Biopharma Quarter: Key Trends and Events of the Second Quarter of 2009

Table of Contents

• Executive Summary
  • Strategic Considerations
  • Stakeholder Implications
• Introduction
• Events Perspective
  • On the Personalized Medicine Front: Steps Forward and Back
    • Fanapt Approval
    • Bristol-Myers Squibb' s Coumadin
  • On the Drug Development Front
    • FDA' s Improved Image
    • First Phase 0 Oncology Trial
    • Support for Rare Diseases
  • On the Marketing Front and the Regulatory Front
    • Social Marketing Push
    • Confi dentiality of Prescriber-Identifi able Data
    • Further Restrictions on DTC Advertising
• Deals Perspective
  • H1N1' s Infl uence on Dealmaking in the Second Quarter
  • Notable M&As
  • Notable Product Deals
  • Therapy-Area Deals
  • Technology Deals
  • Focus on Stem Cells
• Generics Perspective: Consistent Growth in a Key Sector
  • First Biosimilar Approval in Japan
  • Leading Generics Companies of 2008
  • Big Pharma Gains a Bigger Footprint in Generics
  • Fallout at Ranbaxy
  • Data Report: Mixed Results for Generics Initiatives
• Strategy Perspective: Focus on the H1N1 Pandemic
  • Swine Flu: Round One
    • A Global Crisis
    • Economic and Public Health Dilemma
    • Epidemiological Background
    • Virus Characteristics
    • Medical Response to Flu
    • Detection
    • Prevention
    • Treatment
  • Swine Flu: Round Two?

Expert Commentaries

• Phase 0 Trials: Implications for Cancer Drug Development
• What Are the Benefi ts of Orphan Drug Status?
• H1N1 Flu Pandemic: Expanding Opportunities for Infl uenza Screening

Tables

• 1. Emerging Diagnostic Profi le Acceptable to 88% of Surveyed Psychiatrists: Genetic Theranostic to Predict Atypical Antipsychotic Effi cacy .
• 2. Orphan Drug Policies in the United States, Europe, and Japan
• 3. Select Findings from Decision Resources' Coverage of Orphan Drug Indications
• 4. Top Company Dealmaking Activity, Q2 2009
• 5. Deals Related to the H1N1 Outbreak, Q2 2009
• 6. Select Deals by Therapeutic Area, Q2 2009
• 7. Collaborations Focused on Stem Cell Technologies, Q2 2009
• 8. Top Ten Infl uenza Vaccines by Revenue, 2008
• 9. Top Five Antivirals for the Treatment of Infl uenza by Revenue, 2008

Figures

• 1. Q2 2009 U.S. Drug Approval Tallies and Highlights
• 2. Number of Q2 Deals, 2006-2009
• 3. Number of Deals Valued at More Than $100 Million in the Second Quarter of Each Year, 2006-2009
• 4. Three Deals, More Than $150 Billion Spent: Pfi zer/Wyeth, Roche/Genentech, and Merck & Co./Schering-Plough, Q1 2009
• 5. Select Mergers and Acquisitions Valued at More Than $50 Million, Q2 2009
• 6. Select Product-Related Deals Valued at More Than $100 Million, Q2 2009
• 7. Percentage of Deals by Therapeutic Area, Q2 2009
• 8. Percentage of Technology-Focused Deals by Technology Type, Q2 2009
• 9. 2008 Revenue of Leading Generics Companies
• 10. Revenue and Profi t for Select Ranbaxy Subsidiaries, 2008
• 11. Growth in the Savings to the U.S. Healthcare System as a Result of Generic Drugs, 2000-2008