XOMA 052 Orphan Drug Designation for Behcet's Disease Recommended by European Medicines Agency
BERKELEY, Calif., July 29, 2010 (GLOBE NEWSWIRE) -- XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced that the Committee for Orphan Medical Products of the European Medicines Agency (EMA) has adopted a positive opinion and recommends the granting of orphan medicinal product designation for XOMA 052, an antibody to interleukin-1 beta, for the treatment of Behcet's disease. Positive opinions are submitted to the European Commission for decision and are generally adopted within 30 days of receipt.
The EMA's orphan drug program is designed to promote the development of drugs to treat life-threatening or chronically debilitating conditions with a prevalence of up to five in 10,000 persons in the European Union (EU). The designation provides EU market exclusivity for up to ten years following approval for the given indication. Other potential benefits include protocol assistance, direct access to centralized marketing authorization procedures and financial incentives.
In June 2010, XOMA announced positive results from an open-label pilot study of XOMA 052 in Behcet's disease patients who were suffering from vision-threatening disease exacerbations, known as uveitis, despite maximal doses of immunosuppressive medicines. All seven patients who enrolled in the trial displayed rapid reduction of intraocular inflammation and improvement in visual acuity or other ophthalmic measures following a single treatment with XOMA 052. Five patients received a second infusion to blunt a developing exacerbation, and all responded to the second infusion. The drug appeared to be safe, and no drug-related adverse events were reported. Preliminary results were presented at the Annual Congress of the European League Against Rheumatism (EULAR) in Rome, Italy and at the International Congress on Behcet's Disease in London earlier this month.
About Behcet's Disease
Behcet's (pronounced beh-CHETS) disease is an orphan disease that causes chronic inflammation of the blood vessels, or vasculitis. Major symptoms can affect the neurological, pulmonary, gastrointestinal and cardiovascular systems, and hallmarks of the disease include uveitis, or inflammation of the intraocular tissues of the eye, and painful ulcers in the mouth and on the genitals. Behcet's disease most commonly affects men and women in their twenties, thirties and forties, and it is typically more severe in men. More than 12,000 patients in the EU are estimated to suffer from Behcet's disease.
About XOMA 052
XOMA 052 is a potent monoclonal antibody with the potential to improve the treatment of patients with a wide variety of inflammatory diseases. XOMA 052 binds strongly to interleukin-1 beta (IL-1 beta), a pro-inflammatory cytokine involved in diseases including Type 2 diabetes, cardiovascular disease, rheumatoid arthritis, gout and auto-inflammatory diseases. IL-1 is a well-validated therapeutic target, with three marketed IL-1 inhibitors that have been used by more than 200,000 patients overall. By binding to IL-1 beta, XOMA 052 inhibits the activation of the IL-1 receptor, thereby preventing the cellular signaling events that produce inflammation.
XOMA is conducting two Phase 2 clinical trials of XOMA 052 in patients with Type 2 diabetes and a Phase 2 trial in Type 1 diabetes and has completed a Phase 2 clinical trial in uveitis of Behcet's disease. The Phase 2 trials follow a successful 98 patient Phase 1 program in Type 2 diabetes patients in which XOMA 052 was shown to be well-tolerated, demonstrated evidence of biological activity in diabetes measures and cardiovascular biomarkers, and had a half-life that may provide convenient dosing of once per month or less frequently. The company has also demonstrated the potential for XOMA 052 in in vivo models of atherosclerosis and cardiac remodeling and in an in vitro model using human myeloma, or plasma cell cancer, cells.
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 with cardiovascular biomarkers, Type 1 diabetes, and
with potential for the treatment of a wide range of inflammatory
conditions. XOMA 052 also has demonstrated positive clinical benefit in
a proof-of-concept trial for the treatment of vision-threatening uveitis
of Behcet's disease.
-- 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, Schering Corporation, a subsidiary of 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, 60 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 215 employees at its Berkeley, California location. For more information, please visit http://www.xoma.com.
Forward-Looking Statements
Certain statements contained herein concerning product development and capabilities of XOMA's technologies 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 inability to comply with NASDAQ's continued listing requirements; the generally unstable nature of current economic conditions; the results of discovery research 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 and licensing relationships; the ability of collaborators, licensees and other third parties 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.
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CONTACT: XOMA Ltd.
Company and Investor Contact:
Carol DeGuzman
510-204-7270
deguzman@xoma.com
Canale Communications
Media Contact:
Carolyn Hawley
619-849-5375
carolyn@canalecomm.com
Released July 29, 2010