TOKYO, July 27, 2013 /CNW/ -
QVA149 (indacaterol/glycopyrronium) is the first once-daily fixed-dose
combination of both a LABA and a LAMA bronchodilator to gain positive
Pivotal Phase III IGNITE data showed QVA149 significantly improved lung
function and patient-reported outcomes including breathlessness and
rescue medication use, compared to current standard of care
QVA149 demonstrated significantly reduced rates of COPD exacerbations
and improved health-related quality of life compared to open-label
tiotropium 18 mcg and glycopyrronium 50 mcg,
Sosei Group Corporation ("Sosei"; TSE Mothers Index: 4565) confirms the
information released by Novartis that the European Medicines Agency's
Committee for Medicinal Products for Human Use (CHMP) has adopted a
positive opinion for approval of once-daily Ultibro® Breezhaler®(indacaterol 85 mcg/glycopyrronium 43 mcg delivered dose, equivalent to
110 mcg/50 mcg metered dose per capsule), as a maintenance
bronchodilator treatment to relieve symptoms in adult patients with
chronic obstructive pulmonary disease (COPD). Ultibro Breezhaler was
developed under the name of QVA149.
QVA149 is an investigational fixed dose combination of two
bronchodilators, indacaterol, a long-acting beta2-adrenergic agonist (LABA) and glycopyrronium, a long-acting muscarinic
QVA149 significantly improved the rate of all exacerbations compared to
open-label (OL) tiotropium 18 mcg, glycopyrronium 50 mcg. The rate of moderate or severe exacerbations was significantly lower
compared to glycopyrronium 50 mcg and numerically lower compared to OL
tiotropium 18 mcg,.
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,,.
The European Commission generally follows the recommendations of the
CHMP and normally grants a marketing authorization within three months
of the opinion. Worldwide submissions and reviews of QVA149 are ongoing
with US filing expected at the end of 2014.
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, fixed-dose combination 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,-. The first eight studies (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK,
BLAZE, ARISE, BEACON) completed in 2012. The studies were 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 five of the Phase III IGNITE trials,-supported the CHMP's positive opinion for QVA149 which demonstrated
statistically significant improvements in bronchodilation versus
treatments widely used as current standards of care. 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, along with
symptomatic improvements,,,. These symptomatic improvements included breathlessness, exercise
tolerance, rescue medication use and health-related quality of life-.
*Total refers to all 11 IGNITE studies.
About Seebri® Breezhaler®
NVA237 (glycopyrronium bromide; brand name: Seebri® Breezhaler® (EU), Seebri® Inhalation Capsules (Japan); ("glycopyrronium")) 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. Glycopyrronium was exclusively licensed to Novartis in April 2005 by
Sosei and its co-development partner Vectura. In Phase III studies
(GLOW 1, 2 and 3) glycopyrronium demonstrated rapid improvements in
lung function after first dose on Day 1 which was sustained for 24
hours and maintained over the 52 week study period compared with
placebo. Glycopyrronium 50 mcg also significantly improved shortness of
breath, health-related quality of life, exacerbation risk, and exercise
endurance versus placebo-. Glycopyrronium is approved in the EU, Japan, Switzerland, Canada,
Australia and a number of other countries.
All Novartis inhaled COPD portfolio products are being developed 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 airflow limitation. The Breezhaler® device allows patients to hear, feel and see that they have taken the
full dose correctly.
Seebri®, Ultibro® and Breezhaler® are registered trademarks of Novartis.
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,. It affects an estimated 210 million people worldwide and is projected
to be the third leading cause of death by 2020,. 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.
Sosei is an international biopharmaceutical company anchored in Japan
with a global reach. It practises a reduced risk business model by
acquiring compounds from, and bringing compounds into, Japan through
exploitation of its unique position within global markets.
For further information about Sosei, please visit http://www.sosei.com.
This press release contains forward-looking statements, including
statements about the discovery, development and commercialisation of
products. Various risks may cause Sosei's actual results to differ
materially from those expressed or implied by the forward-looking
statements, including: adverse results in clinical development
programmes; failure to obtain patent protection for inventions;
commercial limitations imposed by patents owned or controlled by third
parties; dependence upon strategic alliance partners to develop and commercialise
products and services; difficulties or delays in obtaining regulatory
approvals to market products and services resulting from development
efforts; the requirement for substantial funding to conduct research
and development and to expand commercialisation activities; and product
initiatives by competitors. As a result of these factors, prospective
investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise
any forward-looking statements, whether as a result of new information,
future events or otherwise.
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function and clinical outcomes versus placebo, indacaterol,
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SOURCE: Sosei Group Corporation
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