0001193125-11-107668.txt : 20110425 0001193125-11-107668.hdr.sgml : 20110425 20110425155709 ACCESSION NUMBER: 0001193125-11-107668 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20110421 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20110425 DATE AS OF CHANGE: 20110425 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NeurogesX Inc CENTRAL INDEX KEY: 0001385830 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 943307935 STATE OF INCORPORATION: CA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-33438 FILM NUMBER: 11777428 BUSINESS ADDRESS: STREET 1: 2215 BRIDGEPOINTE PARKWAY STREET 2: SUITE 200 CITY: SAN MATEO STATE: CA ZIP: 94404 BUSINESS PHONE: 650-358-3300 MAIL ADDRESS: STREET 1: 2215 BRIDGEPOINTE PARKWAY STREET 2: SUITE 200 CITY: SAN MATEO STATE: CA ZIP: 94404 8-K 1 d8k.htm FORM 8-K Form 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

April 25, 2011 (April 21, 2011)

Date of Report (date of earliest event reported)

 

 

NEUROGESX, INC.

(Exact name of Registrant as specified in its charter)

 

 

 

Delaware   001-33438   94-3307935

(State or other jurisdiction of

incorporation or organization)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification Number)

2215 Bridgepointe Parkway, Suite 200, San Mateo, California 94404

(Address of principal executive offices)

(650) 358-3300

(Registrant’s telephone number, including area code)

N/A

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


Item 8.01. Other Events

On April 21, 2011, NeurogesX, Inc. (the “Company”) issued a press release regarding the Company’s plan to hold an Investor Day on April 29, 2011 and to announce and review financial results for the first quarter ended March 31, 2011. A copy of the press release is filed as Exhibit 99.1, to this Form 8-K, and is deemed to be filed for purposes of the Securities Exchange Act of 1934, as amended.

 

Item 9.01. Financial Statements and Exhibits.

 

  (d) Exhibits

 

Exhibit 99.1    Press release entitled “NeurogesX to Host Investor Day on April 29 - Review of First Quarter 2011 Results - Update of Qutenza Launch”


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  NEUROGESX, INC.
Date: April 25, 2011   By:  

/s/ Stephen F. Ghiglieri

    Stephen F. Ghiglieri
    Executive Vice President, Chief Operating Officer
    Chief Financial Officer


Exhibit List

 

Exhibit 99.1   Press release entitled “NeurogesX to Host Investor Day on April 29 - Review of First Quarter 2011 Results - Update of Qutenza Launch”
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

LOGO

 

NeurogesX, Inc.

Stephen Ghiglieri

Executive Vice President, COO

and CFO

(650) 358-3310

 

The Ruth Group

Stephanie Carrington (investors)

(646) 536-7017

scarrington@theruthgroup.com

 

Jason Rando (media)

(646) 536-7025

jrando@theruthgroup.com

NeurogesX to Host Investor Day on April 29

- Review of First Quarter 2011 Results -

- Update of Qutenza Launch -

San Mateo, Calif., (April 21, 2011) – NeurogesX, Inc. (NASDAQ: NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced today that it will host an investor day on Friday, April 29, 2011, from 8:15 am - 11:00 am EDT at The New York Palace Hotel in New York. As part of the presentation, management will announce and review results for the first quarter ended March 31, 2011.

The Investor Day will be webcast live and archived for 30 days on the investor relations section of the NeurogesX website at www.neurogesx.com.

The Company will provide an update on the US launch of the Qutenza® (capsaicin) 8% patch and on the development of NGX-1998. A physician panel will discuss issues related to the practice of pain medicine, experiences and patient reactions to Qutenza.

About NeurogesX, Inc.

NeurogesX, Inc. (Nasdaq: NGSX) is a San Francisco Bay Area-based biopharmaceutical company focused on developing and commercializing novel pain management therapies. NeurogesX was founded on the concept that use of prescription-strength capsaicin could help manage the pain associated with neuropathic pain conditions. Since its inception, NeurogesX has leveraged its passion to help people with pain to efficiently develop this concept, resulting in the commercial launch of Qutenza® (capsaicin) 8% patch in 2010. The Company continues to apply its knowledge and expertise in the development of other novel treatments for pain.

The Company’s lead product, Qutenza, is a localized dermal delivery system containing prescription strength capsaicin that 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


LOGO

 

being marketed by Astellas Pharma Europe Ltd. (Astellas), the European subsidiary 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 is currently preparing to submit a supplemental new drug application (sNDA) to expand the U.S. label for Qutenza for the management of pain due to HIV-associated neuropathy (HIV-AN) also known as HIV-distal sensory polyneuropathy (HIV-DSP).

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 three Phase 1 studies and patient dosing is underway in a Phase 2 clinical trial in PHN patients.

The Company’s early-stage pipeline includes pre-clinical compounds which are prodrugs of acetaminophen and various opioids. The Company has evaluated certain of these compounds in vitro and in vivo.

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 the submission of a supplemental new drug application for label expansion of Qutenza. 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: difficulties or delays in the commercialization of Qutenza, including with respect to the successful marketing or manufacture and supply of Qutenza; physician or patient reluctance to use Qutenza, despite the Company’s efforts and strategies to commercialize Qutenza; and difficulties or delays in the further development of Qutenza for additional indications. For further information regarding these and other risks related to NeurogesX’ business, investors should consult NeurogesX’ filings with the Securities and Exchange Commission.

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