Genentech/Xoma delay US Xanelim submission

Genentech and Xoma have delayed the estimated filing date of theirBiologics License Application submission to the US Food and Drug Administration for the intravenously-administered psoriasis treatment Xanelim (efalizumab) to the summer of 2002, from late 2001/early 2002, due to an additional pharmacokinetics study requested by the agency.

The study aims to confirm that Xanelim material used for clinical trial testing, which was produced by Xoma, is equivalent to that planned for large-scale manufacturing. Production was moved to the Genentech facility, where minor modifications have been made.

The delay will now give Genentech/Xoma's rival Biogen an advantage in the race to bring the first new treatment for psoriasis to market. Biogen recently filed for marketing approval in the USA and Europe for its drug Amevive (alefacept) for the treatment of moderate-to-severe chronic plaque psoriasis which covers at least 10% of the body (Marketletter August 13), and said on October 5 that these applications had been accepted.