Vectura announced that its licensee, Novartis, reported positive data from the first Phase III clinical trial with the once-daily COPD therapy NVA237 (glycopyrronium bromide). The pivotal 26-week Glow1 placebo-controlled study met its primary endpoint of demonstrating that the long-acting muscarinic antagonist significantly improved bronchodilation.
Vectura and partner Sosei licensed NVA237 to Novartis in 2005. Vectura says launch of the drug for once-daily COPD monotherapy is planned for 2012. The first launch of QVA149, a fixed-dose combination therapy comprising NVA237 and Novartis’ one long-acting beta2 agonist indacaterol, is planned for 2013. Indacaterol itself is already approved in over 50 countries, with an FDA decision expected in July.
Vectura received a $7.5 million milestone payment from Novartis in May last year on the latter’s start of Phase III development with QVA149 in patients with COPD. The Phase III program includes two separate year-long international trials. The first will compare the effects of treatment using either QVA149 or NVA237 monotherapy on the rate of exacerbations in nearly 2,000 patients with severe or very severe COPD. The second placebo-controlled trial will evaluate the long-term safety and tolerability of QVA149 in 339 patients.