Attached files
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| 8-K - FORM 8-K - NeurogesX Inc | d8k.htm |
 Launching a New Approach
to Pain Management J P Morgan 28 th Annual Healthcare Conference January 14, 2010 Exhibit 99.1 |
 2 2 Forward Looking Statements The Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: Except for the historical information herein, the matters discussed in this presentation include forward-looking statements and risks and uncertainties.
Examples of such forward looking statements, include but are not limited to
statements regarding: the timing of launch and commercialization of Qutenza in the US and EU; market acceptance of, and demand for, NeurogesX’ products; strategies and expectations regarding reimbursement of Qutenza; obtaining and maintaining regulatory approval; sufficiency of
cash resources; potential future payments from Astellas pursuant to our collaboration agreements; and development activities for NeurogesX’ products including Qutenza and NGX-1998. The forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could cause actual results
to differ materially. Factors that may affect the outcome of
forward-looking statements are explained in the risks factors section of
our filings with SEC, including our Form 10-K for the 2008 fiscal year
which was filed with the SEC on March 26, 2009 and our Form 10-Q for the
third quarter of 2009, which was filed on November 9, 2009. .
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 3 NeurogesX – Pain Management Focus • Differentiated lead product • Locally-acting analgesic in dermal delivery system • Single treatment – up to 12 weeks of pain reduction • EU Approved (May 2009) • US Approved (November 2009) Product Launch Strategy Broad Pain Management Pipeline Proven Management Track Record • US: 1H 2010 – NGSX sales force • EU: 1H 2010 – Astellas Pharma Europe • Improved capsaicin delivery model – NGX-1998 • Multiple early-stage pain prodrug candidates • Drug development, regulatory and commercialization • Results-oriented Partnering to build Qutenza Franchise • Eastern Europe, Middle East, Africa – Astellas • ROW – open for partnering |
 Why
NeurogesX • Neuropathic pain – a large, unsatisfied market • Novel product concept – One treatment, up to 12 weeks of pain reduction – Treats the site of pain • Approved in US and EU – Planned launch in first half of 2010 • Experienced management – Commercial, manufacturing, clinical, regulatory • Strong history of performance • Financially well positioned |
 2009
in Review – Putting NGSX on the Map • FDA approval, November 2009 – Management of pain associated with PHN – Single administration, up to 12 weeks of reduced pain – No contraindications/no REMS – Orphan Designation • EU Marketing Application Approved May 2009 – Peripheral neuropathic pain, nondiabetic adults, alone or in combination with other medicinal products for pain – Approved in all 27 EU member states • Ex-US Commercialization Agreement with
Astellas, June 2009 |
 6 Qutenza ® EU Commercial Partnership • Astellas licensed Qutenza commercialization rights – Countries in Europe, Middle East and Africa – Covers EU development, including post-marketing commitments • Economics for NeurogesX – EUR 30 MM (~$42 MM) upfront for Qutenza – EUR 5 MM (~$7 MM) upfront for NGX-1998 option/development – Up to EUR 70 MM in additional
milestone/NGX-1998 option payments – Royalties on sales – high teens to mid twenties • Option to license NGX-1998 – Up-front payments to accelerate development – Opportunity to share late-stage development costs upon opt-in
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 Pathophysiology of Postherpetic Neuralgia • Reactivation of varicella zoster virus (chicken pox virus) which lies dormant for many years in sensory neurons • Virus reactivates with age or immunocompromised states, resulting in painful skin eruption (i.e., herpes zoster or shingles) • Acute shingles rash heals in about 2 to 4 weeks and pain usually subsides • Despite healing of rash, for 10 to 20% of shingles patients the pain persists for months to years; this condition is known as postherpetic neuralgia (PHN) |
 8 8 Treatment Procedure • Identify painful area • Apply topical anesthetic • Apply Qutenza patch – Cut to conform to painful area – Apply 30 or 60 minutes dependent on indication/location of pain – Remove – Clean area with proprietary gel |
 Market Research by NeurogesX • Qualitative (US/EU) • Qualitative/Quantitative • Payer Qualitative • Patient Qualitative • Message Testing • Concept • Qualitative/Quantitative • Pricing US |
 10 10 Q26. What advantages does this product have over currently available treatments for
moderate to severe neuropathic pain? (Check all that apply) Physician Survey on Qutenza ® Attributes Source: 2007 NeurogesX quantitative market research (n=305). 57% 67% 69% 71% 76% 79% 83% Rapid onset Can use in combination therapy No / low systemic side effects Good safety profile Non-sedating Site specific Three -month duration of action Product X Advantages |
             11 Favorable Physician Consideration
as First-Line Therapy SOURCE: 2007 NeurogesX quantitative market research (n=208) % PHN Patients treated for First-Line Therapy Percentage Total (n =208) Before Profile After Profile Change - 25.4 - Gabapentin 25.1 17.8 -7.3 Pregabalin 19.5 14.9 -4.6 Duloxetine 11.8 8.4 -3.4 Lidocaine patch 5% 9.1 6.1 -3.0 Other 34.5 27.4 -7.1 Q31. Thinking about first-line agents for chronic pain therapy excluding breakthrough or immediate pain relief, how do you anticipate you will prescribe neuropathic pain agents for PHN patients to whom you initiate treatment, once Product X is introduced? |
 Quantitative Market Research Participants Physician Type Number of Participants Pain Management (PMD) 44 Anesthesiology Pain Management (APM) 43 Primary Care Physician (PCP) 95 Physical Medicine & Rehabilitation (PM&R) 50 Neurologists 50 Infectious Disease 18 Total 300 Source: 2009 NeurogesX Quantitative Market Study (n=300)
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 Number of Patients Treated Q: In a typical month, how many patients do you treat? 0 10 20 30 40 50 60 PHN PDN HIV Chemo Induced Post Surgical Pain Specialist Other Specialists PCP Source: 2009 NeurogesX Quantitative Market Study (n=300)
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 Patients Controlled, Uncontrolled and Naive <65 <65 <65 65+ 65+ 65+ 0 5 10 15 20 25 30 35 40 45 50 Pain Specialist Other Specialists PCP Controlled Uncontrolled Naïve Source: 2009 NeurogesX Quantitative Market Study (n=300)
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 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Pain Specialists Other Specialists PCPs Very Favorable Favorable Neutral Unfavorable Very Unfavorable Overall Impression of Qutenza ® Q: Please rate your overall impression of Product X on a scale of 1 to 5. Source: 2009 NeurogesX Quantitative Market Study (n=300)
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 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Pain Specialists PCPs Others Pain Specialists PCPs Others Pain Specialists PCPs Others Very Likely Likely Unlikely Very Unlikely Willingness to Prescribe Qutenza ® for PHN First Line Agent Second Line Agent Combination Agent Likelihood of Prescribing Product X as… Source: 2009 NeurogesX Quantitative Market Study (n=300)
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 Qutenza ® Usage – In Office Versus Referrals Out Q: Do you think you would treat patients with Product X yourself or would you refer patients to a pain specialist or other physician? n=300 90.8% 81.1% 83.1% 9.2% 18.9% 16.9% 0% 20% 40% 60% 80% 100% Pain Specialists PCPs Others Specialty Treat Patients Myself Refer Patients to Another Physician Source: 2009 NeurogesX Quantitative Market Study (n=300)
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 Establish Qutenza ® as the differentiated treatment for PHN that delivers efficacy with tolerability through a single application that provides 3 months of pain relief Motivate and enable patients to access Qutenza ® Minimize procedural challenges so that decisions are based on safety and efficacy Develop organizational readiness to execute launch and carry out
the brand vision Revolutionize the Revolutionize the treatment of PHN by treatment of PHN by establishing establishing Qutenza Qutenza ® ® as as the only therapy that the only therapy that maximizes efficacy, safety maximizes efficacy, safety and duration of action and duration of action Qutenza ® Launch Brand Vision Launch Imperatives |
 Qutenza ® Total Office Call Nurse Educators Pain Specialist Office Physician Qutenza Reimbursement Hotline Qutenza ® Specialty Distribution Sales Force RRM Training Training |
 Three Regions 20 |
 Launch Strategy • MDs Reached • MDs trained • MDs converted to treating MDs Then move to next Phase |
 Project Team Leader (PTL) Commercial Operations Marketing Sales Medical Affairs Medical Information Drug Safety/ Pharmacovigilance Reimbursement Regulatory Manufacturing Support Services Finance Legal IT Quality Assurance Project Manager (PM) Distribution Managing internally – outsourcing many operational elements Toll-free # Launch Team in Place |
 Specialty Distribution Channel Hospital Specialty Hospital Distribution Medical Benefit “Buy and Bill” Specialty Distributors Pharmacy Benefit “Assignment of Benefit” Specialty Pharmacies |
 Reimbursement Strategies Strategies Coverage: Secure Coverage as a Physician-administered Product Coding: Obtain Codes Needed to Support Coverage as a Physician- administered Product Billing: Minimize Physicians’ Billing-related Barriers to use for QUTENZA ® |
 25 NeurogesX is Seeking Local Coverage Determinations by MAC Medical Directors Ultimate Decision Ultimate Decision Makers: Makers: Contractor (MAC) Contractor (MAC) Medical Directors Medical Directors Patients Influencers * KOL = Key Opinion Leaders KOLs* /Societies CACs Meet with contractors prior to launch to introduce Qutenza Attend CAC and pre-CAC meetings Develop relationships with KOLs and CACs to build support for Part B coverage Develop patient advocates, demonstrating need for physician administration |
 Product Coding Strategy • Applied for a unique J-code to facilitate Part B / medical benefit reimbursement (submitted Dec. 2009) • Apply for a C-code to facilitate ‘pass-through’ payment HOPD • Support use of a miscellaneous drug code (J3490), pending permanent J-code issuance • Build private payer relationships to enhance likelihood of issuance of temporary Q-code or private payer S-code
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 Procedure Code Strategy *Assumes existing codes are not appropriate or do not provide adequate
reimbursement. • Determine if payers favor any existing CPT code(s) • Request a temporary G-code for administration of Qutenza ® * • Pursue a new CPT code* • Be prepared to navigate use of miscellaneous code at launch* |
 Qutenza ® – Protected Franchise • Issued Patents cover Qutenza through 2016 • Patent term extension filed – through 2021 • Orphan designation – 7 year market exclusivity • NCE designation – 5 year data exclusivity |
 Preclinical Phase 1 Phase 2 Phase 3 Marketing Application Regulatory Approval Marketed 29 Product Pipeline Opioid Prodrug NGX-6052 Acetaminophen Prodrugs NGX-5752 NGX-9674 NGX-1576 Qutenza ® : Management of PHN (US) Qutenza ® : HIV-DSP Qutenza ® : PDN NGX-1998 Qutenza ® : Peripheral Neuropathic Pain in Non-Diabetic Adults (EU) Prodrug Partnering Opportunities Astellas 1H 2010 launch Preparing to enter Phase 2 NGSX 1H 2010 launch |
 NGX-1998 Product Target Profile • Liquid formulation, prescription strength capsaicin – More versatile delivery model – Target application time <15 minutes – Expand opportunity to physician office setting • Three Phase 1 studies completed • Development strategy being refined – Resume development in 2010 |
 31 31 Financial Summary • $57 M cash (9/30/09) – Runway to support US commercial launch through 2010 – Evaluating additional funding strategies • Conservative cash management focused on priorities – Spend will increase in coming quarters to support launch – Resumption of NGX-1998 development in 2010 • 2010 Guidance and performance metrics – More to come as we approach launch |
 1H09 MAA Decision for Qutenza (Approved) 1H09 EU Commercial Partnership 2H09 PDUFA for Qutenza ® (PHN) 1H10 Qutenza ® EU Launch (Astellas TBD) 1H10 Qutenza ® US Launch 2H10 Resume NGX-1998 development program 32 32 2009 – 2010 Milestones |
 NASDAQ: NGSX |