SPECIAL REPORT: Getting Maximum Benefit from Combination Products

Table of Contents

• Executive Summary
  • Strategic Considerations
  • Stakeholder Implications
• The Breadth and Scope of Combination Products
  • From a Regulatory Perspective
  • Recent Biologic and Device Approvals
  • Drug-and-Device Combinations Going Strong
• Strategic Use of Combination Products
• Recent Market Success of Fixed-Dose Combinations
  • Fixed-Dose Combination Blockbusters
    • GlaxoSmithKline' s Advair/Seretide
    • AstraZeneca' s Symbicort and Boehringer Ingelheim' s Combivent
    • Merck/Schering-Plough' s Vytorin/Inegy
    • Novartis' s Lotrel
    • HIV/AIDS Combination Blockbusters
    • Antibacterial Combination Blockbusters
    • Combination Blockbusters in a Contraceptive Franchise
  • Signifi cant Interest in Combination-Drug Markets
  • Brand Pharmaceutical Companies
  • Generics Pharmaceutical Companies
• Notable Trends
  • More Timely Development of Combinations
  • Intercompany Collaborations on Fixed-Dose Combinations
    • Bristol-Myers Squibb and Gilead Sciences
    • AstraZeneca and Abbott
    • Schering-Plough and Novartis
  • Multiple Combinations
  • Greater Acceptance of Combination Products in Japan
  • Start-Up Companies Dedicated to Combinations in Novel Indications
    • CombinatoRx
    • Orexigen
    • Vicus Therapeutics
• Life-Cycle Management and Market Dynamics
  • Fragmented Diabetes Markets
    • Thiazolidinedione Franchises
  • Renaissance in NSAID Combinations Following COX-2 Inhibitor Troubles
    • AstraZeneca/Pozen
    • GlaxoSmithKline/Pozen
• Fixed-Dose Combination Drugs in Development
  • Cardiovascular Combinations
    • Pfi zer' s Torcetrapib/Lipitor Combination
    • Novartis' s Exforge
    • Merck/Schering-Plough' s Lipitor and Zetia
    • Daiichi Sankyo' s CS-8663
    • Merck' s MK-0524A and MK-0524B
    • Abbott' s Simcor
    • Cross-Indication Combination Therapies
  • Respiratory Combinations
    • Schering-Plough and Novartis LABA and Corticosteroid Combinations
    • Nycomed and Sanofi -Aventis' s Formoterol and Alvesco Combination
    • GlaxoSmithKline and Theravance' s Promising Fixed-Dose Combinations for COPD
• Outlook
• Appendix-World' s Best-Selling Combination Products by Therapeutic Category, 2006

Expert Commentary

• Expert Commentary: Fixed-Dose Combinations of Antiretroviral Drugs in HIV Therapy Regimens
• Expert Commentary: Patent Expirations and the Availability of Generic-and-Generic Combinations Loom Heavily Over Type 2 Diabetes Markets
• Expert Commentary: Choosing the Right Drugs for the Combination Is of Paramount Importance
• Expert Commentary: Opportunities for Respiratory Fixed-Dose Combinations

Tables

• 1. Start-Up Companies Dedicated to Drug Repurposing
• 2. Summary Table: Key Opportunities and Challenges in Combination Product Development According to Decision Resources Experts

Figures

• 1. Best-Selling Fixed Combination Blockbusters Worldwide, 2006
• 2. Best-Selling Combination Products by Therapeutic Category, 2006
• 3. Big Pharma' s Degree of Interest in Combination Products, 2006
• 4. Life-Cycle Management Through Fixed-Dose Combinations in Diabetes
• 2a. Fragmented Market Dynamics in Diabetes, 2000-2006
• 3a. Vytorin Enjoys Tremendous Success While Caduet Struggles