Genentech and XOMA Obtain Results From Xanelim --Efalizumab-- Pharmacokinetic Study
SOUTH SAN FRANCISCO & BERKELEY, Calif., Apr 5, 2002 (BW HealthWire) -- Genentech Inc. (NYSE: DNA chart, msgs) and XOMA Ltd. (Nasdaq: XOMA chart, msgs) today announced that a pharmacokinetic study conducted on Xanelim(TM) (efalizumab) comparing XOMA-produced material and Genentech-produced material did not achieve pre-defined statistical definition for comparability. The study suggested that the Genentech material achieved a slightly higher serum concentration than the XOMA material. Genentech and XOMA will work closely with the U.S. Food and Drug Administration (FDA) to determine next steps, but this will probably delay the filing of a Biologics Licensing Application (BLA) with the FDA for Xanelim beyond summer 2002.
"Genentech and XOMA are encouraged by the Xanelim safety and efficacy data collected to date," said Susan D. Hellmann, M.D., M.P.H., Genentech's executive vice president, Development and Product Operations and chief medical officer. "We continue to enroll patients into ongoing Xanelim clinical trials, including additional studies to expose more patients to the Xanelim material being produced at Genentech for marketing after approval. Genentech now plans to submit data from an additional ongoing efficacy study using Xanelim material produced at Genentech to the FDA and, contingent upon successful discussions with the FDA, expects to be able to submit data from this efficacy study before the end of 2002."
During Phase III Xanelim testing, minor manufacturing modifications were made to allow for large-scale material production. Last year the FDA requested a pharmacokinetic study to confirm the comparability of Xanelim material used in clinical trials, which was primarily produced at XOMA, and Xanelim material produced at Genentech for marketing after product approval. As part of the Xanelim clinical program, the companies had earlier successfully completed a number of internal evaluations, including animal pharmacokinetic studies, which supported comparability of the two materials.
Xanelim is a targeted T-cell modulator that is designed to target three key processes in the cascade of events that lead to psoriasis. These targeted processes are: (1) binding of T-cells through interactions with adhesion molecules on the endothelial cell surface; (2) migration of T-cells into the skin; and (3) activation of T-cells, all of which may be linked to the abnormal growth of skin cells and the painful, elevated scaly patches of skin (lesions) typical among psoriasis sufferers |
