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

Qutenza(TM) Receives Positive Committee Recommendation in European Union

Corporate Highlights:

- CHMP issued positive opinion recommending approval of Qutenza(TM) (formerly NGX-4010) for treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other medicinal products for pain

- Qutenza NDA accepted for review by U.S. FDA for PHN

Upcoming 2009 Milestones:

- European commercial partnership for Qutenza anticipated first half of 2009

- European Commission decision on MAA for Qutenza for the treatment of peripheral neuropathic pain in non-diabetic adults alone or in combination with other medicinal products for pain anticipated first half of 2009

- FDA PDUFA date of August 16, 2009 for Qutenza NDA to manage pain associated with PHN

SAN MATEO, Calif., March 20 /PRNewswire-FirstCall/ -- NeurogesX, Inc. (Nasdaq: NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, today reported results for the fourth quarter and full year ended December 31, 2008 and provided an update on recent developments.

During 2008, NeurogesX continued to make significant progress on the regulatory front in the United States and Europe. In October 2008, the Company submitted a new drug application (NDA) on schedule to the U.S. Food and Drug Administration (FDA) requesting marketing approval of Qutenza for the management of pain associated with postherpetic neuralgia (PHN). In December 2008, the NDA was accepted by the FDA for review, resulting in a Prescription Drug User Fee Act (PDUFA) date of August 16, 2009.

Regarding the European regulatory process for Qutenza, on March 19, 2009, the Committee for Medicinal Products for Hu
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SOURCE NeurogesX, Inc.
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