This book systematically explains how LCM strategies can help the pharmaceutical industry maximize the value of its patented brands through effective drug development programs and brand management. The authors share their combined 50 years of experience in the industry, citing numerous recent examples and case histories, and demonstrating how different measures can be combined to create winning strategies. The text helps pharmaceutical professionals understand challenges facing the industry and the role LCM has in confronting them, and offers a look ahead to predict which LCM strategies will continue to be effective in the future. A must-read for pharmaceutical executives and managers.

Acknowledgments xviiIntroduction xixPART A Lifecycle Management Business Environment 11. Challenges Facing the Branded Drug Industry 31.1 Depleted NME Pipelines/Lower R&D Efficiency 41.2 Higher Development Costs 81.3 Safety Concerns 91.4 Tougher Environment for Pricing, Reimbursement, and Listing 121.5 Increased Competition 161.6 Earlier Genericization 171.7 Faster Sales Erosion Following Patent Expiry 181.8 Poor Image of Branded Drug Industry 201.9 Diversification 262. The Life Cycle of Industries, Technologies, and Brands 302.1 Diffusion of Innovations 302.2 The Lifecycle Curve 322.3 Lifecycle Phases 343. The Life Cycle of a Pharmaceutical Brand 383.1 Lifecycle Curve of Pharmaceuticals 413.2 Factors Affecting Rate of Conversion to Generics 443.3 The Life Cycle of a Pharmaceutical Brand 46PART B Lifecycle Management Regulatory and Legal Environment 554. The Generic Approval Process 574.1 United States 574.2 Europe 594.3 Japan 615. Hatch-Waxman Legislation and Its Effects on LCM 625.1 Hatch-Waxman Act of 1984 625.2 Medicare Modernization Act of 2003 645.3 FDA Amendments Act of 2007 655.4 Q1 Program Supplemental Funding Act of 2008 665.5 Discussion of Hatch-Waxman Legislation 666. U.S. Health-Care Reform 2010 697. European Sector Inquiry 72PART C Patents and Exclusivities 778. Patents and Other Intellectual Property Rights 798.1 Nonpatent Intellectual Property Rights 798.2 What Are Patents? 818.3 What Is Patentable? 838.4 How Long Does a Patent Last? 878.5 Patent Term Restoration in the United States 878.6 Supplementary Protection Certificates in Europe 888.7 Patent Term Extension in Japan 898.8 How Are Patents Obtained? 898.9 Patent Enforcement 918.10 Types of Patents 928.11 KSR versus Teleflex--Raising the Nonobviousness Bar 948.12 Patent Strategy 969. Nonpatent Exclusivities 999.1 NCE Exclusivity (United States) 999.2 New Clinical Study Exclusivity (United States) 1009.3 Data and Marketing Exclusivity (Europe) 1009.4 Data Exclusivity (Japan) 1019.5 Orphan Drug Exclusivity 1019.6 Pediatric Exclusivity 1039.7 180-Day Generic Product Exclusivity 10510. Patent Settlements 107PART D Developmental LCM 11311. Strategic Principles of Developmental LCM 11511.1 Developmental LCM Goal 1: Provide a Meaningful Improvement in Clinical Profile 11611.2 Developmental LCM Goal 2: Increase the Potential Real-World Patient Potential for the Brand 11811.3 Developmental LCM Goal 3: The Ability to Generate an ROI 12011.4 Developmental LCM Goal 4: The Ability to Enhance Market Exclusivity of the Brand Franchise 12112. Indication Expansion and Sequencing 12312.1 Categories of Indication Expansion 12313. Patient Subpopulations and Personalized Medicine 13113.1 What Does a Good Patient Selection Strategy Look Like? 13513.2 Patient Selection without Predictive Criteria: Post Hoc Approaches 13813.3 What about the Patients Who Are Not Selected? 13914. New Dosage Strengths, New Dosage Regimens 14014.1 New Dosage Strengths 14014.2 New Dosage Regimens 14115. Reformulation, New Routes of Administration, and D rug Delivery 14315.1 Reformulation and New Routes of Administration 14315.2 Drug Delivery Devices 14916. Fixed-Dose Combinations (FDCs) and C o-Packaging 15217. Second-Generation Products and Modified Chemistry 15917.1 Isomerism 16017.2 Polymorphism 16117.3 Salts, Ethers, and Esters 16217.4 Prodrugs and Metabolites 16318. Other Development LCM Strategies 16518.1 Manufacturing Strategies 16518.2 White Papers and Citizen Petitions 166PART E Commercial LCM 16719. Strategic Principles of Commercial LCM 16919.1 Commercial LCM Goal 1: The Ability to Drive Widespread and Preferential Patient Access to the Brand 17019.2 Commercial LCM Goal 2: The Ability to Defend Market Access and Formulary Position 17019.3 Commercial LCM Goal 3: The Ability to Optimize Profitability of the Brand Franchise 17120. Geographical Expansion and Optimization 17220.1 Geographic Expansion 17420.2 Harmonization and Rationalization 17521. OTC S witching 17821.1 What to Switch: Choosing the Best Approach 17921.2 Where to Switch: Dealing with Intermarket Variability 18121.3 When to Switch: Balancing the Product Life Cycle? 18321.4 How to Make the Switch Successful: What Corporate Support Is Required? 18422. Brand Loyalty and Service Programs 18623. Strategic Pricing Strategies 19023.1 Pricing Strategy and Tactics in the Launch and Growth Phases 19023.2 Pricing Strategy and Tactics Following Patent Expiry 19324. Generic Strategies and Tactics 19825. Exit Strategies 204PART F Biologics and Biosimilars 20726. Biologics and LCM 20926.1 Emergence of Biotech 20926.2 Some Definitions 21026.2.1 Biologics 21026.3 Uptake and Value of Biologics 21126.4 LCM of Biologics 21327. Biosimilars and T heir Impact on Biologic LCM 21727.1 Changing Terminology: Biogenerics, Biosimilars, and FOBs 21727.2 Why Are Biosimilars a Big Deal? 21927.3 How Are Biosimilars Different? 22027.4 Biosimilar Approval Pathways 22027.5 Substitution of Biosimilars 22327.6 Innovator Responses to Biosimilar Threats 22527.7 The Future for Biologics LCM 22627.8 The Emergence of the "Innovasimilar" Biopharma Company 22927.9 Final Words 231PART G The Integrated Brand LCM Strategy and Its Implementation 23328. Strategic Goals of LCM Brand Plans 23528.1 Position to Market 23528.2 Comparative Clinical Profile versus Gold Standard 23728.3 Level of Market Unmet Need 23729. Ten Keys to Successful LCM 23829.1 Excellent Functional Expertise 23829.2 Visible Management Support 24429.3 Unambiguous Ownership 24529.4 An Early Start 24629.5 A Robust "Broad to Bespoke" Process 24829.6 Focus on "High LCM Value Brands" 24929.7 Adequate Resources 25029.8 Measurements and Rewards 25029.9 Training and Support 25229.10 Realism 25230. Organizational Structures and Systems for Ensuring Successful LCM 25430.1 Organization of Project and Brand Management 25430.2 Project and Brand LCM Structures 25930.3 LCM Center of Excellence 26330.4 Composition of the LCM CoE 26631. The LCM Process: Description, Timing, and Participants 26831.1 Purpose of the LCM Process 26831.2 Timing of the LCM Process 26931.3 Description of the LCM Process 271PART H Integrating LCM with Portfolio Management 27732. Principles of Portfolio Management 27933. LCM Projects in the Development Portfolio 28434. Managing Established Brand Portfolios 28634.1 What Do You Do with a Priority Established Brand? 28834.2 What about the Nonpriority Brands? 28934.3 Building the Ideal Established Brands Portfolio 290Conclusions 291APPENDIX: Case Histories 2941 Case History: Market and Product-Shaping Dynamics in Action 2942 Case History: Optimizing Clinical Profile versus Gold Standards 2983 Case History: Partnering to Ensure Reimbursement and Collect Cost-Effectiveness Data 2994 Case History: Active Metabolites and Late-Listed Patents 3015 Case History: A Fixed-Dose Combination (FDC) that Could Not Fail, or Could It? 3036 Case History: Indication Expansion 3057 Case History: Killing a Franchise through Over-the-Counter (OTC) Switching 3078 Case History: Moving FDCs to the Fore in Diabetes 3089 Case History: FDCs and Multiple Dosage Strengths 31010 Case History: Building Compliance Support Program 31211 Case History: Targeting Responders with High-Price Cancer Agents 31412 Case History: Failure of a "No-Brainer" LCM Strategy 31513 Case History: At-Risk Launches and Prodrug Patents 32014 Case History: New Dosages, FDC, and Patent Litigation 32215 Case History: High Regulatory Hurdles for Lifestyle Drugs 32516 Case History: Big Money from Orphan Indications 32717 Case History: Not Giving Up on a Controversial Brand 33018 Case History: Expanding a Medical Aesthetics Franchise with an Ophthalmic Drug 33219 Case History: Patent Expiry of the Biggest Drug Brand Ever 33520 Case History: Early Out-Licensing by Biotech: Take the Money and Run 33621 Case History: Codevelopment and Comarketing Deals End in a Megamerger 33822 Case History: A Hugely Successful LLCM Switch Strategy: Business Needs and Reputational Issues Collide 34423 Case History: Combining Production Outsourcing with Settlement with a Generic Competitor 34924 Case History: Reformulating for Success in Osteoporosis 35125 Case History: Isomerism, Polymorphism, and Settlements 35426 Case History: Payers versus Brand for Patient Selection 35627 Case History: Litigation Can Delay Generic Entry in the OTC Field Too 35828 Case History: Inconsistent Court Decisions Can Hurt Both Brand and Generic Companies 36029 Case History: Holding on to an Antipsychotic Franchise 36230 Case History: LCM Creates an Almost Immortal Brand 36431 Case History: LCM of a Women's Health Franchise 36632 Case History: Indication Expansion/New Dosage Strength 369INDEX 371