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): April 25, 2000
XOMA LTD.
- --------------------------------------------------------------------------------
(Exact name of registrant as specified in its charter)
BERMUDA
- --------------------------------------------------------------------------------
(State or other jurisdiction of incorporation)
0-14710 52-2154066
- --------------------------------------- ---------------------------------
(Commission File Number) (IRS Employer Identification No.)
2910 Seventh Street, Berkeley, California 94710
- --------------------------------------------------------------------------------
(Address of principal executive offices) (Zip code)
Registrant's telephone number, including area code (510) 644-1170
--------------------------
- --------------------------------------------------------------------------------
(Former name or former address, if changed since last report)
<PAGE>
Item 5. Other Events
------------
On April 25, 2000, XOMA Ltd. issued the announcement attached hereto as
Exhibit 1, which is incorporated herein by reference.
Item 7. Exhibits
--------
1. Press Release dated April 25, 2000.
<PAGE>
-2-
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: April 25, 2000 XOMA LTD.
By: /s Christopher J. Margolin
--------------------------------
Christopher J. Margolin
Vice President, General
Counsel and Secretary
<PAGE>
EXHIBIT INDEX
Number Description
- ------ -----------
1. Press Release dated April 25, 2000
XOMA contacts:
Ellen Martin or Peter Davis
510-644-1170 or 1-800-BIO-XOMA
Thomson IR: Juliane Snowden (investors) 212-510-9286
Karina Byrne (media) 212-510-9266
NEUPREX(R) MENINGOCOCCEMIA BIOLOGICS LICENSE APPLICATION SUBMISSION TO BE
DELAYED
Berkeley, CA N April 25, 2000 N In a recent meeting with members of the U.S.
Food and Drug Administration (FDA), representatives from XOMA Ltd. (Nasdaq:
XOMA) and Baxter Healthcare Corporation (NYSE: BAX) discussed results from the
Phase III trial that tested NEUPREX(R) (rBPI21) in pediatric patients with
severe meningococcemia. Senior representatives of the FDA indicated that the
data presented were not sufficient to support the filing of a biologics license
application (BLA) at this time. XOMA and Baxter are therefore examining ways to
supply the additional data necessary to proceed with the filing.
"Because of the clear unmet medical need and the importance of advancing new
therapies in this disease, we are exploring several approaches to provide the
necessary data to the FDA,O said Norbert Riedel, Ph.D., President of Hyland
Immuno's Recombinant business. OAlthough conducting clinical trials in this rare
disease is difficult, we will continue to work closely with the agency to
identify a practical path to achieve approval. We believe this product has
considerable potential in multiple diseases and are evaluating several
additional indications.O
In the double-blinded, placebo-controlled 395-patient Phase III study patients
who received NEUPREX(R) showed reductions in mortality and limb loss, the most
serious consequences of this disease. In addition, more patients in the
NEUPREX(R) group returned to their pre-illness POPC score, which is a commonly
used comprehensive measure of functional and neurological status in pediatric
intensive care. There were no safety issues in the study. Detailed trial data
will be disclosed in an article to be published in an appropriate peer-reviewed
scientific journal.
"We feel we have generated compelling data in an extremely challenging clinical
setting,O said Jack Castello, Chairman, President and CEO of XOMA. OWe will
continue to work with Baxter and the FDA to find a way to provide additional
data as needed to further confirm our trial results. We are also working with
Baxter to choose additional NEUPREX(R) indications to advance into the
clinic.
Meningococcemia
Outbreaks of meningococcal disease have become more frequent in recent years,
especially among small children and young adults. Caused by the same species of
bacteria responsible for meningococcal meningitis, meningococcemia is
characterized by a rapid onset of life-threatening symptoms and consequent high
mortality. In survivors, common morbidities include gangrene followed by
amputations and/or central nervous system damage. Although first-line
antibiotics generally control the meningococcal bacteria, there is no current
treatment for the toxic inflammatory cascade triggered by the bacterial
endotoxins that can lead to abnormal blood clotting, organ failure, shock and
death.
<PAGE>
BPI platform
In January, Baxter and XOMA announced an agreement in which Baxter's Hyland
Immuno division acquired the worldwide rights to the NEUPREX(R) product for
meningococcemia and all future anti-bacterial and anti-endotoxin indications.
XOMA has an ongoing agreement with Allergan Inc. to develop ophthalmic
anti-infective products using rBPI in combination with antibiotics. The first
milestone was achieved in December 1999, confirming that an antibiotic/rBPI21
combination is active against various bacterial strains that cause eye
infections, including antibiotic-resistant strains.
The Company continues to hold discussions with potential partners for the
Mycoprex(a) antifungal program and is advancing development of BPI-derived
anti-angiogenic compounds that may be useful in treating retinal diseases,
tumors and inflammatory diseases.
Antibody platform
Genentech and XOMA started Phase III clinical testing of the anti-CD11a antibody
product in moderate-to-severe psoriasis patients in December 1999. A second
Phase III psoriasis trial and a Phase I/II study in kidney transplant patients
commenced in the first quarter of 2000.
Preclinical development continues on XOMAOs ING-1 antibody oncology product.
ING-1 binds to an antigen found on epithelial cell cancers, such as breast,
prostate, colorectal and others, and recruits cells from the patientOs own
immune system to kill the tumor cells.
Discussions are in progress with potential partners for XOMAOs Genimune(a)
product and its related targeted gelonin fusion technology. Genimune(a) is a
protein fusion that combines an antibody-based targeting component with gelonin,
a proprietary cytotoxin. Medical targets are T and B-cell mediated autoimmune
diseases and immune system cancers.
About XOMA
XOMA develops and manufactures biopharmaceuticals in Berkeley and Santa Monica,
California. Medical targets include infectious diseases, immunologic and
inflammatory disorders, and cancer. The companyOs infectious disease product
development platform is BPI (bactericidal/permeability-increasing protein), a
human protein with multiple anti-infective properties. Drs. Peter Elsbach and
Jerrold Weiss discovered BPI at New York University School of Medicine (NYU).
NYU collaborates with XOMA to extend and apply BPI-related research to
pharmaceutical development. In addition to its antibody product development
programs, the company owns a patented Human Engineering method for reducing
antibody immunogenicity. XOMA has also granted more than 20 licenses to its
proprietary cell expression system for manufacturing recombinant proteins
(including antibodies) to U.S. and European biotechnology and pharmaceutical
companies.
For more information, visit XOMAOs web site at www.xoma.com
The statements made in this news release related to regulatory approval,
collaborative and licensing relationships, clinical testing and other aspects of
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
timing or results of pending or future clinical trials, changes in the status of
collaborative relationships, and actions by the U.S. Food and Drug
Administration or the U.S. Patent and Trademark Office, are discussed in XOMAOs
most recent annual reports on
Page 2
<PAGE>
Form 10-K and in other SEC filings. Consider such risks carefully in evaluating
XOMAOs prospects.
###
Page 3
