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): September 27, 1999
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) 644-1170
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(Former name or former address, if changed since last report)
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Item 5. Other Events
On September 27, 1999, XOMA Ltd. issued the announcement attached hereto as
Exhibit 1, which is incorporated herein by reference.
Item 7. Exhibits
1. Press Release dated September 27, 1999.
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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: September 27, 1999 XOMA LTD.
By: /s/ Christopher J. Margolin
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Christopher J. Margolin
Vice President, General
Counsel and Secretary
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EXHIBIT INDEX
Number Description
1. Press Release dated September 27, 1999
Exhibit 1
XOMA CONTACTS: Peter Davis or Ellen Martin
510-644-1170 or 1-800-BIO-XOMA
XOMA home page @ http://www.xoma.com
Thomson Financial: Rhonda Chiger 212-510-9280 or
Jacqueline Franchetti 212-701-1949
XOMA DISCONTINUES PHASE III TRIAL OF NEUPREX(R) IN TRAUMA
Berkeley, CA--September 27, 1999--XOMA Ltd. (Nasdaq: XOMA) today announced that
patient enrollment has been discontinued in its Phase III clinical trial testing
NEUPREX(R) (rBPI21) in trauma patients with severe blood loss. The decision was
based on an interim safety and efficacy analysis of data from 842 patients by an
independent Data Safety Monitoring Board (DSMB). Although the DSMB raised no
safety concerns, they indicated that the interim results were not sufficient to
meet the predetermined efficacy criteria for continuing the trial, and
recommended stopping accrual.
"This trial was based on a positive Phase II program, so we were surprised by
these interim results," said Jack Castello, Chairman, President and CEO of XOMA.
"We need to complete our analysis of the data from the more than 1100 patients
finally accrued in order to better understand what happened in this trial. We
remain confident in the product, and are moving ahead with our detailed analysis
of data from the recently completed Phase III meningococcemia trial for review
by the FDA. We will also continue our other BPI-related partnering and
development activities, including our antifungal and ophthalmic development
programs."
XOMA Ltd. develops and manufactures biopharmaceuticals in Berkeley and Santa
Monica, California. Medical targets include bacterial and fungal infections,
infectious complications (such as those that may follow trauma or surgery),
inflammatory and immunologic disorders. NEUPREX(R) is the first of several
products XOMA is developing from BPI (bactericidal/permeability-increasing
protein), a human protein and natural defense against infections. BPI was
discovered by Peter Elsbach, MD, and Jerrold Weiss, PhD, at New York University
School of Medicine. XOMA has collaborated with NYU since 1991 to extend and
apply BPI-related research to commercial pharmaceutical development.
Additionally, XOMA is collaborating with Genentech to develop an antibody,
anti-CD11a (hu1124), soon to enter Phase III studies in moderate-to-severe
psoriasis and Phase I in kidney transplant patients.
Statements made in this press release relating to the timing of clinical trials
and other aspects of product development, regulatory approvals, 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 which
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 the Company's collaborative
relationships, and actions by the U.S. Food and Drug Administration or the U.S.
Patent and Trademark Office, are discussed in the Company's most recent annual
report on Form 10-K and in other SEC filings. Consider such risks carefully in
evaluating XOMA's prospects.
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