DUBLIN, Ireland, Sept. 18, 2017 /PRNewswire/ -- Theravance
Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma") today
highlighted that GlaxoSmithKline plc (GSK) and Innoviva, Inc.
(Innoviva) have received a positive opinion from the European
Medicines Agency's (EMA) Committee for Medicinal Products for Human
Use (CHMP), recommending marketing authorization for the Closed
Triple (the triple combination therapy of fluticasone furoate,
umeclidinium, and vilanterol in a single ELLIPTA®
inhaler, with a proposed brand name of Trelegy Ellipta). The Closed
Triple is a drug development program for which Theravance Biopharma
has an economic interest in future payments that may be made by GSK
or one of its affiliates pursuant to its agreements with Innoviva
(formerly Theravance, Inc.). Should the Closed Triple be approved
and commercialized, 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%.
Theravance Biopharma is not responsible for any costs related to
the Closed Triple.
In an announcement dated September 15,
2017, GSK and Innoviva stated that the CHMP had issued a
positive opinion recommending marketing authorization for the
Closed Triple as a maintenance treatment in adult patients with
moderate to severe chronic obstructive pulmonary disease (COPD) who
are not adequately treated by a combination of an inhaled
corticosteroid and a long-acting beta2-agonist. A CHMP positive
opinion is one of the final steps before marketing authorization is
granted by the European Commission. The announcement from GSK and
Innoviva also noted that a final decision by the European
Commission is anticipated by around the end of 2017. Additionally,
the companies noted that regulatory applications have been
submitted and are undergoing assessment in a number of other
countries, including the US, Australia and Canada. The Closed Triple is an
investigational medicine not yet approved for use as a single
inhaler triple therapy anywhere in the world.
The Closed Triple combination therapy represents a unique
approach to COPD treatment by seeking to combine the activity of
three molecules with different mechanisms of action in a single,
simple-to-use delivery device. The combination treatment includes:
fluticasone furoate (FF), an inhaled corticosteroid; umeclidinium
(UMEC), a long-acting muscarinic antagonist (LAMA); and vilanterol
(VI), a long-acting beta2-adrenergic agonist (LABA).
This combination has been formulated to be delivered once-daily in
GSK's ELLIPTA® dry powder inhaler.
Current trends in the treatment of COPD with combination therapy
support Theravance Biopharma's view that there is significant
market potential for a first-in-class, once-daily triple therapy in
a single inhaler. According to GSK, approximately one-third of COPD
patients are already utilizing open triple therapy and the
progressive nature of the disease indicates that COPD patients will
need access to more effective therapies over time. Additionally,
results from the Salford Lung Study, a Phase 3 real-world
effectiveness trial of two of the components of Closed Triple (FF
and VI) in COPD, were strongly supportive of the benefits of
once-daily therapy.
The ongoing clinical development program for the Closed Triple
in COPD includes the IMPACT study, a large Phase 3 trial designed
to evaluate the efficacy and safety of the triple combination
treatment compared to dual COPD therapies (FF/VI and UMEC/VI).
Results of the IMPACT study are expected to be reported by GSK in
2017. The Closed Triple is also in development for the treatment of
symptomatic asthma, and the completion of the Phase 3 CAPTAIN study
in asthma is planned for 2018 according to GSK.1
Notes:
1 Regulatory and clinical milestones as reported by
Glaxo Group Limited or one of its affiliates (GSK)
About Theravance Biopharma
Theravance Biopharma, Inc. 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 drug development programs, including the Closed Triple (the
combination of fluticasone furoate, umeclidinium, and vilanterol in
a single ELLIPTA® inhaler, with a proposed brand name of
Trelegy Ellipta), currently in development for the treatment of
COPD and 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.
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 and
results of clinical studies, the potential benefits and mechanisms
of action of the Company's product and product candidates and the
Company's expectations for product candidates through development,
potential regulatory approval and commercialization. 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, 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 products, 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
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission (SEC) on August 9,
2017. In addition to the risks described above and in
Theravance Biopharma's other 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.