Conference Call Scheduled Today at 4:30pm ET
European Commission Decision on Qutenza(TM) Expected in 1H 2009
Company to Provide Update on FDA review of Qutenza During Conference Call Today
- 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
Upcoming 2009 Milestones:
- European Commission decision on MAA for Qutenza anticipated first half of 2009
- European commercial partnership for Qutenza targeted first half of 2009
- FDA PDUFA date of August 16, 2009 for Qutenza NDA to manage pain associated with PHN
SAN MATEO, Calif., May 7 /PRNewswire-FirstCall/ -- NeurogesX, Inc. (Nasdaq: NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, today reported results for the first quarter ended March 31, 2009 and provided an update on recent developments.
During the first quarter of 2009, NeurogesX continued to focus on seeking regulatory approvals and on pre-commercialization activities for its lead product candidate Qutenza (formerly NGX-4010). On March 19, 2009, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) issued a positive opinion recommending approval of the marketing authorization application (MAA) for Qutenza for the treatment of peripheral neuropathic pain in non-diabetic adults, either alone or in combination with other medicinal products for pain.
The CHMP's recommendation for the MAA, filed under the centralized procedure, is subject to a final decision by the European Commission, usually rendered approximately 60 to 90 days after the CHMP's recommendation. In preparation for potential marketing authorization and commercialization, NeurogesX has continued active discussions with potential European marketing partners and anticipates completing a transaction in the first half of 2009.
Qutenza is also undergoing U.S. regulatory review, and the United States Food and Drug Administration (FDA) has scheduled a Prescription Drug User Fee Act (PDUFA) date of August 16, 2009 to review the new drug application (NDA) for the management of pain associated with postherpetic neuralgia (PHN).
Anthony DiTonno, President and CEO, commented, "We are confident that Qutenza is closer than ever to commercialization as we await the European Commission's decision on our MAA, expected within the coming weeks. We are in late stage discussions with potential European commercial partners for Qutenza, supported by the proposed broad E.U. label for peripheral neuropathic pain conditions in non-diabetic adults, either alone or in combination with other medicinal products for pain. We also continue to plan for the potential U.S. commercialization of Qutenza. Our top priority remains to secure U.S. and European regulatory approvals and become a commercial-stage company. We look forward to several upcoming milestones in 2009."
First Quarter 2009 Financial Results
Total operating expenses for the first quarter of 2009 were approximately $4.5 million, down 46% from approximately $8.3 million in the same period of 2008. The decrease primarily resulted from a $3.5 million decrease in research and development costs. Year-over-year operating expenses were lower as the Company deferred development programs in order to focus resources on regulatory processes and to continue preparations for potential commercialization of Qutenza in both Europe and the United States.
Net loss for the first quarter of 2009 was approximately $4.6 million, compared to a net loss of approximately $8.0 million for the first quarter of 2008. Net loss per share attributable to common stockholders was $0.26 per share and $0.46 per share for the three months ended March 31, 2009 and 2008, respectively, based on weighted average shares outstanding of 17,568,600 and 17,468,395 respectively.
Cash, cash equivalents and short-term investments were approximately $18.8 million at March 31, 2009, compared to $24.5 million at December 31, 2008.
Stephen Ghiglieri, CFO, commented, "We have focused our cash resources to prosecute our MAA and NDA for Qutenza and to support strategies for obtaining adequate reimbursement for Qutenza in the United States, while deferring further clinical development of Qutenza, NGX-1998 and our preclinical prodrug development programs. As a result of our conservative cost management strategy, we believe that our cash runway is sufficient to last at least until December 31, 2009. Potential near-term proceeds from a European commercial partnership, which we expect to finalize in the first half of 2009, would provide additional runway and have not been accounted for in our current cash forecast. As we pursue European and U.S. commercial partnerships, and other non-equity based sources of funding, we do not currently intend to raise equity capital in the public markets at our present valuation."
Currently, NeurogesX is primarily focused on completing the development through regulatory approval, of Qutenza for patients with PHN in the United States and for peripheral neuropathic pain in non-diabetic adults in the E.U.
The CHMP's positive opinion recommending E.U. approval 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 of Qutenza following approval. Post-marketing commitments are often required by the CHMP as a condition for recommending approval. An open-label safety study of Qutenza in on-label indications is planned to be conducted following launch of Qutenza in the E.U. In addition, a protocol evaluating the clinical safety and efficacy of Qutenza in painful diabetic neuropathy will be discussed with the CHMP following approval of the MAA. It is anticipated that these studies could potentially be conducted and/or funded by a European commercial partner.
NGX-1998 is the Company's second-generation, liquid formulation of the same active ingredient found in Qutenza. The liquid formulation is being developed to address neuropathic pain conditions, providing similar efficacy in a shorter treatment time versus Qutenza. NGX-1998 has been evaluated in three Phase 1 studies and is currently being considered for entry into Phase 2 evaluation, subject to receipt of additional funding.
NeurogesX is also seeking business development partners to advance its acetaminophen and opioid prodrug product candidates.
Conference Call Details
The Company will hold its quarterly conference call today at 4:30 p.m. ET (1:30 p.m. PT) to discuss first quarter 2009 results and recent corporate updates.
To participate, please dial 1-877-407-0789 (USA) or 1-201-689-8562 (International). To access the live web cast please visit the Investor Relations section on the corporate web site at http://www.neurogesx.com.
A replay of the conference call will be available beginning May 7, 2009 at 7:30 p.m. ET (4:30 p.m. PT) and ending on May 17, 2009 by dialing 1-877-660-6853 (USA) or 1-201-612-7415 (International), Account Number: 3055, Conference ID Number: 320580. A replay of the webcast will also be available on the corporate website for one month, through June 7, 2009.
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 QutenzaTM, a dermal high-concentration capsaicin patch designed to manage pain associated with peripheral neuropathic pain conditions. NeurogesX submitted a new drug application (NDA) for Qutenza with the U.S. Food and Drug Administration (FDA) in October 2008 for PHN, which was accepted and filed by the FDA in December 2008. On March 19, 2009, a marketing authorization application (MAA) for Qutenza received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending approval 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 awaiting the European Commission's decision on the CHMP's opinion, a process which normally takes approximately 60 to 90 days.
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 decision on the MAA and the PDUFA date for the NDA; NeurogesX' plans, and expected timing, with regard to seeking partnerships for its product candidates; the sufficiency of cash resources to fund the NeurogesX' operations through at least December 31, 2009; the ability to secure funding through commercial partnerships; expectations regarding expenses and cash burn rate; expectations with respect to seeking funding; the potential markets for NeurogesX' product candidates; and the expected benefits of NeurogesX' product candidates. 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, positive results in clinical trials, or the recommendation of the CHMP for MAA approval, may not be sufficient to obtain FDA or European regulatory approval; any regulatory approvals which are received may offer more limited indications than anticipated; unexpected expenses; inability to enter into or obtain adequate funding under commercial or other strategic partnerships; NeurogesX' product candidates may have unexpected adverse side effects or inadequate therapeutic efficacy; physician or patient reluctance to use Qutenza or NGX-1998, if approved, or the inability of physicians to obtain sufficient reimbursement for such procedures; potential alternative therapies; maintaining adequate patent or trade secret protection without violating the intellectual property rights of others; and other difficulties or delays in, clinical development, obtaining regulatory approval, market acceptance and commercialization of NeurogesX' product candidates and the advantages of NeurogesX' product candidates over other pain therapies. For further information regarding these and other risks related to NeurogesX' business, investors should consult NeurogesX' filings with the Securities and Exchange Commission.
NEUROGESX, INC. (A Development Stage Company) CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share data) (unaudited) Three Months Ended March 31, ---------------------------- 2009 2008 ------ ------ Operating expenses: Research and development(1) $2,326 $5,781 General and administrative(2) 2,189 2,487 ------ ------ Total operating expenses 4,515 8,268 ------ ------ Loss from operations (4,515) (8,268) Interest income 33 504 Interest expense (120) (243) Other income (expense), net -- 17 -------- -------- Net loss $(4,602) $(7,990) ======== ======== Basic and diluted net loss per share attributable to common stockholders $(0.26) $(0.46) ======== ======== Shares used to compute basic and diluted net loss per share attributable to common stockholders 17,568,600 17,468,395 ========== ========== Non-cash stock-based compensation expense included in operating expenses: (1) Research and development $259 $198 (2) General and administrative 248 201 ---- ---- $507 $399 ==== ====
NEUROGESX, INC. (A Development Stage Company) CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) March 31, December 31, 2009 2008 --------- ----------- (unaudited) (1) ----------- ----------- Assets Current assets: Cash and cash equivalents $6,561 $10,435 Short-term investments 12,286 14,071 Prepaid expenses and other current assets 362 412 Restricted cash 40 40 ------ ------- Total current assets 19,249 24,958 Property and equipment, net 420 468 Restricted cash 160 160 Other assets -- 4 ------- ------- Total assets $19,829 $25,590 ======= ======= Liabilities and Stockholders' Equity Current liabilities: Accounts payable $478 $370 Accrued compensation 601 1,039 Accrued research and development 623 1,067 Other accrued expenses 621 540 Notes payable - current portion 1,982 2,833 ------- ------- Total current liabilities 4,305 5,849 Non-current liabilities: Notes payable - non-current portion -- 191 Deferred rent 367 276 ------- ------- Total non-current liabilities 367 467 Commitments and contingencies Stockholders' equity: Common stock 18 18 Additional paid-in capital 209,877 209,370 Deferred stock-based compensation (1) (2) Accumulated other comprehensive income 9 32 Deficit accumulated during the development stage (194,746) (190,144) -------- -------- Total stockholders' equity 15,157 19,274 ------- ------- Total liabilities and stockholders' equity $19,829 $25,590 ======= ======= (1) The balance sheet at December 31, 2008, has been derived from the audited consolidated financial statements at that date. NeurogesX, Inc. Stephen Ghiglieri Chief Financial Officer (650) 358-3310 The Ruth Group Sara Ephraim (investors) (646) 536-7002 firstname.lastname@example.org Jason Rando (media) (646) 536-7025 email@example.com
|SOURCE NeurogesX, Inc.|
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