NeurogesX Reports Second Quarter 20...(rtnership with Astellas fulfilled an imp...)

Date:8/7/2009

rtnership with Astellas fulfilled an important part of our global commercialization strategy by providing for the commercialization of Qutenza in Europe. In the U.S., the PDUFA date extension for Qutenza in PHN was not unexpected given the recent data requests from the FDA. We believe this revised timeline allows us to stay on track, assuming an approval in November, for a potential U.S. launch of Qutenza in the first half of 2010. The NeurogesX team has performed exceptionally, both in responding to agency requests and successfully navigating the European regulatory processes to gain marketing approval in the European Union. Our timeliness in responding to FDA requests has allowed for what we view as a favorable result with only a three-month extension to our PDUFA date. With Astellas as our partner, we are confident in its ability to effectively launch Qutenza in the European Union and we are now focusing our resources on the potential for U.S. commercialization as our PDUFA date approaches."

Second Quarter 2009 Financial Results

Total operating expenses for the second quarter of 2009 were approximately $5.4 million, down 23% from approximately $7.0 million in the same period of 2008. The decrease was primarily attributed to a decline of approximately $1.4 million in research and development costs. During the second quarter of 2009, NeurogesX conducted the FDA-requested Study C123 in support of the NDA for Qutenza in PHN, but continued to defer non-clinical and clinical expenses for all other development programs in order to focus on activities related to regulatory reviews in the United States and European Union.

Net loss for the second quarter of 2009 was approximately $5.4 million, compared to a net loss of approximately $6.9 million for the second quarter of 2008. Net loss per share attributable to common stockholders was $0.31 per share and $0.40 per share for the three months ended Ju
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SOURCE NeurogesX, Inc. Copyright©2009 PR Newswire. All rights reserved

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