Novartis (NVS) has a wide range of products and is not dependent on a single product to drive growth. Moreover, the company boasts a robust pipeline. Recently, Novartis provided an update on Xolair and secukinumab.
Novartis received positive news when the U.S. Food and Drug Administration (:FDA) approved Xolair for an additional indication. Xolair is now approved in the U.S. for the treatment of chronic idiopathic urticaria (CIU), in adults and adolescents (12 years and above) with inadequate response to H1-antihistamine treatment. CIU is known as chronic spontaneous urticaria (CSU) outside U.S. Earlier this month Xolair won approval for the CSU indication (as a combination therapy) in Europe.
We note that Xolair is already approved in the U.S. for moderate-to-severe persistent allergic asthma. Novartis licensed Xolair from Roche (RHHBY). Roche markets Xolair in the U.S. Xolair sales in 2013 were up 24% y/y to $613 million.
Novartis has also progressed well with the development of its psoriasis candidate, secukinumab (AIN457). Recently, Novartis reported results from 2 pivotal phase III studies, FEATURE and JUNCTURE, which evaluated secukinumab in clearing patients' skin.
Secukinumab consistently demonstrated high efficacy when administered with a convenient pre-filled syringe (PFS) or autoinjector/pen. Both the studies met all primary and pre-specified secondary endpoints. The patients rapidly achieved almost clear skin, consistent with the head-to-head phase III FIXTURE psoriasis study where secukinumab showed superiority over Enbrel.
Novartis has also started enrolling patients in a phase IIIb head-to-head psoriasis study (:CLEAR) on secukinumab versus Stelara. The study is expected to enroll 640 patients.
We note that Novartis filed the candidate for marketing approval in the EU and the U.S. in the fourth quarter of 2013 for the treatment of moderate-to-severe plaque psoriasis.