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August 05, 2008 11:02 ET

Get a Deep Insight Into the Commercial and Pipeline Insight: Fibromyalgia - Approvals Legitimize Condition and Expose Underserved Patient Population

LONDON, UNITED KINGDOM--(Marketwire - Aug. 5, 2008) - Reportlinker.com announces that a new market research report related to the Pharmaceutical industry industry is available in its catalogue.

Commercial and Pipeline Insight: Fibromyalgia - Approvals legitimize condition and expose underserved patient population

http://www.reportlinker.com/p091763/Commercial-and-Pipeline-Insight-Fibromyalgia---Approvals-legitimize-condition-and-expose-underserved-patient-population.html

Introduction

With a considerable patient potential and large medical unmet need, the untapped fibromyalgia market represents a lucrative opportunity for pharmaceutical companies. Estimated to total around $650m in 2007 in the seven major markets, Datamonitor forecasts the market to grow to over $2.4 billion in 2017.

Scope

- Analysis of clinical trial design and treatment guidelines in fibromyalgia.

- Fibromyalgia market sizing assessment with detailed methodology.

- Detailed profiles of key late-stage pipeline products for fibromyalgia, with indication-specific forecasts to 2017.

- Case study analysis of Pfizer's launch strategy for Lyrica (pregabalin) as well as assessment of development timeline.

Highlights

The approval of Pfizer's Lyrica transformed the previously unchartered fibromyalgia market and provided a new level of validity for this disputed condition.

In June 2008, Eli Lilly's dual serotonin and norepinephrine reuptake inhibitor (SNRI) Cymbalta (duloxetine) became the second FDA approved fibromyalgia treatment. Datamonitor forecasts seven major market Cymbalta sales for fibromyalgia to peak at in excess of half a billion US dollars in 2012 prior to US and EU patent expiries.

As has been successful for Pfizer, televised direct-to-consumer (DTC) drug advertising campaigns will continue to be an important marketing tool for new players, providing a boost to sales and adding further legitimacy to the condition.

Reasons to Purchase

- Understand the current fibromyalgia market dynamics and how they are expected to evolve out to 2017.

- Benchmark key late-stage pipeline fibromyalgia compounds against the current market leading brand, supported by insight from key opinion leaders.

- Assess seven major market sales forecasts of marketed and key late-stage pipeline fibromyalgia drugs.

ABOUT DATAMONITOR HEALTHCARE 2

About the Central Nervous System pharmaceutical analysis team 2

CHAPTER 1 EXECUTIVE SUMMARY 3

Scope of the analysis 3

Contributing experts 4

Datamonitor insight into the fibromyalgia market 5

Relevant reports 8

CHAPTER 2 MARKET OVERVIEW AND POTENTIAL 10

Definition and etiology 11

The cause and underlying mechanisms of fibromyalgia remain unknown 11

Research finds various chemical imbalances in patients 13

Proof of a genetic basis is hampered by patient heterogeneity 14

Diagnosis 14

American College of Rheumatology (1990) research criteria for fibromyalgia 15

1. History of widespread pain has been present for at least 3 months 15

2. Pain in 11 of 18 tender point sites on digital palpation 15

Co-morbidities 17

There are significant overlaps with other conditions 17

Epidemiology of fibromyalgia 18

Prevalence and incidence 19

Fibromyalgia is around seven times more common in women than men and increases with age 20

Experts and patient groups believe fibromyalgia is more common 21

Referral patterns, diagnosis and treatment rates 23

Patients are generally referred by primary care physicians to rheumatologists 23

Over half of the prevalent fibromyalgia population remain undiagnosed 24

Nearly all diagnosed patients receive drug therapy of some sort 25

Market sizing 25

Cheap generic drugs have historically made up the vast majority of fibromyalgia prescriptions 25

Clinical unmet needs 26

Need for a better understanding of disease etiology and pathophysiology 27

Need to improve pain reduction and control 28

Need to reduce sleep disturbances 29

CHAPTER 3 MARKETED BRAND DYNAMICS AND TREATMENT GUIDELINES 31

Marketed brands overview 32

Lyrica (pregabalin) 32

Drug overview 32

Forecast to 2017 38

Drug assessment 39

SWOT analysis 41

Pivotal clinical trial data 41

Other controlled clinical trials of Lyrica in fibromyalgia 45

Safety and tolerability 47

Treatment guidelines 49

European guidelines - EULAR evidence-based guidelines 49

Objectives - to provide evidence-based recommendations for the treatment of fibromyalgia 49

Methodology - developed by a multidisciplinary fibromyalgia task force representing 11 European countries 49

Results - 146 pharmacological and non-pharmacological studies were evaluated 51

EULAR recommendations 51

Meta-analysis was hampered by high variability in outcome measures used 53

US guidelines - the 2004 American Pain Society Guidelines 53

APS guidelines developed by an interdisciplinary panel of 13 pain management experts 53

APS guidelines recommend physicians start patients with a tricyclic antidepressant or cyclobenzaprine 54

New guidelines need to include new possible first-line options 54

CHAPTER 4 FORECAST ANALYSIS 56

Key events 57

Product launches in the US and 5EU 58

Product launches in Japan 58

Patent expiries 59

Data definitions, limitations and assumptions 61

Standard units 61

Derivation of sales forecasts and pricing trends 61

Forecast methodology 61

CHAPTER 5 PIPELINE OVERVIEW - R&D DYNAMICS AND APPROACH 62

Pipeline overview 63

Pipeline mainly consists of drugs indicated for other CNS indications 63

Classification of pipeline products 65

SNRI/NSRI antidepressants 65

GABA receptor modulators 66

Dopamine receptor agonists 67

Alpha adrenoceptor modulators 67

Others 68

Clinical trial design 68

Trials need to show improvements in both pain outcomes and function measures 68

Visual Analog Scale 69

Patient Experience Diary (PED) 69

Brief Pain Inventory 70

Patient Global Impression of Change (PGIC) scale 70

SF-36 physical component summary (PCS) score 70

Fibromyalgia Impact Questionnaire (FIQ) 71

OMERACT aims to standardize fibromyalgia endpoint requirements and measures 71

Agencies will review their clinical trial requirements based on OMERACT findings 71

OMERACT 8 continued work initiated at the first fibromyalgia workshop 2 years earlier 72

CHAPTER 6 LATE-STAGE DRUG ANALYSIS & FORECASTS 73

Late-stage pipeline comparative forecasts 74

Late-stage pipeline drug assessment summary 74

SNRI/NSRI antidepressant pipeline drugs 75

Cymbalta (duloxetine) 76

Drug overview 76

Forecasts to 2017 79

Drug assessment 80

Marketing factors 81

Patient potential 86

Clinical trial data 88

Milnacipran 97

Drug overview 97

Forecasts to 2017 99

Drug assessment 101

Marketing factors 101

Patient potential 104

Clinical trial data 105

Pristiq (desvenlafaxine) 114

Drug overview 114

Clinical trial data 115

AD-337 115

Drug overview 115

Clinical trial data 116

GABA receptor modulator pipeline drugs 117

Xyrem (sodium oxybate) 117

Drug overview 117

Forecasts to 2017 119

Drug assessment 120

Marketing factors 121

Patient potential 124

Clinical trial data 127

Lunesta (eszopiclone) 130

Drug overview 130

Clinical trial data 130

Dopamine receptor agonist pipeline drugs 131

Neupro (rotigotine) 133

Drug overview 133

Clinical trial data 134

Terguride 135

Drug overview 135

Clinical trial data 135

Alpha adrenoceptor modulator pipeline drugs 136

Esreboxetine 137

Drug overview 137

Clinical trial data 137

AGN 203818 139

Drug overview 139

Other pipeline drugs 139

Vimpat (lacosamide) 140

Drug overview 140

Clinical trial data 141

Neurotropin 142

Drug overview 142

Clinical trial data 142

NRC-027F 143

Drug overview 143

Flupirtine 143

Drug overview 143

Clinical trial data 144

PF-738502 145

Drug overview 145

CHAPTER 7 COMMERCIAL IMPACT AND CASE STUDY ANALYSIS 146

Introduction 147

Evaluation of Pfizer's successful Lyrica launch strategy 147

Pfizer sponsored unbranded fibromyalgia advertising campaign 148

Pfizer launches branded DTC campaign 150

BIBLIOGRAPHY 155

Journal papers, books, and conference abstracts 155

Websites 164

Datamonitor reports 171

APPENDIX 173

Market sizing calculations 173

Methodology, assumptions and caveats 176

Top 10 prescribed products for fibromyalgia (minus Lyrica and Cymbalta) in the 5EU and Japan in 2007 178

Clinical guidelines - classification schemes 179

Recently discontinued fibromyalgia projects or those assumed on-hold 180

5EU IMS standard unit dose-dependent Lyrica prices 181

Report methodology 181Contributing experts 183

About Datamonitor 183

About Datamonitor Healthcare 184

About the Disease analysis team 184

Disclaimer 186

List of Tables

Table 1: Prevalence of symptoms in fibromyalgia patients 11

Table 2: Key fibromyalgia epidemiology study results, 1995-2006 19

Table 3: Prevalence of fibromyalgia across the seven major markets, 2008 20

Table 4: Fibromyalgia prevalence as quoted by various fibromyalgia organizations/associations, 2008 22

Table 5: Lyrica: key facts, 2008 32

Table 6: Key events impacting Lyrica, 2008-2017 39

Table 7: Summary of the 14-week Lyrica Phase III fibromyalgia trial 42

Table 8: Baseline characteristic of patients enrolled in the Crofford et al. (2005) pregabalin trial 45

Table 9: Adverse reaction incidence of Lyrica in controlled trials for fibromyalgia 47

Table 10: EULAR recommendations for the management of fibromyalgia, 2007 52

Table 11: Stepwise fibromyalgia management as recommended by the 2004 American Pain Society treatment guidelines 54

Table 12: Summary of findings from pharmacological studies in fibromyalgia according to Arnold (2006) 55

Table 13: Forecast launch dates of fibromyalgia drugs in the US and 5EU, 2008-2017 58

Table 14: Forecast launch dates of fibromyalgia drugs in Japan, 2008-2017 58

Table 15: Key patent expiries for key marketed and late-stage pipeline fibromyalgia drugs in the US and 5EU 59

Table 16: Pipeline drugs in clinical development for fibromyalgia, 2008 63

Table 17: Key SNRI/NSRI antidepressants in late-stage development for fibromyalgia, 2008 76

Table 18: Cymbalta: key facts, 2008 77

Table 19: Key events impacting Cymbalta, 2008-2017 80

Table 20: Duloxetine in fibromyalgia treatment-emergent adverse events: 6-month treatment phase1 93

Table 21: Results of the Arnold et al. (2005) duloxetine trial 96

Table 22: Milnacipran: key facts, 2008 98

Table 23: Key events impacting milnacipran, 2008-2017 100

Table 24: The most common treatment emergent adverse events of milnacipran in placebo-controlled trial fibromyalgia 111

Table 25: Key GABA receptor modulators in late-stage development for fibromyalgia, 2008 117

Table 26: Xyrem: key facts, 2008 118

Table 27: Key events impacting Xyrem, 2008-2017 120

Table 28: Key dopamine receptor agonists in late-stage development for fibromyalgia, 2008 132

Table 29: Key alpha adrenoceptor modulators in late-stage development for fibromyalgia, 2008 136

Table 30: Key 'other' products in late-stage development for fibromyalgia, 2008 140

Table 31: Total US fibromyalgia market value estimation, 2004-07 173

Table 32: Total 5EU fibromyalgia market value estimation, 2004-07 174

Table 33: Total Japan fibromyalgia market value estimation, 2004-07 175

Table 34: Top 10 prescribed products for fibromyalgia (minus Lyrica and Cymbalta) in the 5EU and Japan, 2007 178

Table 35: Breakdown of the evidence and strength criteria used in the EULAR fibromyalgia management recommendations, 2007 179

Table 36: Recently discontinued or fibromyalgia projects or those assumed on-hold, 2008 180

Table 37: IMS standard unit price of Lyrica at three different doses across the 5EU, 2007 181

Table 38: Datamonitor drug assessment parameters 182

List of Figures

Figure 1: Drug assessment summary overview of key marketed and key pipeline fibromyalgia drugs, 2008 7

Figure 2: Historical (2004-07) and forecast (2008-2017) fibromyalgia sales revenue for key marketed and pipeline drugs across the seven major markets 8

Figure 3: The fibromyalgia 'tender points' 16

Figure 4: Estimated value of fibromyalgia sales in seven major markets, 2004-07 26

Figure 5: Timeline of Lyrica's fibromyalgia clinical and regulatory development, 2004-08 33

Figure 6: Lyrica dosing for fibromyalgia 35

Figure 7: Fibromyalgia-specific sales ($m) forecast for Lyrica in the seven major markets, 2008-2017 38

Figure 8: Datamonitor's competitive positioning analysis for Lyrica in fibromyalgia across the seven major markets, 2008-2017 40

Figure 9: Lyrica SWOT analysis in the fibromyalgia market, 2008 41

Figure 10: Lyrica Patient Global Impression of Change results 43

Figure 11: Diagram of patient flow in the Crofford et al. (2005) pregabalin trial 46

Figure 12: Incidence of selected adverse reactions and discontinuation rates in controlled fibromyalgia trials of Lyrica 48

Figure 13: Impact of key events on the fibromyalgia market, 2008-2017 57

Figure 14: Comparative fibromyalgia-specific sales ($m) forecast for key late-stage pipeline drugs (and Cymbalta) in the seven major markets, 2008-2017 74

Figure 15: Drug assessment summary overview of key late-stage pipeline fibromyalgia drugs, 2008 75

Figure 16: Fibromyalgia-specific sales ($m) forecast for Cymbalta in the seven major markets, 2008-2017 79

Figure 17: Datamonitor's competitive positioning analysis for Cymbalta in fibromyalgia across the seven major markets,, 2008-2017 81

Figure 18: Cymbalta home page, 2008 (up to June 13, 2008) 84

Figure 19: Cymbalta home page, 2008 (June 16, 2008) 86

Figure 20: Phase III duloxetine fibromyalgia study design 90

Figure 21: Brief Pain Inventory (BPI) average pain scores of duloxetine in fibromyalgia patients: ?30% improvement from baseline to endpoint at 3 and 6 month acute treatment phases 91

Figure 22: Brief Pain Inventory (BPI) average pain scores of duloxetine in fibromyalgia patients: ?50% improvement from baseline to endpoint at 3 and 6 month acute treatment phases 92

Figure 23: Diagram of patient flow in the Arnold et al. (2005) duloxetine trial 94

Figure 24: Fibromyalgia-specific sales ($m) forecast for milnacipran in the seven major markets, 2008-2017 99

Figure 25: Datamonitor's competitive positioning analysis for milnacipran in fibromyalgia across the seven major markets,, 2008-2017 101

Figure 26: Composite responder rates-for fibromyalgia syndrome (Pain + PGIC + SF-36 PCS); completer analysis at 3 and 6 months from milnacipran Study FMS-031 109

Figure 27: Composite responder rates-for fibromyalgia Pain (Pain + PGIC); completer analysis at 3 and 6 months from milnacipran Study FMS-031 110

Figure 28: Diagram of patient flow in the Vitton et al. (2004) milnacipran trial 113

Figure 29: Fibromyalgia-specific sales ($m) forecast for Xyrem in the seven major markets, 2008-2017 119

Figure 30: Datamonitor's competitive positioning analysis for Xyrem in fibromyalgia across the seven major markets,, 2008-2017 121

Figure 31: Sodium oxybate fibromyalgia clinical program overview 127

Figure 32: Pfizer sponsored My Fibro Relief website 149

Figure 33: Lyrica website homepage 152

Figure 34: US Lyrica promotional spend versus standard unit prescriptions, 2007 153

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Commercial and Pipeline Insight: Fibromyalgia - Approvals legitimize condition and expose underserved patient population

http://www.reportlinker.com/p091763/Commercial-and-Pipeline-Insight-Fibromyalgia---Approvals-legitimize-condition-and-expose-underserved-patient-population.html

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