Regulatory submission for inhaled once-daily QVA149 is expected in 2012.
Vectura received a $7.5 million milestone payment from Novartis on the latter’s start of Phase III development with its combination bronchodilator, QVA149, in patients with chronic obstructive pulmonary disease (COPD). The drug is a once-daily dry powder bronchodilator comprising a fixed dose of Vectura’s long-acting beta2-agonist, QAB149 (indacaterol), and the long-acting muscarinic antagonist, NVA237 (glycopyrronium bromide).
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.
“This is the first once-daily LAMA/LAGBA combination product to enter Phase III trials, and with an anticipated filing date of 2012 it could provide an important future addition to the available treatment options for COPD,” comments Chris Blackwell, Ph.D., Vectura’s CEO.
Novartis received European regulatory clearance for Indacaterol in November 2009. The drug has since been launched in Germany, Ireland, and Denmark. Vectura and Novartis say they remain on track to file additional data requested by FDA for U.S. regulatory submission during the second half of 2010. Novartis is also developing NVA237 under a 2005 licensing deal signed with Vectura and its co-development partner, Sosei. Phase III trials with NVA237 were initiated in June 2009, and Novartis has stated it expects to file for approval in 2011.
Novartis’ marketed respiratory products include Tobi for the treatment of P. aeruginosa infections in cystic fibrosis patients, Xolair for allergic asthma, and Foradil for the treatment of asthma and COPD. The firm made about $1.19 billion in sales of respiratory products in 2009, up 15% in local currencies compared with 2008.