Switzerland-based pharmaceutical company,
) 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
) 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
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
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.
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