Healthcare Industry News: XOMA
News Release - September 6, 2006
XOMA's NEUPREX(R) Granted Orphan Status in EuropeXOMA Proceeding With Marketing Assessment
BERKELEY, Calif.--(HSMN NewsFeed)--Sept. 6, 2006--XOMA Ltd (Nasdaq:XOMA ) announced today that the European Commission has granted an orphan medicinal product designation to XOMA's drug NEUPREX® (opebacan) in meningococcal disease, a potentially life-threatening bacterial infection predominantly affecting young children. XOMA is currently completing the regulatory assessment for NEUPREX® under the European Medicines Agency's (EMEA) exceptional circumstances mechanism and plans to base its application on existing phase III clinical trial data for NEUPREX®.
"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®," 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® clinical trials database will be sufficient to support a marketing authorization in Europe."
Orphan Medicinal Product Designation
The European orphan designation for NEUPREX® 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 provides a pathway for marketing authorization where the applicant is unable to provide comprehensive data on efficacy and safety under normal conditions of use. The EMEA has indicated that the information already available about NEUPREX® and the circumstances for obviating 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® 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® 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, 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 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 that can lead to organ failure, shock and death.
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 success at obtaining a marketing approval for NEUPREX® 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, 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.
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