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
September 27, 2011 (September 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
(Registrants 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 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On September 21, 2011, Jeffrey Tobias informed NeurogesX, Inc. (the Company) that he was resigning as Executive Vice President, Research and Development and Chief Medical Officer, effective as of October 16, 2011.
On September 27, 2011, the Company and Dr. Tobias entered into a consulting agreement to provide for Dr. Tobias to continue providing certain services to the Company on and after October 16, 2011 to support upcoming clinical and regulatory activities of the Company which are anticipated to include the unblinding of data from the currently ongoing Phase 2 study in NGX-1998 as well as the recently submitted supplemental new drug application for Qutenza in patients with HIV-associated peripheral neuropathy. The terms of the consulting agreement include up to 16 hours of consulting services per month for nine months (at an hourly rate of $450.00), continued vesting of Company options and other equity awards currently held by Dr. Tobias over the term he provides consulting services, and extending the post-termination option exercise period for Company options currently held by Dr. Tobias to 12 months following the termination of his consulting services.
On September 27, 2011, the Company issued a press release related to the resignation of Jeffrey Tobias. A copy of this press release is attached to this Current Report on Form 8-K as Exhibit 99.1, and is hereby incorporated by reference into this Item 5.02.
Item 9.01. Financial Statements and Exhibits.
The following exhibit is filed as part of this Form 8-K.
Exhibit No. |
Description | |
99.1 | Press Release entitled NeurogesX Announces Resignation of EVP of Research and Development and Chief Medical Officer Jeffrey K Tobias, MD. |
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: September 27, 2011 | By: | /s/ Stephen F. Ghiglieri | ||
Stephen F. Ghiglieri | ||||
Executive Vice President, Chief Operating Officer and Chief Financial Officer |
Exhibit List
Exhibit No. |
Description | |
99.1 | Press Release entitled NeurogesX Announces Resignation of EVP of Research and Development and Chief Medical Officer Jeffrey K Tobias, MD. |
Exhibit 99.1
NeurogesX, Inc. Stephen Ghiglieri Executive Vice President, COO and CFO (650) 358-3310 sghiglieri@neurogesx.com |
The Ruth Group Stephanie Carrington (investors) (646) 536-7017 scarrington@theruthgroup.com
Victoria Aguiar (media) (646) 536-7013 vaguiar@theruthgroup.com |
NeurogesX Announces Resignation of EVP of Research and
Development and Chief Medical Officer Jeffrey K Tobias, MD
Dr. Tobias to Consult on Near Term Clinical and Regulatory Activities
San Mateo, Calif., (September 27, 2011) NeurogesX, Inc. (NASDAQ: NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced today the resignation of Jeffrey K Tobias MD, EVP, CMO effective October 16th, 2011. Dr. Tobias has agreed to serve as a consultant to the Company providing advice on clinical and regulatory matters, which are anticipated to include the unblinding of data from the currently ongoing Phase 2 study in NGX-1998, as well as the recently submitted sNDA for Qutenza in patients with HIV-PN.
NeurogesX has commenced an executive search for a Chief Medical Officer.
Anthony DiTonno, President and Chief Executive Officer, commented, Jeff has contributed so much to our success that we are sad to see him leave and wish him good luck in his new opportunity. Jeff has been a valued member of management since November 2005 and has overseen the clinical development of Qutenza and NGX-1998, a topically applied liquid formulation containing a high concentration of capsaicin. His professionalism and dedication to the NeurogesX is reflected in his agreement to consult for the Company.
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 Companys 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 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 has submitted a supplemental new drug application (sNDA) to expand the U.S. label for Qutenza for the management of pain due to HIV-associated peripheral neuropathy (HIV-PN) also known as HIV-associated neuropathy (HIV-AN) and HIV-distal sensory polyneuropathy (HIV-DSP).
The Companys 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 enrollment and dosing has been completed in a Phase 2 clinical trial in PHN patients.
The Companys early-stage pipeline includes pre-clinical compounds which include a number of prodrugs of acetaminophen. 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 and expectations regarding the consulting services expected to be performed by Dr. Tobias. Such statements are based on managements current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to: difficulties or delays in the further development of Qutenza for additional indications, including difficulties or delays in receipt of FDA approval of the sNDA to expand the U.S. label for Qutenza for the management of pain due to HIV-PN; market acceptance of Qutenza in already approved indications may not be sufficient to support further pursuit of an expanded label for Qutenza, including as a result of physician or patient reluctance to use Qutenza; Qutenza and NeurogesX other product candidates may have unexpected adverse side effects; and unexpected or increased expenses in the commercialization and continued development of Qutenza or the development of NGX-1998. For further information regarding these and other risks related to NeurogesX business, investors should consult NeurogesX filings with the Securities and Exchange Commission.