Novartis data presented at ERS showcases once-daily COPD portfolio and further demonstrates efficacy of Ultibro® Breezhaler® (QVA149)
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Novartis International AG /
Novartis data presented at ERS showcases once-daily COPD portfolio and further
demonstrates efficacy of Ultibro® Breezhaler® (QVA149)
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The issuer is solely responsible for the content of this announcement.
* New analyses in the IGNITE clinical trial program showed that QVA149
provided superior, rapid and sustained improvements in lung function and
significantly reduced shortness of breath versus comparator therapies[1],[2]
* BLAZE study also demonstrated significant improvements in shortness of
breath with QVA149 compared to tiotropium 18 mcg in patients with moderate-
to-severe COPD[3]
* SPARK study showed similar rates of reduction in exacerbations with once-
daily Seebri(®) Breezhaler(®) (glycopyrronium bromide) and open-label
tiotropium 18 mcg in patients with severe-to-very severe COPD[4],[5]
Basel, September 8, 2013 - Novartis announced today new analyses of data for
once-daily Ultibro(®) Breezhaler(® )(investigational QVA149 - indacaterol 85
mcg/glycopyrronium 43 mcg delivered dose, equivalent to 110 mcg/50 mcg metered
dose per capsule), which showed significant improvements in lung function,
shortness of breath and health-related quality of life for chronic obstructive
pulmonary disease (COPD) patients versus all comparators[1],[2].These data were
part of 39 respiratory abstracts presented at the European Respiratory Society
(ERS) Annual Congress in Barcelona, Spain.
First results from a pooled analysis of 4,891 COPD patients in the IGNITE
clinical trial program (SHINE, ILLUMINATE and SPARK studies) showed that QVA149
provided superior, rapid and sustained improvements in lung function, and
significantly reduced shortness of breath, compared to placebo, once-daily
indacaterol maleate 150 mcg, glycopyrronium 50 mcg, open-label (OL) tiotropium
18 mcg and twice-daily salmeterol/fluticasone fixed dose combination (FDC SFC)
50 mcg/500 mcg[1],[2]. These improvements were maintained throughout the
duration of the trials[1],[2].
"COPD is known to affect an estimated 210 million people worldwide[6] and is
projected to be the third leading cause of death by 2020[7].Many patients find
COPD symptoms really tough to cope with - even if they're already taking
treatment," said Tim Wright, Head of Development, Novartis Pharmaceuticals.
"Novartis is pleased that these new analyses further support that the efficacy
of dual therapy, which has the potential to make a real difference to peoples'
lives."
Currently being assessed in a clinical trial program involving over 10,000
patients[8]-[18], investigational QVA149 is a Fixed-Dose Combination (FDC) of
two bronchodilators, Onbrez(®) Breezhaler(®) (indacaterol maleate), a long-
acting beta(2)-adrenergic agonist (LABA) and Seebri(®) Breezhaler(®)
(glycopyrronium bromide), a long-acting muscarinic antagonist (LAMA). Both are
currently used by healthcare professionals as individual therapies to treat
COPD.
QVA149 recentlyreceived a positive opinion for approval from the European
Medicine Agency's (EMA) Committee for the Human use of Medicinal Products (CHMP)
in July 2013 as a maintenance bronchodilator treatment to relieve symptoms in
adult patients with COPD.
About additional data presented at ERS
A new evaluation of patients with moderate-to-severe COPD from the BLAZE study
showed that QVA149 provided significant improvements in patient-reported
shortness of breath compared to tiotropium 18 mcg[3].
Clinical data for Seebri(®) Breezhaler(®) (glycopyrronium bromide) presented at
ERS included efficacy and safety results from the SPARK study[4],[5]. At Week
64, once-daily glycopyrronium 50 mcg showed similar efficacy to OL tiotropium
18 mcg in reducing the rate of exacerbations, improving lung function and
health-related quality of life, and reducing rescue medication use in patients
with severe-to-very severe COPD[4].
In analyses from the SPARK study, glycopyrronium 50 mcg (via Breezhaler(®))
showed a safety profile in patients with severe-to-very severe COPD that was
similar to OL tiotropium 18 mcg (via HandiHaler(®))[5].
These results build upon the data previously presented from the glycopyrronium
bromide Phase III GLOW trials and provide further evidence for Seebri(®)
Breezhaler(®) as a once-daily LAMA option for COPD patients.
About the IGNITE clinical trial program
In the Phase III IGNITE clinical trial program, QVA149 is being investigated for
the treatment of COPD patients as an inhaled, once-daily, FDC of indacaterol
maleate and glycopyrronium bromide. IGNITE is one of the largest international
clinical trial programs in COPD comprising 11 studies in total (ILLUMINATE,
SHINE, BRIGHT, ENLIGHTEN, SPARK, BLAZE, ARISE, BEACON, RADIATE, LANTERN, FLAME)
with more than 10,000* patients across 52 countries[8]-[20]. The first eight
studies (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK, BLAZE, ARISE, BEACON)
completed in 2012. The studies are designed to investigate the efficacy, safety
and tolerability, lung function, exercise endurance, exacerbations, shortness of
breath and quality of life in patients treated with QVA149.
Results from the Phase III IGNITE trials[8]-[18]demonstrated statistically
significant improvements in bronchodilation with QVA149 versus comparator
treatments widely used as current standards of care[21]. Data showed that QVA149
significantly improved bronchodilation compared to OL tiotropium 18 mcg, SFC 50
mcg/500 mcg, indacaterol maleate 150 mcg, glycopyrronium 50 mcg and placebo
providing a rapid onset within five minutes, and sustained bronchodilation
during a 24 hour period which was maintained for up to 26 weeks[22]. In the
IGNITE Phase III trial program, QVA149 also showed symptomatic improvements
versus placebo in COPD patients[8],[9],[11],[21]. These symptomatic improvements
included shortness of breath, exercise tolerance, rescue medication use and
health-related quality of life[8],[9],[11],[21].
In clinical studies, QVA149 demonstrated an acceptable safety profile with no
meaningful differences between the treatment groups (placebo, indacaterol 150
mcg, glycopyrronium 50 mcg, OL tiotropium 18 mcg, SFC 50 mcg/500 mcg) in the
incidence of adverse and serious adverse events[8],[9],[10],[11],[22].
*Total refers to all 11 IGNITE studies.
About the Novartis COPD portfolio
Novartis is committed to addressing the unmet medical needs of COPD patients and
improving their quality of life by providing innovative medicines and devices.
Onbrez(®) Breezhaler(® )(indacaterol maleate) is a long-acting beta(2)-
adrenergic agonist (LABA) that offers clinically relevant 24 hour
bronchodilation combined with a rapid onset of action within five minutes at
first dose, as demonstrated in the INERGIZE Phase III trial program[23]-[27].
Onbrez(®) Breezhaler(®) 150 mcg once-daily provided greater clinical benefit in
terms of reduced shortness of breath, lower use of rescue medication and
improved health status, compared with blinded tiotropium bromide 18 mcg in
patients with moderate-to-severe COPD[34]. Onbrez(®) Breezhaler(®)is approved in
approximately 100 countries around the world for maintenance bronchodilator
treatment of airflow obstruction in adult patients with COPD[38]. It was first
launched in the EU (150 mcg and 300 mcg once-daily doses) and has since received
approvals in markets worldwide including Japan (Onbrez(® )Inhalation Capsules
150 mcg once-daily) and US (Arcapta(TM) Neohaler(TM )75 mcg once-daily).
Once-daily Seebri(®) Breezhaler(®) (glycopyrronium bromide) is a novel inhaled
long-acting muscarinic antagonist (LAMA; also referred to as a long-acting
anticholinergic) indicated as a maintenance bronchodilator treatment to relieve
symptoms in adult patients with COPD[39]. Glycopyrronium bromide was exclusively
licensed to Novartis in April 2005 by Vectura and its co-development partner
Sosei. Phase III data from the GLOW 1, 2 and 3 studies demonstrated that
glycopyrronium 50 mcg delivered rapid and significant sustained improvements in
lung function (measured by mean FEV(1)) from Day 1 compared with placebo and
sustained this for 24 hours over 52 weeks, and significantly improved exercise
endurance versus placebo[40]-[42]. Seebri(®) Breezhaler(®) is approved in the
EU/EEA, Japan, Switzerland, Canada, Australia and a number of other countries.
Novartis continues development of respiratory products for delivery via a
single-dose dry powder inhaler (SDDPI) called the Breezhaler(®) device which has
low air flow resistance, making it suitable for patients with different severity
of airflow limitation[43]. The Breezhaler(®) device allows patients to hear,
feel and see that they have taken the full dose correctly[39].
Novartis is committed to addressing the unmet medical needs of COPD patients and
improving their quality of life by providing innovative medicines and devices.
About COPD
COPD is a progressive life-threatening disease that makes it hard to breathe,
with symptoms that have a destructive impact on patients' function and quality
of life[7],[44]. It affects an estimated 210 million people worldwide[7] and is
projected to be the third leading cause of death by 2020[6]. COPD is often
considered to be a disease of later years, but estimates suggest that 50% of
those with COPD are now less than 65 years old, resulting in increases in
absenteeism, premature retirement and reductions in workforce participation[45].
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "investigational," "projected," "potential," "currently
being assessed," "positive opinion," "committed," "continues development," or
similar expressions, or by express or implied discussions regarding marketing
approvals for Ultibro Breezhaler or other investigational products, or regarding
potential future revenues from such products. You should not place undue
reliance on these statements. Such forward-looking statements reflect the
current views of management regarding future events, and involve known and
unknown risks, uncertainties and other factors that may cause actual results to
be materially different from any future results, performance or achievements
expressed or implied by such statements. There can be no guarantee that Ultibro
Breezhaler will be approved for sale in any market or at any particular time.
Nor can there be any guarantee that any other investigational products will be
submitted or approved for sale in any market or at any particular time. Neither
can there be any guarantee that Ultibro Breezhaler or any other investigational
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particular, management's expectations regarding such products could be affected
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release as a result of new information, future events or otherwise.
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