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

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.

Report 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.
[Fade out the market survey infos]

ABOUT DATAMONITOR HEALTHCARE 2
About the Infectious Diseases analysis team 2
CHAPTER 1 EXECUTIVE SUMMARY 3
Objective of the analysis 3
Scope of the analysis 3
Datamonitor insight into the vaccines market for adults and elderly 4
Contributing experts 5
Related reports 6
Upcoming related reports 6
CHAPTER 2 VACCINES FOR ADULTS AND ELDERLY - MARKET OVERVIEW 8
Adult vaccines - the next blockbusters? 8
Currently recommended vaccines 9
Routine vaccinations 10
Booster vaccinations for adults and elderly 11
Vaccines for catch-up and high-risk populations 11
Market influencers 12
The increasing age of the population is a key driver for adult vaccination 13
Challenges are associated with the lack of homogeneity in the immune status of adults and elderly 14
New technologies better suited to vaccine design for the elderly are emerging 15
It will be challenging to achieve high turn-out rates for vaccination among adults and elderly 17
Increasing awareness of vaccine-preventable diseases will result in greater interest in vaccination 19
A private market could emerge for adult vaccines 20
Strategies for maximum market penetration 21
CHAPTER 3 PNEUMOCOCCAL VACCINATION IN ADULTS AND ELDERLY 23
Summary 23
Disease background 23
Epidemiology 25
Invasive pneumococcal disease is associated with high incidence and death rates 25
The elderly are at high risk of infection and show highest death rates associated with invasive pneumococcal disease 26
The introduction of childhood vaccination with Prevnar has also reduced the incidence of invasive pneumococcal disease caused by vaccine serotypes in the elderly 29
Recommendations 32
Coverage 34
Comparator therapy: Pneumovax 23 (Merck & Co/Sanofi Aventis) 37
Unmet needs 41
Pipeline vaccines 43
Prevnar 13 (Wyeth) 44
Vaccine profile 44
Clinical trial data 45
Marketing factors 53
Satisfaction of unmet needs 53
Potential role in boosting 55
Datamonitor vaccine assessment summary 58
GlaxoSmithKline's pneumococcal conjugate candidates 61
Intercell's pneumococcal vaccine 64
Market opportunity and forecast 65
Pneumococcal vaccination in elderly and adults has a significant commercial potential 65
Assumptions made for forecasting the pneumococcal vaccines market 66
Country forecasts 68
Six major markets 68
US 72
5EU 75
France 77
Germany 79
Italy 81
Spain 84
UK 86
CHAPTER 4 ZOSTER VACCINES 88
Summary 88
Disease background 88
Course of disease - shingles occurs upon reactivation of varicella zoster virus 88
Post-herpetic neuralgia is the most concerning complication of shingles 90
Epidemiology 91
In the western major markets, around 2 million people suffer from herpes zoster infections every year 91
So far, there is no clear evidence of an increase in shingles incidence following routine infant varicella vaccination; however, more data are needed 93
Vaccination recommendations 95
Cost-efficacy considerations 97
Comparator therapy: Zostavax (Merck & Co) 99
Vaccine profile 99
Efficacy 100
Safety 103
Strengths and weaknesses 103
Unmet needs 104
Pipeline vaccines 105
Market opportunity and forecast 106
Historical sales performance 106
Assumptions made for forecasting the zoster vaccines market 108
Country forecasts 109
Six major markets 109
US 111
5EU 113
France 114
Germany 115
Italy 116
Spain 119
UK 120
CHAPTER 5 BOOSTER VACCINES 122
Summary 122
Current situation 123
Recommended vaccines 123
Currently marketed vaccines 125
Future outlook 127
Existing booster indications may be rolled out to additional countries 128
New indications are likely to be added to the booster portfolio 130
BIBLIOGRAPHY 132
Literature 132
APPENDIX A 140
Forecasts 140
Forecast methodology 140
Datamonitor forecast methodology 140
Datamonitor's patient-based forecasting model 141
Limitations of the patient-based forecasting model 143
APPENDIX B - MARKET FORECAST DATA 144
Six major markets 144
US 145
5EU 146
France 147
Germany 148
Italy 149
Spain 150
UK 151
APPENDIX C 152
Contributing experts 152
Report methodology 152
About Datamonitor 152
About Datamonitor Healthcare 153
About the Infectious Diseases analysis team 154
Key therapy team members 155
Holger Rovini, Head of Respiratory and Infectious Diseases 155
Hedwig Kresse, Senior Analyst, Infectious Diseases 155
Disclaimer 156
[Fade out table of contents]

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
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
[Fade out list of tables / figures]