LONDON, Nov. 21, 2016
/PRNewswire/ -- 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.
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
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 'Risk factors' in the company's Annual Report on Form 20-F for
2015.
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).
Registered in England &
Wales:
No. 3888792
Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
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SOURCE GlaxoSmithKline plc