DUBLIN, Nov. 28, 2017 /PRNewswire/ -- Theravance
Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma") today
highlighted the filing of a supplemental New Drug Application
(sNDA) with the U.S. Food and Drug Administration (FDA) for the use
of Trelegy Ellipta, the triple combination therapy of fluticasone
furoate, umeclidinium, and vilanterol (FF/UMEC/VI) in a single
ELLIPTA® inhaler, for an expanded indication for the
maintenance treatment of airflow obstruction and reduction of
exacerbations in patients with chronic obstructive pulmonary
disease (COPD). If this sNDA is approved, the labeled indication
for Trelegy Ellipta would include a wider population of patients
with COPD who are at risk of an exacerbation and require triple
therapy.
Trelegy Ellipta is a product in which Theravance Biopharma has
an economic interest in future payments that may be made by
GlaxoSmithKline (GSK) or one of its affiliates pursuant to its
agreements with Innoviva (formerly Theravance, Inc.). Theravance
Biopharma is entitled to receive an 85% economic interest in the
royalties paid by GSK on worldwide net sales. Those royalties are
upward-tiering from 6.5% to 10%, resulting in cash flows to
Theravance Biopharma of approximately 5.5% to 8.5% of worldwide net
sales of Trelegy Ellipta. Theravance Biopharma is not responsible
for any costs related to Trelegy Ellipta.
Trelegy Ellipta is the first treatment to provide a combination
of three molecules in a single inhaler that only needs to be taken
once a day. The unique combination treatment includes: FF, an
inhaled corticosteroid; UMEC, a long-acting muscarinic antagonist
(LAMA); and VI, a long-acting beta2-adrenergic agonist
(LABA). This combination has been formulated to be delivered
once-daily in GSK's simple-to-use delivery device, the
ELLIPTA® dry powder inhaler.
In a press release dated November 23,
2017, GSK and Innoviva announced the submission of data from
the landmark IMPACT study to the FDA to support an expanded label
for Trelegy Ellipta. In the IMPACT study, Trelegy Ellipta showed
superiority to the dual combination therapies Anoro Ellipta and
Relvar/Breo Ellipta on multiple endpoints, including exacerbation
rates, lung function and health related quality of life.
Trelegy Ellipta is approved for use in the US for the long-term,
once-daily, maintenance treatment of COPD patients who are
receiving Breo (FF/VI) and require additional bronchodilation or
who are receiving Breo and Incruse (UMEC). If approved, the sNDA
would broaden this indication.
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 gastrointestinal
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 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 and Europe 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 (including the data therefrom), 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), product sales and the Company's
expectations for its 2017 operating loss, excluding share-based
compensation. 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 products, risks
associated with establishing and maintaining sales, marketing and
distribution capabilities with appropriate technical expertise and
supporting infrastructure, and risks of developing an institutional
customer mix for VIBATIV® (telavancin) that meet the
Company's plan for the product. 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.
Contact Information:
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
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SOURCE Theravance Biopharma, Inc.