LONDON, June 2, 2016 /PRNewswire/ -- GlaxoSmithKline plc
(LSE: GSK) and Innoviva, Inc. (Nasdaq: INVA) today announced that,
following discussions with the US Food and Drug Administration
(FDA), GSK has brought forward the plan to file a New Drug
Application (NDA) in the US for the once-daily closed triple
combination therapy, fluticasone furoate/umeclidinium/vilanterol
(FF/UMEC/VI; a combination inhaled corticosteroid, longacting
muscarinic antagonist, long-acting beta agonist) for patients with
chronic obstructive pulmonary disease (COPD). The US regulatory
submission is now anticipated by the end of 2016, rather than the
first half of 2018, as previously expected.
The NDA for the closed triple combination therapy will comprise
data now in hand from the closed triple combination therapy
development programme, as well as data from studies with FF, UMEC
and VI either alone or in combination.
The companies continue to expect an EU regulatory submission of
the closed triple combination therapy for COPD by the end of
2016.
About closed triple therapy
The closed triple therapy
is a combination of three molecules: fluticasone furoate (FF), an
inhaled corticosteroid (ICS), umeclidinium (UMEC), an
anti-cholinergic, also known as a long-acting muscarinic antagonist
(LAMA) and vilanterol (VI), a long-acting
beta2-adrenergic agonist (LABA) delivered once-daily in
GSK's Ellipta® dry powder inhaler.
About the ongoing clinical programme in COPD
The
ongoing clinical programme in patients with COPD comprises two
studies investigating the effectiveness and safety of closed triple
therapy compared to existing COPD treatments.
- The FULFIL (Lung FUnction and quality of LiFe assessment
in COPD with closed trIpLe therapy) study, which began in 2015 and
is expected to read out later in 2016 to support EU filing, is
assessing whether the closed triple therapy can improve lung
function and health-related quality of life compared with
Symbicort® (budesonide/formoterol), a twice-daily
ICS/LABA combination delivered via the Turbohaler®
inhaler.
- The IMPACT (InforMing the PAthway of COPD Treatment)
study, which began in 2014 and is expected to read out in 2017, is
investigating whether FF/UMEC/VI can reduce the rate of
exacerbations compared with two, once-daily dual therapies from
GSK's existing portfolio: FF/VI, an ICS/LABA combination and
UMEC/VI, a LAMA/LABA combination.
The closed triple combination of FF/UMEC/VI is not approved for
use anywhere in the world.
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.
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.
RELVAR®, BREO®, ANORO® and ELLIPTA® are trademarks of the
GlaxoSmithKline group of companies. SYMBICORT® and TURBOHALER® are
trademarks of AstraZeneca.
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GSK
enquiries:
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UK Media
enquiries:
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David
Mawdsley
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+44 (0) 20 8047 5502
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(London)
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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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Ziba Shamsi
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+44 (0) 20 8047 5543
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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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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
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South San Francisco,
CA
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investor.relations@inva.com
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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. Such
forward-looking statements involve substantial risks, uncertainties
and assumptions. Examples of such statements include statements
relating to: the development, regulatory and commercial plans for
closed triple combination therapy, the commercialization of
RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA® in the jurisdictions in
which these products have been approved; the strategies, plans and
objectives of the company
(including the company's growth strategy and corporate
development initiatives beyond the existing respiratory portfolio);
the timing, manner, amount and planned growth of anticipated
potential capital returns to stockholders (including, without
limitation, statements regarding the company's expectations of
future share purchases and future cash dividends); the status and
timing of clinical studies, data analysis and communication of
results; the potential benefits and mechanisms of action of product
candidates; expectations for product candidates through development
and commercialization; the timing of regulatory approval of product
candidates; projections of revenue, expenses and other financial
items; and risks related to the implementation of our share
repurchase program as currently contemplated. 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 include, among others, risks related to: lower than
expected future royalty revenue from respiratory products partnered
with GSK, delays or difficulties in commencing or completing
clinical studies, the potential that results from clinical or
non-clinical studies indicate product candidates are unsafe or
ineffective, dependence on third parties to conduct its clinical
studies, delays or failure to achieve and maintain regulatory
approvals for product candidates, and risks of collaborating with
third parties to discover, develop and commercialize products.
Other risks affecting Innoviva 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 March 31, 2016, which are on file with the
Securities and Exchange Commission (SEC) and available on the SEC's
website at www.sec.gov. Additional information will also be
set forth in those sections of Innoviva's Quarterly Report on Form
10-Q for the quarter ended June 30,
2016, which will be filed with the SEC in the third quarter
of 2016. 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. Innoviva
assumes no obligation to update its forward-looking statements on
account of new information, future events or otherwise, except as
required by law.
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Registered Office: 980
Great West Road
Brentford, Middlesex
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SOURCE GlaxoSmithKline plc