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Last updated on April 17, 2014 at 17:30 EDT

Seebri® Inhalation Capsules Receive MHLW Approval as Once-daily Maintenance Treatment for COPD in Japan

September 27, 2012

TOKYO, September 28, 2012 /PRNewswire/ –

        - 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(R) 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(R) Inhalation Capsules improved lung function,
          reduced shortness of breath, reduced exacerbations, and improved quality of life up to
          52 weeks versus placebo[1]-[4]
        - GLOW2 study showed Seebri(R) Inhalation Capsules provided 24-hour
          bronchodilation and is superior to placebo and similar to open-label tiotropium in
          improving lung function[2]

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(R) (glycopyrronium bromide) Inhalation Capsules 50 mcg administered
through the Breezhaler(R) 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(R) 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[1]-[4].

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[2]. 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[1]-[4].

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
(p<0.01)[1].

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 exploratory arm[2].

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 p<0.001)[3].

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(R) device as an
active control. The data from this study showed that glycopyrronium had a similar safety
profile to OL tiotropium[4]. In all studies, glycopyrronium was shown to have an overall
safety profile similar to placebo[4].

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(R) (glycopyrronium bromide)

Seebri(R) (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[1]-[4]. 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(R) Breezhaler(R) in Europe, which applies to all 27 EU member states,
plus Iceland and Norway. The US filing for glycopyrronium bromide is expected in 2014.

About QVA149

QVA149 is an investigational inhaled, once-daily, fixed-dose combination of
indacaterol maleate and glycopyrronium bromide delivered through the Breezhaler(R) 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[5]-[17]. 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(R) 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(R) device allows patients to hear, feel and see that they have
taken the drug correctly[5].

About COPD

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[18] and is predicted to be the third leading cause of death by 2020[19].
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[
20].

References

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SOURCE Sosei Group Corporation


Source: PR Newswire