XOMA Reviews Priorities for 2010 and 2009 Accomplishments
BERKELEY, Calif., Jan. 19, 2010 (GLOBE NEWSWIRE) -- XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, today provided a summary of its priorities for 2010 and accomplishments during 2009.
"In 2009, we continued to advance our lead product candidate, XOMA 052, an antibody to interleukin-1 beta (IL-1 beta), into Phase 2 development as a potentially paradigm-shifting anti-inflammatory approach to the treatment of Type 2 diabetes and cardio-metabolic diseases," said Steven B. Engle, XOMA's Chairman and Chief Executive Officer. "Most significantly, we expanded the XOMA 052 program beyond our focus on diabetes to cardiovascular disease. This expansion was supported by results from our Phase 1 trials demonstrating benefit in biomarkers of cardiovascular disease, animal studies evaluating XOMA 052 in cardio-metabolic disease models, and studies with other IL-1 targeting agents that have shown the potential for cardiovascular benefit from IL-1 inhibition, some results of which are expected to be presented at the American College of Cardiology meeting in March."
Priorities for 2010
-- Report interim results from an 80 patient, Phase 2a trial of XOMA 052 in
Type 2 diabetes with 60 patients on drug and 20 patients on placebo. In
this trial, 60 patients receive the same dose of XOMA 052 during the
first three months and then are randomized to an additional three months
of treatment at the same, a higher or a lower dose, or placebo.
-- Conduct a Phase 2a XOMA 052 cardio-metabolic trial to further define its
potential cardiovascular benefit.
-- Initiate a 325 patient Phase 2b dose-ranging trial based upon the
availability of adequate resources.
-- Pursue a partnership for the development and commercialization of XOMA
052.
-- Publish results from completed XOMA 052 Phase 1 trials and preclinical
studies and present the results at American Diabetes Association
Scientific Sessions and at other medical meetings.
-- Enter into new antibody phage display library and other technology
collaboration agreements.
-- Increase biodefense revenue to $20 million or more, with a potential IND
filing for the XOMA 3AB anti-botulism antibody.
-- Advance the proprietary preclinical pipeline.
2009 Accomplishments
XOMA 052 and Proprietary Pipeline
-- Initiated XOMA 052 Phase 2 development program focused on Type 2
diabetes and cardiovascular disease.
-- Successfully completed the XOMA 052 Phase 1 development program, which
enrolled 98 Type 2 diabetes patients, of whom 81 received active drug
and 17 received placebo. The trial evaluated single dose intravenous and
subcutaneous administration and multi-dose subcutaneous administration
of XOMA 052. The results demonstrated that XOMA 052 is well tolerated at
all doses evaluated with a pharmacokinetic profile that supports monthly
or less frequent dosing. Further, a multiple dose regimen of XOMA 052
showed clinically meaningful reductions in diabetic measures and
cardiovascular and inflammatory biomarkers. Results were presented at
the American Diabetes Association and the International Diabetes
Federation meetings.
-- Presented results demonstrating the potential of XOMA 052 in animal
models of cardiovascular disease in which significantly reduced plaque
formation in the aorta and trends toward improved lipid profiles with a
murine version of XOMA 052 were shown, compared to control. In another
study, mice treated with XOMA 052 had a statistically significant
reduction in total cholesterol without reduction in high density
lipoprotein, as well as a reduction in triglycerides and free fatty
acids compared to control.
-- At the European Association for the Study of Diabetes annual meeting in
September, XOMA reported results demonstrating that XOMA 052 regulates
IL-1 beta signaling, reducing pathologically high levels that cause
disease while allowing normal and beneficial low levels. This regulatory
mechanism of action for XOMA 052 differs from some antibodies to IL-1
which are designed to completely block all contact between target and
receptor, and if shown in clinical studies, may confer safety advantages
in chronic diseases including diabetes and cardiovascular diseases.
-- Conducted reviews of the XOMA 052 clinical and preclinical results and
planned programs with internationally recognized opinion leaders in
diabetes and cardiovascular disease.
-- Announced Phase 2 trial in Type 1 diabetes funded by the Juvenile
Diabetes Research Foundation.
-- Received U.S. and European patents covering XOMA 052 expiring in 2027
and 2026, respectively.
-- Advanced additional preclinical development candidates in
cardio-metabolic and inflammatory diseases and oncology.
Technology Licensing, Collaboration Agreements and Royalty Revenue
-- Revenues from technology licensing and collaboration agreements totaled
$48 million through September 30, 2009. In addition, the company
announced a total of $14 million in revenue late in the year as a result
of additional agreements.
-- Royalty revenue was $28.9 million through September 30, 2009, and
included a $25 million prepayment by Genentech for XOMA's royalty
interest in LUCENTIS(TM).
Biodefense
-- Advanced XOMA 3AB, an anti-botulism antibody, into pre-IND studies.
-- Obtained $3.9 million in new government contracts for the development of
antibodies to the H1N1/H5N1 and SARS viruses.
-- Presented new XOMA technology for the development and evaluation of
multiple antibody "cocktail" formulations.
Financial
-- Revenues in the nine months ended September 30, 2009 were $76.8
million.
-- Strengthened balance sheet through full repayment of a loan from Goldman
Sachs Specialty Lending Holdings, Inc.
-- As a result of the company's improved financial status and in particular
the full repayment of the outstanding loan, at XOMA's request, its
independent registered public accounting firm removed a qualification
regarding XOMA's ability to continue as a going concern in an updated
report on its financial statements for the fiscal year ended December
31, 2008.
-- Completed a restructuring of the organization in January 2009 which
resulted in annualized cost savings of approximately $27 million.
About XOMA
XOMA discovers, develops and manufactures novel antibody therapeutics for its own proprietary pipeline as well as through license and collaborative agreements with pharmaceutical and biotechnology companies, and under its contracts with the U.S. government. The company's proprietary product pipeline includes:
-- XOMA 052, an anti-IL-1 beta antibody in Phase 2 clinical development for
Type 2 diabetes, Type 1 diabetes and cardiovascular disease, with
potential for the treatment of a wide range of inflammatory
conditions.
-- XOMA 3AB, an antibody candidate in pre-IND studies to neutralize the
botulinum toxin, among the most deadly potential bioterror threats,
under development through funding provided by the National Institute of
Allergy and Infectious Diseases of the National Institutes of Health
(Contract # HHSN266200600008C).
-- A preclinical pipeline with candidates in development for several
diseases.
In addition to its proprietary pipeline, XOMA develops products with premier pharmaceutical companies including Novartis AG, Merck & Co., Inc. and Takeda Pharmaceutical Company Limited.
XOMA's technologies have contributed to the success of marketed antibody products, including LUCENTIS(r) (ranibizumab injection) for wet age-related macular degeneration and CIMZIA(r) (certolizumab pegol) for rheumatoid arthritis and Crohn's disease.
The company has a premier antibody discovery and development platform that incorporates an unmatched collection of antibody phage display libraries and proprietary Human Engineering(tm), affinity maturation, Bacterial Cell Expression (BCE) and manufacturing technologies. BCE is a key breakthrough biotechnology for the discovery and manufacturing of antibodies and other proteins. As a result, more than 50 pharmaceutical and biotechnology companies have signed BCE licenses, and several licensed product candidates are in clinical development.
XOMA has a fully integrated product development infrastructure, extending from pre-clinical science to approval, and a team of about 200 employees at its Berkeley, California location. For more information, please visit http://www.xoma.com.
The XOMA Ltd. logo is available at https://www.globenewswire.com/newsroom/prs/?pkgid=5960
Forward-Looking Statements
Certain statements contained herein concerning timing of initiation of or availability of results of clinical trials, entry into a XOMA 052 development partnership or potential licensing and collaboration arrangements or 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.
Among other things, the timing of initiation or availability of results of clinical trials may be delayed or may never occur as a result of unavailability of resources, actions or inaction by our present or future collaboration partners, insufficient enrollment in such trials or unanticipated safety issues; and a XOMA 052 partnership or other licensing or collaboration arrangements may not be entered into in the timeframes indicated or at all.
These risks, including those related to inability to comply with NASDAQ's continued listing requirements, the generally unstable nature of current economic conditions; the results of discovery and 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 existing collaborative relationships; the ability of collaborators and other partners to meet their obligations; XOMA's ability to meet the demands of the United States government agency with which it has entered into its government contracts; competition; market demands for products; scale-up and marketing capabilities; availability of additional licensing or collaboration opportunities; international operations; share price volatility; XOMA's financing needs and opportunities; uncertainties regarding the status of biotechnology patents; uncertainties as to the costs of protecting intellectual property; and risks associated with XOMA's status as a Bermuda company, are described in more detail in XOMA's most recent filing on Form 10-K and in other SEC filings. Consider such risks carefully when considering XOMA's prospects.
CONTACT: XOMA Ltd.
Investor Contact:
Carol DeGuzman
510-204-7270
deguzman@xoma.com
Porter Novelli Life Sciences
Media Contact:
Carolyn Hawley
619-849-5375
chawley@pnlifesciences.com
Released January 19, 2010
