RNS23 Sep 2013 08:27
Vectura Group plc
Ultibro® Breezhaler® (QVA149), a first-in-class once-daily dual bronchodilator approved for COPD patients in Europe
· Ultibro®Breezhaler® (QVA149) is the first once-daily dual bronchodilator to gain European Commission approval as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD
· Pivotal Phase III IGNITE data showed QVA149 significantly improved lung function and patient-reported outcomes including breathlessness and rescue medication use, compared to current standards of care1-3
· COPD is a progressive disease affecting up to 10% of adults across Europe4 and is projected to be the third leading cause of death by 20205
Chippenham, UK - 23 September 2013: Vectura Group plc (LSE: VEC) ("Vectura"), confirms the information released today by Novartis announcing that the European Commission approved once-daily Ultibro® Breezhaler® (indacaterol 85 mcg / glycopyrronium 43 mcg) as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). Ultibro® Breezhaler® was developed under the name QVA149.
Dual bronchodilation with QVA149 is expected to set a new standard of care in COPD by combining the proven efficacy and safety benefits of two established Novartis COPD treatments; the LABA*, Onbrez® Breezhaler® (indacaterol), and the LAMA**, Seebri® Breezhaler® (glycopyrronium bromide). Both these components are delivered through the Breezhaler® inhalation device, as is QVA149, and are widely available in many countries around the world.
Dr Chris Blackwell, Chief Executive of Vectura, commented:
"The approval in Europe of QVA149, delivered through the Breezhaler® device, is another important event for both Vectura and for patients with COPD. This innovative, once-daily therapy provides another option for patients to address unmet needs associated with their disease and improve their quality of life. The approval of QVA149 in the EU triggers a $10 million milestone to Vectura."
The approval of QVA149 was based on the comprehensive IGNITE Phase III clinical trial program, one of the largest international trial programs in COPD comprising 11 studies in total with more than 10,000 patients from 52 countries1-3,6-15. From the eight IGNITE studies which completed in 20121-3,6-10, data showed that QVA149 significantly improved lung function versus several current standard treatments1-3,6 and showed significant symptomatic improvements versus placebo in breathlessness, exercise tolerance, rescue medication use and health-related quality of life1,2,6. QVA149 also demonstrated statistically significant symptomatic improvements in breathlessness, rescue medication use and health-related quality of life compared to open-label (OL) tiotropium 18 mcg1. The rate of all COPD exacerbations (mild, moderate
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