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NeurogesX Reports Fourth Quarter and Year-End 2007 Financial Results
Date:3/26/2008

rmulation product candidate, NGX-1998, in the first half of 2008."

Regulatory and Commercialization Plans for NGX-4010

NeurogesX submitted an MAA for NGX-4010, which was accepted by the EMEA under the centralized filing procedure in September 2007. The Company's MAA seeks approval in the European Union for a broad indication of peripheral neuropathic pain, which includes PHN, HIV-DSP and PDN, among others. The submission was based upon existing clinical trial data, which as of the date of the filing included the Company's first two successful Phase 3 studies, one each in PHN and HIV-DSP. NeurogesX is evaluating strategies regarding its MAA that may include adding to the dossier the Company's second successful Phase 3 study in PHN (C117) and its second Phase 3 study in HIV-DSP (C119), in which the primary endpoint was not met, to potentially support broad label approval, or approval of a subset of indications in neuropathic pain.

NeurogesX expects to submit an NDA for NGX-4010 with the FDA in the second half of 2008 for PHN. The Company is currently evaluating its clinical and regulatory strategies with regard to the HIV-DSP indication, including the potential for conducting additional studies to support an approval in this indication.

NeurogesX retains exclusive worldwide commercialization rights for NGX- 4010 and intends to establish a focused specialty sales force in the United States to address its target market of pain centers and physicians. NeurogesX intends to enter into commercial partnerships for marketing and distribution outside the United States.

Fourth Quarter and Year-End 2007 Financial Results

For the three months ended December 31, 2007, total operating expenses were approximately $8.1 million, including $0.3 million of non-cash stock- based compensation expense, compared to total operating expenses of approximately $9.3 million, including $2.0 million of non-cash stock-based compensation expense, for the sam
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SOURCE NeurogesX, Inc.
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