XOMA News XOMA Successfully Completes Initial $15 Million BioDefense Contract with NIAID
BERKELEY, Calif.--(BUSINESS WIRE)--XOMA Ltd. (Nasdaq:XOMA) today announced that it has received
final acceptance from the National Institute of Allergy and Infectious
Diseases (NIAID), a part of the National Institutes of Health (NIH), of
all deliverables under Contract No. HHSN266200500004C. This $15 million
contract with NIAID was awarded to XOMA in March of 2005 to develop
manufacturing processes for three anti-botulinum neurotoxin monoclonal
antibodies.
With the completion of this first contract, XOMA has created production
cell lines using its proprietary antibody expression systems, built and
qualified master and manufacturer’s working
cell banks, developed production processes and produced initial cGMP
quantities of the three antibodies.
“XOMA’s expertise at
developing therapeutic monoclonal antibodies was tangibly demonstrated
in our performance on this contract, as was our ability to successfully
provide all deliverables on time and on budget,”
said John L. Castello, chairman of the board, president, and chief
executive officer of XOMA. We expect to continue performing at this
level on the $16 million follow-on contract we announced on July 31, and
we believe XOMA is well positioned to continue supporting the U.S.
Government’s critical biodefense initiatives.”
About Botulism Neurotoxin (BoNT)
With the deliberate exposure of postal workers, other government
employees, and the American public to Bacillus anthracis spores,
there is an urgent need to devise effective measures to protect U.S.
citizens from the harmful effects of biological agents used as
instruments of terror. Botulinum neurotoxins are one of these biological
threats and new vaccines, therapies and diagnostics are needed to
counter the potential terrorist use of these toxins.
XOMA Biologic 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 http://www.niaid.nih.gov.
About XOMA
XOMA is a leader in the discovery, development and manufacture of
therapeutic antibodies, with a therapeutic focus that includes cancer
and immune diseases. XOMA has royalty interests in RAPTIVA®
(efalizumab), a monoclonal antibody product marketed worldwide (by
Genentech, Inc. (NYSE:DNA) and Serono, SA) to treat moderate-to-severe
plaque psoriasis, and LUCENTIS™(ranibizumab injection), a monoclonal antibody product marketed
worldwide (by Genentech and Novartis AG (NYSE:NVS)) to treat neovascular
(wet) age-related macular degeneration.
The company has built a premier antibody discovery and development
platform that includes access to seven of the leading commercially
available antibody phage display libraries and XOMA’s
proprietary Human Engineering™ and bacterial
cell expression (BCE) technologies. More than 45 companies have signed
BCE licenses. XOMA’s development
collaborators include Lexicon Genetics, Inc. (Nasdaq:LEXG), Novartis,
Schering-Plough Corporation (NYSE:SGP) and Takeda Pharmaceutical Company
Limited (TSE4502:Takeda). With a fully integrated product development
infrastructure, XOMA’s product development
capabilities extend from preclinical sciences to product launch. For
more information, please visit the company's website at www.xoma.com.
Certain statements contained herein concerning current collaborations
and product development or that otherwise relate to future periods are
forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933 and Section 21E of the Securities Exchange Act of
1934. These statements are based on assumptions that may not prove
accurate.Actual results could differ materially from those
anticipated due to certain risks inherent in the biotechnology industry
and for companies engaged in the development of new products in a
regulated market. Among other things, XOMA may not be able to produce
the required antibodies and/or formulation to the satisfaction of NIAID,
and XOMA’s work may not support entry into
Phase I trials.These and otherrisks, including those
related to the results of discovery research and preclinical testing;
the manufacture of antibodies under cGMP requirements; the timing or
results of pending and future clinical trials (including the design and
progress of clinical trials; safety and efficacy of the products being
tested; action, inaction or delay by the FDA, European or other
regulators or their advisory bodies; and analysis or interpretation by,
or submission to, these entities or others of scientific data);
uncertainties regarding the status of biotechnology patents;
uncertainties as to the cost of protecting intellectual property;
changes in the status of the existing collaborative and licensing
relationships; the ability of collaborators, licensees and other third
parties to meet their obligations; market demand for products; scale up
and marketing capabilities; competition; international operations; share
price volatility; XOMA’s financing needs and
opportunities and risks associated with XOMA’s
status as a Bermuda company, are described in more detail in XOMA’s
most recent annual report on Form 10-K and in other SEC filings.Consider
such risks carefully in considering XOMA’s
prospects.