[ Raptiva BLA accepted, Genentech/XOMA ]
XOMA Announces Notification of FDA Acceptance of Raptiva - Efalizumab - Biologics License Application
Thursday February 27, 7:20 pm ET
BERKELEY, Calif.--(BUSINESS WIRE)--Feb. 27, 2003--XOMA Ltd. (Nasdaq:XOMA - News) announced today that the U.S. Food and Drug Administration (FDA) has formally acknowledged receipt of the December 23, 2002 submission of the Biologics License Application (BLA) for Raptiva(TM) (Efalizumab). Raptiva(TM) is a recombinant humanized monoclonal antibody under evaluation for the treatment of moderate-to-severe plaque psoriasis.
"We are pleased that the Raptiva(TM) BLA filing has been accepted by the FDA," said Jack Castello, XOMA's chairman, president and chief executive officer. "This follows Serono's recent announcement that it has already filed for approval in the European Union and has plans to file in Canada, Australia and Switzerland yet this quarter. In the months ahead, we will look forward to working closely with Genentech and the FDA in the review and approval process."
The BLA submission is based on three Phase III studies and includes efficacy and safety data from more than 2,100 patients with moderate-to-severe-plaque psoriasis treated with Raptiva(TM). In clinical trials, Raptiva(TM) showed fast onset of clinical response and control of plaque psoriasis over a one-year period of treatment.
Serono S.A. (virt-x:SEO), Genentech's marketing partner outside the U.S. and Japan, also announced this week that it has submitted a Marketing Authorization Application (MAA) to the European Agency for the Evaluation of Medicinal Products (EMEA) for European Union approval of Raptiva(TM) for psoriasis.
About Raptiva(TM)
Raptiva(TM), a recombinant humanized monoclonal antibody, is designed to inhibit the adhesion of T-lymphocytes to other cell types by inhibiting the binding of LFA-1 to ICAM-1. This mechanism of action has a number of effects depending upon the cell type, which include: (1) inhibition of T-lymphocyte activation, proliferation and cytokine release, (2) inhibition of T-lymphocyte migration, (3) inhibition of T-lymphocyte interactions with tissue-specific cells. In Phase III studies, Raptiva(TM) was given as a once-a-week subcutaneous injection.
Raptiva(TM) is currently in Phase II trials for rheumatoid arthritis and psoriatic arthritis and is being explored for use in other autoimmune diseases through a collaboration between Genentech and XOMA. Serono S.A. (virt-x: SEO and NYSE: SRA) has an exclusive license to market Raptiva(TM) worldwide outside of the United States and Japan.
About XOMA
XOMA develops and manufactures antibody and other protein-based biopharmaceuticals for disease targets that include cancer, immunological and inflammatory disorders, and infectious diseases. XOMA's programs include collaborations: with Genentech, Inc. on the Raptiva(TM) antibody for psoriasis (BLA Submission), rheumatoid arthritis (Phase II), psoriatic arthritis (Phase II) and other indications; with Baxter Healthcare Corporation to develop NEUPREX® (rBPI-21) for Crohn's disease (Phase II) and other indications; with Millennium Pharmaceuticals, Inc. on two biotherapeutic agents, CAB2 and MLN01, for certain vascular inflammation indications (preclinical); and with Onyx Pharmaceuticals, Inc. on its ONYX-015 product for various cancers (current activities suspended, pending partnership discussions). Earlier-stage development programs include compounds to treat cancer, retinopathies, autoimmune diseases and infections. |
