Novartis' Ph3 success advances blockbuster COPD program

On a day that Novartis ($NVS) is earning kudos for its ability to gain new drug approvals, the pharma company is reporting fresh progress with its closely-watched COPD program. A Phase III study of NVA237, its LAMA program, hit its primary endpoint. Patients taking the drug demonstrated a significantly improved lung function compared to the placebo arm while maintaining a good safety profile.

The news leaves Novartis on track to launch the once-daily treatment of NVA237 next year, while following up with a combination drug that matches NVA237 and its long-acting LABA drug indicaterol, which is now under FDA review. That combo therapy, QVA149, is a favorite of analysts, who say it could go on to revolutionize treatment of COPD and earn megablockbuster returns.

"We are very encouraged that results from the initial pivotal GLOW1 trial, showing significantly increased lung function with a positive safety profile, have provided further confirmation of the clinical potential of NVA237 as a novel once-daily LAMA therapy for COPD patients," said Shinichi Tamura, CEO of Sosei.

The news helped buoy Vectura's stock this morning. Vectura and Sosei licensed NVA237 to Novartis several years ago. GSK and Pfizer will both be studying today's data closely. QVA149 could topple Glaxo's multibillion-dollar Advair franchise along with Pfizer's Spiriva. Helvea analyst Karl-Heinz Koch recently told Reuters that the combo program could "set a new standard" for COPD, which is growing into a $20 billion market.

- see the Novartis release