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 19 April
2018
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
--
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
Issued:
18 April 2018, London UK - LSE Announcement
Landmark IMPACT study published in NEJM shows significant benefits
of Trelegy Ellipta for patients with COPD
Once-daily single inhaler triple therapy superior to Relvar/Breo
Ellipta and Anoro Ellipta across multiple endpoints including
exacerbations, lung function and quality of life
GlaxoSmithKline
plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today
announced the publication in the New England Journal of Medicine
(NEJM) of the landmark IMPACT study, one of the biggest ever
conducted in patients with chronic obstructive pulmonary disease
(COPD) with a history of exacerbation.1
In the
study, Trelegy Ellipta (fluticasone
furoate/umeclidinium/vilanterol, 'FF/UMEC/VI' 100/62.5/25mcg)
achieved superiority to members of two different classes of dual
combination therapy, Relvar/Breo (FF/VI) and Anoro
(UMEC/VI), on the primary endpoint of reduction in the annual
rate of on-treatment moderate/severe exacerbations (p<0.001) and
a range of other clinically important outcomes, including lung
function and health-related quality of life.
Results
from additional secondary and other endpoints published today,
include:
●
A statistically significant 34%
reduction in COPD hospitalisations (severe exacerbations) for
Trelegy compared to Anoro (0.13 vs. 0.19 per year; p<0.001) and
a reduction of 13% compared to Relvar/Breo which was not
statistically significant (0.13 vs. 0.15; p=0.064).
●
A significant reduction in the
risk of on-treatment all-cause mortality was observed for both
inhaled corticosteroid containing arms compared to
Anoro.
●
A 42.1% reduction in the risk of
on-treatment all-cause mortality was observed for Trelegy compared
to Anoro (1.20% vs. 1.88%; p=0.011).
To
fully understand the implications of the all-cause mortality
observation, off-treatment data also need to be considered. Work is
ongoing to investigate this further and will be presented at future
scientific meetings.
Dave
Allen, Head, Respiratory Therapy Area R&D, GSK, said, "Reducing
exacerbations to keep patients out of hospital is a key goal of
COPD management alongside improving lung function and quality of
life. The IMPACT study shows how Trelegy Ellipta can help patients
with a history of exacerbation achieve these goals. We believe its
publication in NEJM is an important addition to the evidence base
that informs the management of this progressive and debilitating
disease."
Dr.
Fernando Martinez, Chief, Division of Pulmonary and Critical Care
Medicine, New York-Presbyterian Hospital/Weill Cornell Medical
Center, said, "IMPACT significantly advances our understanding
of COPD management by addressing a number of key evidence
gaps. By comparing various combinations of effective
medications in the same device the study clarifies which type of
patient gains greatest benefit from each class of medicine. As many
patients experience frequent exacerbations or 'flare ups', which
can often result in hospitalisation, these data will be highly
relevant to patients and clinicians as they consider the optimal
treatment."
The
safety profile of single inhaler triple therapy was consistent with
the safety profile of the individual components. 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. Consistent with previous
studies, the incidence of pneumonia as a serious adverse event was
4%, 4%, and 3% for FF/UMEC/VI, FF/VI and UMEC/VI,
respectively.
Dr Ted
Witek, Senior Vice President and Chief Scientific Officer at
Innoviva notes, "The role of inhaled corticosteroids ("ICS") in
COPD have long been debated, and this landmark trial provides
further evidence of their benefit in the population studied and
compelling data towards clarifying the role of ICS containing
regimens in the COPD treatment paradigm. We congratulate our
partners at GSK for this vital contribution to the field of
respiratory medicine."
Results
from IMPACT were submitted to the regulatory authorities in the US
and EU in November 2017 and February 2018, respectively. Further
regulatory submissions in other countries are expected in
2018.
About IMPACT
The landmark InforMing the PAthway of COPD Treatment
(IMPACT)
study is the first to directly compare three commonly-used COPD
combination treatment classes delivered using the same dose and
inhaler. It is the second of two phase 3 studies designed to
investigate the efficacy and safety of FF/UMEC/VI in a single
inhaler compared to other commonly-used COPD combination
treatments.2
It
evaluated as its primary endpoint the annual rate of on-treatment
moderate/severe exacerbations for FF/UMEC/VI (100/62.5/25mcg)
compared with FF/VI (100/25mcg) and UMEC/VI (62.5/25mcg), two
once-daily dual COPD therapies from GSK's existing portfolio. Other
secondary and multiple pre-defined protocol 'other' endpoints
included lung function, patient reported outcomes, including
health- related quality of life measures, and all-cause mortality.
A range of safety endpoints were also analysed.
Patients
had moderate to very severe symptomatic COPD with a history of
exacerbation in the prior 12 months. This is representative of
approximately 50% of the global COPD patient
population.3
In the study, 10,355 patients were treated in 37 countries in over
1,035 study centres globally, making it one of the biggest COPD
studies ever conducted.
About Trelegy Ellipta (FF/UMEC/VI)
FF/UMEC/VI
is the first COPD treatment to provide a combination of three
molecules in a single inhaler that only needs to be taken in a
single inhalation, once a day. It contains fluticasone furoate, an
inhaled corticosteroid, umeclidinium, a long-acting muscarinic
antagonist; and vilanterol, a long-acting beta2-adrenergic agonist,
delivered in GSK's Ellipta dry powder inhaler, which is used across
the entire new portfolio of inhaled COPD medicines.
Data
from across multiple clinical programmes have demonstrated the
benefit of the molecules in FF/UMEC/VI both alone and in
combination, for the treatment of COPD.
FF/UMEC/VI was approved in the US in September 2017 for the
long-term, once-daily, maintenance treatment of patients with COPD,
including chronic bronchitis and/or emphysema, who are on a
fixed-dose combination of FF/VI for airflow obstruction and
reducing exacerbations in whom additional treatment of airflow
obstruction is desired or for patients who are already receiving
UMEC and a fixed-dose combination of FF/VI.
Full US Prescribing Information, including BOXED WARNING and
Medication Guide are available at:
https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Trelegy/pdf/TRELEGY-PI-MG-IFU.PDF
FF/UMEC/VI was approved for use in Europe in November 2017
as a
maintenance treatment in adult patients with moderate to severe
COPD who are not adequately treated by a combination of an inhaled
corticosteroid and a long-acting beta2-agonist. The European Summary of Product Characteristics
is available at: https://www.medicines.org.uk/emc/medicine/34357
Regulatory
applications for once-daily single inhaler triple therapy
FF/UMEC/VI have been submitted and are undergoing assessment in a
number of other countries.
About COPD
COPD is a progressive lung disease that is thought to affect around
384 million people worldwide.4
For people living with COPD, the inability to breathe normally can
consume their daily lives and make simple activities, like walking
upstairs, an everyday struggle. Patients with COPD suffer from
symptoms of breathlessness and many have a significant risk of
exacerbations. Managing these aspects of the disease drives
physician treatment choice.
Long-term exposure to inhaled 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.5
Every
person with COPD is different, with different needs, different
challenges and different goals. Understanding this and providing
support to help meet these needs is the foundation of GSK's
work.
GSK's commitment to respiratory disease
GSK has
led the way in developing innovative medicines to advance the
management of asthma and COPD for nearly 50 years. Over the last
five years we have launched six innovative medicines responding to
continued unmet patient need, despite existing therapies. This is
an industry leading portfolio in breadth, depth and innovation,
developed to reach the right patients, with the right
treatment.
We
remain at the cutting-edge of scientific research into respiratory
medicine, working in collaboration with patients and the scientific
community to offer innovative medicines aimed at helping to treat
patients' symptoms and reduce the risk of their disease worsening.
While respiratory diseases are clinically distinct, there are
important pathophysiological features that span them, and our
ambition is to have the most comprehensive portfolio of medicines
to address a diverse range of respiratory diseases. To achieve
this, we are focusing on targeting the underlying disease-driving
biological processes to develop medicines with applicability across
multiple respiratory diseases. This approach requires extensive
bioinformatics, data analytic capabilities, careful patient
selection and stratification by phenotype in our clinical
trials.
Important Safety Information (ISI)
The
following ISI is based on the Highlights section of the US
Prescribing Information for FF/UMEC/VI. Please consult the full
Prescribing Information for all the labelled safety
information.
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 Trelegy
Ellipta in patients with asthma have not been established. Trelegy
Ellipta is not indicated for the treatment of asthma.
Trelegy
Ellipta is contraindicated in patients with severe hypersensitivity
to milk proteins or any of the ingredients.
Trelegy
Ellipta should not be initiated in patients experiencing episodes
of acutely deteriorating COPD. Do not use Trelegy Ellipta to treat
acute symptoms.
Trelegy
Ellipta should not be used in combination with other medicines
containing LABA because of risk of overdose.
Candida
albicans infection of the mouth and pharynx has occurred in
patients treated with fluticasone furoate, a component of Trelegy
Ellipta. Monitor patients periodically. Advise the patient to rinse
his/her mouth with water without swallowing after inhalation to
help reduce the risk.
There
is an increased risk of pneumonia in patients with COPD taking
Trelegy Ellipta. Monitor patients for signs and symptoms of
pneumonia.
Patients
who use corticosteroids are at risk for potential worsening of
infections (e.g. existing tuberculosis; fungal, bacterial, viral,
or parasitic infections; or ocular herpes simplex). Use Trelegy
Ellipta with caution in patients with these infections. More
serious or even fatal course of chickenpox or measles can occur in
susceptible patients.
There
is a risk of impaired adrenal function when transferring from
systemic corticosteroids. Taper patients slowly from systemic
corticosteroids if transferring to Trelegy Ellipta.
Hypercorticism
and adrenal suppression may occur with very high dosages or at the
regular dosage of Trelegy Ellipta in susceptible individuals. If
such changes occur, consider appropriate therapy.
If
paradoxical bronchospasm occurs, discontinue Trelegy Ellipta and
institute alternative therapy.
Use
Trelegy Ellipta with caution in patients with cardiovascular
disorders because of beta-adrenergic stimulation.
Assess
patients for decrease in bone mineral density initially and
periodically thereafter after prescribing Trelegy
Ellipta.
Close
monitoring for glaucoma and cataracts is warranted in patients
taking Trelegy Ellipta. Worsening of narrow-angle glaucoma may
occur. Use with caution in patients with narrow-angle glaucoma and
instruct patients to contact a healthcare provider immediately if
symptoms occur.
Worsening
of urinary retention may occur in patients taking Trelegy Ellipta.
Use with caution in patients with prostatic hyperplasia or
bladder-neck obstruction and instruct patients to contact a
healthcare provider immediately if symptoms occur.
Use
Trelegy Ellipta with caution in patients with convulsive disorders,
thyrotoxicosis, diabetes mellitus, and ketoacidosis.
Be
alert to hypokalemia and hyperglycemia in patients taking Trelegy
Ellipta.
The
most common adverse reactions reported for Trelegy Ellipta
(incidence ≥1%) are headache, back pain, dysgeusia, diarrhea,
cough, oropharyngeal pain, and gastroenteritis.
GSK - a
science-led global healthcare company with a special purpose: to
help people do more, feel better, live longer. For further
information please visit www.gsk.com.
Trade marks are owned by or licensed to the GSK group of
companies.
Innoviva - Innoviva is focused on bringing
compelling 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®,
ANORO®
ELLIPTA®
and TRELEGY® 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®
and
ANORO®
ELLIPTA®.
In addition, Innoviva retains a 15 percent economic interest in
future payments made by GSK for TRELEGY® ELLIPTA® and
earlier-stage programs partnered with Theravance Biopharma, Inc.
For more information, please visit Innoviva's website at
www.inva.com.
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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Karen
Hagens
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+1 919
483 2863
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(North
Carolina)
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Juan
Carlos Molina
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+1 919
483 0471
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(North
Carolina)
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Sarah
Spencer
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+1 215
751 3335
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(Philadelphia)
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Analyst/Investor
enquiries:
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Sarah
Elton-Farr
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+44 (0)
20 8047 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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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) 238-9640
investor.relations@inva.com
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(Brisbane,
Calif.)
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Cautionary statement regarding forward-looking
statementsGSK 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 2017.
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, 2017, which is on file with the Securities and
Exchange Commission (SEC) and available on the SEC's website
at www.sec.gov.
Additional factors may be described in those sections of Innoviva's
Quarterly Report on Form 10-Q for the quarter ended March 31, 2018,
to be filed with the SEC in the second quarter of 2018. 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
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References (accessed March 2018)
1.
Lipson DA et al. Once-Daily Single Inhaler Triple Versus Dual
Therapy in Patients with COPD. New England Journal of Medicine.
2018.
2.
Lipson DA et al. FULFIL Trial: Once-Daily Triple Therapy for
Patients with Chronic Obstructive Pulmonary Disease. Am J Resp Crit
Care Med. 2017.
3.
GSK data on file. RF/CPD/0003/18. Frequency of acute exacerbations
of COPD among patients treated with maintenance therapy in three
observational studies.
4. Global Strategy for
the Diagnosis, Management and Prevention of COPD, Global Initiative
for Chronic Obstructive Lung Disease (GOLD) 2017. Available
from: http://goldcopd.org.
5.
Diagnosis of COPD. World Health
Organization. Available at:
http://www.who.int/respiratory/copd/diagnosis/en/
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: April
19, 2018
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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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