Optimizing Lifecycle Management: Maximizing commercial lifespan through label expansion and combination products

Table of Contents

Executive summary

• Product lifecycle and management challenges
• Influencing the commercial lifespan of the drug
• Accessing broader patient populations
• Fixed dose combinations

Chapter 1 Product lifecycle and management challenges

• Summary
• Introduction
• The lifecycle of biopharmaceutical drugs
  • Development lifecycle
  • Commercial lifecycle
• Managing the lifecycle
  • Longer development time
  • Slower product uptake via reimbursement hurdles
  • Peak sales potential is reduced by higher competition
  • Earlier lifecycle decline due to therapeutic substitution

Chapter 2 Influencing the commercial lifespan of a drug

• Summary
• Bargaining power of biopharmaceutical brands
  • Brand equity
• Patent protection and "freedom to operate"
  • Strategic patenting
    • Patent prosecution superhighway
  • Patent protection for biologics
• Data exclusivity
  • Difference between data exclusivity and patent protection
  • 8+2+1 system in the EU
  • Data exclusivity in the US
  • Data exclusivity in Japan
  • Data exclusivity in the context of biologics

Chapter 3 Accessing broader patient populations

• Summary
• Drug labeling and market access
• Off-label drug usage
  • Commercial incentives and disincentives
  • Payors stance on off-label reimbursement
  • Case study: Avastin and Lucentis
• Expanding the label
  • Role in product lifecycle management
    • New indications
    • Pediatric extensions and special populations
    • Modified indications and expanded usage
  • Case study: Yaz
  • Case study: Remicade
• Indication expansion
  • Choosing the primary indication
  • Related versus unrelated indications
  • Sequence of indication expansion
  • Timing of indication expansion
    • Launching early in commercial lifecycle
    • Launching late in commercial lifecycle
  • Seroquel: Using indication expansion and drug reformulation synergistically
• Recent trends in indication expansion
  • Indication expansion for NDAs
  • Indication expansion for biologics

Chapter 4 Fixed dose combinations

• Summary
• Introduction
  • Clinical challenges in FDC development
  • FDC patents
  • Data exclusivity for FDCs
• Role in product lifecycle maximization
  • Case study: Advair' s role in GSK' s asthma franchise
  • Case study: How Vytorin influenced Zocor' s patent expiry
  • Case study: BiDil' s value proposition reinvented
• FDC uptake by geography
  • Case study: FDCs for hypertension
• Clinical rationale
  • Synergistic efficacy or safety
  • Easier Rx management
    • Correlation between FDC usage and drug compliance
    • Correlation between drug compliance & improved clinical outcomes
• FDC usage by therapy area
• Key success factors and competitive hurdles
  • Endorsement by treatment guidelines
  • Perceived synergy effects over free combination
  • Compliance advantage over the free combination
  • Usage of mono compounds prior to FDC launch
  • Discount compared to cheapest free combination
  • Time-to-LOE of parent brand

Chapter 5 Appendix

• Primary research methodology
• Glossary
• Index

List of Figures

• Figure 1.1: Summary of lifecycle of medicinal drugs
• Figure 1.2: Transition probabilities for clinical phases
• Figure 1.3: Out-of-pocket and capitalized costs of developing a drug ($m)
• Figure 1.4: Time taken for development of new pharma & biotech drugs
• Figure 1.5: Approval timelines at CDER for priority NDAs, 1999-08
• Figure 1.6: Approval timelines at CDER for standard NDAs, 1999-08
• Figure 1.7: Imperatives of efficient lifecycle management
• Figure 1.8: Increasing importance of payors as stakeholders
• Figure 1.9: Tougher payor environments are slowing product uptake
• Figure 1.10: Therapeutic substitution and formulary access
• Figure 2.11: 8+2+1 data exclusivity system in Europe
• Figure 2.12: Data exclusivity and patent protection in the US
• Figure 3.13: On and off-label decision making by payors
• Figure 3.14: Off-label usage of Avastin: a pharmacoeconomic model for wet AMD
• Figure 3.15: Yaz: Label expansion & sales growth - US ($m), 2006-08
• Figure 3.16: Remicade: Label expansion & sales growth - US ($m), 2001-08
• Figure 3.17: Time between launch of original and new indications in the US (by ATC), 1999-08
• Figure 3.18: Time between launch of original and new indications in the US (by ATC), 1999-08 (contd)
• Figure 3.19: Considerations in launching new indications early in the lifecycle
• Figure 3.20: Considerations in launching new indications late in the lifecycle
• Figure 3.21: Lifecycle management: Seroquel and Seroquel XR
• Figure 3.22: New indication approvals for NDAs, 1999-2008
• Figure 3.23: New indication approvals for Orphan drugs, 1999-08
• Figure 3.24: New indication approvals with priority reviews, 1999-08
• Figure 3.25: Increasing clinical and commercial potential for Remicade
• Figure 4.26: FDC approvals in the US, 1999-08
• Figure 4.27: Advair: FDA approvals and patent protection
• Figure 4.28: Advair-Serevent sales in the US: maintaining revenues post patent expiry of Flovent
• Figure 4.29: Zocor-Vytorin-Zetia brand timeline
• Figure 4.30: Cushioning the patent cliff: Zocor-Vytorin-Zetia sales in US ($m), 2001-08
• Figure 4.31: FDC usage for hypertension across major markets
• Figure 4.32: Drug classes with maximum FDC approvals in the US, 1999-08

List of Tables

• Table 2.1: Data exclusivity periods by country
• Table 3.2: Success drivers and barriers in indication expansion
• Table 3.3: Unmet needs prevalent within an indication
• Table 3.4: Commercial considerations in prioritizing new indications
• Table 3.5: Disease areas and related sub-populations for hypertension and heart failure
• Table 3.6: New indication approvals by drug class, 1999-08
• Table 4.7: FDC case studies