Roche (RHHBY) 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 (CIU).
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 indication with Novartis (NVS).
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 Bayer (BAYRY) and Eli Lilly and Company (LLY) currently look better positioned with a Zacks Rank #2 (Buy).