GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ:
INVA) today announced the filing by GSK of a regulatory submission
with the European Medicines Agency for 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 of the
submission of a New Drug Application for FF/UMEC/VI in the US in
November 2016.
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 EU regulatory submission of closed triple therapy comprises
a Marketing Authorisation Application for a maintenance treatment
to relieve symptoms of adult patients with COPD. It is based on
data from the closed triple combination therapy development
programme including data from the phase III FULFIL study, as well
as data from studies with FF, UMEC and VI either alone or in
combination.
Dave Allen, Head, Respiratory Therapy Area Unit, R&D, said,
“Many patients with COPD are already at an advanced stage when they
are diagnosed. Prescribing patterns show the importance of having a
range of options available to meet the differing needs of
individual patients. An approval of our closed triple therapy in
Europe would complement our portfolio of inhaled therapies designed
for once-daily dosing in a single inhaler, offering patients a
convenient, alternative option.”
Mike Aguiar, CEO of Innoviva, Inc., added, “The EU filing of the
closed triple combination is the latest development in our
long-standing collaboration with GSK. If approved, FF/UMEC/VI as
once daily triple combination in a single inhaler could be a
meaningful addition to the treatment options available for advanced
COPD patients.”
Regulatory submissions of closed triple therapy for COPD are
anticipated in the rest of the world beginning in 2017. The closed
triple combination of FF/UMEC/VI is not approved for use anywhere
in the world.
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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