Qutenza(TM) (NGX-4010) Receives Positive Committee Recommendation in European Union
SAN MATEO, Calif., March 19 /PRNewswire-FirstCall/ -- NeurogesX, Inc. , a biopharmaceutical company focused on developing and commercializing novel pain management therapies, today announced it will hold a conference call on Friday, March 20, 2009 at 9:00 a.m. ET (6:00 a.m. PT) to discuss fourth quarter and year-end 2008 results and the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) positive opinion recommending approval of Qutenza(TM) (formerly NGX-4010), for the treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other medicinal products for pain.
The conference call will be hosted by Anthony DiTonno, President and Chief Executive Officer, and Stephen Ghiglieri, Chief Financial Officer.
To participate, please dial 1-877-407-0789 (USA) or 1-201-689-8562 (International). To access the live web cast please visit the Investor Relations section on the corporate web site at http://www.neurogesx.com.
A replay of the conference call will be available beginning March 20, 2009 at 12:00 p.m. ET (9:00 a.m. PT) and ending on March 30, 2009 by dialing 1-877-660-6853 (USA) or 1-201-612-7415 (International), Account Number: 3055, Conference ID Number: 317851. A replay of the webcast will also be available on the corporate website for one month, through April 20, 2009.
About NeurogesX, Inc.
NeurogesX 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 Qutenza, 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 submitted a new drug application (NDA) for Qutenza to the U.S. Food and Drug Administration (FDA) in October 2008 for PHN, which was accepted for filing by the FDA in December 2008. A marketing authorization application (MAA) for Qutenza received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending approval for peripheral neuropathic pain in non-diabetic adults alone or in combination with other medicinal products for pain. NeurogesX is currently awaiting the European Commission’s decision on the CHMP’s opinion.
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 has completed three Phase 1 studies and NeurogesX is currently evaluating the timing of entering Phase 2 development.
NeurogesX’ early stage product pipeline includes pre-clinical compounds, which are prodrugs of acetaminophen and various opioids. The company has evaluated these compounds in vitro and in vivo and is currently seeking development partners for these programs.
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 the European Commission’s decision on the CHMP’s recommendation for approval of the MAA for Qutenza in the European Union; NeurogesX’ plans to seek and timing to obtain a commercial partner for Qutenza in Europe; the expected benefits of NeurogesX’ product candidates and its plans with regard to seeking potential development partners for its early stage product pipeline. 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; 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; NeurogesX’ product candidates may have unexpected adverse side effects or inadequate therapeutic efficacy; physician or patient reluctance to use Qutenza 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.
CONTACT: Stephen Ghiglieri, Chief Financial Officer, NeurogesX, Inc.,
+1-650-358-3310; or (investors) Stephanie Carrington, +1-646-536-7017,
scarrington@theruthgroup.com, Sara Ephraim, +1-646-536-7002,
sephraim@theruthgroup.com, or (media) Jason Rando, +1-646-536-7025,
jrando@theruthgroup.com, all of The Ruth Group, for NeurogesX, Inc.
Web site: http://www.neurogesx.com/
