ERS 2012 Preview: QVA-149-LABA/LAMA FDC well Positioned to Take a Share in the Second Line and Third Line Setting for Treatment of COPD
Novartis announced positive clinical data of QVA-149 from fifth and final successful pivotal clinical study result (SPARK) from IGNITE program on August 30th, 2012. The fixed dose LABA and LAMA combination-QVA149 met the primary end point in reducing the overall rate of exacerbations in COPD patients as compared to NVA237 / Seebri and Spiriva. Looking at cumulative data from all existing trials (ENLIGHTEN, ILLUMINATE, SPARK, and SHINE), QVA149 has clearly demonstrated that it is superior to existing treatment in patients refractory to once daily Spiriva. About 25-30% of Spiriva (LAMA) prescriptions have LABA’s as co-prescribed drugs. QVA149 would provide the convenience of single therapy and once approved should cannibalize sales of Spiriva, twice daily LABA’s and to some extent Advair. Pfizer alliance agreement on Spiriva as such is terminating in 2014 in the US and 2012-2013 in the EU and hence any market share loss would be immaterial from Pfizer perspective. The LABA/LAMA FDC will also impact to some extent the share of Advair, as about 30-35% of Spiriva prescriptions have Advair as a co-prescription. The data from ILLUMINATE study reinforce the superior efficacy QVA149 over Seretide/Advair. We forecast $4 billion in market potential for LABA/LAMA FDC. GSK’s fixed dose combination of Vilanterol (Once daily LABA) and Umeclidinium bromide (LAMA) to be launched around the same time would as well compete for a share.
