NeurogesX Reports Fourth Quarter and Year-End 2008 Results
Qutenza(TM) Receives Positive Committee Recommendation in European Union
- CHMP issued positive opinion recommending approval of Qutenza(TM) (formerly NGX-4010) for treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other medicinal products for pain
- Qutenza NDA accepted for review by U.S. FDA for PHN
Upcoming 2009 Milestones:
- European commercial partnership for Qutenza anticipated first half of 2009
- European Commission decision on MAA for Qutenza for the treatment of peripheral neuropathic pain in non-diabetic adults alone or in combination with other medicinal products for pain anticipated first half of 2009
- FDA PDUFA date of
During 2008, NeurogesX continued to make significant progress on the regulatory front in
Regarding the European regulatory process for Qutenza, on
Fourth Quarter and Year-End 2008 Financial Results
Total operating expenses for the fourth quarter of 2008 were approximately
Net loss for the fourth quarter of 2008 was approximately
For the 12 months ended
Cash, cash equivalents and short-term investments were approximately
NeurogesX’ near-term focus is to secure regulatory approvals of the NDA and MAA for Qutenza. The CHMP’s positive opinion recommending approval in the E.U. of Qutenza for the treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other medicinal products for pain, was made in reliance on NeurogesX’ commitment to conduct certain post-marketing studies. These post-marketing commitments, which are often required by the CHMP as a condition of an approval recommendation, may include an open-label safety study of Qutenza in on-label indications, as well as a clinical safety and efficacy study in painful diabetic neuropathy. These studies could potentially be conducted and/or funded by a European commercial partner, and the timing for initiating such studies will be provided following the European Commission’s decision regarding final marketing authorization for Qutenza.
NGX-1998, the Company’s second-generation, liquid formulation of the same active ingredient found in Qutenza, has completed three Phase 1 studies. The most recent of these studies was in 36 healthy volunteers to evaluate potential control formulations for use in later-stage clinical studies. The liquid formulation may address neuropathic pain conditions in areas of the skin that are difficult to target through a dermal patch application, and potentially offers similar efficacy in a shorter application time versus Qutenza. NeurogesX is currently evaluating the timing to initiate Phase 2 development of NGX-1998.
NeurogesX continues to pursue business development opportunities to advance its opioid and acetaminophen prodrugs.
- NGX-9674 and NGX-5752, novel prodrugs of acetaminophen, have completed in vivo and in vitro preclinical studies, in which they demonstrated approximately 10 times greater solubility in water versus acetaminophen.
- NGX-1576, a novel prodrug coupling acetaminophen to a liver protectant, has been evaluated in vitro and in vivo. Equivalent dose levels of NGX-1576 in mice produced significantly less liver toxicity than acetaminophen, while additional data demonstrated the production of equivalent plasma levels of acetaminophen.
- NGX-6052, the most advanced molecule synthesized in NeurogesX’ opioid prodrug platform, has been evaluated in proof of concept in vivo and in vitro preclinical studies for its potential to deliver therapeutic efficacy with an abuse-deterrent profile and improved side effect profile.
Conference Call Details
The Company will hold its quarterly conference call today at
To participate, please dial 1-877-407-0789 (
A replay of the conference call will be available beginning
About NeurogesX, Inc.
NeurogesX (NASDAQ: NGSX) is a biopharmaceutical company focused on developing and commercializing novel pain management therapies. Its initial focus is on chronic peripheral neuropathic pain, including postherpetic neuralgia (PHN), painful HIV-distal sensory polyneuropathy (HIV-DSP) and painful diabetic neuropathy (PDN). NeurogesX’ late-stage product portfolio is led by its product candidate Qutenza(TM), a dermal high-concentration capsaicin patch designed to manage pain associated with peripheral neuropathic pain conditions, that the Company believes offers significant advantages over other pain therapies. NeurogesX submitted a new drug application (NDA) for Qutenza with the U.S. Food and Drug Administration (FDA) in
NeurogesX’ second 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. NGX-1998 has completed three Phase 1 studies and NeurogesX is currently evaluating the timing of entering Phase 2 development.
NeurogesX’ early stage product pipeline includes pre-clinical compounds which are prodrugs of acetaminophen and various opioids. The company has evaluated these compounds in vitro and in vivo and is currently seeking development partners for these programs.
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, the expected timing and outcome of regulatory decisions and the label approval being sought or that may be obtained with respect to the MAA for Qutenza in the European Union and the NDA for Qutenza with the FDA, including the timing of European Commission approval of the MAA and the PDUFA date for the NDA; NeurogesX’ plans, and expected timing, with regard to seeking partnerships for its product candidates, including potential commercial partners for Qutenza in the European Union and
NEUROGESX, INC. (A Development Stage Company) CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share data) (unaudited) Three Months Ended Twelve Months Ended December 31, December 31, 2008 2007 2008 2007 Operating expenses: Research and development (1) $2,497 $5,654 $16,104 $25,321 General and administrative (2) 2,155 2,412 10,182 7,455 Total operating expenses 4,652 8,066 26,286 32,776 Loss from operations (4,652) (8,066) (26,286) (32,776) Interest income 56 443 1,057 1,673 Interest expense (152) (272) (792) (1,219) Other income (expense), net (40) 6 (14) 366 Net loss (4,788) (7,889) (26,035) (31,956) Accretion of redeemable convertible preferred stock - - - (4,626) Net loss attributable to common stockholders $(4,788) $(7,889) $(26,035) $(36,582) Basic and diluted net loss per share attributable to common stockholders $(0.27) $(0.58) $(1.49) $(4.06) Shares used to compute basic and diluted net loss per share attributable to common stockholders 17,553,133 13,570,572 17,519,415 9,017,627 Non-cash stock-based compensation expense included in operating expenses: (1) Research and development $148 $158 $745 $893 (2) General and administrative 185 184 755 869 $333 $342 $1,500 $1,762
NEUROGESX, INC. (A Development Stage Company) CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) December 31, 2008 2007 (unaudited) (1) Assets Current assets: Cash and cash equivalents $10,435 $31,478 Short-term investments 14,071 21,373 Prepaid expenses and other current assets 412 585 Restricted cash 40 - Total current assets 24,958 53,436 Property and equipment, net 468 453 Restricted cash 160 240 Other assets 4 56 Total assets $25,590 $54,185 Liabilities and Stockholders' Equity Current liabilities: Accounts payable $370 $1,712 Accrued compensation 1,039 680 Accrued research and development 1,067 1,198 Other accrued expenses 540 1,848 Notes payable - current portion 2,833 3,859 Total current liabilities 5,849 9,297 Non-current liabilities: Notes payable - non-current portion 191 3,024 Deferred rent 276 156 Accrued research and development - non-current - 347 Total non-current liabilities 467 3,527 Stockholders' equity: Common stock 18 17 Additional paid-in capital 209,370 205,417 Deferred stock-based compensation (2) (15) Accumulated other comprehensive income 32 51 Deficit accumulated during the development stage (190,144) (164,109) Total stockholders' equity 19,274 41,361 Total liabilities and stockholders' equity $25,590 $54,185 (1) The balance sheet at December 31, 2007, has been derived from the audited consolidated financial statements at that date.
NeurogesX, Inc. The Ruth Group Stephen Ghiglieri Stephanie Carrington / Sara Ephraim (investors) Chief Financial Officer (646) 536-7017 / 7002 (650) 358-3310 email@example.com firstname.lastname@example.org Jason Rando (media) (646) 536-7025 email@example.com
SOURCE NeurogesX, Inc.