NeurogesX Reports Second Quarter 20...(n near-term development activities inclu...)

Date:8/7/2009

n near-term development activities, including EU post-marketing studies of Qutenza and the further evaluation of NGX-1998. Qutenza was approved in Europe with the condition that NeurogesX will complete post-marketing studies, including an open-label safety study in on-label indications of peripheral neuropathic pain in non-diabetic adults, either alone or in combination with other medicinal products for pain. Under the agreement with Astellas, EU post-marketing commitments will be funded and conducted by Astellas.

In addition to funding post-marketing studies for Qutenza, the agreement with Astellas included an option fee of EUR 5 million (approximately $7 million) as an upfront payment to accelerate development of NGX-1998 as part of the co-development and commercialization option for NGX-1998. NeurogesX is currently evaluating the design and timing of further development efforts for this program. The decision to license NGX-1998 by Astellas is subject to their option right under the agreement. If Astellas retains and exercises such option right, they would be required to pay further payments to NeurogesX. In addition, if such option is exercised, the companies would collaborate on Phase 3 clinical development.

NeurogesX is also seeking business development partners to advance its acetaminophen and opioid prodrug product candidates.

• NGX-9674 and NGX-5752, novel prodrugs of acetaminophen, have been evaluated in in vivo and in vitro preclinical studies and have demonstrated approximately 10 times greater solubility in water versus acetaminophen.
• NGX-1576, a novel prodrug coupling acetaminophen to a liver protectant, has been evaluated in vitro and in vivo. Equivalent dose levels of NGX-1576 in mice produced significantly less liver toxicity than acetaminophen, while additional data demonstrated the production of equivalent plasma levels of acetaminophen. <
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SOURCE NeurogesX, Inc. Copyright©2009 PR Newswire. All rights reserved

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