Xanelim: Who got what?
In the Phase III trials of Xanelim for psoriasis by partners Xoma Ltd. and Genentech Inc., some of the patients received Xanelim produced by XOMA and some received Xanelim manufactured by DNA. The companies haven't disclosed if they did an analysis of any differences in efficacy or safety. But results of an FDA-requested pharmacokinetic clinical trial now show that the products have different pharmacokinetic profiles, which could undermine the strength of the companies' efficacy and safety databases.
Last week, the companies reported that the study showed that the Xanelim efalizumab anti-CD11a antibody manufactured by XOMA has slightly different pharmacokinetic properties than the Xanelim manufactured by DNA, which achieved slightly higher serum concentrations than XOMA's product...