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 21 November 2016
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:
Monday, 21 November 2016, London UK - LSE Announcement
GSK files regulatory submission in US for once-daily closed triple
combination therapy FF/UMEC/VI for patients with COPD
GlaxoSmithKline
plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today
announced the filing by GSK of a regulatory submission with the US
Food and Drug Administration for the once-daily, closed triple
combination therapy fluticasone furoate/umeclidinium/vilanterol
(FF/UMEC/VI 100/62.5/25 mcg) for patients with chronic obstructive
pulmonary disease (COPD). This follows the announcement earlier
this year of plans to bring forward the timing of the US filing
from the first half of 2018.
The
closed triple combination therapy comprises three medicines:
fluticasone furoate, an inhaled corticosteroid (ICS), umeclidinium,
a long-acting muscarinic antagonist (LAMA) and vilanterol, a
long-acting beta2-adrenergic
agonist (LABA), delivered once-daily in GSK's Ellipta® dry powder
inhaler.
The US
regulatory submission of the closed triple therapy comprises a New
Drug Application for the maintenance treatment of patients with
COPD, including chronic bronchitis and emphysema. It is based on
data from the closed triple combination therapy development
programme, as well as data from studies with FF, UMEC and VI either
alone or in combination.
Dave
Allen, Head of Respiratory R&D, said, "COPD is a progressive
disease and its impact on patients can worsen over time. As
reflected in the recently updated GOLD COPD Strategy*, for those
patients with advanced disease, multiple therapies such as
ICS/LAMA/LABA combinations are often required and are typically
delivered via two or more inhalers with potentially differing dose
regimens. This first regulatory submission of our closed triple
therapy brings us a step closer to providing a once-daily treatment
in a single Ellipta inhaler as an alternative option for those
patients who require multiple therapies."
Mike
Aguiar, CEO of Innoviva, Inc., added "We are delighted that the US
submission has been achieved some 18 months earlier than planned.
If approved, FF/UMEC/VI as a once daily triple combination in a
single inhaler could be a meaningful addition to the treatment
options available for advanced COPD patients."
A
regulatory filing in the EU is planned in the coming weeks and is
expected to be followed by submissions in other countries beginning
in 2017. The closed triple combination of FF/UMEC/VI is not
approved for use anywhere in the world.
*The Global Strategy for the
Diagnosis, Management and Prevention of COPD, Global Initiative for
Chronic Obstructive Lung Disease (GOLD) 2017. Available
from: http://goldcopd.org.
Accessed: November 2016
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. COPD is thought to affect
329 million people worldwide.
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.
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®
and, if approved and
commercialized, VI monotherapy, as well. 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 - 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.
RELVAR®,
BREO®,
ANORO®
and ELLIPTA®
are trademarks of the GlaxoSmithKline
group of companies.
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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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Sarah
Macleod
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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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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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GSK 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 'Risk factors' in the company's Annual Report on Form 20-F for
2015.
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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, 2015 and Quarterly Report on Form 10-Q for the
quarter ended September 30, 2016, 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).
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Registered in England & Wales:
No. 3888792
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Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
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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.
GlaxoSmithKline plc
(Registrant)
Date: November
21, 2016
By: VICTORIA
WHYTE
----------------------
Victoria Whyte
Authorised
Signatory for and on
behalf
of GlaxoSmithKline plc