Blueprint
FORM 6-K
SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549
Report of Foreign Issuer
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For
period ending 01 November
2017
GlaxoSmithKline plc
(Name
of registrant)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address
of principal executive offices)
Indicate
by check mark whether the registrant files or
will
file annual reports under cover Form 20-F or Form 40-F
Form
20-F x Form 40-F
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Indicate
by check mark whether the registrant by furnishing the
information
contained in this Form is also thereby furnishing the
information
to the Commission pursuant to Rule 12g3-2(b) under the
Securities
Exchange Act of 1934.
Yes
No x
Wednesday
1 November 2017, London UK - LSE Announcement
GSK study demonstrates superiority of Anoro Ellipta to Stiolto
Respimat in improving lung function in chronic obstructive
pulmonary disease
GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ:
INVA) today announced positive data from a study comparing a
once-daily long-acting muscarinic antagonist (LAMA) and a
long-acting beta agonist (LABA) fixed-dose
combination, Anoro Ellipta (umeclidinium/vilanterol
62.5mcg/25mcg; UMEC/VI) and Stiolto Respimat (tiotropium/olodaterol
5mcg/5mcg; TIO/OLO), for symptomatic patients with chronic
obstructive pulmonary disease (COPD). These data have been
published today in Advances in
Therapy1
and are being presented today at the
CHEST annual meeting of the American College of Chest Physicians in
Toronto, Canada.
The
primary endpoint for this eight-week, open-label, cross-over study
of 236 patients with COPD was the demonstration of non-inferiority
of UMEC/VI compared to TIO/OLO in improving lung function, as
measured by trough FEV1 (Forced Expiratory Volume in 1 second) at
week eight. This endpoint was met and, furthermore, UMEC/VI
demonstrated superiority to TIO/OLO, with a difference in treatment
effect of 52mL on trough FEV1 at week eight (UMEC/VI 180mL vs.
TIO/OLO 128mL; 95% CI: 28, 77; p<0.001).
Both
treatments demonstrated a comparable tolerability and safety
profile with an overall incidence of
on-treatment adverse events of 25% in the UMEC/VI group and 31% in
the TIO/OLO group. The most frequently-reported adverse events were
upper respiratory tract infections (UMEC/VI 8%; TIO/OLO 9%), cough
(UMEC/VI 1%; TIO/OLO 1%) and diarrhoea (UMEC/VI 1%; TIO/OLO
1%).
Eric
Dube, SVP, Head Global Respiratory, GSK said, "Improving lung
function is a clear goal in patients with COPD.2 The challenge for
healthcare professionals to date has been the lack of
differentiation within the LAMA/LABA class. That is why we have
conducted this study, as the first in-class head-to-head comparison
of two fixed-dose once-daily LAMA/LABAs. These data demonstrate
that UMEC/VI (Anoro) provides superior lung function improvements
to the comparator TIO/OLO."
Michael
Aguiar, CEO of Innoviva said, "COPD is a progressive, chronic
disease, affecting over 300 million people worldwide. We believe
that these data clearly demonstrate the benefit of Anoro Ellipta
versus Stiolto Respimat for symptomatic moderate COPD patients
whose primary therapeutic need is additional bronchodilatation and
we are very pleased with these results."
About COPD
COPD is
a disease of the lungs that includes chronic bronchitis, emphysema
or both. COPD is characterised by obstruction to airflow that
interferes with normal breathing. 384 million people have
COPD2 and
it is estimated to become the 3rd leading cause of death worldwide
by 2030.3
Long-term exposure to lung irritants that damage the lungs and the
airways are usually the cause of COPD. Cigarette smoke,
breathing in second hand smoke, air pollution, chemical fumes or
dust from the environment or workplace can all contribute to COPD.
Most people who have COPD are at least 40 years old when symptoms
begin.
About the Head-to-Head Study
The Anoro Ellipta
(umeclidinium/vilanterol 62.5mcg/25mcg; UMEC/VI)
versus Stiolto Respimat
(tiotropium/olodaterol 5mcg/5mcg; TIO/OLO) head-to-head study is the first direct
comparison of two fixed-dose once-daily LAMA/LABA combination
therapies for COPD.
The study involved 236 adult symptomatic (MMRC >/= 2) patients
with moderate COPD (post bronchodilator FEV1 ≤50 and
≥70% of predicted value), not receiving inhaled
corticosteroid therapy at inclusion in the study, from 34 centres
across Germany, Spain, UK and US. The primary objective of the
study was to demonstrate that UMEC/VI was non-inferior to TIO/OLO
in lung function at week eight, as measured by trough FEV1 (Forced
Expiratory Volume in 1 second) with a non-inferiority margin of
-50mL in the per protocol (PP) population. If non-inferiority was
established, which was the case, superiority was then tested in the
intent-to-treat (ITT) population.
The study was an 8-week, multicentre, randomised, open-label,
two-period cross-over design. After an initial two week run-in
period, eligible patients were randomised to receive UMEC/VI
(62.5/25 mcg one inhalation once-daily) via the Ellipta inhaler
followed by TIO/OLO 5/5 mcg (2 puffs of TIO/OLO 2.5/2.5 mcg
once-daily) via the Respimat inhaler (each for 8 weeks with an
interim 3-week washout), or vice versa. Treatments were
administered open-label, since the inhalers were potentially
identifiable, but spirometry was conducted in assessor-blind
conditions.
Commitment to respiratory disease
GSK has
been a leader in respiratory for over 45 years, developing new and
first-in-class medicines, approaches and insights which have helped
to influence and support the management of asthma and COPD. The
company is relentless in striving to expand knowledge and the
understanding of respiratory disease to help transform the way that
medicines are developed. GSK is focused on identifying new
scientific insights, applying our expertise and developing
innovative new medicines that enable clinicians to tailor treatment
to the individual needs of patients and help patients to live every
breath.
About Anoro Ellipta
Anoro
Ellipta (umeclidinium and vilanterol inhalation powder) is a
combination of two bronchodilators in a single dry powder inhaler,
the Ellipta. It contains umeclidinium (UMEC), a long-acting
muscarinic antagonist (LAMA) and vilanterol (VI), a long-acting
beta2
agonist (LABA). The dose of UMEC/VI is labelled as 55/22mcg in
Europe (delivered dose) and 62.5/25mcg in the US (dispensed dose)
and is delivered in the Ellipta inhaler.
Important Safety Information for Anoro Ellipta in the
US
The following Important Safety Information (ISI) is based on the
Highlights section of the Prescribing Information for Anoro
Ellipta. Please consult the full Prescribing Information for
all the labeled safety information for Anoro Ellipta.
Long-acting beta2-adrenergic
agonists (LABA), such as vilanterol, increase the risk of
asthma-related death. A placebo-controlled trial with another LABA
(salmeterol) showed an increase in asthma-related deaths. This
finding with salmeterol is considered a class effect of all
LABA. The safety and efficacy of Anoro in patients with
asthma have not been established. Anoro is not indicated for
the treatment of asthma.
Anoro is contraindicated in patients with severe hypersensitivity
to milk proteins or any ingredients.
Anoro should not be initiated in patients during rapidly
deteriorating or potentially life-threatening episodes of COPD, or
as rescue therapy for the treatment of acute episodes of
bronchospasm, which should be treated with an inhaled, short-acting
beta2-agonist.
Anoro should not be used more often than recommended, at higher
doses than recommended, or in conjunction with additional medicine
containing a LABA, as an overdose may result.
Anoro should be used with caution when considering coadministration
with long-term ketoconazole and other known strong cytochrome P450
3A4 inhibitors because increased cardiovascular adverse effects may
occur.
Anoro can produce paradoxical bronchospasm, which may be
life-threatening.
Anoro should be used with caution in patients with cardiovascular
disorders, especially coronary insufficiency, cardiac arrhythmias,
and hypertension.
Anoro should be used with caution in patients with convulsive
disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in
patients who are unusually responsive to sympathomimetic
amines.
Anoro should be used with caution in patients with narrow-angle
glaucoma. Instruct patients to contact a physician immediately
should any signs or symptoms of narrow-angle glaucoma
occur.
Anoro should be used with caution in patients with urinary
retention, especially in patients with prostatic hyperplasia or
bladder neck obstruction. Instruct patients to contact a
physician immediately should any signs or symptoms of urinary
retention occur.
Beta-adrenergic agonist medicines may produce significant
hypokalemia and transient hyperglycemia in some
patients.
The most common adverse reactions (incidence ≥1% and more
common than placebo) with Anoro were pharyngitis, sinusitis, lower
respiratory tract infection, constipation, diarrhea, pain in
extremity, muscle spasms, neck pain, and chest pain.
Beta2-agonists,
such as vilanterol should be administered with extreme caution to
patients being treated with monoamine oxidase inhibitors, tricyclic
antidepressants, or drugs known to prolong the QTc interval or
within 2 weeks of discontinuation of such agents, because the
effect of adrenergic agonists on the cardiovascular system may be
potentiated.
Use beta‐blockers
with caution as they not only block the pulmonary effect of
beta‐agonists,
such as vilanterol, but may produce severe bronchospasm in patients
with COPD.
Use with caution in patients taking non-potassium-sparing
diuretics, as electrocardiographic changes and/or hypokalemia
associated with non-potassium-sparing diuretics may worsen with
concomitant beta-agonists.
Avoid co-administration of Anoro with other
anticholinergic-containing drugs as this may lead to an increase in
anticholinergic adverse effects such as cardiovascular effects,
worsening of narrow-angle glaucoma, and worsening of urinary
retention.
Full US prescribing information is available at:
US Prescribing Information for Anoro Ellipta.
GSK - one of the world's
leading research-based pharmaceutical and healthcare companies - is
committed to improving the quality of human life by enabling people
to do more, feel better and live longer. For further
information please visit www.gsk.com.
ANORO®,
and ELLIPTA®
are trade marks of the GlaxoSmithKline
group of companies. STIOLTO and RESPIMAT are trade marks of
Boehringer Ingelheim.
Innoviva - Innoviva is focused on bringing
compelling new medicines to patients in areas of unmet need by
leveraging its significant expertise in the development,
commercialization and financial management of bio-pharmaceuticals.
Innoviva's portfolio is anchored by the respiratory assets
partnered with Glaxo Group Limited (GSK), including
RELVAR®/BREO®
ELLIPTA®
and
ANORO®
ELLIPTA®,
which were jointly developed by Innoviva and GSK. Under the
agreement with GSK, Innoviva is eligible to receive associated
royalty revenues from RELVAR®/BREO®
ELLIPTA®,
ANORO®
ELLIPTA®.
In addition, Innoviva retains a 15 percent economic interest in
future payments made by GSK for earlier-stage programs partnered
with Theravance Biopharma, Inc., including the closed triple
combination therapy for COPD. For more information, please visit
Innoviva's website at www.inva.com.
References
1.
Feldman G et al. Advances
in Therapy 2017; vol. 34: DOI
10.1007/s12325-017-0626-4
2. GOLD 2017 Global Strategy for the
Diagnosis, Management and Prevention of COPD. Available
from: http://goldcopd.org/gold-2017-global-strategy-diagnosis-management-prevention-copd/
[Last accessed: Oct. 2017]
3. World Health Organization. Chronic
obstructive pulmonary disease. Available from: http://www.who.int/respiratory/copd/en/
[Last accessed: Oct. 2017]
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GSK enquiries:
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UK
Media enquiries:
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Simon
Steel
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+44 (0)
20 8047 5502
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(London)
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David
Daley
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+44 (0)
20 8047 5502
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(London)
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US
Media enquiries:
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Sarah
Alspach
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+1 202
715 1048
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(Washington,
DC)
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Sarah
Spencer
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+1 215
751 3335
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(Philadelphia)
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Karen
Hagens
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+1 919
483 2863
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(North
Carolina)
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Analyst/Investor
enquiries:
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Sarah
Elton-Farr
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+44 (0)
208 047 5194
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(London)
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Tom
Curry
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+ 1 215
751 5419
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(Philadelphia)
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Gary
Davies
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+44 (0)
20 8047 5503
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(London)
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James
Dodwell
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+44 (0)
20 8047 2406
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(London)
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Jeff
McLaughlin
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+1 215
751 7002
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(Philadelphia)
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Innoviva, Inc. enquiries:
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Investor
Relations:
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Eric
d'Esparbes
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+1
(650) 238-9605
investor.relations@inva.com
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(Brisbane,
Calif.)
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Cautionary statement regarding forward-looking
statements
GSK
cautions investors that any forward-looking statements or
projections made by GSK, including those made in this announcement,
are subject to risks and uncertainties that may cause actual
results to differ materially from those projected. Such factors
include, but are not limited to, those described under Item 3.D
Principal risks and uncertainties in the company's Annual Report on
Form 20-F for 2016.
Innoviva
forward-looking statements
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 and future
events, including the development, regulatory and commercial plans
for closed triple combination therapy and the potential benefits
and mechanisms of action of closed triple combination therapy.
Innoviva 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. Such
forward-looking statements involve substantial risks, uncertainties
and assumptions. These statements are based on the current
estimates and assumptions of the management of Innoviva as of the
date of this press release and are subject to risks, uncertainties,
changes in circumstances, assumptions and other factors
that may cause the actual
results of Innoviva 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 are described under the headings
"Risk Factors" and "Management's Discussion and Analysis of
Financial Condition and Results of Operations" contained in
Innoviva's Annual Report on Form 10-K for the year ended December
31, 2016 and Quarterly Report on Form 10-Q for the quarter ended
June 30, 2017, which are on file with the Securities and Exchange
Commission (SEC) and available on the SEC's website at
www.sec.gov.
In addition to the risks described above and in Innoviva's other
filings with the SEC, other unknown or unpredictable factors also
could affect Innoviva'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. The information in
this press release is provided only as of the date hereof, and
Innoviva assumes no obligation to update its forward-looking
statements on account of new information, future events or
otherwise, except as required by law. (INVA-G).
Registered in England & Wales:
No. 3888792
Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
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GlaxoSmithKline plc
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(Registrant)
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Date: November
01, 2017
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By: VICTORIA
WHYTE
--------------------------
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GlaxoSmithKline plc
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