LONDON & BRISBANE, Calif.--(BUSINESS WIRE)--
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
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.
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).
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Source: Innoviva, Inc.
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