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Pipeline Progress at Novartis

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Novartis’ (NVS) 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 urticaria (CSU).

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 Roche (RHHBY). 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 boost sales. 

Novartis currently carries a Zacks Rank #3 (Hold). Right now, Allergan (AGN) and Bayer (BAYRY) look well placed with a Zacks Rank #2 (Buy).

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