Novartis/Vectura's QVA149 is filed as a treatment for COPD in Europe; Certican EU approval

The UK’s Vectura Group (LSE: VEC) confirmed that its partner, Swiss drug giant Novartis (NOVN: VX) has filed for European approval for QVA149, (indacaterol maleate/glycopyrronium bromide) an investigational drug for chronic obstructive pulmonary disease (COPD) triggering a $5 million milestone payment to Vectura. Along with its third-quarter results (The Pharma letter October 25), Novartis also said that a regulatory filing in the USA was expected by end-2014. The news saw Vectura’s share edge 0.6% higher to 90 pence in morning trading yesterday.

Novartis filed a marketing authorization application to the European Medicines Agency for QVA149, an investigational inhaled, once-daily, fixed-dose combination of indacaterol maleate and glycopyrronium bromide for the treatment of adult patients with COPD. The first five studies in the Phase III IGNITE clinical trial program for QVA149 formed the basis of the filing. ILLUMINATE, SHINE, SPARK and BRIGHT met their respective superiority primary endpoints of FEV1 area under the curve (AUC) for 0-12 hours at 26 weeks versus salmeterol/fluticasone, mean trough FEV1 at 26 weeks versus both indacaterol maleate and glycopyrronium bromide, reduction in the rate of exacerbations versus glycopyrronium bromide, and exercise endurance time at 21 days versus placebo. The data from ENLIGHTEN demonstrated that QVA149 has a similar overall adverse event profile to placebo.

Chris Blackwell, chief executive of Vectura, commented yesterday: “The IGNITE program is among the largest COPD clinical trial programs performed, the results from which provide strong support as to the effectiveness and safety of QVA149 and its potential to treat patients suffering from this progressive disease, a multi-billion dollar market that is expected to see continued growth. Today’s news follows the recent approval of Seebri Breezhaler [glycopyrronium bromide] in Europe and Canada and Seebri Inhalation Capsules in Japan, further highlighting Vectura's expertise in the respiratory therapeutic area.”