SAN MATEO, Calif., Aug. 13 NeurogesX, Inc.(Nasdaq: NGSX), a biopharmaceutical company focused on developing andcommercializing novel pain management therapies, today reported results forthe quarter ended June 30, 2008.
In the second quarter of 2008, the Company continued on its path towardpotential commercialization of its lead product candidate, NGX-4010, a dermalcapsaicin patch designed for the treatment of certain neuropathic painconditions. On the U.S. regulatory front, the Company has been preparing aNew Drug Application (NDA) to support marketing approval of NGX-4010 for thetreatment of post-herpetic neuralgia (PHN), and is on track to submit an NDAto the U.S. Food and Drug Administration (FDA) later this year.
The Company continues to pursue the European approval of its MarketingAuthorization Application (MAA) for NGX-4010 in neuropathic pain, which theEuropean Medicines Agency (EMEA) accepted for review in September 2007. InSeptember of 2008, the Company, with the EMEA's agreement, plans to submitresponses to the regulatory agency's Day 120 questions, which are part of thereview process for the MAA.
In addition to focusing on regulatory activities for NGX-4010, NeurogesXhas made significant progress with its second product candidate, NGX-1998, ahigh-concentration liquid capsaicin formulation. During the second quarter of2008, the Company submitted and opened an Investigational New Drug (IND)application for NGX-1998 and commenced patient enrollment in a Phase 1clinical study.
Anthony DiTonno, President and CEO, commented, "NeurogesX' primary focusis to secure European and U.S. marketing approvals for NGX-4010 and preparefor the potential commercialization of this product candidate. If ourregulatory processes proceed as planned, NGX-4010 could potentially receive adecision from the EMEA on our MAA in the first half of 2009 potentiallyfollowed by a decision from the FDA on our NDA in late 2009 or early 2010. Wecontinue our discussions with potential European partners and remain focusedon securing a partnership prior to European regulatory approval. In theUnited States, we continue investing in pre-commercialization activities withregard to NGX-4010, including those surrounding our pricing and reimbursementstrategies. We remain confident that a significant market opportunity existsfor NGX-4010. Based on our market research, physicians and patients arelooking for additional options to help control neuropathic pain. We believethat NGX-4010 may address these patients with pain as a localized treatmentthat operates at the site of pain, rather than the central nervous system,with the potential to provide up to 12 weeks of relief from a single 60-minutetreatment procedure. As data from our clinical trials have shown, NGX-4010may have the potential to be used as both a first- or second-line therapy. Wehave also initiated a Phase 1 study of NGX-1998, our second product candidatein development, to potentially expand our ability to address the marketopportunity that we are initially targeting with NGX-4010."
Second Quarter 2008 Financial Results
Total operating expenses for the second quarter of 2008 were approximately$7.0 million, including $395,000 of non-cash stock-based compensation expense,compared to approximately $7.4 million, including $201,000 of non-cashstock-based compensation expense, for the second quarter of 2007. The decreasein operating expenses was primarily attributed to lower costs associated withclinical studies of NGX-4010 and NGX-1998. Partially offsetting lower clinicalcosts were expenses related to pre-commercialization activities for NGX-4010,higher general and administrative expenses due to increased spending oninfrastructure in support of NeurogesX' growth, the costs of being a publiccompany, and the costs associated with pursuing the Company's MAA andpreparing for an NDA filing later this year