BERKELEY, Calif.--(BUSINESS WIRE)--Sept. 7, 2006--XOMA Ltd. (Nasdaq:XOMA - News) today announced successful results with a research formulation of XOMA 629 (formerly XMP.629). XOMA has initiated a development program with the goal of reentering clinical trials of the topically-applied reformulated drug in mild to moderate acne in 2007.
“After evaluating the results of our earlier Phase II clinical trial in 253 patients and after conducting additional laboratory work, we concluded that a reformulation of our original gel was needed to increase its skin penetration and improve other characteristics,” said John L. Castello, chairman of the board, president and chief executive officer. “We have conducted additional testing on research formulations of XOMA 629 and are happy to report that we have developed a reformulation that meets our criteria for skin penetration and anti-microbial activity.”
XOMA is currently conducting preclinical studies to optimize the reformulated product, with the goal of amending its Investigational New Drug application and initiating Phase I clinical trials in 2007. “While we will have to start at Phase I with our reformulated product, the path to approval of topical preparations in acne is well established and our experience in this indication should allow us to expedite development significantly,” remarked Mr. Castello.
About XOMA 629
XOMA 629 is a novel synthetic peptide compound derived from bactericidal/permeability-increasing protein (BPI) -- a human host-defense protein that is part of the body’s early lines of defense against invading microorganisms. In preclinical studies, XOMA 629 has shown potent anti-bacterial activity against P. acnes, believed to be the major causative agent in acne. XOMA 629 also has shown similar activity against antibiotic-resistant strains of P. acnes, including strains resistant to other antibiotics such as erythromycin or clindamycin.
About Acne
According to the American Academy of Dermatology, acne affects nearly 100% of adolescents and nearly half of adults over 25 in the U.S. Various sources estimate that 15-40% of Americans seek medical treatment for acne by their mid teens. It is estimated that every year, five million prescriptions for oral antibiotics are dispensed for acne treatment in the U.S.
About XOMA
XOMA is a leader in the discovery, development and manufacture of therapeutic antibodies, with a therapeutic focus that includes cancer and immune diseases. XOMA has royalty interests in RAPTIVA® (efalizumab), a monoclonal antibody product marketed worldwide (by Genentech, Inc. and Serono, SA) to treat moderate-to-severe plaque psoriasis, and LUCENTIS(TM) (ranibizumab injection), a monoclonal antibody product marketed worldwide (by Genentech and Novartis AG) to treat neovascular (wet) age-related macular degeneration.
The company has built a premier antibody discovery and development platform that includes access to seven of the leading commercially available antibody phage display libraries and XOMA’s proprietary Human Engineering(TM) and bacterial cell expression (BCE) technologies. More than 45 companies have signed BCE licenses. XOMA’s development collaborators include Lexicon Genetics, Inc., Novartis, and Schering-Plough Corporation. With a fully integrated product development infrastructure, XOMA’s product development capabilities extend from preclinical sciences to product launch. For more information, please visit the company’s website at www.xoma.com.
Certain statements contained herein concerning 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. Such statements include, but are not limited to XOMA’s goal of entering clinical trials in 2007, and the possibility that XOMA will expedite development of XOMA 629 significantly. 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 discovery research and preclinical 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); uncertainties regarding the status of biotechnology patents; uncertainties as to the cost of protecting intellectual property; changes in the status of the existing collaborative and licensing relationships; the ability of collaborators, licensees and other third parties to meet their obligations; market demand for products; scale up and marketing capabilities; competition; international operations; share price volatility; XOMA’s financing needs and opportunities and risks associated with XOMA’s status as a Bermuda company, are described in more detail in XOMA’s most recent annual report on Form 10-K and in other SEC filings. Consider such risks carefully in considering XOMA’s prospects.
Contact: XOMA Ltd. Paul Goodson, 510-204-7270 (Investor Relations) goodson@xoma.com
Source: XOMA Ltd.
