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Current Treatments, Unmet Needs, and Opportunities in Treating Pediatric Crohn’s Disease

Decision Resources, Inc, November 2011

Crohn’s disease (CD) is a relapsing/remitting inflammatory disease of the gastrointestinal (GI) tract. Many of the conventional treatments available for treating children with CD have serious side effects. Interviewed experts indicate substantial unmet needs in current treatment. With only one approved therapy for children—Janssen Biotech/Merck’s Remicade (infliximab)—this market presents a reasonable opportunity for drug developers.

Questions Answered:

- Pediatric CD is a rare disorder. What is the total diagnosed prevalent population for pediatric CD? What is the estimated growth rate of the diagnosed prevalent population by age in the 2010-2020 time period? What age-group will exhibit the maximum growth rate per year in our 2010-2020 study period?

- Remicade is the only approved therapy for pediatric CD patients. What is experts’ opinion of Remicade? Are physicians satisfied with this agent? When do physicians prescribe this agent?

- Interviewed experts indicate that new therapies for pediatric CD is a high unmet need. Are there enough therapies available to treat pediatric CD? What are the drawbacks of the current therapies? What other areas of unmet need do interviewed experts identify? In the opinion of the interviewed experts, how crucial are these unmet needs?

Scope:

- Markets covered: United States.

- Primary research: Four interviews with thought leaders who are pediatric gastroenterologists in the United States and work closely with CD patients.

- Disease Overview: Etiology, pathophysiology, and symptoms and diagnosis of pediatric CD.

- Epidemiology: Diagnosed prevalence of pediatric CD in 2011; estimated diagnosed prevalence by age-group in the 2010-2020 time period.

- Current treatments: Major therapies used to treat pediatric CD.

- Unmet needs: Key considerations for drug developers.

Executive Summary
- Strategic Considerations
- Stakeholder Implications

Introduction
- Disease Overview
- Etiology

Pathophysiology

Abnormal Immune Response
- Enhanced Intestinal Permeability
- Pathogen-Associated Molecular Pattern Recognition

Chronic Inflammation
- Cytokines
- Lipid Mediators
- Cell Adhesion Molecules
- Protein Kinases
- Altered T-Cell Apoptosis

Epidemiology and Patient Populations
- Overview
- Disease Definition
- Methods

Symptoms, Complications, and Diagnosis
- Intestinal Complications
- Risk of Colon Cancer
- Major Differences Between Pediatric and Adult Disease Presentation and Phenotype

Current Treatments for Pediatric Crohn’s Disease
- Oral Aminosalicylates
- Corticosteroids
- Immunosuppressants
- Biological Agents/TNF-Alpha Inhibitors
- Antibiotics
- Nutritional Therapy

Unmet Needs and Considerations for Drug Developers
- Prognostic Tests and Treatment Approaches
- Treatment Options
- Efficacious Pediatric Therapies with Better Safety Profiles than Current Agents
- Monitoring Disease and Other Unmet Needs

Appendix A. Bibliography

About the Authors

- Abbott
- Bayer
- Biogen Idec
- Dava Pharmaceuticals
- Elan
- GlaxoSmithKline
- Janssen Biotech
- Merck
- Pfizer
- Prometheus
- Salix
- Shire
- Teva
- UCB
- Warner Chilcott

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