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NeurogesX Reports Third Quarter 2009 Results
Date:11/6/2009

SAN MATEO, Calif., Nov. 6 /PRNewswire-FirstCall/ --

3Q09 Corporate Highlights:

  • Completed transfer of Qutenza(TM) E.U. Marketing Authorization to Astellas Pharma Europe Ltd.
  • Made significant progress in commercial readiness activities
  • Expanded management team to include VP Sales; Senior Director, Marketing; and Director, Commercial Operations
  • Appointed Bradford S. Goodwin to board as director and Audit Committee chairman

Upcoming 2009 Milestones:

  • FDA PDUFA date November 16, 2009 for Qutenza NDA to manage pain associated with PHN

NeurogesX, Inc. (Nasdaq: NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, today reported results for the third quarter ended September 30, 2009.

During the third quarter of 2009, NeurogesX prioritized three key initiatives: 1) supporting the ongoing U.S. Food and Drug Administration (FDA) review of the new drug application (NDA) for Qutenza for postherpetic neuralgia (PHN), 2) preparing for potential commercial launch of Qutenza in the United States pending FDA approval and 3) supporting Astellas Pharma Europe Ltd., the commercial partner for Qutenza in Europe, the Middle East and Africa, in their efforts to prepare for a Qutenza launch in the European Union in 2010.

In the U.S., NeurogesX is currently awaiting a decision from FDA regarding its NDA for Qutenza to manage pain associated with PHN. The agency has assigned an extended Prescription Drug User Fee Act (PDUFA) date of November 16, 2009. In preparation for the possible approval and subsequent planned launch of Qutenza in the United States in the first half of 2010, the Company continued to make significant advances in a number of key product laun
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SOURCE NeurogesX
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Related biology technology :

1. NeurogesX to Present at Two November Conferences
2. NeurogesX to Present at UBS Global Life Sciences Conference
3. NeurogesX to Present at Upcoming Fall Conferences
4. NeurogesX Appoints New Board Director and Audit Committee Chairman
5. NeurogesX Reports Second Quarter 2009 Results
6. NeurogesX Announces New PDUFA Date for Qutenza(TM) New Drug Application
7. NeurogesX to Hold Conference Call to Discuss Second Quarter 2009 Financial Results
8. NeurogesX Added to Russell 3000 Index
9. NeurogesX Provides U.S. Regulatory Update for Qutenza(TM)
10. NeurogesX to Present at Needham Life Sciences Conference
11. NeurogesX Receives European Commission Approval for Qutenza(TM)
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