The Company's lead product, Qutenza ®, is currently approved in the United States and the European Union. Qutenza ® is now available in the United States for the management of neuropathic pain associated with postherpetic neuralgia (PHN). In Europe, Qutenza ® is being marketed by Astellas Pharma Europe Ltd. (Astellas), the European affiliate of Tokyo-based Astellas Pharma Inc., for the treatment of peripheral neuropathic pain in non-diabetic adults, either alone or in combination with other medicinal products for pain.
The Company's 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 such as PHN. NGX-1998 has completed four Phase 1 clinical trials and one Phase 2 clinical trial in PHN patients, and the Company believes that NGX-1998 is ready to enter Phase 3 development.
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 statements regarding: potential efficacy and safety of NGX-1998 and Qutenza; the convenience of use of NGX-1998; NGX-1998 being ready for entry into Phase 3 development and enabling a Phase 3 clinical trial of NGX-1998 by the end of 2012. 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: NGX-1998 may fail to demonstrate sufficient safety or efficacy in clinical trials to support further development or potential marketing approval; Qutenza may fail to demonstrate sufficient efficacy to support further development for additional indications; difficulties or delays in further clinical development of NGX-1998, including difficulties or delays in initiating Phase 3 clinical trials; Qutenza, NGX-1998 and NeurogesX' other product candidates may have unexpected adverse side effects; delay or prevention of development activities due to unexpected expenses or a lack of sufficient resources; and difficulties or delays in identifying potential strategic partners for Qutenza and NGX-1998 and negotiating and entering into agreements with such entities. For further information regarding these and other risks related to NeurogesX' business, investors should consult NeurogesX' filings with the Securities and Exchange Commission.
CONTACT: NeurogesX, Inc. Stephen Ghiglieri Executive Vice President, COO and CFO (650) 358-3310 firstname.lastname@example.org Additional Contacts: The Ruth Group Stephanie Carrington / Nicole Greenbaum (investors) (646) 536-7017 / 7009 email@example.com / firstname.lastname@example.org Victoria Aguiar (media) (646) 536-7013 email@example.com
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