A key European approval for a drug delivery device has handed Cambridge UK BioMedTech business Vectura a new $10 million windfall just days after the technology was confirmed for Japanese markets with a $2.5m payback.
Vectura, whose device development group is based in Cambridge, has received EC approval for its Ultibro® Breezhaler® (QVA149) device for chronic obstructive pulmonary disease (COPD) patients in Europe.
The device 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 data showed QVA149 significantly improved lung function and patient-reported outcomes including breathlessness and rescue medication use, compared to current standards of care.
COPD is a progressive disease affecting up to 10 per cent of adults across Europe and is projected to be the third leading cause of death by 2020.
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, Vectura’s chief executive, said: “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.”
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