Novartis could file for FDA approval of QVA149 and NVA237 in 2014.
Vectura confirmed that its partner Novartis has reported positive data from a fourth Phase III study evaluating the inhaled COPD therapy QVA149, which combines Vectura’s long-acting muscarinic antagonist NVA237 (glycopyrronium bromide) with Novartis’ own long-acting beta2 agonist indacaterol. The Illuminate study in over 500 patients demonstrated that once-daily treatment with QVA149 was more effective than twice-daily seretide in terms of improving lung function.
All four QVA149 trials in the Ignite program (the Illuminate, Shine, Bright, and Enlighten studies) have now been successfully completed, and will form the basis of regulatory submission for QVA149 in the EU, Japan, and other countries. Three more QVA149 studies (Spark, Blaze, and Arise) are due for completion in 2012. Meanwhile, Novartis’ discussions with FDA have led to an agreed Phase III study design for QVA149 and NVA237 in the U.S. Both these drugs could be filed with FDA in 2014, Vectura notes.
Novartis licensed NVA237 from Vectura and Sosei in 2005. Vectura says it has to date received $35 million from Novartis as part of the licensing agreement, and could earn up to another $152.5 million in regulatory and commercialization targets for both the NVA237 monotherapy, and the QVA149 combination product.