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 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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GSK enquiries:UK Media enquiries:Simon Steel, +44 (0) 20
8047 5502, (London)David Daley, +44 (0) 20 8047 5502, (London)Sarah
Macleod, +44 (0) 20 8047 5502, (London)orUS Media enquiries:Sarah
Alspach, +1-202-715-1048, (Washington, DC)Sarah Spencer,
+1-215-751-3335, (Philadelphia)Karen Hagens, +1-919-483-2863,
(North Carolina)orAnalyst/Investor enquiries:Tom Curry,
+1-215-751-5419, (Philadelphia)Gary Davies, +44 (0) 20 8047 5503,
(London)James Dodwell, +44 (0) 20 8047 2406, (London)Jeff
McLaughlin, +1-215-751-7002, (Philadelphia)orInnoviva, Inc.
enquiries:Investor Relations:Eric d’Esparbes,
+1-650-238-9605investor.relations@inva.com(Brisbane, Calif.)
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