Once-daily Seebri® Breezhaler® Receives Positive CHMP Opinion to Treat COPD Patients in the EU
TOKYO, June 25, 2012 /PRNewswire/ –
- 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
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(R) Breezhaler(R)
(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 treatments.
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 also demonstrated.
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 (both p<0.001).
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(R) Breezhaler(R) (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(R) Breezhaler(R) (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
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
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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
 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
 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; 08:15-16:30].
 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.
 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
 QVA149 A2303 (SHINE). Data on file, Novartis Pharma AG. ClinicalTrials.gov
 QVA149 A2307 (ENLIGHTEN). Data on file, Novartis Pharma AG. ClinicalTrials.gov
QVA149 2305 (BRIGHT). Data on file, Novartis Pharma AG. ClinicalTrials.gov
 QVA149 2313 (ILLUMINATE). Data on file, Novartis Pharma AG. ClinicalTrials.gov
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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.
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SOURCE Sosei Group Corporation