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

Published by: Datamonitor

Published: Jul. 2, 2008 - 193 Pages

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

About the Central Nervous System pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Scope of the analysis

Contributing experts

Datamonitor insight into the fibromyalgia market

Relevant reports

CHAPTER 2 MARKET OVERVIEW AND POTENTIAL

Definition and etiology

The cause and underlying mechanisms of fibromyalgia remain unknown

Research finds various chemical imbalances in patients

Proof of a genetic basis is hampered by patient heterogeneity

Diagnosis

American College of Rheumatology (1990) research criteria for fibromyalgia

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

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

Co-morbidities

There are significant overlaps with other conditions

Epidemiology of fibromyalgia

Prevalence and incidence

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

Experts and patient groups believe fibromyalgia is more common

Referral patterns, diagnosis and treatment rates

Patients are generally referred by primary care physicians to rheumatologists

Over half of the prevalent fibromyalgia population remain undiagnosed

Nearly all diagnosed patients receive drug therapy of some sort

Market sizing

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

Clinical unmet needs

Need for a better understanding of disease etiology and pathophysiology

Need to improve pain reduction and control

Need to reduce sleep disturbances

CHAPTER 3 MARKETED BRAND DYNAMICS AND TREATMENT GUIDELINES

Marketed brands overview

Lyrica (pregabalin)

Drug overview

Forecast to 2017

Drug assessment

SWOT analysis

Pivotal clinical trial data

Other controlled clinical trials of Lyrica in fibromyalgia

Safety and tolerability

Treatment guidelines

European guidelines - EULAR evidence-based guidelines

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

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

Results - 146 pharmacological and non-pharmacological studies were evaluated

EULAR recommendations

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

US guidelines - the 2004 American Pain Society Guidelines

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

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

New guidelines need to include new possible first-line options

CHAPTER 4 FORECAST ANALYSIS

Key events

Product launches in the US and 5EU

Product launches in Japan

Patent expiries

Data definitions, limitations and assumptions

Standard units

Derivation of sales forecasts and pricing trends

Forecast methodology

CHAPTER 5 PIPELINE OVERVIEW - R&D DYNAMICS AND APPROACH

Pipeline overview

Pipeline mainly consists of drugs indicated for other CNS indications

Classification of pipeline products

SNRI/NSRI antidepressants

GABA receptor modulators

Dopamine receptor agonists

Alpha adrenoceptor modulators

Others

Clinical trial design

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

Visual Analog Scale

Patient Experience Diary (PED)

Brief Pain Inventory

Patient Global Impression of Change (PGIC) scale

SF-36 physical component summary (PCS) score

Fibromyalgia Impact Questionnaire (FIQ)

OMERACT aims to standardize fibromyalgia endpoint requirements and measures

Agencies will review their clinical trial requirements based on OMERACT findings

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

CHAPTER 6 LATE-STAGE DRUG ANALYSIS & FORECASTS

Late-stage pipeline comparative forecasts

Late-stage pipeline drug assessment summary

SNRI/NSRI antidepressant pipeline drugs

Cymbalta (duloxetine)

Drug overview

Forecasts to 2017

Drug assessment

Marketing factors

Patient potential

Clinical trial data

Milnacipran

Drug overview

Forecasts to 2017

Drug assessment

Marketing factors

Patient potential

Clinical trial data

Pristiq (desvenlafaxine)

Drug overview

Clinical trial data

AD-337

Drug overview

Clinical trial data

GABA receptor modulator pipeline drugs

Xyrem (sodium oxybate)

Drug overview

Forecasts to 2017

Drug assessment

Marketing factors

Patient potential

Clinical trial data

Lunesta (eszopiclone)

Drug overview

Clinical trial data

Dopamine receptor agonist pipeline drugs

Neupro (rotigotine)

Drug overview

Clinical trial data

Terguride

Drug overview

Clinical trial data

Alpha adrenoceptor modulator pipeline drugs

Esreboxetine

Drug overview

Clinical trial data

AGN 203818

Drug overview

Other pipeline drugs

Vimpat (lacosamide)

Drug overview

Clinical trial data

Neurotropin

Drug overview

Clinical trial data

NRC-027F

Drug overview

Flupirtine

Drug overview

Clinical trial data

PF-738502

Drug overview

CHAPTER 7 COMMERCIAL IMPACT AND CASE STUDY ANALYSIS

Introduction

Evaluation of Pfizer's successful Lyrica launch strategy

Pfizer sponsored unbranded fibromyalgia advertising campaign

Pfizer launches branded DTC campaign

BIBLIOGRAPHY

Journal papers, books, and conference abstracts

Websites

Datamonitor reports

APPENDIX

Market sizing calculations

Methodology, assumptions and caveats

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

Clinical guidelines - classification schemes

Recently discontinued fibromyalgia projects or those assumed on-hold

5EU IMS standard unit dose-dependent Lyrica prices

Report methodology

Contributing experts

About Datamonitor

About Datamonitor Healthcare

About the Disease analysis team

Disclaimer

List of Tables

Table 1: Prevalence of symptoms in fibromyalgia patients

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

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

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

Table 5: Lyrica: key facts, 2008

Table 6: Key events impacting Lyrica, 2008-2017

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

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

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

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

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

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

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

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

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

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

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

Table 18: Cymbalta: key facts, 2008

Table 19: Key events impacting Cymbalta, 2008-2017

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

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

Table 22: Milnacipran: key facts, 2008

Table 23: Key events impacting milnacipran, 2008-2017

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

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

Table 26: Xyrem: key facts, 2008

Table 27: Key events impacting Xyrem, 2008-2017

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

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

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

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

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

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

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

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

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

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

Table 38: Datamonitor drug assessment parameters

List of Figures

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

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

Figure 3: The fibromyalgia 'tender points'

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

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

Figure 6: Lyrica dosing for fibromyalgia

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

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

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

Figure 10: Lyrica Patient Global Impression of Change results

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

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

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

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

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

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

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

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

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

Figure 20: Phase III duloxetine fibromyalgia study design

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

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

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

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

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

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

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

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

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

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

Figure 31: Sodium oxybate fibromyalgia clinical program overview

Figure 32: Pfizer sponsored My Fibro Relief website

Figure 33: Lyrica website homepage

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

Abstract

• 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.

• 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.

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