EMA CHMP adopts positive opinion for Seebri Breezhaler to treat COPD

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 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.

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.

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."