Novartis plans 2011 filing for both NVA237 monotherapy and as combination with indacaterol.

Vectura and Sosei each received a $7.5 million milestone payment from Novartis on the latter’s initiation of a Phase III trial with NVA237 in chronic obstructive pulmonary disease (COPD). The international, placebo-controlled trial will include about 1,000 COPD patients. It’ll compare the effects of this once-daily, long-acting muscarinic antagonist or tiotropium bromide.

Vectura’s share price nudged up 3% on this announcement. The firm along with its co-development partner, Sosei, licensed NVA237 to Novartis in 2005. Novartis plans to launch the drug both as a once-daily COPD monotherapy and (also in combination with its own investigational long-acting beta2 agonist, QAB149 indacaterol.

The NVA237-QAB140 combination is known as QVA149. Novartis expects to file for approval of both NVA237 monotherapy and the QVA149 combination therapy in 2011. Regulatory filings for indacaterol as monotherapy for COPD were submitted to the regulatory authorities in the U.S. and Europe at the end of 2008.

Vectura and Sosei have now each received $15 million from the NVA237 deal with Novartis and is eligible to split up to $375 million in development and commercial milestones for both the monotherapy and combination products.

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