Genetech and Xoma say a pharmacokinetics study, to be included in a potential submission to the FDA for Xanelim, will delay the filing date to summer of 2002.
Analyst Matthew Geller says he had expected a filing in Q4 2001 or Q1 2002. He believes the delay may turn out to be net positive, as a new timeline would permit long-term treatment and retreatment studies to be completed before a filing. He adds the delay has no impact on EPS estimates for 2002 since he did not expect approval and launch of Xanelim until 2003. He notes the delay could be a positive for Biogen with its competitive product Amevive. He sees a $0.44 2001 loss, and a $0.50 2002 loss.