COPD patients in Phase III GLOW trials experienced improved lung
function, reduced shortness of breath, reduced exacerbations, and
improved quality of life[1,2,3,4]
GLOW2 study showed Seebri Breezhaler provided 24-hour bronchodilation
and was superior to placebo and similar to open-label tiotropium in
improving lung function
TOKYO, June 25, 2012 /CNW/ - Sosei Group Corporation ("Sosei"; TSE
Mothers Index: 4565) confirms the information released today by
Novartis that the European Medicines Agency's Committee for Medicinal
Products for Human Use (CHMP) has adopted a positive opinion for Seebri® Breezhaler® (glycopyrronium/NVA237) 44 mcg delivered dose (50 mcg glycopyrronium
per capsule), as a once-daily inhaled maintenance bronchodilator
treatment to relieve symptoms in adult patients with chronic
obstructive pulmonary disease (COPD). Seebri Breezhaler is a
long-acting muscarinic antagonist (LAMA), a type of bronchodilator that
is recommended in COPD global treatment strategies as maintenance
therapy administered either alone or in combination with other
Data from three of the Novartis Phase III GLOW trials informed the
CHMP's positive opinion for Seebri Breezhaler and included 1,996 COPD
patients from around the world with many in EU countries[1,2,3,4,6].
GLOW1 demonstrated the clinically significant superiority of Seebri
versus placebo for lung function improvements at 12 weeks measured by
trough FEV1 (p<0.01). GLOW2 demonstrated a similar magnitude of effect and also showed that
Seebri was similar to open-label (OL) tiotropium over 52 weeks measured
by improvements in trough FEV1 compared to placebo. In addition to demonstrating benefits in terms of lung function, Seebri
Breezhaler exhibited a rapid onset of action within five minutes at
first dose and reduced exacerbations. Significant benefits in both breathlessness and health-related quality
of life, as measured by the Transition Dyspnea Index (TDI) and St.
George's Respiratory Questionnaire (SGRQ) compared to placebo, were
The GLOW3 study showed that after Seebri Breezhaler was administered in
the morning, patients experienced improved exercise tolerance from the
first dose onward. Overall, patients treated with Seebri Breezhaler experienced a
significant 21% improvement in exercise endurance versus placebo at the
end of the study (day 21), with a significant 10% increase from day one
In all studies, Seebri Breezhaler was well tolerated with an incidence
of adverse events similar to placebo[1,2,3,4,6].
The European Commission generally follows the recommendations of the
CHMP and usually delivers its final decision within three months of the
CHMP recommendation. Worldwide submissions and reviews of Seebri® Breezhaler® (glycopyrronium bromide/NVA237) are ongoing. The US filing for Seebri
Breezhaler is expected in 2014.
CEO of Sosei, Shinichi Tamura commented:
"This positive opinion for Seebri Breezhaler is a value enhancing
milestone for both Sosei and its co-development partner Vectura. The
drug was developed to Phase II proof-of-principle by the two companies
before being licensed to Novartis and, when approved, will be the
second once-daily inhaled treatment in the LAMA class for COPD
patients. This innovative therapy has the potential to reduce breathlessness,
increase the capacity to exercise and help improve quality of life. We
look forward also to key Phase III QVA149 data with filing in Europe expected in 2012."
Notes for editors:
About Seebri Breezhaler
Seebri® Breezhaler® (glycopyrronium bromide/NVA237) is an investigational LAMA developed as
a once-daily inhaled maintenance therapy for the treatment of COPD.
Glycopyrronium bromide was licensed to Novartis in April 2005 by Sosei
and its co-development partner Vectura. It was submitted for regulatory
approval in Europe in Q3 2011 and Japan in Q4 2011.
In addition to Seebri Breezhaler, also under development is QVA149
(indacaterol maleate 110 mcg/glycopyrronium bromide 50 mcg), an
investigational inhaled, once-daily, fixed dose combination of
glycopyrronium bromide and the LABA indacaterol maleate.
The first four Novartis QVA149 Phase III studies in the treatment of
COPD all met their primary endpoints[7,8,9,10]. The results of the SHINE, BRIGHT, ENLIGHTEN and ILLUMINATE studies,
which are key components of the IGNITE program, demonstrate the
potential of QVA149 in the treatment of COPD[7,8,9,10].
COPD is a progressive disease associated mainly with tobacco smoking,
air pollution or occupational exposure, which can cause obstruction of
airflow in the lungs resulting in debilitating bouts of breathlessness.
It affects an estimated 210 million people worldwide and is predicted to be the third leading cause of death by 2020. Although COPD is often thought of as a disease of the elderly, 50% of
patients are estimated to be within the ages of 50 and 65, which means
that half of the COPD population are likely to be impacted at the peak
of their earning power and family responsibilities.
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.
 D'Urzo A, et al. Efficacy and safety of once-daily NVA237 in patients with
moderate-to-severe COPD: the GLOW1 trial. Respiratory Research 2011,
12:156 (7 December 2011).
 Kerwin E, et al. NVA237 once daily provides rapid and sustained bronchodilation in COPD
patients, with efficacy similar to tiotropium: The GLOW2 trial.
[Abstract A2920: Thematic poster session B41: Monday, 21 May, 2012;
 Korenblat P, et al. NVA237 once daily improves dyspnea and health-related quality of life
in patients with COPD: The GLOW2 trial. [Abstract A2254: Poster
discussion session A101: Sunday, 20 May, 2012; 14:00-16:30].
 Kerwin E, et al. NVA237 once daily reduces COPD exacerbations with similar rates to
tiotropium: The GLOW2 trial. [Abstract A2255: Poster discussion session
A101: Sunday, 20 May, 2012; 14:00-16:30].
 Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global
Strategy for the Diagnosis, Management, and Prevention of Chronic
Obstructive Pulmonary Disease. Updated 2011.
 Beeh K, Drollmann A, Di Scala L, Smith R. Once-daily NVA237 improves
exercise endurance from first dose in patients with COPD: the GLOW3
trial. Eur Respir J 2011;38(Suppl. 55):P4497
 QVA149 A2303 (SHINE). Data on file, Novartis Pharma AG.
ClinicalTrials.gov identifier: NCT01202188.
 QVA149 A2307 (ENLIGHTEN). Data on file, Novartis Pharma AG.
ClinicalTrials.gov identifier: NCT01120717.
 QVA149 2305 (BRIGHT). Data on file, Novartis Pharma AG.
ClinicalTrials.gov identifier: NCT01294787.
 QVA149 2313 (ILLUMINATE). Data on file, Novartis Pharma AG.
ClinicalTrials.gov identifier: NCT01315249.
 Global Alliance Against Chronic Respiratory Diseases (GARD). Global
surveillance, prevention and control of chronic respiratory diseases: a
comprehensive approach. Available at: http://www.who.int/gard/publications/GARD%20Book%202007.pdf Last accessed 22 May 2012.
 Fletcher MJ et al., COPD Uncovered: An International survey on the impact of chronic
obstructive pulmonary disease (COPD) on a working age population. BMC Public Health 2011;11:612.
SOURCE Sosei Group Corporation
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