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NeurogesX Reports Fourth Quarter and Year-End 2008 Results
Date:3/20/2009

man Use (CHMP) of the European Medicines Agency (EMEA) issued a positive opinion recommending approval of the marketing authorization application (MAA) for Qutenza for the treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other medicinal products for pain. The MAA, filed under the centralized procedure, is subject to a final decision by the European Commission on the CHMP's recommendation. This decision is usually rendered approximately 60 to 90 days from the date of the CHMP's recommendation.

Anthony DiTonno, President and CEO, commented, "With the final European Commission decision expected within the next 60 to 90 days, and a U.S. marketing application under review, we believe that we are closer than ever before to becoming a commercial enterprise. We are pleased with the proposed label for Qutenza in the European Union, which includes all peripheral neuropathic pain conditions in non-diabetic adults either alone or in combination with other medicinal products for pain and supports our goal of finalizing a commercial partnership for the European Union during the first half of 2009. In the United States our NDA for Qutenza was accepted and is currently under review by the FDA for the PHN indication, with a scheduled PDUFA date of August 16, 2009. We continue to plan for the potential U.S. commercialization of Qutenza. Both our U.S. and European commercial strategies continue to focus on maximizing the value of Qutenza, and we are excited about the upcoming events for the coming year."

Fourth Quarter and Year-End 2008 Financial Results

Total operating expenses for the fourth quarter of 2008 were approximately $4.7 million and for the year ended December 31, 2008 were approximately $26.3 million, compared to approximately $8.1 million and $32.8 million in the same periods of 2007, respectively. The year-over-year decreases in operating expenses of 42% and 20% in the
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SOURCE NeurogesX, Inc.
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