NeurogesX Reports Second Quarter 2012 Results

GlobeNewswire

Friday, August 3rd 2012

Q2 2012 and Recent Highlights:

Business development process proceeding for NGX-1998 and Qutenza
End-of-Phase 2 meeting package submitted and accepted by FDA
Astellas enrolled first patient in EU clinical trial for Qutenza® in peripheral neuropathic pain, enrollment ongoing in Phase 3 DPN study
Received notice of three U.S. patent allowances covering next generation, prescription-strength capsaicin product candidate NGX-1998 and proprietary cleansing gel
Obtained Japanese patent for NGX-1998 and allowance for additional Japanese patent application

SAN MATEO, Calif., Aug. 3, 2012 (GLOBE NEWSWIRE) -- NeurogesX, Inc. (OTCQB:NGSX) (OTCBB:NGSX), a specialty pharmaceutical company focused on developing and commercializing a portfolio of novel non-opioid, pain management therapies, today provided an update on recent developments and reported results for its second quarter ended June 30, 2012.

Recent Developments

During the second quarter of 2012, the U.S. Food and Drug Administration (FDA) accepted the Company's request for an End-of-Phase 2 meeting to discuss Phase 3 clinical development of the Company's next generation product candidate NGX-1998 as a treatment for certain neuropathic pain conditions. The Company submitted a briefing package to the FDA in anticipation of that meeting.

Concurrently, and in conjunction with global life sciences advisor JSB-Partners, NeurogesX is continuing the process to identify and select a development and commercialization partner for NGX-1998 and Qutenza® (8% capsaicin patch). The Company is seeking partnerships in the United States and other major global markets that remain unpartnered.

NeurogesX' European partner Astellas Pharma Europe Ltd., the European headquarters of Tokyo-based Astellas Pharma Inc., announced on July 24, 2012, that it had enrolled the first patient in its ELEVATE clinical trial in the European Union. This trial is the first study to compare Qutenza to pregabalin as a treatment for peripheral neuropathic pain. Pregabalin is an oral therapy widely used for peripheral neuropathic pain. The earliest results of the ELEVATE study, which will evaluate the efficacy and safety of the Qutenza topical patch against pregabalin, are expected in 2014. Astellas continues enrollment in two studies in patients with painful diabetic peripheral neuropathy (DPN) with a goal of label expansion to include the DPN population in the EU label.

In June and July 2012, NeurogesX received three notices of allowance from the United States Patent and Trademark Office for patent applications covering, or which are complementary to, NGX-1998. The first and second allowed applications expand on NeurogesX' current patent entitled, "Methods and Compositions for Administration of TRPV1 Agonists." The first includes claims that more specifically define the components of the liquid formulation of NGX-1998, and the second relates to methods of treating capsaicin-responsive conditions with a liquid formulation containing between 10% and 30% by weight of a TRPV1 agonist and certain penetration enhancer combinations. The third allowed application is entitled, "Compositions and Kits for the Removal of Irritating Compounds from Bodily Surfaces." This allowed application includes claims relating to methods for removing capsaicin from the body using a surfactant-free, polyethylene glycol gel, and is complementary to the NGX-1998 patent family. The patents issuing from the first and second applications have terms that will expire in 2024, and the patent issuing from the third will expire in 2023.

Also in June 2012, the Japanese Patent Office (JPO) issued patent No. 4931128 to NeurogesX for NGX-1998. The patent, entitled "Methods and Compositions for Administration of TRPV1 Agonists," will remain in effect in Japan until 2024. The issued claims include formulation, system, and kit claims. The JPO separately allowed NeurogesX patent application No. 2008-504395, entitled "Oils of Capsaicinoids and Methods of Making and Using the Same." These allowed claims relate to the composition and creation of capsaicinoid oils and oils for treating capsaicin-responsive conditions. The patent scheduled to issue from this application is expected to expire in 2026.