SOUTH SAN FRANCISCO and BERKELEY, Calif.--(BUSINESS WIRE)--Sept. 17, 2002--Genentech, Inc. (NYSE: DNA - News) and XOMA Ltd. (Nasdaq: XOMA - News) today announced that a randomized Phase III study with Raptiva(TM) (efalizumab), an investigational therapy for moderate-to-severe psoriasis, achieved its primary efficacy endpoint. The primary endpoint of the study was to compare the percentage of patients who achieved 75 percent or greater improvement in Psoriasis Area and Severity Index (PASI) scores (PASI 75) after 12 weeks of Raptiva therapy with patients receiving placebo. Genentech and XOMA plan to include this data as part of a Biologics License Application (BLA) to be filed with the U.S. Food and Drug Administration (FDA).
"The data from this trial, conducted with Genentech material, are consistent with data obtained from previous Phase III studies with Raptiva that used both Genentech and XOMA material," said Hal Barron, M.D., FACC, Genentech's vice president, Medical Affairs. "These results provide additional support for Raptiva as a therapy for patients with moderate-to-severe psoriasis. Genentech and XOMA will be discussing the data with the FDA in conjunction with plans to file the BLA by the end of 2002."
Serono S.A. (virt-x: SEO and NYSE: SRA) has an exclusive license to market Raptiva internationally outside of the United States, Japan and certain other Asian countries, and plans to file Raptiva with European authorities in the first quarter of 2003.
The FDA requested that the current Phase III study be completed before the filing of a BLA for Raptiva after results from a pharmacokinetic study suggested that Genentech-produced Raptiva material showed a slightly higher serum concentration than XOMA-produced Raptiva material. Previous Phase III trials were conducted with both Genentech and XOMA material.
"I'm particularly pleased with the positive results from this latest Phase III study, because they enable us to move closer towards the goal of providing a safe and effective psoriasis therapy to patients who need better treatment options," said Jack Castello, XOMA's chief executive officer.
Genentech and XOMA will present the data from this study at an upcoming medical meeting.
This double-blind, placebo-controlled, multicenter efficacy study enrolled 556 patients with moderate-to-severe plaque psoriasis who were randomized in a 2 to 1 ratio to receive 12 weekly subcutaneous injections of 1 mg/kg of Raptiva or placebo. The trial also measured several secondary endpoints at 12 weeks, including the Overall Lesion Severity (OLS) scale, the percentage of patients achieving 50 percent or greater improvement in PASI scores (PASI 50) and the percentage of PASI improvement over time. As was the case with the primary endpoint, the secondary endpoints were consistent with data obtained from previous Phase III Raptiva studies.
The safety profile in this study was similar to previous Raptiva trials conducted with both Genentech and XOMA material. Adverse events that occurred more often in the Raptiva arm included mild-to-moderate headache, general aches/pains, chills, nausea and fever. |
