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Phase III Results Showed Omalizumab Significantly Reduced Disease Severity In Patients With A Chronic Form Of Hives Who Failed Standard Therapy

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced results from a Phase III trial, ASTERIA II, which demonstrated that omalizumab met its primary endpoint in patients with moderate to severe chronic idiopathic urticaria (CIU), who remained symptomatic despite treatment with approved H1 antihistamine doses 1. The data were published today in the New England Journal of Medicine and will be presented tomorrow at the American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting in San Antonio, TX.

CIU, also referred to as chronic spontaneous urticaria (CSU) outside the United States, is a skin condition characterized by red, swollen, itchy hives on the skin 2,3 and is diagnosed when hives spontaneously present and reoccur for more than six weeks 2. Angioedema, or swelling of the deep layers of skin, is common in patients with CIU 4,5. At any given time, the prevalence of CIU is approximately 0.5 percent to 1 percent worldwide 4,5. Currently, H1 antihistamines are the only approved therapy for patients suffering from CIU.

"We are pleased with the results of the ASTERIA II study, as people with chronic idiopathic urticaria unresponsive to H1 antihistamines need new treatment options,” said Hal Barron, M.D., chief medical officer and head of Global Product Development. “We look forward to sharing the results of two additional Phase III omalizumab CIU studies at upcoming medical meetings this year.”

Genentech plans to file a supplemental biologics license application (sBLA) with the U.S. Food and Drug Administration (FDA) for omalizumab in CIU later this year. The ASTERIA II data are the first Phase III results to be presented from the omalizumab clinical trial program in CIU, which also includes two additional Phase III studies (GLACIAL and ASTERIA I) investigating the efficacy and safety profile of omalizumab over 24-week treatment duration.

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