Genentech says IgE concerns unwarranted

Investor concerns over the potential toxicity of omalizumab ( rhuMAb-E25), a humanized monoclonal antibody against IgE being developed by Genentech (DNA) with partners Tanox (TNOX) and Novartis (NVS; SWX:NOVN), sent shares of DNA down $5 to $156 on Tuesday. Investors appeared to be worried that at doses 3-27 times higher than the maximum dose of omalizumab used in Phase III clinical testing, the partners' second-generation antibody (rhuMAb-E26) caused thrombocytopenia (reduction in platelet count) in monkeys.

However, DNA told BioCentury that sustained reductions in platelet count or bleeding abnormalities were not seen in the 1,950 patients treated with omalizumab in Phase III trials, and that the FDA was notified of the rhuMAb-E26 preclinical results prior to the agency's acceptance of the BLA for omalizumab. The partners in June submitted a BLA to the FDA for omalizumab to treat asthma and allergies. Omalizumab also is under review in Europe and Australia. ...