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Genentech Reports Positive Topline Data From Xolair Phase III Studies

Genentech, a member of the Roche Group (RHHBY), said Omalizumab has met both co-primary endpoints and key secondary endpoints across both POLYP 1 and POLYP 2 phase III trials for the treatment of adults with chronic rhinosinusitis with nasal polyps (CRSwNP) who have not adequately responded to intranasal corticosteroids. Xolair (Omalizumab) significantly reduced nasal polyps and congestion symptoms in adults with chronic rhinosinusitis with nasal polyps in both studies. Xolair was well tolerated and the safety profile was consistent with the previous trials.

In the US., Novartis and Genentech, Inc. jointly develop and co-promote Xolair. Outside the US, Novartis markets Xolair and records its sales. The companies plan to discuss the results with the FDA.

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