebulization in patients with chronic obstructive
pulmonary disease (COPD). In addition, data from two phase 3 trials
will be presented that analyzed the predictors of suboptimal peak
inspiratory flow rate (sPIFR) in patients with COPD.
YUPELRI and PERFOROMIST are indicated for the maintenance
treatment of COPD. Neither product should be initiated in patients
with acutely deteriorating COPD. YUPELRI should be used with
caution in patients with narrow angle glaucoma or in patients with
prostatic hyperplasia or bladder-neck obstruction. PERFOROMIST
should not be used as monotherapy for asthma due to an association
with asthma related death. See the full prescribing information for
complete information about these products.
Details of the presentations at CHEST 2019 are as follows:
Tolerability and Efficacy of Revefenacin When Administered
With Formoterol via Nebulization
- Poster Number: E1085
- Date/time: Tuesday, October 22,
2019, 1:55 – 2 p.m. CT
- Session: 4336
- Location: Exhibit Hall, Poster Area 4
Predictors of Suboptimal Peak Inspiratory Flow Rate in
Patients With Chronic Obstructive Pulmonary Disease: Analyses From
the Revefenacin Phase 3 Program
- Poster Number: E1081
- Date/time: Tuesday, October 22,
2019, 1:35 – 1:40 p.m. CT
- Session: 4336
- Location: Exhibit Hall, Poster Area 4
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. YUPELRI is a once-daily, nebulized bronchodilator for the
maintenance treatment of patients with COPD and is compatible with
any standard jet nebulizer connected to a mouthpiece.
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. Theravance Biopharma is eligible to
receive up to $259 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).
About COPD
COPD is a growing and devastating disease
that is the third leading cause of death in the U.S.1
Nearly 15.7 million Americans (6.4%) report that they have been
diagnosed with COPD and more 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 YUPELRI®
YUPELRI®
(revefenacin) inhalation solution is a once-daily nebulized LAMA
approved for the maintenance treatment of COPD in the U.S. 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 YUPELRI is positioned as a
first-in-class once-daily single-agent bronchodilator product for
COPD patients who require, or prefer, nebulized therapy. YUPELRI'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.
YUPELRI is a registered trademark of Mylan N.V.
Important Safety Information
YUPELRI is
contraindicated in patients with hypersensitivity to revefenacin or
any component of this product.
YUPELRI should not be initiated in patients during acutely
deteriorating or potentially life-threatening episodes of COPD, or
for the relief of acute symptoms, i.e., as rescue therapy for the
treatment of acute episodes of bronchospasm. Acute symptoms should
be treated with an inhaled short-acting beta2-agonist.
As with other inhaled medicines, YUPELRI can produce paradoxical
bronchospasm that may be life-threatening. If paradoxical
bronchospasm occurs following dosing with YUPELRI, it should be
treated immediately with an inhaled, short-acting bronchodilator.
YUPELRI should be discontinued immediately and alternative therapy
should be instituted.
YUPELRI should be used with caution in patients with
narrow-angle glaucoma. Patients should be instructed to immediately
consult their healthcare provider if they develop any signs and
symptoms of acute narrow-angle glaucoma, including eye pain or
discomfort, blurred vision, visual halos or colored images in
association with red eyes from conjunctival congestion and corneal
edema.
Worsening of urinary retention may occur. Use with caution in
patients with prostatic hyperplasia or bladder-neck obstruction and
instruct patients to contact a healthcare provider immediately if
symptoms occur.
Immediate hypersensitivity reactions may occur after
administration of YUPELRI. If a reaction occurs, YUPELRI should be
stopped at once and alternative treatments considered.
The most common adverse reactions occurring in clinical trials
at an incidence greater than or equal to 2% in the YUPELRI group,
and higher than placebo, included cough, nasopharyngitis, upper
respiratory infection, headache and back pain.
Coadministration of anticholinergic medicines or OATP1B1 and
OATP1B3 inhibitors with YUPELRI is not recommended.
YUPELRI is not recommended in patients with any degree of
hepatic impairment.
Please see the full Prescribing Information.
For additional information please contact us at
800-395-3376.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
About Theravance Biopharma
Theravance Biopharma, Inc.
("Theravance Biopharma") is a diversified biopharmaceutical company
primarily focused on the discovery, development and
commercialization of organ-selective medicines. Our purpose is to
create transformational medicines to improve the lives of patients
suffering from serious illnesses. Our research is focused in the
areas of inflammation and immunology.
In pursuit of our purpose, we apply insights and innovation at
each stage of our business and utilize our internal capabilities
and those of partners around the world. We apply organ-selective
expertise to biologically compelling targets to discover and
develop medicines designed to treat underserved localized diseases
and to limit systemic exposure, in order to maximize patient
benefit and minimize risk. These efforts leverage years of
experience in developing lung-selective medicines to treat
respiratory disease, including FDA-approved YUPELRI®
(revefenacin) inhalation solution indicated for the maintenance
treatment of patients with chronic obstructive pulmonary disease
(COPD). Our pipeline of internally discovered programs is targeted
to address significant patient needs.
We have an economic interest in potential future payments from
Glaxo Group or one of its affiliates (GSK) pursuant to its
agreements with Innoviva, Inc. relating to certain programs,
including TRELEGY ELLIPTA.
For more information, please visit www.theravance.com.
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 (including the data therefrom), the potential
characteristics, benefits and mechanisms of action of the Company's
product and product candidates, and the Company's expectations for
product candidates through development and potential regulatory
approval and commercialization (including their potential as
components of combination therapies and their differentiation from
other products or potential products). 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), risks
that product candidates do not obtain approval from regulatory
authorities, the feasibility of undertaking future clinical trials
for our product candidates based on policies and feedback from
regulatory authorities, 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 products, 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 5, 2019 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 approximately
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 outcome
of clinical trials. These statements are made pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act
of 1995. Because forward-looking statements inherently involve
risks and uncertainties, actual future results may differ
materially from those expressed or implied by such
statements. Factors that could cause or contribute to such
differences include, but are not limited to any changes in,
interruptions to, or difficulties with Mylan's or its partners'
ability to develop, manufacture, and commercialize products; the
effect of any changes in Mylan's or its partners' customer and
supplier relationships and customer purchasing patterns; other
changes in third-party relationships; the impact of competition;
changes in the economic and financial conditions of the businesses
of Mylan or its partners; the scope, timing, and outcome of any
ongoing legal proceedings and the impact of any such proceedings on
Mylan's or its partners' business; any regulatory, legal, or other
impediments to Mylan's or its partners' ability to bring products
to market; actions and decisions of healthcare and pharmaceutical
regulators, and changes in healthcare and pharmaceutical laws and
regulations, in the United States
and abroad; Mylan's and its partners' ability to protect
intellectual property and preserve intellectual property rights;
risks associated with international operations; other 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
- American Lung Association. "Chronic Obstructive Pulmonary
Disease (COPD)"
http://www.lung.org/lung-health-and-diseases/lung-disease-lookup/copd.
Accessed on August 30, 2019.
- Center for Disease Control, COPD
https://www.cdc.gov/copd/index.html. Accessed on August 30, 2019.
- TBPH market research (N=160 physicians); Refers to US COPD
patients.
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SOURCE Mylan N.V.; Theravance Biopharma, Inc.