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Roth OC Growth Stock ConferenceFebruary 16-18, 2009
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 that may involve a number of risks and uncertainties,
including but not limited to, projections of future sales, operating income, returns on
invested assets, obtaining and maintaining regulatory approval processes, market
acceptance of, and continuing demand for, NeurogesX’ products and other risks detailed
from time to time in the Company’s Securities and Exchange Commission filings. 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.
NeurogesX – Pain Management Focus
• Locally-acting analgesic formulated in dermal patch
• Pain relief up to 12 weeks demonstratedDifferentiated Lead Product: QUTENZA™Differentiated Lead Product: QUTENZA™
Strong Clinical Dossier /Marketing Applications Under Review
Strong Clinical Dossier /Marketing Applications Under Review
Commercialization StrategyCommercialization Strategy
Deep Pain Management PipelineDeep Pain Management Pipeline
Strong Management Track RecordStrong Management Track Record
• NDA (PHN) submitted October 2008 • MAA (peripheral neuropathic pain) filed Sept 2007• Potential regulatory decisions in 1H09 (MAA) and
3Q09 (NDA)
• U.S: specialty sales force; potential co-promotion• EU: partner (discussions in process)
• Multiple early stage pain prodrug candidates• Potential co-development opportunities
• Drug development, regulatory and commercialization• Results oriented – proven track record
4
Meeting our IPO Commitments
2H07 Confirmatory Phase 3 study in PHN
2H07 NGX-4010 EU Marketing Application
1H08 Confirmatory Phase 3 study in HIV-DSP
1H08 NGX-1998 IND filing
1H08 Continue NGX-1998 clinical program
1H08 Initiate NGX-4010 PDN program
2H08 NGX-4010 NDA filing (PHN)
Product Pipeline
Preclinical Phase 1 Phase 2 Phase 3Marketing
Application
Clinical Program Initiated 2008
MAA Filed 2007
QUTENZA™ (NGX-4010): PHN
Qutenza: HIV-DSP
Qutenza: PDN
NGX-1998
NDA Filed and
Accepted
Opioid Prodrug Partnering OpportunitiesNGX-6052
Acetaminophen Prodrug Partnering Opportunities
NGX-6100
NGX-9674
NGX-1576
6
$3B Neuropathic Pain Market Opportunity
Indication
• Chronic (PHN, PDN, HIV-DSP)
• Caused by sensory nerve damage
• Substantial unmet medical need
• Current therapy limitations
Market Opportunity
• Large and growing
• 6 M sufferers (U.S.)
• >$3 B annual sales (69% from anticonvulsants)
• Branded product access
CAGR 11%
$9
$8
$7
$6
$5
$4
$3
$2
$1
0 2005 2010 2015
Source: Jain Biopharma 2006
Annual US Pain Product Sales
$ in Billions
7
Anticonvulsants AntidepressantsTopical
AnestheticOpioids
QUTENZA™ (NGX-4010)
Efficacy +++ +++ ++ +++ +++
Dosing BID-TID QD-BID 12-hours / day QD-TIDSingle
application
Duration of Effect
6-12 hours 6-24 hours 12 hours 4-48 hours >12 weeks
Onset 1-3 weeks 1-3 weeks 1-3 weeks Hours 1-14 days
Safety
Somnolence dizziness, nausea,
confusion, weight gain
Somnolence, nausea,
constipationRash, pruritis
Sedation, respiratory depression,
nausea, vomiting, bowel dysfunction,
disorientation
No systemic side effectsTransient
procedure- related burning and erythema
Pain Management Options
8
QUTENZA™ (NGX-4010): Localized Pain Management Therapy
• Direct delivery to pain site• Dermal patch formulation• High concentration trans-capsaicin• Simple, well-tolerated in-office
procedure• 3 months relief from single application
9
Qutenza: A Simple Effective Procedure
• Identify painful area
• Apply topical anesthetic
• Apply Qutenza patch Cut to conform to painful area Apply 30 to 60 minutes Remove Clean area with proprietary gel
10
Initial Qutenza Indication
Post-Herpetic Neuralgia (PHN)
NDA Submitted, Accepted for Review by FDA…
Postherpetic Neuralgia (PHN)
Indication• Shingles (herpes zoster): reactivation of
chickenpox• Persistent post-shingles pain
Patient Population• Up to 20% of shingles patients • Poor treatment response• Population estimates vary
Orphan to 500K in U.S.
12
Phase 3 Trial IndicationPrimary
Endpoint MetSecondaryEndpoint
C117 PHN32% avg. pain
reduction during weeks 2-8 (p=0.01)
Responders (30%) 46% (p=0.019)
C116 PHN
30% avg. pain reduction during
weeks 2-8 (p = 0.001)
Responders (30%) 42% (p=0.034)
Qutenza: Positive Phase 3 Data in PHN
C116 PHN
Qutenza: Value Proposition in PHN
% Decrease from
Baseline
-50
-45
-40
-35
-30
-25
-20
-15
-10
-5
0
1 2 3 4 5 6 7 8 9 10 11 12Baseline
Week
C108 PHN
C110 PHN
C111 PHN
C117 PHN
% Change from Baseline in NPRS Scores [mean SE]
13
14
Lyrica ® 300 mg
(Study 045)Lyrica ® 300 mg
(Study 196)Qutenza
(Study C116)†Qutenza
(Study C117)†
Change -2.1 -1.7 -1.7 -1.8
% Change -30.0%* -25.4%* -30.1% -33.5%
50% Response 28% 27% 29% 31%
PGIC (much/very much)
40% 27% 36% 37%
Qutenza Versus Lyrica in PHN
† Week 8
• Calculated from mean absolute change/mean baseline scores
Lyrica data from FDA SBA
15
Qutenza Market Research:
Significant Potential…
16
All groupsQ26. What advantages does this product have over currently available treatments for moderate to severe neuropathic pain? (Check all that apply)
Physician Survey on Qutenza Advantages
Source: NeurogesX quantitative market study (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
17
Favorable Physician Consideration as First-Line Therapy
SOURCE: NeurogesX quantitative research (n=208)
Percentage of PHN prescriptions for first-line therapy(mean)
Total(n =208)
Before Profile After Profile Change
Qutenza 25.4%
gabapentin 25.1% 17.8% -7.3%
pregabalin (Lyrica®) 19.5% 14.9% -4.6%
duloxetine (Cymbalta®) 11.8% 8.4% -3.4%
lidocaine patch 5% (Lidoderm®) 9.1% 6.1% -3.0%
Other 34.5% 27.4% -7.1%
18
Positive Patient Feedback
• ~2/3 respondents would ask physicians about Qutenza or try it upon physician recommendation
Source: NeurogesX qualitative market research (n=78).
“I would definitely try it once -- it’s all-natural, how is it going to hurt me?” – PHN patient, NY
“I would definitely try it once -- it’s all-natural, how is it going to hurt me?” – PHN patient, NY
63% 64%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Likelihood to ask physician about drug
Likelihood to try drug if physician recommends
Likelihood to ask about and try drug (Patients responding 6 or 7 on a 7-
point scale)
19
Qutenza
Commercialization Strategy
20
IM
FP
N
Others
AN
PM
APM
RHU
P
Source: NDC 6/04 - Prometrics Analysis
18%
20%
10%
24%
6%
4%
4%
5%
9%
Commercialization Strategy
Source: FIRSTMARK April 2006
Office Pain
Services
Pain Clinic
Hospital
Pain Clinic
• Concentrated market
~5,000 clinics
~10,000 physicians
• U.S. sales force targeting specialists
Phased roll out likely
80 – 100 reps at peak
Co-promotion potential in PC market
EU Commercialization Partner
23%14%
63%
Temporary Codes: Improve Ease of Reimbursement/Market Access
2009 2010 2011 2012
PDUFA Date
Qutenza J-Code
Permanent CPT code for
procedure
Misc. J-Code
Temporary Q or Misc CPT or Category III CPT code for procedure
Qutenza C-Code (Medicare - Hospital
Outpatient ONLY)
Misc. C-Code (Medicare -
Hospital Outpatient
ONLY)NGX-4010Reimbursement
Treatment ProcedureReimbursement
• Temporary codes (product + procedure) shortly after launch• Permanent Codes 1-2 years post-launch
Qutenza Summary
• $3B Growing Neuropathic Pain Market Large, underserved market with current product limitations Strong growth for branded products (> generics growth) Positive patient and physician feedback
• Approaching commercialization Marketing applications filed in EU and U.S. Pre-commercialization activities ongoing (pricing, reimbursement) Potential regulatory decisions in 1H09 (EMEA) and 3Q09 (FDA)
• Potential Commercialization in late 2009 and early 2010 Europe: Launch 2H 09 with commercial partner (discussions ongoing) US: Launch 1H 10 with own sales force and/or potential partner
23
NGX-1998:
Next Generation Pain Management
Non-Patch Formulation Using Qutenza’s API
24
NGX-1998: Phase 1 ResultsSimilar Efficacy in Less Time versus Qutenza
0.0
2.0
4.0
6.0
8.0
10.0
12.0
14.0
16.0
18.0
20.0
Control NGX-4010 (60 min) NGX-1998 (25 min) NGX-1998 (15 min) NGX-1998 (5 min)
* Preliminary data: N=28
ENF counts [mean SEM]*
ENF Counts (fibers/mm)
Potential control formulations under evaluation for future trials
Product Pipeline
Preclinical Phase 1 Phase 2 Phase 3Marketing
Application
Clinical Program Initiated 2008
MAA Filed 2007
QUTENZA™ (NGX-4010): PHN
Qutenza: HIV-DSP
Qutenza: PDN
NGX-1998
NDA Filed and
Accepted
Opioid Prodrug Partnering OpportunitiesNGX-6052
Acetaminophen Prodrug Partnering Opportunities
NGX-6100
NGX-9674
NGX-1576
NGX-1576 (Hybrid Prodrug)
• Simultaneously releases both acetaminophen and precursor for glutathione synthesis in liver
• Murine model showed NGX-1576 at equimolar dose levels provides:– Comparable systemic
exposure to acetaminophen– Significantly reduced acute
hepatoxicityA
PA
P (
µg/
mL)
100
75
50
25
Time (hr)321 4
NGX-1576APAP
AST ALT
APAPAPAP
NGX-1576
Control
NGX-1576
Control100
200
300
Uni
ts/L
27
Financial Summary
• $30.8 M cash (9/30/08) Runway through EU and US regulatory decisions Evaluating non-equity based funding strategies No plans for near-term equity financing in public markets
• Conservative cash management focused on priorities U.S. and EU regulatory review process Pre-commercialization activities – reimbursement strategies
• Dedicated partnership effort EU commercialization partnership strategy Potential U.S. co-promotion Potential for opioid and acetaminophen prodrug collaborations
28
2009 – 2010 Milestones
1H09 MAA Decision for Qutenza (neuropathic
pain)
1H09 EU Commercial Partnership
2H09 PDUFA for Qutenza (PHN)
2H09 Qutenza EU Launch
1H10 Qutenza U.S. Launch
NASDAQ: NGSX