Biotech in Autoimmune Inflammatory Disease

Biotech in Autoimmune/Inflammatory Disease 2004:
Revolutionizing the Market

This report assesses the role that biotechnology is playing in the field of autoimmune/inflammatory disease
therapies and is focused on uncovering why biotech drugs are proving to be the future of autoimmune disease
treatment.

The value of biological drugs indicated for autoimmune diseases was roughly $6800 million in 2003. Biologics are
no doubt transforming the treatment of autoimmune diseases such as multiple sclerosis, rheumatoid arthritis,
inflammatory bowel disease, and psoriasis. The first biologic for the treatment of asthma was approved in 2003
and competition is increasing amongst biotech companies poised to market what will be the first new lupus drug
in over thirty years.

The value of biotech in autoimmune diseases is set to triple by 2008 and this report provides information, insight,
and analysis that will help industry players better understand this burgeoning market.

This report was written to provide vital analysis and information to members of the biotech, pharmaceutical, and
venture capital industries and includes the following:

• 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
2008

• Integrative discussion of clinical data and key trials for already marketed and 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

• Up-to-date reporting on influential parterning/licensing deals in the field

Pricing & Delivery
This report is available to single users for $999. A company-wide license of this report is available for $1999.

To order a copy, contact sales@arrowheadpublishers.net, call us at 1-612-929-5203, or fill out our faxback
order form. Sample pages of the report are available upon request.

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          Types of MS
3.3          Causes
3.4          Risk Factors
3.5          Global Impact of MS
3.6          Financial Costs Associated with MS
3.7          An Overview of Treatment Options for MS
3.8          Biological Response Modifiers (BRMs) and Their Value in the MS Market
3.8.1       Avonex
3.8.2       Betaseron
3.8.3       Rebif
3.8.3.1   The EVIDENCE Trial
3.9          How Do the BRMs Compete with Other MS Therapies
3.9.1       Copaxone
3.9.2       Novantrone
3.10        Antegren: Is This Emerging Biologic a Threat to the Competition?
3.10.1     What This Means for the MS Market
3.11        New Delivery Methods as Competitive Tools
3.11.1     Room Temperature Formulations
3.11.2     Pre-filled Pre-mixed Syringes
3.11.3     New Indications for Progressive MS
3.12        R & D Trends
3.12.1     Future Alternatives for MS Therapy
3.13        Forecasting Future Sales of the BRMs
3.13.1     Avonex
3.13.2     Betaseron
3.13.3     Rebif
3.14        The Future of the MS Market
4           Inflammatory Bowel Disease
4.1         Disease Overview
4.2         Crohn's Disease vs Ulcerative Colitis: What Distinguishes the Two Diseases
4.3         Etiology of IBD
4.4         Symptoms and Diagnosis of IBD
4.5         The Demographic Impact of IBD
4.6         The Economic Impact of IBD
4.7         Traditional Therapies: What They Do and Don't Do
4.8         Surgery as an Option
4.9         Can Biologics Begin to Meet Unmet Need in IBD
4.9.1       Remicade in More Detail: A Revolution in the Treatment of Crohn's Disease
4.9.1.1    Clinical Efficacy
4.10        New Products and New Indications in IBD Therapy
4.10.1     Humira
4.10.2     Leukine
4.10.3     CDP-870
4.10.4     Antegren
4.10.5     Alicaforsen
4.10.6     MLN-02
4.10.7     Protein Design Labs' Three New Drugs
4.10.8     RDP58
4.11        Do Research and Development Trends Favor Biologic Therapy
4.12        Will Biologics Be Approved for Ulcerative Colitis in the Near Future?
4.13        Key Biologic Research and Development Trends in IBD Therapy
4.14        What are the Threats to the Biologics Class?
4.15        IBD Therapy Market Forecast

5            Rheumatoid Arthritis
5.1          Disease Overview
5.2          Etiology of Rheumatoid Arthritis
5.3          The Impact of Rheumatoid Arthritis
5.4          Historical Treatment of Rheumatoid Arthritis
5.5          How do the Cox-2s Fit into the RA Market
5.6          How are the Biological Response Modifiers Changing the Face of RA Therapy?
5.7          With What Drugs Are the Biological Response Modifiers Competing?
5.7.1       Arava: Competitive with BRMs?
5.8          The Cost of RA Biologics
5.9          Medicare Reform in the US: Impact on RA Market
5.9.1       Medicare Self-Injectable Demo Project: A Challenge to Remicade
5.9.2       The New Prescription Drug Bill's Impact on RA Therapy Competition
5.10        Profiling the Biologic DMARDs
5.10.1     Remicade
5.10.1.1 Clinical Efficacy
5.10.1.2 Market Position and Sales
5.10.2     Enbrel
5.10.2.1 Clinical Efficacy
5.10.2.2 Market Position and Sales
5.10.3     Humira
5.10.3.1 Clinical Efficacy and Dosage
5.10.3.2 Market Position and Sales
5.10.4     Predicting Future Sales of the Biologic Class in RA Treatment
5.10.4.1 Remicade
5.10.4.2 Enbrel
5.10.4.3 Humira
5.11        Overall Market Forecast for Biologic Treatment of RA 2004-2008
5.12        Emerging Biologics for RA
5.12.1     CDP-870
5.12.2     MRA
5.12.3     Eculizumab
5.12.4     IDEC-151
5.13        The Future of Rheumatoid Arthritis Treatment

6           Psoriasis
6.1          Disease Overview
6.2          Psoriasis Types
6.3          The Demographic Impact of Psoriasis
6.4          Traditional Pharmacological Treatment for Psoriasis
6.5          Why Are Biologic Therapies Emerging?
6.6          What Are the New Biologics on the Market?
6.6.1       Amevive
6.6.1.1    Clinical Efficacy
6.6.1.2    Market Competition and Future Sales
6.6.1.3    Future Sales of Amevive
6.6.2       Raptiva
6.6.2.1    Clinical Efficacy
6.6.2.2    Market Competition and Future Sales
6.7          What are the Emerging Biologics?
6.7.1       Enbrel
6.7.1.1    Clinical Efficacy
6.7.1.2    Anticipated Market Position
6.7.2       Remicade
6.7.2.1    Clinical Efficacy
6.7.2.2    Anticipated Market Position
6.8          Future Sales of the Biologic Class in Psoriasis
6.9          Research and Development Trends

7           Asthma
7.1          Disease Overview
7.2          Epidemiology
7.3          Economic Impact
7.4          Classifications
7.5          Current Therapeutic Options for Asthma
7.5.1       Bronchodilators
7.5.2       Anti-Inflammatories
7.6          Biologic Targets in Asthma Therapy
7.7          Xolair: The First Biologic for Asthma-Will it Alter Market Dynamics?
7.7.1       How Does Xolair Work?
7.7.2       Clinical Efficacy
7.7.3       Market Penetration and Strategies
7.8          Research and Development Trends, by Company
7.8.1       Roche
7.8.2       Protein Design Labs
7.8.3       Regeneron
7.8.4       GlaxoSmithKline
7.8.5       Schering-Plough
7.9          The Future of Biologics in Asthma Treatment

8          Systemic Lupus Erythematosus (SLE)
8.1         Disease Overview
8.2         Epidemiology
8.3         The Difficulties of Diagnosing SLE
8.4         The Economic Impact of SLE
8.5         Current Treatment Options for SLE Patients
8.6         Therapy Regimens
8.7         Unmet Need in SLE
8.8         The Importance of Biomarkers and the Development of New Drugs for Lupus
8.9          New Biologics: How Do They Fit Into Therapeutic Regimens
8.10       Companies Engaged in Biological Drug Development for SLE
8.10.1    La Jolla Pharmaceutical
8.10.2    Genentech
8.10.3    Human Genome Sciences
8.10.4    Elusys
8.10.5    Teva Pharmaceuticals
8.10.6    Competition from Non-Biologics
8.10.6.1 GeneLabs
8.10.6.2 Roche
8.11        Future of the Lupus Therapy Market

Tables and Graphs
Graph 2.1        Autoimmune Disease Prevalence, by Specific Disease
Table 3.1         Incidence of MS in Countries of High Prevalence
Table 3.2         Leading MS Therapy Delivery Routes and Dosage
Table 3.3         Sales of Leading MS Therapies, 2000-2003
Graph 3.1         Market Share of Leading MS Therapies, 2003
Graph 3.2         Graph Geographic Market Share of Leading MS Therapies, United States 2003
Graph 3.3         Graph Geographic Market Share of Leading MS Therapies, Rest of World 2003
Graph 3.4         Sales of Avonex 2000-2003
Graph 3.5         Sales of Betaseron 2000-2003
Graph 3.6         Sales of Rebif 2000-2003
Graph 3.7         BRMs vs Other Key MS Therapies, by Sales 2000-2003
Graph 3.8         Sales of Copaxone 2000-2003
Graph 3.9         Anticipated Sales of Antegren 2005-2009
Table 3.4          New MS Drugs in Development
Table 3.5          Future Sales of Avonex 2004-2008
Table 3.6          Future Sales of Betaseron 2004-2008
Table 3.7          Future Sales of Rebif 2004-2008
Graph 3.10       Future Sales of BRMs in the MS Market 2004-2008
Table 4.1          IBD Facts
Graph 4.1         IBD Therapy Market Share 2003
Table 4.2          Value of the IBD Therapy Market 1998-2003
Graph 4.2         Value of the IBD Therapy Market, 1998-2003, Remicade vs Others
Graph 4.3         Sales of Remicade 1999-2003
Table 4.3           Protein Design Labs IBD Pipeline
Table 4.4           Research and Development Pipeline for IBD
Table 4.5           Forecasting Growth in the IBD Therapy Market 2003-2008
Graph 4.4          Forecasting Growth in the IBD Therapy Market 2003-2008
Table 5.1           Prevalence of Chronic Conditions Causing Disabilities
Table 5.2           Sales of Biologics for Rheumatoid Arthritis, 1999-2003
Graph 5.1          Growth of the Biologics in Rheumatoid Arthritis 1999-2003
Table 5.3           Approved DMARDs for Rheumatoid Arthritis
Graph 5.2          Market Share of DMARDs: Traditional vs Biologics, 2003
Table 5.4           Profiles of the Leading DMARDs
Table 5.5           Sales of Remicade 1999-2003
Graph 5.3          Sales of Remicade 1999-2003
Table 5.6           Sales of Enbrel, 1999-2003
Graph 5.4          Sales of Enbrel, 1999-2003
Graph 5.5          Sales Forecast for Remicade 2003-2008
Graph 5.6          Sales Forecast for Enbrel 2003-2008
Graph 5.7          Sales Forecast for Humira 2003-2008
Table 5.7           Financial Growth of the Biologics in the RA Market 2003-2008 ($ mn)
Table 5.8           Biologic Pipeline for Rheumatoid Arthritis Therapy Market
Table 5.9           RA Drug Development by Mechanism of Action
Table 6.1           Estimated Demographic Impact of Psoriasis in the US
Table 6.2           Best-Selling Traditional Psoriasis Therapies 2002
Table 6.3           Forecasted Sales of Amevive 2003-2009
Graph 6.1          Forecasted Sales of Amevive 2003-2008
Table 6.4           Future Sales of Raptiva 2004-2008
Graph 6.2          Future Sales of Raptiva 2004-2008
Graph 6.3          Anticipated Revenue from Psoriasis Biologics 2004-2008
Table 6.5           New Drugs Being Developed for Psoriasis
Table 7.1           Best-Selling Asthma Drugs, 1999-2002
Graph 7.1          Financial Forecast for Xolair 2004-2008
Graph 7.2          Sales Forecast for Biologics for Asthma 2004-2008
Table 7.2           New Biologic Medications Under Development for Asthma
Graph 8.1          SLE Death Rates Among Women
Table 8.1           Biologics in Pipeline for Treatment of Lupus
Graph 8.2          Future Sales of Biologics for Lupus 2005-2009




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