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Roche Files sBLA for Xolair

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Roche (RHHBY - Free Report) has a solid position in the breast cancer market with drugs like Herceptin, Perjeta, and Kadcyla in its kitty for the treatment of patients suffering from HER2+ breast cancer.

The company continues to innovate further to strengthen its already dominant position. Meanwhile, apart from making efforts to develop its breast cancer franchise, Roche is also keen to develop drugs for other indications. Roche has a deep pipeline and we are pleased with Roche’s efforts to develop drugs for other franchises.

Roche recently announced that it has filed a supplemental Biologics License Application (sBLA) for the subcutaneous use of Xolair (omalizumab) in patients suffering from chronic idiopathic urticaria (CIU).

The sBLA has been accepted by the FDA which will take a decision by the second quarter of 2014.

We note Xolair is being jointly developed by Novartis (NVS - Free Report) and Roche. 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.

The sBLA was based on positive results from two, global, multi-center, randomized, double-blind, placebo-controlled phase III studies (ASTERIA I and ASTERIA II) wherein it was observed that Xolair was effective and safe in the treatment of CIU compared to placebo.

In addition, a third phase III study, GLACIAL, evaluated the safety profile of Xolair as an add-on therapy in CIU patients who remained symptomatic despite other treatments with antihistamines.

Xolair generated sales of CHF 386 million in the first half of 2013, up 11% year over year. The successful development and commercialization of Xolair for the CIU indication will further boost sales.

Roche currently carries a Zacks Rank #1 (Strong Buy). Right now, other large-cap pharma stocks like GlaxoSmithKline (GSK - Free Report) and Bayer (BAYRY - Free Report) also look attractive. Both carry a Zacks Rank #2 (Buy).

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