XOMA's NEUPREX(R) Granted Orphan Status in Europe; XOMA Proceeding With Marketing Assessment.BERKELEY, Calif. -- XOMA Ltd (Nasdaq:XOMA) announced today that the European Commission European Commission, branch of the governing body of the European Union (EU) invested with executive and some legislative powers. Located in Brussels, Belgium, it was founded in 1967 when the three treaty organizations comprising what was then the European Community has granted an orphan medicinal product medicinal product, n a substance administered to humans or animals through injection, application, oral ingestion, inhalation, and so forth, whose purpose is to ultimately restore health or eliminate disease in an individual. designation to XOMA's drug NEUPREX(R) (opebacan) in meningococcal disease, a potentially life-threatening bacterial infection predominantly affecting young children. XOMA is currently completing the regulatory assessment for NEUPREX(R) under the European Medicines Agency's (EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. ) exceptional circumstances mechanism and plans to base its application on existing phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the data for NEUPREX(R). "Meningococcal disease is a life-threatening condition with a large unmet medical need, and we are very pleased with the European Commission's orphan designation for NEUPREX(R)," said Jack Castello, chairman of the board, president, and chief executive officer of XOMA. "We are proceeding as quickly as possible with our marketing assessment for the drug in Europe, and we are going to be working closely with the EMEA to determine whether the extensive NEUPREX(R) clinical trials database will be sufficient to support a marketing authorization in Europe." Orphan Medicinal Product Designation The European orphan designation for NEUPREX(R) provides XOMA with several important advantages prior to and after a marketing approval for the drug: --No-cost formal scientific advice through the Scientific Advice Working Party --Reduced marketing authorization fees --Ten year market exclusivity upon marketing authorization Approval Under Exceptional Circumstances Approval under exceptional circumstances provides a pathway for marketing authorization where the applicant is unable to provide comprehensive data on efficacy and safety under normal conditions
tr.v. ob·vi·at·ed, ob·vi·at·ing, ob·vi·ates To anticipate and dispose of effectively; render unnecessary. See Synonyms at prevent. extensive additional clinical trials in this rare disease fit within the intent of this European legislation. Based on this understanding, XOMA is now completing its regulatory assessment for this approval pathway for NEUPREX(R) in Europe. XOMA has also held meetings with key opinion leaders and confirmed their continuing interest in the clinical use of opebacan based on its extensive safety database, the results from the phase III clinical trial in meningococcal disease and the ongoing unmet therapeutic need for this life-threatening condition. Approval under exceptional circumstances may include post-approval commitments to allow for periodic reassessment of the safety of the product. XOMA's next step in the exceptional circumstances regulatory process is to obtain formal scientific advice from EMEA concerning the suitability of the existing NEUPREX(R) data in supporting a marketing authorization application. XOMA plans to complete its regulatory assessment for Europe in the first quarter of 2007. About Meningococcal Disease Meningococcal disease is an infection of the blood caused by the gram-negative bacterium Neisseria meningitidis Neisseria men·in·git·i·dis n. The bacteria that is the causative agent of cerebrospinal meningitis; meningococcus. Neisseria meningitidis , and is one of the few diseases that can kill an otherwise healthy child within hours. The disease is characterized by very rapid onset of life-threatening symptoms with high mortality. In survivors, gangrene gangrene, local death of body tissue. Dry gangrene, the most common form, follows a disturbance of the blood supply to the tissues, e.g., in diabetes, arteriosclerosis, thrombosis, or destruction of tissue by injury. and associated amputations and/or central nervous system damage are common morbidities. Although the bacteria that cause meningococcal disease are generally controlled by first-line antibiotics, there is no current treatment for the toxic inflammatory cascade triggered by bacterial endotoxin Endotoxin A biologically active substance produced by bacteria and consisting of lipopolysaccharide, a complex macromolecule containing a polysaccharide covalently linked to a unique lipid structure, termed lipid A. that can lead to organ failure, shock and death. 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(R) (efalizumab), a monoclonal antibody monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing 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 Novartis AG Swiss pharmaceutical company. It was formed through the 1996 merger of two Swiss firms: Ciba (see Ciba-Geigy) and Sandoz, a chemical company with interests in pharmaceuticals, nutrition, and agriculture. ) to treat neovascular (wet) age-related macular degeneration Age-related macular degeneration (ARMD) Degeneration of the macula (the central part of the retina where the rods and cones are most dense) that leads to loss of central vision in people over 60. . The company has built a premier antibody discovery and development platform that includes access to seven of the leading commercially available antibody phage display phage display n. A technique using recombinant DNA technology to create bacteriophages with a desired peptide embedded in the surface of their protein shells. libraries and XOMA's proprietary Human Engineering(TM) and bacterial cell expression (BCE BCE abbr. 1. Bachelor of Chemical Engineering 2. Bachelor of Civil Engineering BCE Abbreviation for before the Common Era. ) 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 success at obtaining a marketing approval for NEUPREX(R) in Europe. Such 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 FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. , 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 Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. and in other SEC filings. Consider such risks carefully in considering XOMA's prospects. |
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