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 15
September 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
--
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:
15 September 2017, London UK - LSE Announcement
Trelegy Ellipta once-daily single inhaler triple therapy receives
positive opinion from the CHMP in Europe for appropriate patients
with COPD
GlaxoSmithKline
plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today
announced that the European
Medicines Agency's (EMA) Committee for Medicinal Products for Human
Use (CHMP) has
issued a positive opinion recommending marketing authorisation
for fluticasone
furoate/ umeclidinium/vilanterol (FF/UMEC/VI) 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 (for effects on symptom control see
section 5.1). The
proposed brand name is Trelegy
Ellipta.
Trelegy
Ellipta is a combination of an inhaled corticosteroid (ICS),
a long-acting
muscarinic antagonist (LAMA) and a long-acting
beta2-adrenergic agonist (LABA), delivered once daily in GSK's
Ellipta dry powder inhaler. It is the first once-daily single
inhaler triple therapy to be granted a positive opinion by the
CHMP. The proposed strength is FF/UMEC/VI 100/62.5/25
mcg.
Patrick Vallance, GSK's President, R&D, said, "
We
believe once-daily single inhaler triple therapy, if approved,
would provide an important option for appropriate patients with
COPD who are receiving ICS/LABA and require additional
bronchodilation, avoiding the need for multiple
inhalers."
Mike
Aguiar, CEO of Innoviva, Inc .
said, "This positive
opinion will lead to a significant therapeutic convenience for
those appropriate patients already on ICS/LABA treatment that
require additional bronchodilation. Trelegy is the latest
development in our collaboration with GSK and is testament to our
ongoing efforts to advance respiratory medicine."
A CHMP positive opinion is one of the final steps before marketing
authorisation is granted by the European Commission. A final
decision by the European Commission is anticipated by around the
end of 2017.
Regulatory
applications have been submitted and are undergoing assessment in a
number of other countries, including the US, Australia and Canada.
FF/UMEC/VI is an investigational medicine not yet approved for use
as a single inhaler triple therapy anywhere in the world. The
proposed trade name 'Trelegy Ellipta' is subject to regulatory
approval.
About COPD
COPD is a common but serious lung disease that is thought to affect
around 384 million people worldwide.1
For people living with COPD, the inability to breathe normally can
consume their daily lives and make simple activities, like walking
up stairs, an everyday struggle.
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.2
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.
About the once-daily single inhaler triple therapy clinical
programme in COPD supporting the European Marketing Authorisation
Application
The
European Marketing Authorisation Application for
Trelegy
Ellipta is supported by efficacy and safety data from the
FF/UMEC/VI development programme, as well as data from studies with
the components either alone, or in combination. Positive top-line
results of the phase 3 FULFIL
(Lung
FU
nction
and quality of L
i
F
e
assessment in COPD with closed trIpLe
therapy) study which investigated once-daily single inhaler triple
therapy compared to twice-daily budesonide/formoterol were
announced
in June
2016 and published
in 2017
(Lipson DA
et al . Am J Resp Crit
Care Med 2017).
Important Safety Information for FF/UMEC/VI in the EU
The
following Important Safety Information is based on a summary of the
Summary of Product Characteristics for Trelegy Ellipta
(FF/UMEC/VI). Please consult the full Summary of Product
Characteristics for all the safety information.
FF/UMEC/VI
is contraindicated in patients with hypersensitivity to either
fluticasone furoate (FF), umeclidinium (UMEC), vilanterol (VI) or
any of the excipients.
FF/UMEC/VI
should not be used in patients with asthma since it has not been
studied in this patient population. FF/UMEC/VI is not indicated for
the treatment of acute episodes of bronchospasm.
In the
event of deterioration of COPD during treatment with FF/UMEC/VI, a
re-evaluation of the patient and of the COPD treatment regimen
should be undertaken.
Administration
of FF/UMEC/VI may produce paradoxical bronchospasm that may be
life-threatening. Cardiovascular
effects, such as cardiac arrhythmias e.g. atrial fibrillation and
tachycardia, may be seen after the administration of muscarinic
receptor antagonists and sympathomimetics, including FF/UMEC/VI.
Therefore, FF/UMEC/VI should be used with caution in patients with
unstable or life-threatening cardiovascular disease.
Systemic
steroids effects may occur with any inhaled corticosteroid (ICS),
particularly at high doses prescribed for long periods. These
effects are much less likely to occur than with oral
corticosteroids. Patients with moderate to severe hepatic
impairment receiving FF/UMEC/VI should be monitored for systemic
corticosteroid-related adverse reactions.
If a
patient presents with symptoms such as blurred vision or other
visual disturbances, the patient should be considered for referral
to an ophthalmologist for evaluation of possible causes which may
include cataract, glaucoma or rare diseases such as central serous
chorioretinopathy (CSCR) which have been reported after use of
systemic and topical corticosteroids.
FF/UMEC/VI
should be used with caution in patients with convulsive disorders
or thyrotoxicosis, in patients who are unusually responsive to
beta2-adrenergic
agonists and in patients with pulmonary tuberculosis or in patients
with chronic or untreated infection.
Consistent
with its antimuscarinic activity, FF/UMEC/VI should be used with
caution in patients with urinary retention or with narrow-angle
glaucoma.
An
increase in the incidence of pneumonia, including pneumonia
requiring hospitalisation, has been observed in patients with COPD
receiving ICS. There is some evidence of an increased risk of
pneumonia with increasing steroid dose but this has not been
demonstrated conclusively across all studies. There is no
conclusive clinical evidence for intra-class differences in the
magnitude of the pneumonia risk among ICS products.
Beta2-adrenergic
agonists may produce significant hypokalaemia in some patients,
which has the potential to produce adverse cardiovascular effects.
The decrease in serum potassium is usually transient, not requiring
supplementation. No clinically relevant effects of hypokalaemia
were observed in clinical studies with FF/UMEC/VI at the
recommended therapeutic dose. Caution should be exercised when
FF/UMEC/VI is used with other medicinal products that also have the
potential to cause hypokalaemia.
Beta2-adrenergic
agonists may produce transient hyperglycemia in some patients. No
clinically relevant effects on plasma glucose were observed in
clinical studies with FF/UMEC/VI at the recommended therapeutic
dose. Upon initiation of treatment with FF/UMEC/VI, plasma glucose
should be monitored more closely in diabetic patients.
This
medicinal product contains lactose. Patients with rare hereditary
problems of galactose intolerance, the Lapp lactase deficiency or
glucose-galactose malabsorption should not take
FF/UMEC/VI.
The
most frequently reported adverse reactions with FF/UMEC/VI were
nasopharyngitis (7%), headache (5%) and upper respiratory tract
infection (2%). Other common adverse reactions (reported with a
frequency of ≥1/100 to <1/10) include: pneumonia,
pharyngitis, rhinitis, influenza, cough, arthralgia and back
pain.
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.
Trade marks are owned by or licensed to the GSK group of
companies.
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
.
GSK enquiries:
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UK
Media enquiries:
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Simon
Steel
|
+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
|
+1 919
483 2863
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(North
Carolina)
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Juan
Carlos Molina
|
+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:
|
Sarah
Elton-Farr
|
+44 (0)
20 8047 5194
|
(London)
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Tom
Curry
|
+ 1 215
751 5419
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(Philadelphia)
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Gary
Davies
|
+44 (0)
20 8047 5503
|
(London)
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James
Dodwell
|
+44 (0)
20 8047 2406
|
(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
|
+1
(650) 238-9605
|
(Brisbane,
Calif.)
|
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
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References (accessed September 2017)
1.
Global Initiative for Chronic Obstructive Lung Disease Global
Initiative for Chronic Obstructive Lung Disease. 2017. Pocket guide
to COPD diagnosis, management, and prevention. Available at:
http://goldcopd.org/wp-content/uploads/2016/12/wms-GOLD-2017-Pocket-Guide.pdf
2.
Diagnosis of COPD. World Health Organisation. 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: September
15, 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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