) continues to make efforts to develop its dermatology portfolio.
The portfolio currently includes psoriasis candidate, secukinumab
(AIN457) and allergy asthma drug Xolair (omalizumab) being
developed for an additional indication of chronic spontaneous
The going has been good for Novartis in the past few days.
Last week, Novartis reported positive results from the FIXTURE
study (the Full year Investigative eXamination of secukinumab vs.
eTanercept Using 2 dosing Regimens to determine Efficacy in
psoriasis), on secukinumab. The study met both primary and
key secondary endpoints.
Meanwhile, Novartis is developing Xolair as a treatment of CSU
in collaboration with
). We remind investors that Roche markets Xolair in the U.S.
Xolair is approved in the U.S. for the treatment of
moderate-to-severe persistent allergic asthma in adolescents
(aged 12 and above) and adults. In the EU, Xolair is approved for
severe persistent allergic asthma in children (aged six and
above), adolescents, and adults.
Novartis announced new results on Xolair from a phase III
study, ASTERIA I. The results from the global, multi-center,
randomized double-blind study, ASTERIA I study, showed that
Xolair was effective and safe in the treatment of chronic
spontaneous urticaria compared to placebo. The data from ASTERIA
I study was consistent with the results obtained from the
previous phase III studies on Xolair - ASTERIA II and GLACIAL -
for the CSU indication.
The study met its primary endpoint of improving Itch Severity
Score (ISS) along with other pre-specified secondary efficacy
endpoints. Based on positive data from various studies, Xolair
was filed for review in the EU and U.S. for the CSU indication in
the third quarter of 2013.
Xolair recorded sales of $289 million in the first half of
2013, up 24% year over year. The successful development and
commercialization of Xolair for the CSU indication will further
Novartis currently carries a Zacks Rank #3 (Hold). Right now,
) look well placed with a Zacks Rank #2 (Buy).
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