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Commercial Insight Neuropathic Pain - A Plethora of Patient

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Commercial Insight: Neuropathic Pain - A Plethora of Patient
Segmentation and Product Differentiation Opportunities

Description:    Neurontin (gabapentin) has finally been knocked off the top spot as a result of fierce generic
                incursion.

                However, Pfizers follow-on Lyrica (pregabalin), Lillys Cymbalta (duloxetine) and Endo/Elans
                Lidoderm (lidocaine patch 5%) are re-establishing market growth and laying the groundwork for
                new entrants.

                Scope of this title:

                - Detailed analysis of key brands, with sales and volume forecasts to 2014 for the neuropathic pain
                indication alone
                - Assessment of current and future opportunities and threats in the neuropathic pain market across
                the seven major pharmaceutical markets
                - Consideration of key events that may affect revenues in each of the seven major pharmaceutical
                markets are applied and discussed
                - Lifecycle management case studies show how previously successful strategies should be applied
                in todays market

                Highlights of this title:

                - After a brief slump in 2005, the neuropathic pain market is forecast to grow to $5.5 billion by
                2015, led by Lyrica and Cymbalta. Pfizers commitment to neuropathic pain and Lillys targeted
                approach are both effective strategies that can be utilized by all new entrants.
                - The presence of generic gabapentin has introduced strong cost competition in the market. Setting
                a competitive price point for a new product is vital as healthcare payers continue to push for lower
                drug prices and generic prescribing although innovation is rewarded with a premium price and a
                high level of reimbursement in most countries.

                The current concerns surrounding the use of NSAIDs and opioids will be beneficial to neuropathic
                pain drug companies as physicians seek alternative analgesics for their patients. However, if they
                are to realize the full potential of the market, companies need to focus on expanding the patient
                potential by supporting physician education programs.

                Reasons to order your copy:

                - Quantify the future size of the neuropathic pain market in each of the seven major markets
                - Understand key product differentiating factors that provide commercial advantages over existing
                therapies
                - Compare market penetration and brand positioning strategies to those successfully employed by
                Pfizer, Endo, and Eli Lilly



Contents:       Chapter 1
                Executive summary 3
                Objective of the analysis 3
                Our insight into the neuropathic pain market 3

                Chapter 2
                Market definition and overview 15
                Market definition for this report 15
                Market sizing assumptions and caveats 15
                Five treatments are approved for neuropathic pain in the US and Europe 15
                US and EU markets comprise sales of approved and non-approved products 16
                Japan market value was calculated using sales of popular NSAIDs 19
Current market situation 19
During 2005 the global market fell by 23% as US physicians switch from Neurontin to generic
gabapentin 19
US market down but European markets show growth 21
Cymbalta, Lyrica, and Lidoderm are restoring market value 22
Strategic scoping and focus 26

Chapter 3
Country market assessments 27
Summary of environmental issues affecting the neuropathic pain market 27
Global opportunities and threats 31
Opportunities 31
Physicians are now turning to alternative analgesics amid concerns over NSAID and opioid use 31
Gain commercial advantage with an improved dosing regimen to gabapentin 31
A mechanism-based treatment approach would be well received 32
General neuropathic pain provides a broader customer base in the EU 32
Subtype-specific labeling provides an opportunity to define and own a market in the US and in
Japan 32
Niche neuropathic pain subtypes can provide orphan drug benefits 34
Fibromyalgia is an attractive new market 35
Treatment guidelines say yes to opioids and no to NSAIDs 35
Journals, medical conferences and CME presentations are effective marketing channels for
neuropathic pain products 38
Maximize market penetration by emphasizing ability to relieve specific symptoms of neuropathic
pain 39
Minimal drug-drug interactions are key in treating HIVNP, DNP, and MSNP patients 39
European parliament approves pediatric legislation 40
Threats 40
Education is needed to improve disease and treatment awareness among PCPs 40
Generic gabapentin introduces strong cost competition in the EU and the US 41
Pharmacovigilance is leading to more stringent post-marketing regulations 43
New EU states may lead to a flood of cheap drug exports 44
Seeking out additional indications is becoming a less effective generic defense strategy 45
US: opportunities and threats 45
Opportunities 45
US pharmacists to play a greater role in neuropathic pain management 45
Medicare Part D reforms will provide a short-term boost, but in the longer term the impact is less
certain 46
Threats 47
Further genericization encouraged by new legislation and public programs 47
$10 billion cut planned in Medicaid between 2005 and 2010 48
A high price point can prevent formulary access for drugs that do not have a significant clinical
differentiating factor 48
The Medicare Part D "doughnut hole" could result in a surge in parallel imports 48
Disclosure of clinical trial results could become mandatory 49
Japan: opportunities and threats 50
Opportunities 50
There is a strong need for regulatory approved medicines 50
Separation of manufacturing and marketing entities benefits both Japanese and foreign companies
51
Fewer outsourcing restrictions enhances manufacturing efficiency 51
Reduced product approval time 52
Harmonization of approval process 52
The Internet is an effective means to reach out to patients 52
Threats 53
Earnings outlook clouded by lower drug prices and higher R&D costs 53
Off-label prescribing is uncommon 53
Generic drug use is expected to increase 54
Flat-sum reimbursement discourages physicians from prescribing highly priced medicines 54
France: opportunities and threats 55
Opportunities 55
Innovative drug development encouraged by price premium and high-level reimbursement 55
Consumers in France readily recognize the Internet as a source of high-quality medical information
56
Threats 56
Education and strong clinical trial data are needed to promote the use of newer drugs 56
Slow referrals can delay access to neuropathic pain drugs 57
French market attractiveness hit by higher taxes, lower prices and a shorter reimbursement 57
Germany: opportunities and threats 58
Opportunities 58
The German Research Network on Neuropathic Pain (GNNP) aims to define a mechanistic approach
to diagnosis and treatment 58
Free pricing system and culture of innovation encourages novel drug development 60
ePharmacy and mail-order drugs legalized 60
Threats 60
National health insurer allowed greater powers to decrease expensive prescribing 60
Italy: opportunities and threats 61
Opportunities 61
Innovative drug development rewarded with premium price and 100% reimbursement 61
Threats 62
Education is needed to tackle low awareness of effective therapies 62
Further pharmaceutical price cuts planned 62
Spain: opportunities and threats 63
Opportunities 63
Planned electronic prescribing will improve access to treatments and promote the rational use of
drugs 63
Threats 64
Price cuts continue unabated 64
New medicines bill pushes more price cuts and increases pharmaceutical tax 64
Government awareness campaign promotes generic use 65
UK: opportunities and threats 65
Opportunities 65
Nurses and pharmacists can now prescribe neuropathic pain drugs 65
New fast track drug assessment process speeds up time between licensing and NICE
recommendations 66
Threats 66
Pricing controls dominate budgetary cost containment strategies 66
The NHS is unreceptive to new treatments compared to the rest of Europe 67

Chapter 4
Forecast analysis 68
Key events 68
New product launches in the US and EU 68
Lamictal XR 68
Neurodex (AVP-923) 69
Ralfinamide 70
Transacin (NGX-4010) 71
Lacosamide 72
XP13512 73
Gabapentin GR 74
Sativex 75
NP-1 76
Traxoprodil 77
Tramadol ER 78
Brivaracetam (UCB 34714) 78
New product launches in Japan 79
Lyrica 79
Cymbalta 80
KN-48 80
Patent expiries 80
Trileptal 80
Actiq 81
Effexor/Effexor XR 81
Lamictal 81
Topamax 82
Lidoderm 82
Keppra 82
Data definitions, limitations and assumptions 82
Standard units 82
Japanese market data 83
Derivation of sales forecasts and pricing trends 83
Drug pricing and genericization assumptions 83
Forecasts 84
Forecast methodology 84

Chapter 5
Commercial impact and lifecycle management: case studies 85
Introduction 85
Market penetration and brand positioning 85
Case study: Commitment to neuropathic pain is key to Pfizers success 85
The glory days of Neurontin are over but Pfizer will battle on 86
Lyrica is priced competitively against generics 88
Pfizer looks set to regrow its neuropathic pain franchise 89
Pfizers legacy benefits other players 90
Case study: Premium price, brand loyalty and off-label use drives Lidoderm sales growth 91
Lidoderm follows the Neurontin model of growth 91
Establish FDA approval before communicating clinical trial data for other pain states 92
COX-II concerns has benefited Lidoderm 95
Case study: Cymbalta positioned as the DNP drug of choice 95
A competitive price point, once daily dosage and simpler titration are key to commercial success 95
Sponsoring treatment guidelines for specific patient groups will help define the market 97
Utilize established diabetes resources to reach out to the DNP customer base 97

APPENDIX A - MARKET DATA AND MAJOR BRAND KEY FACTS 99
Summary neuropathic pain market data 99
Anticonvulsant market data 100
Antidepressant market data 107
Other drugs market data 108

APPENDIX B - MARKET FORECAST DATA AND METHODOLOGY 111
Global market forecasts 111
5EU market forecasts 112
US market forecasts 113
Japan market forecasts 114
France market forecasts 115
Germany market forecasts 116
Italy market forecasts 117
Spain market forecasts 118
UK market forecasts 119

FORECAST METHODOLOGY 119
ICD-10 codes 119
Sales calculations 121

APPENDIX C 123
Contributing experts 123
Biographies 123
Bibliography 124
Clinical trial data 124
General 125
Treatment guidelines 126
Websites 127
Report methodology 128

List of Tables
Table 1: Key players in the neuropathic pain market 23
Table 2: Global sales performance of key brands in the neuropathic pain market, 2004-05 24
Table 3: Neuropathic pain subtypes and abbreviations 33
Table 4: First-line recommendations for neuropathic pain, 2004 36
            Table 5: Ex-manufacturer price of Neurontin vs. generic gabapentin in the US 42
            Table 6: Average wholesaler price of Neurontin vs. generic gabapentin in the US, 2006 43
            Table 7: Late stage R&D pipeline for neuropathic pain in Japan 50
            Table 8: Cost comparison of 30 days treatment of PHN with generic gabapentin vs. Lyrica in the
            US, 2005 88
            Table 9: Lidoderm clinical trials 94
            Table 10: Cost comparison of 30 days treatment of DNP with Cymbalta vs. Lyrica in the US, 2006
            96
            Table 11: Summary Market Data 99
            Table 12: Neurontin: key facts 100
            Table 13: Lyrica: key facts 101
            Table 14: Topamax: key facts 102
            Table 15: Lamictal: key facts 103
            Table 16: Tegretol: key facts 104
            Table 17: Trileptal: key facts 105
            Table 18: Keppra: key facts 106
            Table 19: Cymbalta: key facts 107
            Table 20: Lidoderm: key facts 108
            Table 21: Oxycontin: key facts 109
            Table 22: Duragesic: key facts 110
            Table 23: Global neuropathic pain drug sales ($m) forecasts, 2005-15 111
            Table 24: 5EU neuropathic pain drug sales ($m) forecasts, 2005-15 112
            Table 25: US neuropathic pain drug sales ($m) forecasts, 2005-15 113
            Table 26: Japan neuropathic pain drug sales ($m) forecasts, 2005-15 114
            Table 27: France neuropathic pain drug sales ($m) forecasts, 2005-15 115
            Table 28: Germany neuropathic pain drug sales ($m) forecasts, 2005-15 116
            Table 29: Italy neuropathic pain drug sales ($m) forecasts, 2005-15 117
            Table 30: Spain neuropathic pain drug sales ($m) forecasts, 2005-15 118
            Table 31: UK neuropathic pain drug sales ($m) forecasts, 2005-15 119
            Table 32: Neuropathic pain market definition by ICD-10 codes 120
            Table 33: Neuropathic pain market definition by ICD-10 codes [continued] 121
            Table 34: Percentage of total value accounted for by neuropathic pain diagnoses, for marketed
            brands and generics, 2005

            List of Figures
            Figure 1: Key events impacting the neuropathic pain market, 1999-2006 20
            Figure 2: Global neuropathic pain market value by class, 2002-05 20
            Figure 3: Global neuropathic pain prescription volume by class, 2002-05 21
            Figure 4: Performance of the US, 5EU and Japan neuropathic pain markets, 2004-05 22
            Figure 5: Breakdown of key brands sales by neuropathic pain vs. other indications, 2005 25
            Figure 6: Summary of environmental issues in the global market, 2006 28
            Figure 7: Summary of environmental issues in the US and Japanese markets, 2006 29
            Figure 8: Summary of environmental issues in the 5EU markets, 2006 30
            Figure 9: Pfizer US and 5EU gapapentin sales, 2001-05 86
            Figure 10: Pfizers neuropathic pain revenues in the EU and US, 2001-05 87
            Figure 11: 5EU gabapentin sales, 2001-05 87
            Figure 12: SWOT analysis of Lyrica, 2006 89
            Figure 13: Lyrica homepage, 2006 90
            Figure 14: SWOT analysis of Lidoderm, 2006 91
            Figure 15: US sales and key milestones for Lidoderm , 2001-05 92
            Figure 16: Lidoderm US sales split by indication, 2005 93
            Figure 17: SWOT analysis of Cymbalta, 2006 96
            Figure 18: US and 5EU quarterly sales of Cymbalta, 2004-06 97



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