The drug: QVA149
The disease: COPD
The developer: Novartis, Vectura
Peak projections: $2 billion-$5 billion
Novartis already has a pair of COPD drugs nearing a potential approval. NVA237 and indacaterol are both expected to scrape together nine-figure earnings. But put them together--which Novartis has done in its late-stage QVA149 program--and you have the much greater potential for changing the entire standard of care, which until now has concentrated largely on controlling the symptoms of smoker's cough.
Some analysts see QVA149 as a potential giant slayer, taking on Advair and Spiriva. But GlaxoSmithKline isn't waiting on the sidelines to see if Novartis can be successful in advancing its megablockbuster. It has its own treatment in the race.
One potential hitch: Dosage. Novartis has been pushing for approval of a 150-mg dose of indacaterol, the long-acting beta agonist (LABA) in the recipe, which the agency's experts have balked at, citing safety concerns. U.S. regulators also don't see much difference in response between the 75- and 150-mg doses, further complicating Novartis' plans for the combo.
This morning, Novartis confirmed some of those dosing fears. The pharma giant says it will be forced to delay the NVA237 application timeline and mount new studies for QVA149 before it can win a U.S. approval. But it's sticking with plans to file in Europe and the rest of the world in 2012.
There's plenty at stake. Helvea's Karl-Heinz Koch has estimated that the combo could be worth $4 billion a year. J.P. Morgan estimated $5 billion, but Weiss of Vontobel has been fretting that without the high-end dose, revenue could be seriously blunted. He predicts $2.8 billion.