Switzerland-based pharmaceutical company, Novartis AG recently announced positive data on its pipeline candidate, QVA149 (indacaterol maleate/glycopyrronium bromide), from a phase III study, SPARK.
The candidate is being studied for the treatment of chronic obstructive pulmonary disease (COPD). The SPARK study met its primary endpoint, showing a significant reduction in the rate of moderate-to-severe COPD exacerbations in comparison to Seebri Breezhaler (glycopyrronium bromide 50 mcg) after 64 weeks.
Additionally data from the study showed that QVA149 was statistically more successful in the reduction of mild, moderate and severe exacerbations in comparison to Seebri Breezhaler (glycopyrronium bromide 50 mcg) and Pfizer Inc.’s Spiriva (tiotropium 18 mcg).
The SPARK study, which will be a part of the initial regulatory submissions for QVA149, in Europe and Japan is a part of the company’s phase III QVA149 development program, IGNITE. SPARK comprises the fifth and final study of this phase III program. We note that, all five clinical studies in this phase III program met their primary endpoints.
COPD which likely affects almost 210 million people worldwide is expected to become the third most important cause of death by 2020. Thus it provides ample commercial opportunities for the candidate upon approval.
Novartis plans to submit QVA149 for regulatory approval in both Europe and Japan in the fourth quarter of 2012. The company also plans a late 2014 US filling of the candidate.
We also note that other than QVA149, Novartis’ COPD portfolio includes Onbrez Breezhaler (indacaterol maleate) which was launched in the US under the brand name Arcapta Neohaler and in Japan under the name Onbrez Inhalation Capsules where it is being co-promoted by Eisai and Co. Ltd .
Currently, we have a Neutral recommendation on Novartis. The company carries a Zacks #3 Rank (Hold rating) in the short run.