Biotech in Autoimmune and Inflammatory Disease 2006, 2nd Edition

Biotech in Autoimmune and Inflammatory Disease 2006, 2nd Edition

Despite their diversity, global healthcare systems are increasingly converging in the need and desire to contain costs of healthcare, and especially those associated with pharmaceuticals. At the same time, Big Pharma are having to contend with a dearth of invention, patent expirations, and increased generic competition, among other factors undermining their profits. In this environment, the importance of market access strategies, especially in terms of pricing, reimbursement and parallel trade are rapidly gaining prominence.

Pharmaceutical and Biotech Market Entrance Strategies examines the key issues that need to be addressed by pharmaceutical and biotechnology companies alike in order to successfully achieve return on investment. The American, European and Japanese markets are undergoing constant harmonisation changes, which are leading to a globalisation of operating procedures and state intervention in healthcare and drug cost containment. This trend has an important impact on the overall environment facing the drug and biotechnology industry - on the one hand, facilitating access to a wider patient base but, on the other, raising the stakes of key pricing and reimbursement decisions.

The value of biological drugs indicated for autoimmune diseases, which affect up to 5% of the total world population, was roughly $11 billion in 2005. Remicade, Enbrel, Humira and Avonex currently lead the autoimmune field. These drugs are transforming the treatment of autoimmune diseases. In addition, novel therapies for psoriasis, asthma, and lupus will in the near future add tremendous revenue to an already rapidly growing field.

Medical, pharmaceutical and biotechnological advances are increasingly supporting the use of biological drugs in the treatment of autoimmune and inflammatory diseases. Indeed, biologics are having a major impact on the treatment of those diseases for which there has been significant unmet need for decades. As the new drugs are capable of targeting disease-causing proteins in a more specific fashion, while also carrying lower risks of adverse side effects, they have considerable advantages over traditional treatments.

Given the above advantages, coupled with more commercial interest, better understanding of disease causes and higher levels of patient familiarity with the new medicines, biologics will continue to undermine the market share of traditional drugs.

This report assesses the current and future position of biologics in the fields of multiple sclerosis, rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematosus, psoriasis and asthma.

Key Features of This Report:

• Thorough financial breakdown of the leading products and companies making an impact in autoimmune disease therapy
• Market analysis and differentiation of biotech vs. synthetic drugs in combatting autoimmune diseases
• Financial forecasts for key autoimmune disease therapies as well as overall disease category value through 2010
• Integrative discussion of clinical data and key trials for already marketed as well as emerging biologics
• Identification and discussion of trends and issues that will have a significant impact on the future of biotech drug sales in the autoimmune market
• Appraisal of development status for key biotech drugs being developed for various autoimmune diseases and discussion of research trends

• Companies interested in understanding the wider opportunities and challenges in the autoimmune and inflammatory disease markets
• Pharma/biotech companies wishing to identify opportunities and threats to products in these markets in order to examine a variety of profit maximization strategies
• Companies interested in understanding the state of R&D in relation to multiple sclerosis, rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematosus, psoriasis and asthma

Table of Contents

1 Methodology and Executive Summary
1.1 Report Objectives
1.2 Research Methodology
1.3 Executive Summary

2 An Introduction to Autoimmune Diseases
2.1 Prevalence and Demographics of Autoimmune Diseases
2.2 Causes of Autoimmune Diseases
2.3 Types of Autoimmune Diseases
2.4 Workings of the Immune System
2.5 Unmet Need in Autoimmune Diseases

3 Multiple Sclerosis
3.1 Disease Overview
3.2 Pathogenesis
3.3 Symptoms
3.4 Types of MS
3.5 Causes
3.6 Risk Factors
3.7 Global Impact of MS and Patient Population
3.8 Financial Costs Associated with MS
3.9 An Overview of Treatment Options for MS
3.10 Biological Response Modifiers (BRMs) and the MS Therapy Market
3.10.1 Avonex
3.10.2 Betaseron
3.10.3 Rebif
3.11 Key Clinical Trial Results and Ongoing Trials Impacting Global Sales
3.12 The Role of Neutralizing Antibodies and MS Therapy Efficacy
3.13 Market Analysis
3.13.1 Sales Data for Leading MS Therapies
3.13.2 SWOT Analysis for Key Products
3.13.3 Market Share
3.13.4 Geographic Market Analysis
3.14 How Do the BRMs Compete with Other MS Therapies?
3.14.1 Copaxone
3.14.2 Novantrone
3.15 Tysabri After the Fall: Will it Regain its Foothold?
3.15.1 Market Prospects for Tysabri Going Forward
3.16 New Delivery Methods as Competitive Tools
3.16.1 Room Temperature Formulations
3.16.2 Pre-filled Pre-mixed Syringes
3.17 R & D Trends
3.17.1 Emerging Therapies
3.17.1.1Leustatin
3.17.1.2Fampridine
3.17.1.3Teriflonomide
3.17.2 Key Biologic Therapies in Development for Multiple Sclerosis
3.17.2.1ABT 874
3.17.2.2Rituxan
3.17.2.3Campath
3.17.2.4Zenapax
3.17.2.5MLN1202
3.17.3 Future Alternatives for MS Therapy
3.18 Forecasting Future Sales of the BRMs
3.18.1 Avonex
3.18.2 Betaseron
3.18.3 Rebif
3.19 The Future of the MS Market

4 Rheumatoid Arthritis
4.1 Disease Overview
4.2 Etiology of Rheumatoid Arthritis
4.3 The Impact of Rheumatoid Arthritis
4.4 Treatment of Rheumatoid Arthritis
4.5 How are the Biological Response Modifiers Changing the Face of RA Therapy?
4.6 With What Drugs Are the Biological Response Modifiers Competing?
4.6.1 Arava: Competitive with BRMs?
4.7 The Cost of RA Biologics
4.8 Medicare Reform in the US: Impact on RA Market
4.8.1 Medicare Self-Injectable Demo Project: A Challenge to Remicade
4.8.2 The New Prescription Drug Bill's Impact on RA Therapy Competition
4.9 Profiling the Biologic DMARDs
4.9.1 Remicade
4.9.1.1 Clinical Efficacy
4.9.1.2 Market Position and Sales
4.9.2 Enbrel
4.9.2.1 Clinical Efficacy
4.9.2.2 Market Position and Sales
4.9.3 Humira
4.9.3.1 Clinical Efficacy and Dosage
4.9.3.2 Market Position and Sales
4.9.4 Kineret
4.9.4.1 Clinical Efficacy and Dosage
4.9.4.2 Market Position and Sales
4.9.5 Orencia
4.9.5.1 Clinical Efficacy and Dosage
4.9.5.2 Market Position and Sales
4.9.6 Rituxan
4.9.6.1 Clinical Efficacy and Dosage
4.9.6.2 Market Position and Sales
4.9.7 Predicting Future Sales of the Biologic Class in RA Treatment
4.9.7.1 Remicade
4.9.7.2 Enbrel
4.9.7.3 Humira
4.9.7.4 Orencia
4.9.7.5 Rituxan
4.10 Overall Market Forecast for Biologic Treatment of RA 2006-2010
4.11 Emerging Biologics for RA
4.11.1 CDP-870
4.11.2 Actemra
4.11.3 AMG 714
4.11.4 Eculizumab
4.11.5 IDEC-151
4.11.6 AMG 719
4.11.7 TAK 715
4.11.8 Golimumab
4.11.9 Denosumab
4.11.10 Pegsunercept
4.11.11 SCIO 469
4.11.12 BMS 561392
4.11.13 Belimumab
4.11.14 Neumega
4.11.15 Belatacept
4.11.16 VX 702
4.11.17 Denileukin
4.12 Research and Development Pipeline Highlights
4.13 The Future of Rheumatoid Arthritis Treatment

5 Systemic Lupus Erythematosus (SLE)
5.1 Disease Overview
5.2 Etiology and Epidemiology
5.3 The Difficulties of Diagnosing SLE
5.4 The Economic Impact of SLE
5.5 Current Treatment Options for SLE Patients
5.6 Therapy Regimens
5.7 Unmet Need in SLE
5.8 The Importance of Biomarkers and the Development of New Drugs for Lupus
5.9 New Biologics: How Will They Fit Into Therapeutic Regimens?
5.10 New SLE Drugs in Development
5.10.1 Riquent
5.10.2 Rituxan
5.10.3 LymphoStat-B
5.10.4 ETI-201
5.10.5 AMG 412
5.10.6 AMG 623
5.10.7 Abatacept
5.10.8 TACI-lg
5.10.9 Actemra
5.10.10 TRX-1
5.10.11 TV-4710
5.11 Key Research and Development Trends in SLE Therapy
5.12 New Alternatives to SLE Biologics
5.12.1 Competition from Non-Biologics in SLE Drug Development
5.12.1.1Prestara
5.12.1.2CellCept
5.12.1.3Linomide
5.13 Future of the Lupus Therapy Market

6 Inflammatory Bowel Disease
6.1 Disease Overview
6.2 Crohn's Disease vs Ulcerative Colitis: What Distinguishes the Two Diseases?
6.3 Etiology of IBD
6.4 Symptoms and Diagnosis of IBD
6.5 The Demographic Impact of IBD
6.6 The Economic Impact of IBD
6.7 Traditional Therapies: What They Do and Don't Do
6.8 Surgery as an Option
6.9 Can Biologics Begin to Meet Unmet Need in IBD?
6.9.1 Remicade in More Detail: A Revolution in the Treatment of Crohn's Disease
6.9.1.1 Clinical Efficacy
6.10 New Products and New Indications in IBD Therapy
6.10.1 Humira
6.10.2 Kremezin
6.10.3 Neumega
6.10.4 Tetomilast
6.10.5 CDP-870
6.10.6 Tysabri
6.10.7 Prograf
6.10.8 Leukine
6.10.9 Alicaforsen
6.10.10 MLN-02
6.10.11 PDL BioPharma's Three New Drugs
6.10.12 Rebif
6.10.13 RDP58
6.11 Do Research and Development Trends Favor Biologic Therapy?
6.12 Key Biologic Research and Development Trends in IBD Therapy
6.13 What are the Threats to the Biologics Class?
6.14 IBD Therapy Market Forecast

7 Psoriasis
7.1 Disease Overview
7.2 Psoriasis Types
7.3 The Demographic Impact of Psoriasis
7.4 Lifestyle and Economic Impact of Psoriasis
7.5 Traditional Pharmacological Treatment for Psoriasis
7.6 Why Are Biologic Therapies Emerging?
7.7 What Are the New Biologics and How Are They Influencing the Market?
7.7.1 Amevive
7.7.1.1 Clinical Efficacy
7.7.1.2 Market Competition and Future Sales
7.7.1.3 Future Sales of Amevive
7.7.2 Raptiva
7.7.2.1 Clinical Efficacy
7.7.2.2 Market Competition and Future Sales
7.7.3 Enbrel
7.7.3.1 Clinical Efficacy
7.7.3.2 Market Competition and Future Sales
7.8 What are the Emerging Biologics for Psoriasis?
7.8.1 Humira
7.8.1.1 Clinical Efficacy
7.8.1.2 Anticipated Market Position
7.8.2 Remicade
7.8.2.1 Clinical Efficacy
7.8.2.2 Anticipated Market Position
7.9 Competition from Non-Biologics
7.9.1 Avandia
7.9.2 Prograf
7.10 Future Sales of the Biologic Class in Psoriasis
7.11 Research and Development Trends in Psoriasis Therapy

8 Asthma
8.1 Disease Overview
8.2 Epidemiology
8.3 Economic Impact
8.4 Classifications
8.5 Current Therapeutic Options for Asthma
8.5.1 Bronchodilators
8.5.2 Anti-Inflammatories
8.5.3 Dietary Supplements
8.6 Biologic Targets in Asthma Therapy
8.7 Xolair: The First Biologic for Asthma - Will it Alter Market Dynamics?
8.7.1 How Does Xolair Work?
8.7.2 Clinical Efficacy
8.7.3 Market Penetration and Strategies
8.8 Research and Development Trends
8.8.1 R411
8.8.2 Zenapax
8.8.3 IL-4/13 Trap
8.8.4 Mepolizumab
8.8.5 SCH 55700
8.9 Key Research and Development Trends in Asthma Therapy
8.10 Threats to the Biologics Class
8.11 The Future for Biologics in Asthma Treatment

List of Tables
Table 3.1 Major Symptoms of Multiple Sclerosis
Table 3.2 Multiple Sclerosis Patient Population, by type
Table 3.3 Incidence of MS in Countries/Regions of High Prevalence
Table 3.4 Key Therapies for Multiple Sclerosis
Table 3.5 Leading MS Therapy Delivery Routes and Dosage
Table 3.6 Global Sales of Leading MS Therapies, 2000-2005 ($ mn)
Table 3.7 Future Sales of Tysabri 2006-2010
Table 3.8 New Multiple Sclerosis Drugs in Development
Table 3.9 Biologics in Clinical Development for MS
Table 3.10 Future Sales of Avonex 2005-2010 ($ mn)
Table 3.11 Future Sales of Betaseron ($ mn)
Table 3.12 Future Sales of Rebif ($ mn)
Table 4.1 Prevalence of Chronic Conditions Causing Disabilities
Table 4.2 Sales of Biologics for Rheumatoid Arthritis, 1999-2005 ($ mn)
Table 4.3 Approved DMARDs for Rheumatoid Arthritis
Table 4.4 Profiles of the Leading DMARDs
Table 4.5 Out-of-Pocket Costs Associated with Demonstration Drug Project
Table 4.6 Sales of Remicade 2000-2005 ($ mn)
Table 4.7 Global Sales of Enbrel 2000-2005 ($ mn)
Table 4.8 Global Sales of Humira 2003-2005 ($ mn)
Table 4.9 Financial Growth Forecast of the Biologics in the RA Market 2006-2010 ($ mn)
Table 4.10 New Rheumatoid Arthritis Drugs in Development
Table 5.1 New Systemic Lupus Erythematosus Drugs in Development
Table 5.2 Forecast SLE Market 2006-2010 ($ mn)
Table 6.1 Principal Alternatives in the Differential Diagnosis of Inflammatory Bowel Disease
Table 6.2 Criteria of Trulove and Witts for Assessing Disease Activity in Ulcerative Colitis
Table 6.3 Prevalence of Crohn's Disease by Age in the United States
Table 6.4 PDL BioPharma's IBD Pipeline
Table 6.5 Inflammatory Bowel Disease Drugs in Development
Table 6.6 Forecasting Growth in the IBD Therapy Market 2006-2010 ($ mn)
Table 7.1 Estimated Demographic Impact of Psoriasis in the US
Table 7.2 Amevive Sales 2003-2005 ($ mn)
Table 7.3 Forecasted Sales of Amevive 2006-2010 ($ mn)
Table 7.4 Raptiva Sales 2003-2005 ($ mn)
Table 7.5 Forecasted Sales of Raptiva 2006-2010 ($ mn)
Table 7.6 Psoriasis Drugs in Development
Table 8.1 Best-Selling Asthma Drugs, 2000-2005 ($ mn)
Table 8.2 New Biologic Medications Under Development for Asthma
Table 8.3 Asthma Therapies Under Development (Phase I and II)

List of Graphs
Graph 2.1 Prevalence of Major Autoimmune Diseases in Women versus Men
Graph 2.2 Autoimmune Disease Prevalence, by Specific Disease (in thousands)
Graph 3.1 Global Sales of Leading MS Therapies 2000-2005 ($ mn)
Graph 3.2 Global Sales of Leading Four MS Therapies, US vs Rest of World 2000-2005 ($ mn)
Graph 3.3 Sales of Avonex 2000-2005 US vs Rest of World ($ mn)
Graph 3.4 Sales of Betaseron 2000-2005 US vs Rest of World ($ mn)
Graph 3.5 Sales of Rebif 2000-2005 US vs Rest of World ($ mn)
Graph 3.6 Sales of Copaxone 2000-2005 US vs Rest of World ($ mn)
Graph 3.7 Market Share of Leading MS Therapies, 2004
Graph 3.8 Market Share of Leading MS Therapies, 2005
Graph 3.9 Market Share of Leading MS Therapies, United States 2004
Graph 3.10 Market Share of Leading MS Therapies, Rest of World 2004
Graph 3.11 Market Share of Leading MS Therapies, United States 2005
Graph 3.12 Market Share of Leading MS Therapies, Rest of World 2005
Graph 3.13 Future Sales of BRMs in the Global MS Market 2006-2010 ($ mn)
Graph 4.1 Growth of the Biologics in Rheumatoid Arthritis 2000-2005 ($ mn)
Graph 4.2 Global Sales of Leading RA Therapies 2000-2005 ($ mn)
Graph 4.3 Market Share of Leading RA Therapies, 2005 (estimated)
Graph 4.4 Market Share of DMARDs: Traditional vs Biologics, 2005
Graph 4.5 Sales of Remicade 2000-2005 ($ mn)
Graph 4.6 Sales of Remicade US vs Rest of World ($ mn)
Graph 4.7 Global Sales of Enbrel, 2000-2005 ($ mn)
Graph 4.8 Sales of Enbrel, 2003-2005, US vs Rest of World ($ mn)
Graph 4.9 Global Sales of Humira, 2003-2005 ($ mn)
Graph 4.10 Humira Sales by Geographical Region 2003 ($ mn)
Graph 4.11 Sales Forecast for Remicade 2006-2010 ($ mn)
Graph 4.12 Sales Forecast for Enbrel 2006-2010 ($ mn)
Graph 4.13 Sales Forecast for Humira 2006-2010 ($ mn)
Graph 4.14 Sales Forecast for Orencia 2006-2010 ($ mn)
Graph 4.15 Sales Forecast for Rituxan 2006-2010 ($ mn)
Graph 4.16 Financial Growth Forecast of the Biologics in the RA Market 2006-2010 ($ mn)
Graph 4.17 Annual Growth of Rheumatoid Arthritis Biologics 2006-2010, by CAGR
Graph 5.1 SLE Death Rates Among Women
Graph 5.2 Sales Forecast for Biologics for Lupus 2006-2010 ($ mn)
Graph 6.1 Prevalence of Crohn's Disease by Age/Percentage in the United States
Graph 6.2 Sales of Remicade 1998-2005
Graph 6.3 Forecasting Sales in the IBD Therapy Market 2006-2010 ($ mn)
Graph 6.4 Forecast Annual Growth in the IBD Therapy Market 2006-2010
Graph 7.1 Amevive Sales 2003-2005 ($ mn)
Graph 7.2 Forecasted Sales of Amevive 2006-2010 ($ mn)
Graph 7.3 Raptiva Sales 2003-2005 ($ mn)
Graph 7.4 Future Sales of Raptiva 2006-2010 ($ mn)
Graph 7.5 Forecasted Sales of Enbrel* 2006-2010 ($ mn)
Graph 7.6 Anticipated Revenue from Psoriasis Biologics 2006-2010 ($ mn)
Graph 7.7 Market Share of Leading Psoriasis Therapies, 2005 (estimate)
Graph 8.1 Annual Growth of Best-Selling Asthma Drugs, 2000-2005
Graph 8.2 Sales of Xolair 2003-2005 US vs Rest of World ($ mn)
Graph 8.3 Financial Forecast for Xolair 2006-2010 ($ mn)
Graph 8.4 Sales Forecast for Biologics for Asthma 2006-2010 ($ mn)
Graph 8.5 Annual Percentage Growth Forecast in the Asthma Biologics Therapy Market 2006-2010

List of Diagrams
Diagram 3.1 Course of Multiple Sclerosis, by Type
Diagram 6.1 Principal Differences Between Ulcerative Colitis and Crohn's Disease