Indacaterol/glycopyrronium bromide regulatory update

Novartis submitted a regulatory application to Japan's Ministry of Health, Labor and Welfare (MHLW) for QVA149 to treat chronic obstructive pulmonary disease (COPD). QVA149 is a fixed-dose combination of glycopyrronium bromide ( NVA237), an inhaled long-acting muscarinic receptor antagonist (LAMA), and indacaterol, a long-acting adrenergic receptor beta 2 agonist (LABA). The submission triggers a "modest" milestone payment to Vectura. Sosei said the submission does not trigger any milestone payments from Novartis, which has worldwide rights to develop and commercialize NVA237 from Sosei and Vectura under a 2005 deal (see BioCentury, April 18, 2005). Sosei and Vectura have each received $37.5 million in milestones under the deal and are eligible to receive an additional $135 million each, plus royalties. ...