Novartis unveils more promising Ph3 data on COPD program

Novartis continues to rack up an impressive set of late-stage data on NVA237, an experimental COPD treatment that is considered a likely winner at the FDA. The data demonstrated the treatment was better than a placebo and just as good as Spiriva.

If Novartis sticks to schedule, a regulatory filing will come later this year and marketing approval may arrive in 2012. But the big money would come from a combo treatment matching NVA237 with indacaterol, a program dubbed QVA149 that could make it to the marketplace in 2013. One of the big questions right now is whether regulators will approve a low or high dose of indacaterol.

"We have factored in sales of below $100 million for NVA237 as a single-agent drug," Helvea's Karl-Heinz Koch tells Dow Jones. "But we are looking for peak sales of $4 billion for QVA149."

"NVA237 has demonstrated its potential benefit for COPD patients in two large pivotal Phase III studies," said Trevor Mundel, Novartis' global head of development. "This new study adds to the growing evidence that NVA237 could be an important treatment option for COPD, and supports our plans to develop a fixed-dose combination with our Onbrez Breezhaler (indacaterol)."

- here's the Dow Jones report