XOMA Designated as a Subcontractor in 5-Year NIAID Effort to Develop Therapeutic Agents
Tuesday November 7, 2:26 pm ET
Subcontract May Be for Up to $28 Million
BERKELEY, CA--(MARKET WIRE)--Nov 7, 2006 -- XOMA Ltd. (NASDAQ:XOMA - News) today announced that it has been designated as a subcontractor under a prime contract between SRI International (SRI) of Menlo Park, California, and the National Institute of Allergy and Infectious Diseases (NIAID). XOMA and SRI are negotiating the final terms of the subcontract, which will run for 5 years and is expected to reach as much as $28.1 million. Under the subcontract, XOMA would manufacture a variety of monoclonal antibody therapeutic agents of importance to NIAID. Successful negotiation of the new subcontract would, if the full $28.1 million were funded, bring the total of XOMA's governmental contract awards to approximately $60 million since March of 2005.
"This is an important achievement for XOMA, since it highlights the US Government's confidence in the quality of our antibody production capabilities as well as demonstrating the success of our new initiative to serve government clients. We are particularly pleased to play such a central role in the development of products deemed to be important for critical biodefense and infectious disease-related products," said John L. Castello, chairman of the board, president, and chief executive officer of XOMA. "This additional contract with NIAID also supports our company's strategy of utilizing our existing assets to generate revenues that will provide a bridge to profitability for XOMA."
XOMA Biologic Development and Manufacturing Overview
With 25 years of experience developing therapeutic antibodies and other proteins, XOMA has built a fully integrated infrastructure that supports biologics development from recombinant DNA engineering and cell expression, through production scale up and cGMP manufacturing. XOMA can rapidly create a production process and advance antibodies into pilot scale production, then complete process scale-up and produce GMP material for use in human clinical trials, Biologics License Applications filings, and initial commercial launch. XOMA's process development and manufacturing capabilities include:
-- Cell line and process development
-- Optimization of production processes, including scale-up
-- Analytical assays and test methods
-- Formulation optimization
-- Pilot plant for process development and scale-up with two 500L
fermenters
-- cGMP manufacturing facility with three production trains of 2750L
capacity
-- Full service Quality infrastructure (Quality Assurance, Quality
Control, Quality Engineering)
-- Filling capability up to 3,000 vials (including labeling and
packaging services) sufficient for clinical trials
-- Stability program, including all stability-indicating assays
For more information, please visit the company's website at www.xoma.com.
About NIAID
NIAID is a component of the National Institutes of Health, an agency of the U.S. Department of Health and Human Services. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on transplantation and immune-related illnesses, including autoimmune disorders, asthma and allergies. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at niaid.nih.gov... |
