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Emerging Therapies to Treat Lupus Erythematosus


Description: Introduction
Lupus erythematosus (LE), a family of chronic autoimmune diseases, ranges from skin disease to life-threatening systemic disease. Multiple therapy options are necessary, even for patients with similar symptoms—and there is great need for agents that can control the complications of systemic disease. LE therapy development is increasing, and many companies are investigating LE as an expansion indication.

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The small lupus erythematosus (LE) patient population poses challenges to companies that are developing agents for this indication: enrollment for clinical trials can be diffi cult, and the sales potential of these agents is limited. What are companies doing to surmount these challenges?
Although effective, few existing agents for cutaneous LE are considered safe enough for long-term use. An effective agent that is safe for prolonged treatment will have a signifi cant competitive advantage. Which agent now in development has the best chance to satisfy this need? Is any agent currently in development likely to displace current first-line therapies? Because of the heterogeneous nature of systemic LE, the market can support many agents. But owing to the number of effective generics available, emerging agents must prove their greater efficacy and safety to ensure adoption. What are the advantages and disadvantages of the emerging therapies’ modes of action? How soon are new therapies likely to reach the market? What are their prospects for success in competition with generics and established therapies?

Scope
Etiology, pathophysiology, and prevalence: relationship of cutaneous lupus erythematosus (CLE) to systemic lupus erythematosus (SLE); prevalence of systemic lupus erythematosus in the three major-market regions by gender.
Current therapies: overview of leading therapies for CLE and for SLE.
Indications covered: CLE (discoid LE), acute CLE, subacute CLE, and SLE.
Emerging therapies: overview of agents for development for CLE and SLE; late-stage agents are discussed in detail.
Market outlook: challenges that emerging agents will face and their prospects for success.

Therapies mentioned inside this report include:
- Abatacept
- Abetimus sodium
- Acitretin
- Amcinonide
- ASF-1096
- Azathioprine
- Belimumab
- Betamethasone
- diproprionate
- Celecoxib
- Chloroquine
- Clobetasol proprionate
- Cyclophosphamide
- Dapsone
- Difl orasone diacetate
- Edratide
- Efalizumab
- Epratuzumab
- Etretinate
- Hydroxychloroquine
- Intravenous gamma
- globulin
- Isotretinoin
- Lefl unomide
- Methotrexate
- Mycophenolate mofetil
- Pimecrolimus
- Prasterone
- Rituximab
- Sirolimus
- Tacrolimus
- Thalidomide
- Triamcinolone acetonide


Contents: Executive Summary
Strategic Considerations
Stakeholder Implications
Introduction
Cutaneous Lupus Erythematosus
Disease Description and Etiology
Prevalence
Connection Between Cutaneous LE and Systemic LE
Overview of Current Drug Therapies
Corticosteroids
Antimalarials
Calcineurin Inhibitors
Anti-Leprosy Agents
Retinoids
Systemic Lupus Erythematosus
Disease Symptoms and Etiology
Prevalence
Overview of Current Drug Therapies
Nonsteroidal Anti-Inflammatory Agents
Corticosteroids
Immunosuppressive/Immunomodulatory Agents
Emerging Therapies for the Treatment of Cutaneous Lupus Erythematosus
Genentech’s Efalizumab
Astion Pharma’s ASF-1096
Emerging Therapies for the Treatment of Systemic Lupus Erythematosus
Immunomodulators
Aspreva/Roche’s Mycophenolate Mofetil
Wyeth’s Sirolimus
Astellas’s Tacrolimus
Biological Agents
Genentech/Biogen Idec’s Rituximab
UCB/Immunomedics’ Epratuzumab
Human Genome Science/GlaxoSmithKline’s Belimumab
Bristol-Myers Squibb’s Abatacept
Teva’s Edratide
Other Approaches
Genelabs Technologies’ Prasterone
La Jolla Pharmaceutical’s Abetimus Sodium
Outlook

Tables
1. Current Therapies for the Treatment of Cutaneous Lupus Erythematosus
2. American College of Rheumatology Criteria for Classification of Systemic Lupus Erythematosus
3. Prevalent Cases of Systemic Lupus Erythematosus in the Three Major-Market Regions by Gender, 2005
4. Current Therapies for the Treatment of Systemic Lupus Erythematosus
5. Emerging Therapies for the Treatment of Cutaneous Lupus Erythematosus
6. Emerging Therapies for the Treatment of Systemic Lupus Erythematosus

Figures
1. Onset and Complications of Systemic Lupus Erythematosus
2. Immunopathological Targets of Emerging Biological Therapies for Systemic Lupus Erythematosus
3. Emerging Agents for SLE Approved or In Development for Other Indications


Companies Mentioned - Active Biotech - Allergan - Altana - Amgen - Aspreva - Astellas - Astion Pharma - Barr - Baxter - Biogen Idec - Biomarin - Boehringer Ingelheim - Bradley Pharmaceuticals - Bristol-Myers Squibb - Celgene - Connetics - Daiichi Sankyo - Duramed - Elusys Therapeutics - Genelabs Technologies - Genentech - GlaxoSmithKline - Human Genome Sciences - Immunomedics - ImmuPharma - La Jolla Pharmaceuticals - Meda - MedImmune - Merck - Neovacs - Novartis - Pfi zer - QLT - Repligen - Roche - Salix - Sanofi -Aventis - Santen - Schering-Plough - Serono - Shionogi - Shire - Stada - Teva - TolerRX - UCB - Wyeth - Xoma - ZymoGenetics


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