UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): March 8, 2005
XOMA LTD.
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(Exact name of registrant as specified in its charter)
Bermuda
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(State or other jurisdiction of incorporation)
0-14710 52-2154066
(Commission File Number) (IRS Employer Identification No.)
2910 Seventh Street, Berkeley, California 94710
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(Address of principal executive offices) (Zip code)
Registrant's telephone number, including area code (510) 204-7200
Not Applicable
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(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any of the
following provisions:
[ ] Written communications pursuant to Rule 425 under the Securities Act (17
CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17
CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c))
Item 1.01. Entry into a Material Definitive Agreement
As previously announced, XOMA Ltd. (the "Company") has entered into a
contract with the National Institute of Allergy and Infectious Diseases
("NIAID"), a part of the National Institutes of Health ("NIH"), to produce three
botulinum neurotoxin monoclonal antibodies designed to protect U.S. citizens
against the harmful effects of biological agents used in bioterrorism. Under the
18-month contract, the Company will develop monoclonal antibody therapeutics
using proprietary antibody expression systems to produce anti-type A-botulinum
neurotoxin monoclonal antibodies including a Master Cell Bank, Manufacturer's
Working Cell Bank and other designated deliverables. The antibodies will be
produced under Good Manufacturing Practices at the Company's manufacturing
facility. The total fixed price of the contract is $15 million. This project
will be 100% funded with Federal funds from NIAID under Contract No.
HHSN266200500004C. SRI International will be a subcontractor under this contract
and will develop potency assays to support antibody characterization. The
contract contains numerous standard terms, relating to such matters as
publicity, intellectual property and termination, provided for in the applicable
federal acquisition regulations and customary in many government contracts.
Item 9.01. Financial Statements and Exhibits
(c) Exhibits. The following exhibit is filed herewith:
Exhibit No. Description
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99.1 Press release dated March 10, 2005
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
Dated: March 11, 2005 XOMA LTD.
By: /s/ Christopher J. Margolin
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Christopher J. Margolin
Vice President, General
Counsel and Secretary
Exhibit 99.1
NEWS RELEASE
Ellen M. Martin Deb McManus, APR
Kureczka/Martin Associates Media Relations
Investor Relations Tel: (510) 204-7240
Tel: (510) 832-2044
Ellie Javadi
SRI International
Media Relations
Tel: (650) 859-4874
XOMA Awarded $15 Million Contract from NIAID to Help Fight Bioterrorism
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--XOMA to Develop Three Anti-Botulinum Neurotoxin Monoclonal Antibodies--
BERKELEY, Calif.--March 10, 2005--XOMA Ltd. (Nasdaq: XOMA) today announced that
it was awarded a $15 million contract from the National Institute of Allergy and
Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH),
to produce three botulinum neurotoxin monoclonal antibodies designed to protect
U.S. citizens against the harmful effects of biological agents used in
bioterrorism.
Under the 18-month contract, XOMA will develop monoclonal antibody therapeutics
using proprietary antibody expression systems to produce anti-type A-botulinum
neurotoxin monoclonal antibodies including a Master Cell Bank (MCB),
Manufacturer's Working Cell Bank (MWCB) and other designated deliverables. The
antibodies will be produced under Good Manufacturing Practices (cGMP) at XOMA's
manufacturing facility. This project will be 100% funded with Federal funds from
NIAID under Contract No. HHSN266200500004C. SRI International, an independent,
nonprofit research institute based in Menlo Park, CA, will be a subcontractor
under this contract and will develop potency assays to support antibody
characterization.
"Numerous events in the United States over the past few years serve as a stark
reminder that the use of biological agents remains a real threat," said John L.
Castello, president, chairman and CEO of XOMA. "As an industry leader in
developing monoclonal antibodies, XOMA is
committed to working with the U.S. government to develop new therapies to
counter these biological threats."
"We have previously stated that an important part of our strategy for achieving
profitability is increased utilization of our process development and
manufacturing assets," continued Castello. "This contract with NIAID is an
important step forward in achieving this objective."
About Botulism Neurotoxin (BoNT)
With the recent 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.
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 SRI
Silicon Valley-based SRI International ( www.sri.com) is one of the world's
leading independent research and technology development organizations. Founded
as Stanford Research Institute in 1946, SRI has been meeting the strategic needs
of clients for almost 60 years. The nonprofit research institute performs
client-sponsored research and development for government agencies, commercial
businesses and nonprofit foundations. SRI's Biosciences Division works with
government agencies and commercial pharmaceutical and biotechnology companies to
provide a broad range of preclinical drug discovery and development services,
including medicinal chemistry, custom synthesis, regulatory support, efficacy
and safety evaluations, pharmacokinetics and metabolism studies, analytical
chemistry and formulation design in production in GLP and cGMP environments. The
division specializes in cancer, infectious disease and neurobiological research.
About XOMA
XOMA develops and commercializes antibody and other protein-based
biopharmaceuticals for cancer, immune disorders and infectious diseases. The
company pipeline includes products from collaborative product development
programs with Chiron Corporation, Millennium Pharmaceuticals, Inc., and Aphton
Corporation. For more information about XOMA's product pipeline and antibody
product development capabilities and technologies, please visit XOMA's website
at http://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. These risks, including those related to the
results of pre-clinical testing, 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), changes in the status of the existing collaborative relationships, the
ability of collaborators and other partners to meet their obligations, market
demand for products, scale up and marketing capabilities, competition,
uncertainties regarding the status of biotechnology patents, uncertainties as to
the cost of protecting intellectual property and risks associated with XOMA's
status as a Bermuda company, are described in more detail in the Company's most
recent annual report on Form 10-K and in other SEC filings.