ABOUT DATAMONITOR HEALTHCARE 2
About the Central Nervous System pharmaceutical analysis team 2

CHAPTER 1 EXECUTIVE SUMMARY 3
Strategic scoping and focus 3
Datamonitor insight into the fibromyalgia market 3
Related reports 5

CHAPTER 2 MARKET DEFINITION AND OVERVIEW 7
Market definition for this report 7
Fibromyalgia market definition 7
Countries and regions included in this report 8
Current seven major market assessment 9
Regional market dynamics 9
The seven major fibromyalgia market value topped $1 billion in 2008 9
The US is by far the largest geographical market both in terms of value and volume 10
Class market dynamics 11
Drug use varies considerably between regions 11
Increasing uptake of branded anticonvulsants and antidepressants have shaped recent market dynamics 13
Future seven major market assessment 14
Scenario forecast overview 14
Base scenario - EMEA fibromyalgia approvals for Savella, Lyrica and Xyrem 15
5EU and Japan rollout will support continued US uptake 16
Emerging European market growth lessens US dominance 19
Anticonvulsant and antidepressant drug classes to dominate market by 2018 20
Fibromyalgia market to become far more brand-centric 21
Alternative scenario - no products gain EU approval 26
Sales in the 5EU remain entirely off-label as no product meets the EMEA's approval specifications 26
Comparison with previous forecast 27
Datamonitor's total market forecast remains relatively unchanged 27
Rest of the world assessment 28
Epidemiology of fibromyalgia in the rest of world 29

CHAPTER 3 BRAND DYNAMICS 31
Overview of competitive landscape 31
Brand dynamics 31
Three FDA approvals in 3 years, no approvals yet in Japan and the EU 31
Pfizer's Lyrica to remain leading fibromyalgia brand through to 2018 32
Approved brands 33
Lyrica (pregabalin; Pfizer) 34
First product approved by the FDA for the treatment of fibromyalgia 34
CHMP negative opinion is a setback for EU market penetration 35
Japan approval predicted for 2012 37
Datamonitor comment and forecasts - despite EU setback, strong continued uptake is expected in all three regions 38
Cymbalta (duloxetine; Eli Lilly and Boehringer Ingelheim) 40
Second product to gain FDA approval for the management of fibromyalgia 40
Negative opinion from EU regulators as efficacy data are deemed insufficient to warrant approval 41
Datamonitor comment and forecasts - no EU approval predicted 42
Savella (milnacipran; Pierre Fabre, Cypress and Forest) 44
Third product to gain FDA approval for fibromyalgia - as correctly predicted by Datamonitor 44
Specific Phase III EU study and adoption of composite responder analysis endpoint bodes well for European submission 45
Study assessing combination with pregabalin could strengthen milnacipran's market position 47
Datamonitor comment and forecasts - potential first-to-market status in EU 48
Forecasted pipeline products 51
Xyrem (sodium oxybate; Jazz Pharma and UCB) 51
Companies remain on-track for 2009 submission but lack of plans for long-term placebo-controlled efficacy trial may be an issue 51
Positive top-line results from first Phase III trial as sodium oxybate meets its primary endpoint 53
Study to assess the potential of a sodium oxybate oral tablet formulation shows intent to address current administration issues 54
Datamonitor comment and forecasts - Xyrem forecasts downgraded 55
Unforecasted pipeline products 58
Vimpat (lacosamide, UCB) 58
Inconclusive proof-of-concept study results adds risk to further developments of lacosamide in fibromyalgia 58
Terguride (ErgoNex) 59
Phase II study outcome unknown but fate of other dopamine agonists indicates limited potential in fibromyalgia 59
Effirma (Oral flupirtine, Adeona Pharmaceuticals) 60
Phase II clinical trial in treatment-refractory fibromyalgia gets the green light 60
Droxidopa (Chelsea Therapeutics) 60
Phase II study will specifically assess the central effect of norepinephrine in fibromyalgia 61
Recently discontinued or on-hold products 62
Neupro (rotigotine patch, UCB) 63
Failed Phase IIa proof-of-concept study leads to belief that Neupro development has been discontinued 63
Esreboxetine (Pfizer) 64
Tactical termination of potential Lyrica follow-on as Pfizer streamlines pipeline 64
Pristiq (desvenlafaxine, Wyeth) 65
Intentions to target fibromyalgia finally come to a close as latest Phase II study is terminated 65
AD-337 (Sosei Group) 66
Project assumed on hold or terminated following non-significant Phase IIa study results in 2007 66
Pramipexole ER (Boehringer Ingelheim) 67
Phase II trial of extended-release pramipexole terminated 3 years after the product's potential in fibromyalgia was formerly established 67
BIBLIOGRAPHY 68
Journal papers 68
Websites 68
Datamonitor reports 73

APPENDIX A 74
Market Assumptions 74
New product launches (as in base forecast) 74
Patent expiries 74
Data definitions, limitations and assumptions 75
Standard units 75
Derivation of sales forecasts and pricing trends 75
Forecast methodology 75

APPENDIX B 76
Contributing experts 76
Conferences attended 76
Report methodology 77
About Datamonitor 77
About Datamonitor Healthcare 77
About the central nervous system analysis team 78
Disclaimer 80

List of Tables
Table 1: Key events impacting the fibromyalgia market, 2007-2018 18
Table 2: Sales forecasts in fibromyalgia in the seven major markets ($m), 2008-2018 24
Table 3: Key fibromyalgia epidemiology study results, 1995-2006 29
Table 4: Approved and forecasted late-stage drug sales ($m) for fibromyalgia in the seven major markets, 2008-2018 32
Table 5: FDA-approved fibromyalgia brands - key facts, 2009 33
Table 6: Datamonitor's estimated launch dates for fibromyalgia products in the seven major markets, 2009-2018 74
Table 7: Patent expiry dates for the approved fibromyalgia brands in the seven major markets, 2009-2019 74

List of Figures
Figure 1: Fibromyalgia market sales value ($m) in the US, 5EU and Japan, 2005-08 9
Figure 2: Fibromyalgia market sales volume (IMS standard units sold, million) in the US, 5EU and Japan, 2005-08 10
Figure 3: Fibromyalgia market volume (standard units) sales dynamics by class in the US, 5EU and Japan, 2008 12
Figure 4: Fibromyalgia market volume (standard units, million) and value ($m) sales by class in the seven major markets, 2005-08 13
Figure 5: Datamonitor's seven major fibromyalgia market forecasts based on two possible scenarios, 2008-2018 15
Figure 6: Fibromyalgia market sales value ($m) in the US, 5EU and Japan, 2006-2018 17
Figure 7: Fibromyalgia-specific sales ($m), growth (CAGR) and market share (%) by region in the seven major markets, 2005-2018 19
Figure 8: Fibromyalgia market volume (IMS standard units sold, millions) and value ($m) by class in the seven major markets, 2006-2018 20
Figure 9: Fibromyalgia-specific sales ($m) of key brands in the seven major markets, 2008 and 2018 22
Figure 10: Datamonitor's 5EU fibromyalgia market scenario forecasts, 2008-2018 27
Figure 11: Comparison of Datamonitor's updated seven major market fibromyalgia market forecast to 2018 with its previous market forecast to 2017 28
Figure 12: Timeline: fibromyalgia therapy approval dates, 2007-09 31
Figure 13: Datamonitor's fibromyalgia-specific sales ($m) forecast for Pfizer's Lyrica (pregabalin) in the seven major markets, 2008-2018 39
Figure 14: Datamonitor's 2008 and updated fibromyalgia-specific sales ($m) forecast for Eli Lilly and Boehringer Ingelheim's Cymbalta (duloxetine) in the seven major markets, 2008-2018 42
Figure 15: Datamonitor's fibromyalgia-specific sales ($m) forecast for Pierre Fabre, Cypress and Forest's Savella (milnacipran) in the seven major markets, 2008-2018 48
Figure 16: Sodium oxybate Phase III fibromyalgia clinical program overview 52
Figure 17: Datamonitor's 2008 and updated fibromyalgia-specific sales ($m) forecast for Jazz and UCB's Xyrem (sodium oxybate) in the seven major markets, 2009-2018 56
Figure 18: Phase II droxidopa fibromyalgia clinical trial design overview 61