Navigation Links
NeurogesX Responds to EMEA's Day 120 Questions
Date:9/24/2008

Regulatory Plans on Track

SAN MATEO, Calif., Sept. 24 /PRNewswire-FirstCall/ -- NeurogesX, Inc. (Nasdaq: NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced today that it has responded on schedule to the European Medicines Agency's (EMEA) Day 120 questions to support the Marketing Authorization Application (MAA) for NGX-4010 in peripheral neuropathic pain.

NeurogesX' MAA for NGX-4010 in peripheral neuropathic pain was accepted for review by the EMEA in September 2007. The Day 120 questions and related responses are part of the agency's ongoing review process of the marketing application.

Anthony DiTonno, President and CEO, commented, "With the submission of our responses to the EMEA's Day 120 questions, we are pleased to reiterate that our regulatory timelines for NGX-4010 remain on track with respect to the MAA review in Europe and our plans to submit a new drug application to the FDA by year end."

About NeurogesX, Inc.

NeurogesX (Nasdaq: NGSX) is a biopharmaceutical company focused on developing and commercializing novel pain management therapies. Its initial focus is on chronic peripheral neuropathic pain, including postherpetic neuralgia (PHN), painful HIV-distal sensory polyneuropathy (HIV-DSP) and painful diabetic neuropathy (PDN). NeurogesX' late stage product portfolio is led by its product candidate NGX-4010, a dermal patch designed to manage pain associated with peripheral neuropathic pain conditions, that the Company believes offers significant advantages over other pain therapies. NeurogesX' marketing authorization application (MAA) to the European Medicines Agency (EMEA) was accepted for review in September 2007 and NeurogesX plans to file a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) in 2008 for PHN.

NeurogesX' second most advanced product candidate, NGX-1998, is a topically applied, liquid formulation containing a high concentration of capsaicin designed to treat pain associated with neuropathic pain conditions. NGX-1998 is currently in a Phase 1 clinical trial. The objective of the development program is to determine the ability of NGX-1998 to provide protracted pain relief from a single treatment. As a liquid, NGX-1998 is expected to be suitable for areas of the skin where dermal patches may be difficult or impractical to apply, such as the hairline. The goal of the NGX 1998 program is to develop a product that has the potential to be used by a broad spectrum of the physician population. NGX-1998 was previously studied in two Phase 1 studies in healthy volunteers conducted under an exploratory investigational new drug application.

Safe Harbor Statement

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). NeurogesX disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to, the expected timing of regulatory filings with respect to NeurogesX' product candidates, including for NGX-4010 the potential filing of an NDA; the timing of the completion of the Phase 1 clinical trial for NGX-1998; the potential markets for NeurogesX' product candidates and the expected benefits of NeurogesX' product candidates. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, NeurogesX' product candidates may have unexpected adverse side effects or inadequate therapeutic efficacy; positive results in clinical trials may not be sufficient to obtain FDA or European regulatory approval; any regulatory approvals which are received may be limited to certain indications; physician or patient reluctance to use NGX-4010 or NGX-1998, if approved, or the inability of physicians to obtain sufficient reimbursement for such procedures; potential alternative therapies; maintaining adequate patent or trade secret protection without violating the intellectual property rights of others; and other difficulties or delays in, clinical development, obtaining regulatory approval, market acceptance and commercialization of NeurogesX' product candidates and the advantages of NeurogesX' product candidates over other pain therapies. For further information regarding these and other risks related to NeurogesX' business, investors should consult NeurogesX' filings with the Securities and Exchange Commission.

NeurogesX, Inc.

Stephen Ghiglieri

Chief Financial Officer

(650) 358-3310

The Ruth Group

Stephanie Carrington / Sara Ephraim (investors)

(646) 536-7017 / 7002

scarrington@theruthgroup.com

sephraim@theruthgroup.com

Jason Rando (media)

(646) 536-7025

jrando@theruthgroup.com


'/>"/>
SOURCE NeurogesX, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. NeurogesX to Present at BioCenturys NewsMakers in the Biotech Industry Conference
2. NeurogesX Appoints New Director to the Board
3. NeurogesX to Present at UBS 2007 Global Life Sciences Conference
4. NeurogesX Expands Senior Management Team
5. NeurogesX to Present at CIBC World Markets 18th Annual Healthcare Conference and Acumen BioFin Rodman & Renshaw 9th Annual Healthcare Conference
6. NeurogesX to Present at Lazard Capital Markets Healthcare Conference
7. NeurogesX, Inc. Announces $25 Million Private Placement
8. NeurogesX Closes $25 Million Private Placement
9. NeurogesX to Present at the 10th Annual BIO CEO & Investor Conference
10. NeurogesX to Present at Roth 2008 OC Growth Stock Conference
11. NeurogesX to Report Fourth Quarter and Year-End 2007 Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/10/2016)... Feb. 10, 2016  IsoRay, Inc. (NYSE MKT: ISR), ... and medical radioisotope applications for the treatment of prostate, ... announced its financial results for the second quarter and ... 2015. --> --> ... of fiscal 2016, which ended December 31, 2015, a ...
(Date:2/10/2016)... 2016  Matchbook, Inc., a company specializing in ... companies, announced today the appointment of Jim ... brings nearly 25 years of experience in supply ... nearly two decades in executive level roles as ... Genzyme and, most recently headed global logistics and ...
(Date:2/10/2016)... ... February 10, 2016 , ... HOLLOWAY AMERICA, a ... Engineering (ISPE) Rocky Mountain Chapter 21st Annual Vendor Exhibition on Thursday, February 18, ... 100 tables for its annual event, which will run from 3:00 p.m. - ...
(Date:2/10/2016)... ... February 10, 2016 , ... SonaCare Medical, LLC reports the ... Sonalinkā„¢ remote monitoring. The inaugural launch of this new technology occurred over the ... Samuel Peretsman to a HIFU technical expert at SonaCare Medical headquarters. , ...
Breaking Biology Technology:
(Date:2/1/2016)... Canada , February 1, 2016 ... technological advancements to drive global touchfree intuitive gesture control ... --> Rising sales of consumer electronics coupled ... gesture control market size through ... consumer electronics coupled with new technological advancements to drive ...
(Date:2/1/2016)... 1, 2016  Wocket® smart wallet ( www.wocketwallet.com ) announces the launch ... Joey Fatone . Las Vegas , where Joey ... --> Las Vegas , where Joey appeared at the ... new video ad was filmed at the Consumer Electronics Show (CES2016) in ... booth to meet and greet fans. --> ...
(Date:1/27/2016)... CHESTER, Ohio , Jan. 27, 2016  Rite ... supplier based in West Chester, Ohio ... their award winning service staff, based in ... technical capacity and ability to provide modifications, installations and ... John Dovalina , CEO of PLUS, commented, "PLUS has ...
Breaking Biology News(10 mins):