This report explains the basics of drug lifecycle and investigates three goals in optimizing product potential- expanding the drug’s patent protected lifespan, accessing broader patient populations and launching line-extensions via FDCs.
The key success factors in each of these pursuits have been clearly identified, emerging trends have been presented and the underlying concepts have been explained to give the reader a clear understanding of current industry dynamics. Case studies on popular products have been used to illustrate these concepts in the real world.
An in-depth analysis of drug approval data provides context for the issues discussed. This information is juxtaposed with historic sales data to explore the correlation between the strategies employed and revenue potential.
Key findings
Drug manufacturers must make the best strategic use of the patent-protected lifespan of a drug, or else risk losing the profit incentives they perceived at the start of the project. (Ch. 1)
In light of the increasing complexity of biopharmaceutical patenting, the ‘freedom to operate’, i.e. to commercialize the invention, is coming under increasing scrutiny. (Ch. 2)
The US Congress’ emerging stance on data exclusivity provisions for biologics will define the length of time a biotechnology company can keep out generic competition in new indications. The biotech industry’s stance is that the current provisions do not provide for enough time to profit from their post-approval R&D investments. (Ch. 2)
The potential for post-approval label expansion is much greater for biologics in comparison to small molecule pharmaceutical drugs. Most biologics on the market today can expect to add significant revenue streams via new indications, and potentially extend their commercial lifespan. (Ch 3)
Over 45% of all new indication approvals granted by the FDA since 1998 belong to drugs that fall in the Genito-urinary system and Nervous system.
If an FDC is launched close to the loss of exclusivity date of the constituent brand, it may be interpreted as a marketing tactic to limit post-LoE revenue losses. If launched early, it may show intent to cater to a genuine unmet need, or to legitimately maximize the potential of the parent molecule(s). (Ch. 4)
Scope of the report
In-depth case studies explore the real-world execution of the issues and challenges discussed in the report.
Analysis of historic drug approval data provides the reader with contextual reference points.
Case studies on Vytorin, Advair and BiDil illustrate the strategies employed by three leading FDC brands.
Brand histories of Yaz, Remicade and Seroquel show how label expansion is fundamental to successful lifecycle management.
Where applicable, these strategies are discussed with reference to specific therapeutic areas or geographies.
Issues related to biologics are highlighted to indicate where they differ from small molecule drugs.
Use this report to
Gain an understanding of legal provision for patent protection and data exclusivity. Understand their role in the context of product lifecycle management
Utilize the historical data on NDA approvals to identify trends and build assumptions into competitive landscape forecasts.
Understand the stance of key stakeholders and implications of off-label drug usage.
Understand the role of FDCs in optimizing the commercial potential of a product asset, and the main challenges in their commercialization
Juxtapose historic sales performance with the timing of indication expansion and FDC based strategies to assess the success or failure
Table of Contents :
Optimizing Lifecycle ManagementExecutive summary 8Product lifecycle and management challenges 8Influencing the commercial lifespan of the drug 9Accessing broader patient populations 10Fixed dose combinations 11Chapter 1 Product lifecycle and management challenges 14Summary 14Introduction 15The lifecycle of biopharmaceutical drugs 15Development lifecycle 17Commercial lifecycle 22Managing the lifecycle 22Longer development time 23Slower product uptake via reimbursement hurdles 24Peak sales potential is reduced by higher competition 25Earlier lifecycle decline due to therapeutic substitution 26Chapter 2 Influencing the commercial lifespan of a drug 30Summary 30Bargaining power of biopharmaceutical brands 31Brand equity 31Patent protection and “freedom to operate” 32Strategic patenting 33Patent prosecution superhighway 35Patent protection for biologics 35Data exclusivity 36Difference between data exclusivity and patent protection 408+2+1 system in the EU 40Data exclusivity in the US 42Data exclusivity in Japan 43Data exclusivity in the context of biologics 44Chapter 3 Accessing broader patient populations 46Summary 46Drug labeling and market access 47Off-label drug usage 47Commercial incentives and disincentives 48Payors stance on off-label reimbursement 49Case study: Avastin and Lucentis 51Expanding the label 53Role in product lifecycle management 53New indications 53Pediatric extensions and special populations 54Modified indications and expanded usage 54Case study: Yaz 55Case study: Remicade 58Indication expansion 59Choosing the primary indication 61Related versus unrelated indications 63Sequence of indication expansion 64Timing of indication expansion 65Launching early in commercial lifecycle 68Launching late in commercial lifecycle 69Seroquel: Using indication expansion and drug reformulation synergistically 70Recent trends in indication expansion 72Indication expansion for NDAs 72Indication expansion for biologics 75Chapter 4 Fixed dose combinations 80Summary 80Introduction 81Clinical challenges in FDC development 81FDC patents 82Data exclusivity for FDCs 83Role in product lifecycle maximization 83Case study: Advair’s role in GSK’s asthma franchise 85Case study: How Vytorin influenced Zocor’s patent expiry 88Case study: BiDil’s value proposition reinvented 90FDC uptake by geography 91Case study: FDCs for hypertension 91Clinical rationale 93Synergistic efficacy or safety 94Easier Rx management 95Correlation between FDC usage and drug compliance 95Correlation between drug compliance & improved clinical outcomes 96FDC usage by therapy area 96Key success factors and competitive hurdles 98Endorsement by treatment guidelines 98Perceived synergy effects over free combination 99Compliance advantage over the free combination 99Usage of mono compounds prior to FDC launch 99Discount compared to cheapest free combination 100Time-to-LOE of parent brand 101Chapter 5 Appendix 103Primary research methodology 103Glossary 107Index 111List of FiguresFigure 1.1: Summary of lifecycle of medicinal drugs 17Figure 1.2: Transition probabilities for clinical phases 18Figure 1.3: Out-of-pocket and capitalized costs of developing a drug ($m) 19Figure 1.4: Time taken for development of new pharma & biotech drugs 20Figure 1.5: Approval timelines at CDER for priority NDAs, 1999-08 21Figure 1.6: Approval timelines at CDER for standard NDAs, 1999-08 21Figure 1.7: Imperatives of efficient lifecycle management 23Figure 1.8: Increasing importance of payors as stakeholders 24Figure 1.9: Tougher payor environments are slowing product uptake 25Figure 1.10: Therapeutic substitution and formulary access 27Figure 2.11: 8+2+1 data exclusivity system in Europe 41Figure 2.12: Data exclusivity and patent protection in the US 43Figure 3.13: On and off-label decision making by payors 50Figure 3.14: Off-label usage of Avastin: a pharmacoeconomic model for wet AMD 52Figure 3.15: Yaz: Label expansion & sales growth – US ($m), 2006-08 57Figure 3.16: Remicade: Label expansion & sales growth – US ($m), 2001-08 59Figure 3.17: Time between launch of original and new indications in the US (by ATC), 1999-08 66Figure 3.18: Time between launch of original and new indications in the US (by ATC), 1999-08 (contd) 67Figure 3.19: Considerations in launching new indications early in the lifecycle 69Figure 3.20: Considerations in launching new indications late in the lifecycle 70Figure 3.21: Lifecycle management: Seroquel and Seroquel XR 71Figure 3.22: New indication approvals for NDAs, 1999-2008 73Figure 3.23: New indication approvals for Orphan drugs, 1999-08 73Figure 3.24: New indication approvals with priority reviews, 1999-08 74Figure 3.25: Increasing clinical and commercial potential for Remicade 77Figure 4.26: FDC approvals in the US, 1999-08 84Figure 4.27: Advair: FDA approvals and patent protection 86Figure 4.28: Advair-Serevent sales in the US: maintaining revenues post patent expiry of Flovent 87Figure 4.29: Zocor-Vytorin-Zetia brand timeline 88Figure 4.30: Cushioning the patent cliff: Zocor-Vytorin-Zetia sales in US ($m), 2001-08 89Figure 4.31: FDC usage for hypertension across major markets 93Figure 4.32: Drug classes with maximum FDC approvals in the US, 1999-08 97List of TablesTable 2.1: Data exclusivity periods by country 39Table 3.2: Success drivers and barriers in indication expansion 61Table 3.3: Unmet needs prevalent within an indication 62Table 3.4: Commercial considerations in prioritizing new indications 62Table 3.5: Disease areas and related sub-populations for hypertension and heart failure 63Table 3.6: New indication approvals by drug class, 1999-08 75Table 4.7: FDC case studies 81
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