Genentech and Novartis' Xolair delayed as FDA asks for more data

Genentech and Novartis face a considerable delay in the marketing oftheir much-anticipated new drug for asthma, Xolair (omalizumab), after the US Food and Drug Administration asked for additional data in its review of the firms' Biologics License Application. In a statement, the companies noted that the agency has asked for more preclinical, clinical and pharmacokinetic information before it will consider approving the drug, which is a monoclonal antibody targeting immunoglobulin E.

Both Genentech and Novartis' shares took a hit on the news, with the former down 15.9% to $43.85 and the latter's USA-listed shares sliding 4.1% to $33.13 on the day of the announcement (July 10). The fallout also wiped 44% off the shares of Tanox Biosystems and 15% off Protein Design Labs, both of which would benefit from a royalty stream from Xolair, to $14.20 and $63.19, respectively.

Launch in 2003/2004?