LONDON, UNITED KINGDOM and SOUTH SAN FRANCISCO, CA--(Marketwired - Jun 2, 2016) - 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, long-acting 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.
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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