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Abstract

Introduction:

Is metabolic syndrome a disease itself-or merely a grouping of diagnoses that identify a person as being at increased risk for cardiovascular disease? Current medical practice, regulatory guidance, and drug development appear to be shifting away from the concept of metabolic syndrome as a discrete condition; rather, aspects of metabolic syndrome-including diabetes, hypertension, dyslipidemia, and obesity-are beginning to be included as part of an assessment of patients' overall global cardiovascular risk. Drug makers are thus likely to have greater success developing agents for the individual components of metabolic syndrome rather than trying to treat multiple aspects concurrently.

Get the Answers Needed to Shape Your Strategy:

• The FDA recently increased the challenges associated with obtaining approval for an agent for metabolic syndrome, stating that the only way an agent will be approved is if it addresses multiple aspects of the disease. What approaches are drug companies taking to fi nding agents that effectively treat multiple components of metabolic syndrome? Which companies already have such agents in Phase II and Phase III trials?
• DiObex is developing an agent to inhibit cortisol production-the primary glucocorticoid in humans. Inhibiting cortisol production provides a potential approach to treating both diabetes and metabolic syndrome. What aspect of DiObex' s agent should help facilitate the agent' s clinical development?
• Despite being the only available agent that treats multiple components of metabolic syndrome, Pfi zer' s Caduet has seen limited uptake. Why aren' t physicians prescribing Caduet more frequently?
• Currently, type 2 diabetes appears to be the indication of focus for most companies developing drugs for metabolic syndrome. Why do companies fi nd type 2 diabetes to be a particularly attractive indication?
• 11beta-HSD1, one of the two 11beta-hydroxysteroid dehydrogenase enzymes that regulate the production of cortisol from cortisone, is attracting a great deal of attention from pharmaceutical companies. Three 11beta-HSD1 inhibitors are currently confi rmed to be in clinical development. Which companies are developing these agents? Which company has reported preliminary results of a Phase IIa trial that indicated a compound' s complete inhibition of 11beta-HSD1?

Scope:

• The metabolic syndrome controversy: disease defi nitions, FDA perspective, payer reimbursement issues.
• Current treatment options: lifestyle modifi cations; treatments for obesity, dyslipidemia, hypertension, and insulin resistance; Pfi zer' s Caduet.
• Strategies for drug development: multimodal approaches and fi xed-dose combinations.
• The future for metabolic syndrome treatment: FDA requirements for new agents, the shift to a focus on reducing overall cardiovascular risk, the likelihood of new agents being approved, reimbursement challenges, antiobesity agents currently in development, and will metabolic syndrome emerge as a discrete indication?

Table of Contents

• Executive Summary
  • Strategic Considerations
  • Stakeholder Implications
• Introduction
• An Overview of Metabolic Syndrome
  • Disease Defi nition
  • Prevalence
• Is Metabolic Syndrome a Discrete Disease?
  • Perspective of Regulatory Agencies
  • Perspective of Payers
• Current Treatment Options
  • FDCs to Treat Dyslipidemia/Hypertension (Pfi zer' s Caduet)
  • Agents to Treat Obesity
  • Agents to Treat Diabetes
• Strategies for Developing Agents for Metabolic Syndrome
  • Multimodal Approaches
    • Peroxisome Proliferator-Activated Receptor Agonists
    • Cortisol Modulators
  • Fixed-Dose Combinations
• What Is the Future for Metabolic Syndrome Treatment?

Tables

• 1. Defi nitions for Metabolic Syndrome
• 2. Prevalent Cases of Metabolic Syndrome, 2006
• 3. Metabolic Syndrome: Current Therapies and 2006 Worldwide Sales
• 4. Agents in Development to Treat Multiple Components of Metabolic Syndrome
• 5. Agents in Development to Treat Single Components of Metabolic Syndrome

Figures

• 1. Prevalent Cases of Metabolic Syndrome and Component Diseases in the Seven Major Markets, 2006
• 2. Prescriptions Attributed to Metabolic Syndrome in the United States, 2000-2006
• 3. Disease Targets of Multimodal and Fixed-Dose Combination Agents for Metabolic Syndrome Components