TMCnet News
Get a Deep Insight Into the Commercial and Pipeline Insight: Fibromyalgia - Approvals Legitimize Condition and Expose Underserved Patient Population(Marketwire Via Acquire Media NewsEdge) LONDON, UNITED KINGDOM, August 5 / MARKET WIRE/ -- 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 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 To order this report: 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 More market research reports here! Contacts: Reportlinker.com Nicolas (718) 887-3024 Email: [email protected] Copyright ? 2008 Marketwire |