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NeurogesX Announces Preliminary Results from Second Phase 3 Clinical Trial in HIV-DSP
Date:2/27/2008

ain. The Company has previously completed three Phase 3 studies in PHN, of which two met their primary endpoint. In those studies, a single, 60-minute treatment with NGX- 4010 applied directly to the site of pain reduced pain for up to 12 weeks. In addition to being studied in PHN, NGX-4010 was also studied in a successful Phase 3 clinical trial in painful HIV-DSP.

Regulatory and Commercialization Plans for NGX-4010

NeurogesX submitted an MAA, 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 painful diabetic neuropathy (PDN), among others. The Company is evaluating strategies regarding its MAA that may include adding to the dossier the Company's second successful Phase 3 study in PHN and this most recent study in HIV-DSP to potentially support a broad label approval, or potentially a subset of indications. The Company expects to submit an NDA with the FDA in the second half of 2008 for PHN and will discuss with the agency the path forward for attaining approval for HIV- DSP.

NeurogesX has retained 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.

Conference Call and Webcast Information

A conference call to review the results of the C119 trial will begin at 5:00 p.m. EST (2:00 p.m. PST) on February 27, 2008 and will be hosted by Anthony DiTonno, President and Chief Executive Officer, Jeffrey Tobias, Chief Medical Officer, and Stephen Ghiglieri, Chief Financial Officer.

The conference call dial-in numbers are 1-877-407-0789 (USA) or 1-201-689-8562 (International). In addition, a dial-up repla
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SOURCE NeurogesX, Inc.
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