) recently announced positive results from a phase III trial
(ASTERIA II: n=323) which is evaluating Xolair (omalizumab) for
an additional indication.
Data from the global, multicenter, randomized, double-blind,
placebo-controlled study revealed that Xolair met its primary
endpoint in patients (aged between 12 to 75 years) suffering from
moderate-to-severe chronic idiopathic urticaria
The patients remained symptomatic despite treatment with
approved H1 antihistamine doses, which as per Roche is the only
approved therapy for the indication.
The study met the primary endpoint in two of the three dose
groups studied and revealed that Xolair when administered every
four weeks led to a significant improvement in the mean weekly
Itch Severity Score (ISS) from baseline.
We note that Xolair is already approved to treat patients with
moderate -to-severe persistent allergic asthma caused by year
round allergens in the air. Roche intends to seek US approval of
the drug for the new indication later in 2013.
We note that Roche is co- developing Xolair for the new
We are positive on the current developments at Roche. A couple
of days ago, the FDA approved Kadcyla (ado-trastuzumab emtansine
or T-DM1) for the treatment of patients suffering from
HER2-positive metastatic breast cancer (mBC).
The approval of Kadcyla will strengthen Roche's HER2
franchise. Roche expects Perjeta, Kadcyla and Actemra to
positively impact results in 2013.
Roche currently carries a Zacks Rank #4 (Sell). However, other
large cap pharma stocks, such as
Eli Lilly and Company
) currently look better positioned with a Zacks Rank #2 (Buy).
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