) 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
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
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
) and Roche. We remind investors that Roche markets Xolair in the
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
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
Roche currently carries a Zacks Rank #1 (Strong Buy). Right
now, other large-cap pharma stocks like
) also look attractive. Both carry a Zacks Rank #2 (Buy).
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