The drug: QVA149
The disease: COPD
The developers: Novartis, Vectura
Peak sales potential: Analysts at Credit Suisse have assigned a 50% probability of success with $750 million peak sales for QVA149 ex-U.S. and a 40% shot at $750 million in the U.S., with some lingering questions over once-daily dosing.
QVA149 has been in the spotlight for a couple of years now, a clear leader in the race to produce a next-gen therapy for an enormous market. The success of the Phase III SPARK study in August sets up Novartis ($NVS) for a near-term regulatory filing in Europe and Japan, with the FDA slated for an application in 2014 as the pharma giant resolves some thorny dosing issues.
QVA149 is a combination of indacaterol and NVA237, which faced delays in the U.S. Novartis and its UK partner Vectura have had their sights set on Advair, GlaxoSmithKline's ($GSK) big COPD drug. GSK and Theravance ($THRX) recently filed for U.S. approval of their new COPD treatment, Relovair, which has produced mixed data in clinical studies. Forest Labs recently gained approval for a new COPD treatment, though most analysts expect it to garner only modest sales. And several other biotechs, including Pearl Therapeutics, have their own programs under way.
GSK may not have wowed anyone with Relovair so far, but it does have another potential treatment up its sleeve. GSK961081 (a MABA, or bifunctional muscarinic antagonist-beta2 agonist) could prove the key to a triple-play COPD treatment delivered in a single device--an innovation that has yet to be pulled off. In midstage studies, GSK saw a significant improvement in lung performance after 29 days of treatment.
Can a triple-play COPD drug protect GSK from Novartis' QVA149?
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