Nuts! Genentech Halts Enrollment In Xolair Peanut Allergy Trial
This article was originally published in The Pink Sheet Daily
Executive Summary
The firm, with collaborators Novartis and Tanox, vows to continue development of the new indication for omalizumab.
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Genentech is halting patient enrollment in a Phase II study of Xolair to treat peanut allergy reactions. The decision to discontinue enrollment is a response to "severe hypersensitivity reactions which occurred in two individuals during the oral food challenge screening process of the trial," President-Product Development Sue Hellman said during the firm's fourth quarter earnings call Jan. 10. The decision "was not related to the safety of Xolair, since neither of the patients had received Xolair" (omalizumab), Hellman said. Xolair was approved in 2003 in adults and adolescents with moderate to severe persistent asthma. Hellman stressed that Genentech - along with collaborators Novartis and Tanox - remains "committed to determining whether or not Xolair may provide protection for patients" with peanut allergies and will meet with food allergy experts and FDA to determine how to proceed. Genentech is also in Phase III trials to evaluate Xolair for pediatric asthma. U.S. sales of Xolair were $93 mil. for the fourth quarter of 2005 and $321 mil. for the full year, the firm announced. -Kathleen Michael |