DUBLIN, Sept. 20, 2017 /PRNewswire/ -- Theravance
Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma") today
highlighted that GlaxoSmithKline plc (GSK) and Innoviva, Inc.
(Innoviva) have reported positive headline results from the
landmark Phase 3 IMPACT study of Trelegy Ellipta, the first and
only FDA approved once-daily single inhaler triple therapy
comprising an inhaled corticosteroid (ICS), long-acting muscarinic
antagonist (LAMA) and long-acting beta agonist (LABA). Trelegy
Ellipta 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.). 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 Trelegy Ellipta.
Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol,
FF/UMEC/VI) is approved in the US for the long-term, once-daily,
maintenance treatment of patients with chronic obstructive
pulmonary disease (COPD) who are receiving Breo (fluticasone
furoate/vilanterol, FF/ VI) and require additional
bronchodilation or who are receiving Breo and Incruse
(umeclidinium, UMEC).
In an announcement dated September 20,
2017, GSK and Innoviva stated the IMPACT study, which
involved 10,355 patients, met its primary endpoint demonstrating
statistically significant reductions in the annual rate of
on-treatment moderate/severe exacerbations for FF/UMEC/VI
(100/62.5/25mcg) when compared with two, once-daily dual COPD
therapies from GSK's existing portfolio. The study showed a:
- 15% reduction for FF/UMEC/VI compared with Relvar/Breo Ellipta
(FF/VI,100/25mcg); 0.91 vs 1.07 per year; p<0.001
- 25% reduction for FF/UMEC/VI compared with Anoro Ellipta
(UMEC/VI, 62.5/25mcg); 0.91 vs 1.21 per year; p<0.001
In addition, statistically significant improvements were
observed across all pre-specified key secondary endpoints and
associated treatment comparisons:
- Change from baseline trough FEV1 at week 52 for
FF/UMEC/VI compared with FF/VI was 97mL; p<0.001 and for
FF/UMEC/VI compared with UMEC/VI was 54mL; p<0.001
- Change from baseline St. George's Respiratory Questionnaire at
week 52 for FF/UMEC/VI compared with FF/VI was -1.8 units;
p<0.001 and for FF/UMEC/VI compared with UMEC/VI was -1.8 units;
p<0.001
- Analysis of time to first on-treatment moderate/severe COPD
exacerbation demonstrated a 14.8% reduction in risk for FF/UMEC/VI
compared with FF/VI; p<0.001, and a 16.0% reduction in risk for
FF/UMEC/VI compared with UMEC/VI; p<0.001
GSK and Innoviva also noted that based on review of the headline
data, the safety profile of FF/UMEC/VI was consistent with the
known profile of the individual medicines and their dual
combinations. The most common adverse events across the treatment
groups were viral upper respiratory tract infection, worsening of
COPD, upper respiratory tract infection, pneumonia and headache.
The incidences of the most frequent serious adverse events were
worsening of COPD: 11%, 11% and 13% for FF/UMEC/VI, FF/VI and
UMEC/VI, respectively; and pneumonia: 4%, 4% and 3% for FF/UMEC/VI,
FF/VI and UMEC/VI, respectively. According to GSK and Innoviva,
full results from the IMPACT study will be presented at upcoming
scientific meetings and in peer-reviewed publications.
About IMPACT
The InforMing the PAthway of COPD Treatment (IMPACT) study was a
randomized, double-blind, 3-arm parallel group, multicenter study
evaluating FF/UMEC/VI (100mcg/62.5mcg/25mcg) versus FF/VI
(100mcg/25mcg) and UMEC/VI (62.5mcg/25mcg), all given once daily
via the Ellipta dry powder inhaler. The total duration of the study
was approximately 55 weeks consisting of a 2-week run-in period,
52-week treatment period and a 1-week safety follow-up period.
Patients had moderate to very severe symptomatic COPD with a
history of exacerbation in the prior 12 months. In the study,
10,355 patients were treated in over 1,035 study centers
globally.
The primary efficacy endpoint was the annual rate of
on-treatment moderate and severe exacerbations. This was compared
for FF/UMEC/VI versus FF/VI and, FF/UMEC/VI versus UMEC/VI. Other
endpoints included lung function and patient reported outcomes,
including health related quality of life measures.
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 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.
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.