Marks first approval for glycopyrronium bromide in COPD, with approval
also expected in the EU in 2012
Approval triggers $2.5m milestone payment to Sosei
Seebri® Inhalation Capsules 50 mcg approved as maintenance COPD treatment will
be available to patients and physicians in Japan by year-end
GLOW trials showed Seebri® Inhalation Capsules improved lung function, reduced shortness of
breath, reduced exacerbations, and improved quality of life up to 52
weeks versus placebo-
GLOW2 study showed Seebri® Inhalation Capsules provided 24-hour bronchodilation and is superior to
placebo and similar to open-label tiotropium in improving lung function
TOKYO, Sept. 28, 2012 /CNW/ - Sosei Group Corporation ("Sosei"; TSE
Mothers Index: 4565) confirms the information released today by
Novartis that the Japanese Ministry of Health, Labor and Welfare (MHLW)
has approved Seebri® (glycopyrronium bromide) Inhalation Capsules 50 mcg administered
through the Breezhaler® device, as a once-daily, long-term, inhaled maintenance bronchodilator
treatment for the relief of various symptoms due to airway obstructive
disease in chronic obstructive pulmonary disease (chronic bronchitis
and emphysema). This marks the first approval for glycopyrronium, with
approval also expected in the EU in 2012, and triggers a $2.5m
milestone payment to Sosei.
The MHLW approved Seebri® Inhalation Capsules based on data from the Novartis Phase III GLOW
trials which demonstrated the safety and efficacy of glycopyrronium 50
mcg and involved 2,159 COPD patients from Japan and around the world
who required maintenance treatment-.
The GLOW trials showed that glycopyrronium, when compared to placebo,
significantly improved lung function over the first four hours after
morning dosing and that this benefit was sustained for 24 hours over a
52-week period. Patients on glycopyrronium demonstrated improved lung function,
reduced shortness of breath, reduced exacerbations, reduced use of
rescue medication, and improved quality of life compared to placebo-.
GLOW1 was a 26-week, randomized, double-blind, placebo-controlled study.
The study demonstrated the clinically significant superiority of
glycopyrronium versus placebo for lung function improvements at 12
weeks (primary endpoint) measured by trough FEV1 (p0.01).
GLOW2 demonstrated a similar magnitude of effect and also showed that
glycopyrronium 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, glycopyrronium 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
(HRQL), as measured by the Transition Dyspnea Index (TDI) and St.
George's Respiratory Questionnaire (SGRQ) compared to placebo, were
also demonstrated. GLOW2 was a 52-week, randomized, double-blind,
placebo-controlled study with OL tiotropium 18 mcg as an active
The GLOW3 study showed that after glycopyrronium was administered in the
morning, patients experienced improved exercise tolerance from the
first dose onward. Overall, patients treated with glycopyrronium
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 p0.001).
GLOW4 was a 52-week study in a Japanese population that examined the
safety profile of glycopyrronium using OL tiotropium 18 mcg
administered in the Handihaler® device as an active control. The data from this study showed that
glycopyrronium had a similar safety profile to OL tiotropium. In all studies, glycopyrronium was shown to have an overall safety
profile similar to placebo.
CEO of Sosei, Shinichi Tamura commented:
"We are delighted with the MHLW approval of Seebri Inhalation Capsules
which marks an important milestone in the evolution of the Sosei
business. The latest Global Initiative for Chronic Obstructive Lung Disease (GOLD)
guidelines recommend long-acting muscarinic antagonists as first-line
therapy for a broad range of COPD patients with moderate to very severe
symptoms. Seebri Inhalation Capsules will provide an important
once-daily treatment option for this serious disease."
Notes for editors
AboutSeebri® (glycopyrronium bromide)
Seebri® (glycopyrronium bromide) Inhalation Capsules is a long acting
muscarinic antagonist (LAMA) developed as a once-daily inhaled
maintenance therapy for the treatment of COPD. Glycopyrronium bromide
was exclusively licensed to Novartis in April 2005 by Sosei and its
co-development partner Vectura. Phase III data from the GLOW 1, 2, 3
and 4 studies demonstrate that glycopyrronium increased patients' lung
function over a 24-hour period compared to placebo with a fast onset of
action at first dose, and improved exercise endurance versus placebo-. In June 2012, the European Medicines Agency's Committee for Medicinal
Products for Human Use (CHMP) adopted a positive opinion for the
approval of Seebri® Breezhaler® in Europe, which applies to all 27 EU member states, plus Iceland and
Norway. The US filing for glycopyrronium bromide is expected in 2014.
QVA149 is an investigational inhaled, once-daily, fixed-dose combination
of indacaterol maleate and glycopyrronium bromide delivered through the
Breezhaler® device. QVA149 is being investigated for the maintenance treatment of
COPD in the Phase III IGNITE clinical trial program. IGNITE is one of
the largest international clinical trial programs in COPD comprising 10
studies in total with more than 7,000 patients across 42 countries-. The first five studies (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK)
have already completed in 2012 with three additional studies (BLAZE,
ARISE, BEACON) expected to complete by the end of the year. The studies
are designed to investigate efficacy, safety and tolerability, lung
function, exercise endurance, exacerbations, breathlessness and quality
of life. Initial filings for regulatory approval are expected in Q4
2012 for Europe and Japan. US filing is expected at the end of 2014.
All Novartis inhaled COPD portfolio products are being developed for
delivery via the Breezhaler® device, a single-dose dry powder inhaler (SDDPI), which has low air
flow resistance, making it suitable for patients with airflow
limitation, such as COPD patients. The Breezhaler® device allows patients to hear, feel and see that they have taken the
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.
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SOURCE: Sosei Group Corporation
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