Blueprint
UNITED STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of May, 2019
Commission
File Number 001-15170
GlaxoSmithKline plc
(Translation
of registrant's name into English)
980 Great West Road, Brentford, Middlesex, TW8
9GS
(Address
of principal executive office)
Indicate by check
mark whether the registrant files or will file annual reports under
cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ____
Issued: 2 May 2019, London UK - LSE Announcement
Phase III CAPTAIN study of Trelegy Ellipta in patients with asthma
meets primary endpoint
GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ:
INVA) today announced headline results from the pivotal phase III
CAPTAIN study of once-daily single inhaler triple therapy Trelegy
Ellipta (fluticasone furoate/umeclidinium/vilanterol: FF/UMEC/VI)
compared to Relvar/Breo Ellipta (FF/VI), in the treatment of
patients living with uncontrolled asthma.
The study met its primary endpoint, demonstrating a statistically
significant 110mL improvement in lung function (measured by change
from baseline in trough FEV1 at
24 weeks of treatment) for FF/UMEC/VI 100/62.5/25mcg
(p<0.001, 95% CI: 66-153 mL) compared with Relvar/Breo
100/25mcg and a statistically significant 92mL improvement in
trough FEV1 for
FF/UMEC/VI 200/62.5/25mcg versus Relvar/Breo 200/25mcg
(p<0.001, 95% CI: 49-135 mL).
The key secondary endpoint was annualised rate of moderate/severe
exacerbations for FF/UMEC/VI (100/62.5/25 and 200/62.5/25) versus
Relvar/Breo (100/25 and 200/25) and demonstrated a 13% (95% CI:
-5.2 to 28.1) reduction in exacerbations, however this was not
statistically significant. Therefore, all subsequent analyses were
considered descriptive.
Dr. Hal Barron, Chief Scientific Officer and President,
R&D, GSK, said: "We
believe a once-daily single inhaler triple therapy that improves
lung function is an advance for patients with uncontrolled asthma
since this option is not currently available. We plan to submit
these data for regulatory review after the full dataset is
available."
CAPTAIN was also designed to investigate two further doses of
FF/UMEC/VI (100/31.25/25 and 200/31.25/25 mcg) compared to
Relvar/Breo (100/25 and 200/25). There were increases in trough
FEV1 of
a similar magnitude to those of FF/UMEC/VI 100/62.5/25 and
200/62.5/25, with no difference in exacerbation
rates.
The safety profile of FF/UMEC/VI was consistent with the known
profile of the individual components and their combinations.
Adverse event rates were similar across all six study arms with the
most common adverse events being reported as nasopharyngitis
(13-15%), headache (5-9%), upper respiratory tract infection (3-6%)
and bronchitis (3-5%).
Dr. Paul Meunier, Vice President of Respiratory Medicine at
Innoviva noted that: "The CAPTAIN study has shown that triple
therapy in a single inhaler provides a potential new treatment
option for asthma management in patients uncontrolled on
ICS/LABA."
Full results from CAPTAIN will be submitted for future presentation
at upcoming scientific meetings and in peer-reviewed
publications.
About CAPTAIN
CAPTAIN (Clinical
study of Asthma Patients receiving Triple therapy through A single
INhaler) is a randomised, double-blind, active controlled, six-arm
parallel group, global multicentre study evaluating FF/UMEC/VI
(100/31.25/25, 100/62.5/25, 200/31.25/25 and 200/62.5/25 mcg)
versus FF/VI (100/25 and 200/25 mcg) given once-daily to patients
whose asthma is inadequately controlled despite treatment with
ICS/LABA (>250mcg/day fluticasone propionate, or equivalent)
maintenance asthma medication. In the study 2,436 patients were
treated across 15 countries with approximately 400 patients
randomly assigned to each of the six treatment
arms.
CAPTAIN evaluated as its primary endpoint the change from baseline
in trough Forced Expiratory Volume in 1 second
(FEV1)
at 24 weeks of treatment. The key secondary endpoint was the
annualised rate of moderate/severe asthma
exacerbations.
About Trelegy Ellipta (FF/UMEC/VI)
Trelegy Ellipta is a combination of three molecules in a single
inhaler. It contains fluticasone furoate, an inhaled
corticosteroid, umeclidinium, a long-acting muscarinic antagonist;
and vilanterol, a long-acting beta agonist, delivered in GSK's
Ellipta dry powder inhaler. FF/UMEC/VI 100/62.5/25 has been
approved under the brand name Trelegy Ellipta since 2017 for use in
chronic obstructive pulmonary disease (COPD).
Trelegy Ellipta is indicated in the US for the long-term,
once-daily, maintenance treatment of airflow obstruction in
patients with COPD, including chronic bronchitis and/or emphysema.
Trelegy Ellipta is also indicated to reduce exacerbations of COPD
in patients with a history of exacerbations.
Trelegy Ellipta is not approved for the relief of acute
bronchospasm or the treatment of asthma anywhere in the
world.
Full US Prescribing Information, including Patient Information is
available at:
https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Trelegy/pdf/TRELEGY-PI-MG-IFU.PDF
Important Safety Information (ISI)
The following ISI is based on the Highlights section of the US
Prescribing Information for Trelegy Ellipta. Please consult the
full Prescribing Information for all the labelled safety
information.
Trelegy Ellipta is NOT indicated for the relief of acute
bronchospasm or for the treatment of asthma.
Trelegy Ellipta is contraindicated in patients with severe
hypersensitivity to milk proteins or any of the
ingredients.
LABA monotherapy increases the risk of serious asthma-related
events.
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
patents for decrease in bone mineral density initially and
periodically thereafter after prescribing Trelegy
Ellipta.
Consider
referral to an ophthalmologist in patients who develop ocular
symptoms or use Trelegy Ellipta long term. 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 upper respiratory tract infection,
pneumonia, bronchitis, oral candidiasis, headache, back pain,
arthralgia, influenza, sinusitis, pharyngitis, rhinitis, dysgeusia,
constipation, urinary tract infection, diarrhea, gastroenteritis,
oropharyngeal pain, cough, and dysphonia.
About asthma
Asthma is a chronic lung disease that inflames and narrows the
airways. Asthma affects 358 million people worldwide. Despite
medical advances, more than half of patients continue to experience
poor control and significant symptoms. At least 30% of patients
adherent to ICS/LABA therapy remain uncontrolled which can
negatively impact their lives.
The causes of asthma are not completely understood but likely
involve an interaction between a person's genetic make-up and the
environment. Key risk factors are inhaled substances that provoke
allergic reactions or irritate the airways.
GSK's commitment to respiratory disease
For 50 years, GSK has led the way in developing medicines that
advance the management of asthma and COPD. From introducing the
world's first selective short-acting beta agonist in 1969, to
launching six treatments in five years to create today's
industry-leading respiratory portfolio, we continue to innovate so
we can reach the right patients, with the right treatment. Working
together with the healthcare community, we apply world-class
science to discover and understand the molecules that become the
medicines of tomorrow. We won't stand still until the simple act of
breathing is made easier for everyone.
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 royalty
management. 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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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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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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James
Dodwell
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+44 (0)
20 8047 2406
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(London)
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Danielle
Smith
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+44 (0)
20 8047 7562
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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
and Media:
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Dan
Zacchei / Alex Kovtun
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+1
(212) 446 9500
dzacchei@sloanepr.com /
akovtun@sloaneprr.com
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(California)
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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 2018.
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, 2018, 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, 2019, 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)
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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: May
02, 2019
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By:/s/ 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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