{"product_id":"pharmaceutical-lifecycle-management-isbn-9780470487532","title":"Pharmaceutical Lifecycle Management","description":"\u003cp\u003e\u003cb\u003eA comprehensive guide to optimizing the lifecycle management of pharmaceutical brands\u003c\/b\u003e  \u003c\/p\u003e\u003cp\u003eThe mounting challenges posed by cost containment policies and the prevalence of generic alternatives make optimizing the lifecycle management (LCM) of brand drugs essential for pharmaceutical companies looking to maximize the value of their products. Demonstrating how different measures can be combined to create winning strategies, \u003ci\u003ePharmaceutical Lifecycle Management: Making the Most of Each and Every Brand\u003c\/i\u003e explores this increasingly important field to help readers understand what they can—and must—do to get the most out of their brands.  \u003c\/p\u003e\u003cp\u003eOffering a truly immersive introduction to LCM options for pharmaceuticals, the book incorporates numerous real-life case studies that demonstrate successful and failed lifecycle management initiatives, explaining the key takeaway of each example. Filled with practical information on the process of actually writing and presenting an LCM plan, as well as how to link corporate, portfolio, and individual brand strategies, the book also offers a look ahead to predict which LCM strategies will continue to be effective in the future.  \u003c\/p\u003e\u003cp\u003eWhile the development of new drugs designed to address unmet patient needs remains the single most important goal of any pharmaceutical company, effective LCM is invaluable for getting the greatest possible value from existing brands. \u003ci\u003ePharmaceutical Lifecycle Management\u003c\/i\u003e walks you through the process step by step, making it indispensable reading for pharmaceutical executives and managers, as well as anyone working in the fields of drug research, development, and regulation. \u003c\/p\u003e\u003cp\u003eAcknowledgments xvii\u003c\/p\u003e \u003cp\u003eIntroduction xix\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart A Lifecycle Management Business Environment 1\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1. Challenges Facing the Branded Drug Industry 3\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e1.1 Depleted NME Pipelines\/Lower R\u0026amp;D Efficiency 4\u003c\/p\u003e \u003cp\u003e1.2 Higher Development Costs 8\u003c\/p\u003e \u003cp\u003e1.3 Safety Concerns 9\u003c\/p\u003e \u003cp\u003e1.4 Tougher Environment for Pricing, Reimbursement, and Listing 12\u003c\/p\u003e \u003cp\u003e1.5 Increased Competition 16\u003c\/p\u003e \u003cp\u003e1.6 Earlier Genericization 17\u003c\/p\u003e \u003cp\u003e1.7 Faster Sales Erosion Following Patent Expiry 18\u003c\/p\u003e \u003cp\u003e1.8 Poor Image of Branded Drug Industry 20\u003c\/p\u003e \u003cp\u003e1.8.1 Prosperity of the Branded Drug Industry 21\u003c\/p\u003e \u003cp\u003e1.8.2 Lack of Innovation 22\u003c\/p\u003e \u003cp\u003e1.8.3 Marketing Spend and Tactics 22\u003c\/p\u003e \u003cp\u003e1.8.4 Safety Issues 23\u003c\/p\u003e \u003cp\u003e1.8.5 Keeping Generics Off the Market 24\u003c\/p\u003e \u003cp\u003e1.9 Diversification 26\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2. The Life Cycle of Industries, Technologies, and Brands 30\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e2.1 Diffusion of Innovations 30\u003c\/p\u003e \u003cp\u003e2.2 The Lifecycle Curve 32\u003c\/p\u003e \u003cp\u003e2.3 Lifecycle Phases 34\u003c\/p\u003e \u003cp\u003e2.3.1 Development Phase 34\u003c\/p\u003e \u003cp\u003e2.3.2 Introduction Phase 35\u003c\/p\u003e \u003cp\u003e2.3.3 Growth Phase 35\u003c\/p\u003e \u003cp\u003e2.3.4 Maturity Phase 36\u003c\/p\u003e \u003cp\u003e2.3.5 Decline Phase 36\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3. The Life Cycle of a Pharmaceutical Brand 38\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e3.1 Lifecycle Curve of Pharmaceuticals 41\u003c\/p\u003e \u003cp\u003e3.1.1 Slow Rate of Growth during the Growth Phase 42\u003c\/p\u003e \u003cp\u003e3.1.2 Lack of a True Maturity Phase 43\u003c\/p\u003e \u003cp\u003e3.1.3 Precipitous Decline Phase 43\u003c\/p\u003e \u003cp\u003e3.2 Factors Affecting Rate of Conversion to Generics 44\u003c\/p\u003e \u003cp\u003e3.2.1 Government Policy 44\u003c\/p\u003e \u003cp\u003e3.2.2 Disease 44\u003c\/p\u003e \u003cp\u003e3.2.3 Size of Brand 45\u003c\/p\u003e \u003cp\u003e3.2.4 Hospital versus Nonhospital Drug Usage 45\u003c\/p\u003e \u003cp\u003e3.2.5 Active Substance and Other Barriers to Entry 46\u003c\/p\u003e \u003cp\u003e3.3 The Life Cycle of a Pharmaceutical Brand 46\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart B Lifecycle Management Regulatory and Legal Environment 55\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4. The Generic Approval Process 57\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e4.1 United States 57\u003c\/p\u003e \u003cp\u003e4.2 Europe 59\u003c\/p\u003e \u003cp\u003e4.3 Japan 61\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5. Hatch–Waxman Legislation and Its Effects on LCM 62\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e5.1 Hatch–Waxman Act of 1984 62\u003c\/p\u003e \u003cp\u003e5.2 Medicare Modernization Act of 2003 64\u003c\/p\u003e \u003cp\u003e5.3 FDA Amendments Act of 2007 65\u003c\/p\u003e \u003cp\u003e5.4 Q1 Program Supplemental Funding Act of 2008 66\u003c\/p\u003e \u003cp\u003e5.5 Discussion of Hatch-Waxman Legislation 66\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6. U.S. Health-Care Reform 2010 69\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7. European Sector Inquiry 72\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart C Patents and Exclusivities 77\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8. Patents and Other Intellectual Property Rights 79\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e8.1 Nonpatent Intellectual Property Rights 79\u003c\/p\u003e \u003cp\u003e8.2 What Are Patents? 81\u003c\/p\u003e \u003cp\u003e8.3 What Is Patentable? 83\u003c\/p\u003e \u003cp\u003e8.3.1 Patentable Subject Matter 83\u003c\/p\u003e \u003cp\u003e8.3.2 Novelty 84\u003c\/p\u003e \u003cp\u003e8.3.3 Inventive Step 85\u003c\/p\u003e \u003cp\u003e8.3.4 Utility 86\u003c\/p\u003e \u003cp\u003e8.3.5 Disclosure 86\u003c\/p\u003e \u003cp\u003e8.4 How Long Does a Patent Last? 87\u003c\/p\u003e \u003cp\u003e8.5 Patent Term Restoration in the United States 87\u003c\/p\u003e \u003cp\u003e8.6 Supplementary Protection Certificates in Europe 88\u003c\/p\u003e \u003cp\u003e8.7 Patent Term Extension in Japan 89\u003c\/p\u003e \u003cp\u003e8.8 How Are Patents Obtained? 89\u003c\/p\u003e \u003cp\u003e8.9 Patent Enforcement 91\u003c\/p\u003e \u003cp\u003e8.10 Types of Patents 92\u003c\/p\u003e \u003cp\u003e8.10.1 Composition of Matter Patent 93\u003c\/p\u003e \u003cp\u003e8.10.2 Medical Use Patent 93\u003c\/p\u003e \u003cp\u003e8.10.3 Formulation Patent 94\u003c\/p\u003e \u003cp\u003e8.11 KSR versus Teleflex—Raising the Nonobviousness Bar 94\u003c\/p\u003e \u003cp\u003e8.12 Patent Strategy 96\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9. Nonpatent Exclusivities 99\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e9.1 NCE Exclusivity (United States) 99\u003c\/p\u003e \u003cp\u003e9.2 New Clinical Study Exclusivity (United States) 100\u003c\/p\u003e \u003cp\u003e9.3 Data and Marketing Exclusivity (Europe) 100\u003c\/p\u003e \u003cp\u003e9.4 Data Exclusivity (Japan) 101\u003c\/p\u003e \u003cp\u003e9.5 Orphan Drug Exclusivity 101\u003c\/p\u003e \u003cp\u003e9.6 Pediatric Exclusivity 103\u003c\/p\u003e \u003cp\u003e9.7 180-Day Generic Product Exclusivity 105\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10. Patent Settlements 107\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart D Developmental LCM 113\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e11. Strategic Principles of Developmental LCM 115\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e11.1 Developmental LCM Goal 1: Provide a Meaningful Improvement in Clinical Profile 116\u003c\/p\u003e \u003cp\u003e11.2 Developmental LCM Goal 2: Increase the Potential Real-World Patient Potential for the Brand 118\u003c\/p\u003e \u003cp\u003e11.3 Developmental LCM Goal 3: The Ability to Generate an ROI 120\u003c\/p\u003e \u003cp\u003e11.4 Developmental LCM Goal 4: The Ability to Enhance Market Exclusivity of the Brand Franchise 121\u003c\/p\u003e \u003cp\u003e\u003cb\u003e12. Indication Expansion and Sequencing 123\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e12.1 Categories of Indication Expansion 123\u003c\/p\u003e \u003cp\u003e\u003cb\u003e13. Patient Subpopulations and Personalized Medicine 131\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e13.1 What Does a Good Patient Selection Strategy Look Like? 135\u003c\/p\u003e \u003cp\u003e13.2 Patient Selection without Predictive Criteria: Post Hoc Approaches 138\u003c\/p\u003e \u003cp\u003e13.3 What about the Patients Who Are Not Selected? 139\u003c\/p\u003e \u003cp\u003e\u003cb\u003e14. New Dosage Strengths, New Dosage Regimens 140\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e14.1 New Dosage Strengths 140\u003c\/p\u003e \u003cp\u003e14.2 New Dosage Regimens 141\u003c\/p\u003e \u003cp\u003e\u003cb\u003e15. Reformulation, New Routes of Administration, and Drug Delivery 143\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e15.1 Reformulation and New Routes of Administration 143\u003c\/p\u003e \u003cp\u003e15.1.1 Switch and Grow Strategy 143\u003c\/p\u003e \u003cp\u003e15.1.2 Expand and Grow Strategy 145\u003c\/p\u003e \u003cp\u003e15.1.3 Generic Defense 145\u003c\/p\u003e \u003cp\u003e15.2 Drug Delivery Devices 149\u003c\/p\u003e \u003cp\u003e\u003cb\u003e16. Fixed-Dose Combinations (FDCs) and Co-Packaging 152\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e17. Second-Generation Products and Modified Chemistry 159\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e17.1 Isomerism 160\u003c\/p\u003e \u003cp\u003e17.2 Polymorphism 161\u003c\/p\u003e \u003cp\u003e17.3 Salts, Ethers, and Esters 162\u003c\/p\u003e \u003cp\u003e17.4 Prodrugs and Metabolites 163\u003c\/p\u003e \u003cp\u003e\u003cb\u003e18. Other Developmental LCM Strategies 165\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e18.1 Manufacturing Strategies 165\u003c\/p\u003e \u003cp\u003e18.2 White Papers and Citizen Petitions 166\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart E Commercial LCM 167\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e19. Strategic Principles of Commercial LCM 169\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e19.1 Commercial LCM Goal 1: The Ability to Drive Widespread and Preferential Patient Access to the Brand 170\u003c\/p\u003e \u003cp\u003e19.2 Commercial LCM Goal 2: The Ability to Defend Market Access and Formulary Position 170\u003c\/p\u003e \u003cp\u003e19.3 Commercial LCM Goal 3: The Ability to Optimize Profi tability of the Brand Franchise 171\u003c\/p\u003e \u003cp\u003e\u003cb\u003e20. Geographical Expansion and Optimization 172\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e20.1 Geographic Expansion 174\u003c\/p\u003e \u003cp\u003e20.2 Harmonization and Rationalization 175\u003c\/p\u003e \u003cp\u003e\u003cb\u003e21. OTC Switching 178\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e21.1 What to Switch: Choosing the Best Approach 179\u003c\/p\u003e \u003cp\u003e21.2 Where to Switch: Dealing with Intermarket Variability 181\u003c\/p\u003e \u003cp\u003e21.3 When to Switch: Balancing the Product Life Cycle? 183\u003c\/p\u003e \u003cp\u003e21.4 How to Make the Switch Successful: What Corporate Support Is Required? 184\u003c\/p\u003e \u003cp\u003e\u003cb\u003e22. Brand Loyalty and Service Programs 186\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e23. Strategic Pricing Strategies 190\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e23.1 Pricing Strategy and Tactics in the Launch and Growth Phases 190\u003c\/p\u003e \u003cp\u003e23.2 Pricing Strategy and Tactics Following Patent Expiry 193\u003c\/p\u003e \u003cp\u003e\u003cb\u003e24. Generic Strategies and Tactics 198\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eBuilding a Generic Portfolio: Old versus New Thinking 202\u003c\/p\u003e \u003cp\u003e\u003cb\u003e25. Exit Strategies 204\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eExecuting the Exit Strategy 206\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart F Biologics and Biosimilars 207\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e26. Biologics and LCM 209\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e26.1 Emergence of Biotech 209\u003c\/p\u003e \u003cp\u003e26.2 Some Definitions 210\u003c\/p\u003e \u003cp\u003e26.2.1 Biologics 210\u003c\/p\u003e \u003cp\u003e26.3 Uptake and Value of Biologics 211\u003c\/p\u003e \u003cp\u003e26.4 LCM of Biologics 213\u003c\/p\u003e \u003cp\u003e26.4.1 Next-Generation Biologics 213\u003c\/p\u003e \u003cp\u003e26.4.2 Reformulation 214\u003c\/p\u003e \u003cp\u003e26.4.3 Indication Expansion 215\u003c\/p\u003e \u003cp\u003e26.4.4 Self-Injection Devices 215\u003c\/p\u003e \u003cp\u003e\u003cb\u003e27. Biosimilars and Their Impact on Biologic LCM 217\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e27.1 Changing Terminology: Biogenerics, Biosimilars, and FOBs 217\u003c\/p\u003e \u003cp\u003e27.2 Why Are Biosimilars a Big Deal? 219\u003c\/p\u003e \u003cp\u003e27.3 How Are Biosimilars Different? 220\u003c\/p\u003e \u003cp\u003e27.4 Biosimilar Approval Pathways 220\u003c\/p\u003e \u003cp\u003e27.4.1 Biosimilars in Europe 220\u003c\/p\u003e \u003cp\u003e27.4.2 Biosimilars in the United States 221\u003c\/p\u003e \u003cp\u003e27.4.3 Biosimilars around the World 222\u003c\/p\u003e \u003cp\u003e27.5 Substitution of Biosimilars 223\u003c\/p\u003e \u003cp\u003e27.5.1 Automatic Substitution 223\u003c\/p\u003e \u003cp\u003e27.5.2 Therapeutic Substitution 224\u003c\/p\u003e \u003cp\u003e27.6 Innovator Responses to Biosimilar Threats 225\u003c\/p\u003e \u003cp\u003e27.7 The Future for Biologics LCM 226\u003c\/p\u003e \u003cp\u003e27.7.1 Legal Strategies in the United States 227\u003c\/p\u003e \u003cp\u003e27.7.2 Indication Expansion in Europe 228\u003c\/p\u003e \u003cp\u003e27.7.3 Brand Loyalty Programs and Services 229\u003c\/p\u003e \u003cp\u003e27.8 The Emergence of the “Innovasimilar” Biopharma Company 229\u003c\/p\u003e \u003cp\u003e27.9 Final Words 231\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart G The Integrated Brand LCM Strategy And its Implementation 233\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e28. Strategic Goals of LCM Brand Plans 235\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e28.1 Position to Market 235\u003c\/p\u003e \u003cp\u003e28.2 Comparative Clinical Profile versus Gold Standard 237\u003c\/p\u003e \u003cp\u003e28.3 Level of Market Unmet Need 237\u003c\/p\u003e \u003cp\u003e\u003cb\u003e29. Ten Keys to Successful LCM 238\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e29.1 Excellent Functional Expertise 238\u003c\/p\u003e \u003cp\u003e29.1.1 Patent Attorneys 239\u003c\/p\u003e \u003cp\u003e29.1.2 Regulatory Affairs 240\u003c\/p\u003e \u003cp\u003e29.1.3 Clinical Development 240\u003c\/p\u003e \u003cp\u003e29.1.4 Formulation Scientists 241\u003c\/p\u003e \u003cp\u003e29.1.5 Marketing and Sales 242\u003c\/p\u003e \u003cp\u003e29.1.6 Manufacturing 243\u003c\/p\u003e \u003cp\u003e29.2 Visible Management Support 244\u003c\/p\u003e \u003cp\u003e29.3 Unambiguous Ownership 245\u003c\/p\u003e \u003cp\u003e29.4 An Early Start 246\u003c\/p\u003e \u003cp\u003e29.5 A Robust “Broad to Bespoke” Process 248\u003c\/p\u003e \u003cp\u003e29.6 Focus on “High LCM Value Brands” 249\u003c\/p\u003e \u003cp\u003e29.7 Adequate Resources 250\u003c\/p\u003e \u003cp\u003e29.8 Measurements and Rewards 250\u003c\/p\u003e \u003cp\u003e29.9 Training and Support 252\u003c\/p\u003e \u003cp\u003e29.10 Realism 252\u003c\/p\u003e \u003cp\u003e\u003cb\u003e30. Organizational Structures and Systems for Ensuring Successful LCM 254\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e30.1 Organization of Project and Brand Management 254\u003c\/p\u003e \u003cp\u003e30.1.1 Functional Structure 255\u003c\/p\u003e \u003cp\u003e30.1.2 Project Structure 255\u003c\/p\u003e \u003cp\u003e30.1.3 Matrix Structure 257\u003c\/p\u003e \u003cp\u003e30.2 Project and Brand LCM Structures 259\u003c\/p\u003e \u003cp\u003e30.3 LCM Center of Excellence 263\u003c\/p\u003e \u003cp\u003e30.4 Composition of the LCM CoE 266\u003c\/p\u003e \u003cp\u003e\u003cb\u003e31. The LCM Process: Description, Timing, and Participants 268\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e31.1 Purpose of the LCM Process 268\u003c\/p\u003e \u003cp\u003e31.2 Timing of the LCM Process 269\u003c\/p\u003e \u003cp\u003e31.3 Description of the LCM Process 271\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart H Integrating LCM with Portfolio Management 277\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e32. Principles of Portfolio Management 279\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e33. LCM Projects in the Development Portfolio 284\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e34. Managing Established Brand Portfolios 286\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e34.1 What Do You Do with a Priority Established Brand? 288\u003c\/p\u003e \u003cp\u003e34.2 What about the Nonpriority Brands? 289\u003c\/p\u003e \u003cp\u003e34.3 Building the Ideal Established Brands Portfolio 290\u003c\/p\u003e \u003cp\u003eConclusions 291\u003c\/p\u003e \u003cp\u003eAppendix: Case histories 294\u003c\/p\u003e \u003cp\u003eA.1 Market and Product-Shaping Dynamics in Action 294\u003c\/p\u003e \u003cp\u003eAlzheimer’s Disease Therapies: Aricept®, Exelon®, and Reminyl®\/Razadyne® 294\u003c\/p\u003e \u003cp\u003eLearnings 297\u003c\/p\u003e \u003cp\u003eA.2 Optimizing Clinical Profi le versus Gold Standards 298\u003c\/p\u003e \u003cp\u003eAngiotensin II Receptor Blockers (ARBs): Cozaar®, Micardis®, and Benicar® 298\u003c\/p\u003e \u003cp\u003eLearnings 299\u003c\/p\u003e \u003cp\u003eA.3 Partnering to Ensure Reimbursement and Collection of Cost-Effectiveness Data 299\u003c\/p\u003e \u003cp\u003eAricept 299\u003c\/p\u003e \u003cp\u003eLearnings 301\u003c\/p\u003e \u003cp\u003eA.4 Active Metabolites and Late-Listed Patents 301\u003c\/p\u003e \u003cp\u003eBuspar® 301\u003c\/p\u003e \u003cp\u003eLearnings 303\u003c\/p\u003e \u003cp\u003eA.5 A Fixed-Dose Combination (FDC) That Could Not Fail, or Could It? 303\u003c\/p\u003e \u003cp\u003eCaduet® 303\u003c\/p\u003e \u003cp\u003eLearnings 304\u003c\/p\u003e \u003cp\u003eA.6 Indication Expansion 305\u003c\/p\u003e \u003cp\u003eCertican®\/Zortress® and Afi nitor® 305\u003c\/p\u003e \u003cp\u003eLearnings 306\u003c\/p\u003e \u003cp\u003eA.7 Killing a Franchise through Over-the-Counter (OTC) Switching 307\u003c\/p\u003e \u003cp\u003eClaritin® 307\u003c\/p\u003e \u003cp\u003eLearnings 308\u003c\/p\u003e \u003cp\u003eA.8 Moving FDCs to the Fore in Diabetes 308\u003c\/p\u003e \u003cp\u003eDiabetes Therapies: Glucophage®, Avandia®, Actos®, and Januvia® 308\u003c\/p\u003e \u003cp\u003eLearnings 310\u003c\/p\u003e \u003cp\u003eA.9 FDCs and Multiple Dosage Strengths 310\u003c\/p\u003e \u003cp\u003eDiovan® and Tekturna®\/Rasilez® 310\u003c\/p\u003e \u003cp\u003eLearnings 312\u003c\/p\u003e \u003cp\u003eA.10 Building a Compliance Support Program 312\u003c\/p\u003e \u003cp\u003eEnbrel® 312\u003c\/p\u003e \u003cp\u003eLearnings 314\u003c\/p\u003e \u003cp\u003eA.11 Targeting Responders with High-Price Cancer Agents 314\u003c\/p\u003e \u003cp\u003eErbitux® 314\u003c\/p\u003e \u003cp\u003eLearnings 315\u003c\/p\u003e \u003cp\u003eA.12 Failure of a “No-Brainer” LCM Strategy 315\u003c\/p\u003e \u003cp\u003eExubera® 315\u003c\/p\u003e \u003cp\u003eLearnings 319\u003c\/p\u003e \u003cp\u003eA.13 At-Risk Launches and Prodrug Patents 320\u003c\/p\u003e \u003cp\u003eFamvir® 320\u003c\/p\u003e \u003cp\u003eLearnings 321\u003c\/p\u003e \u003cp\u003eA.14 New Dosages, FDC, and Patent Litigation 322\u003c\/p\u003e \u003cp\u003eFosamax® 322\u003c\/p\u003e \u003cp\u003eLearnings 324\u003c\/p\u003e \u003cp\u003eA.15 High Regulatory Hurdles for Lifestyle Drugs 325\u003c\/p\u003e \u003cp\u003eGirosa® 325\u003c\/p\u003e \u003cp\u003eLearnings 327\u003c\/p\u003e \u003cp\u003eA.16 Big Money from Orphan Indications 327\u003c\/p\u003e \u003cp\u003eGleevec® 327\u003c\/p\u003e \u003cp\u003eLearnings 329\u003c\/p\u003e \u003cp\u003eA.17 Not Giving Up on a Controversial Brand 330\u003c\/p\u003e \u003cp\u003eIressa® 330\u003c\/p\u003e \u003cp\u003eLearnings 332\u003c\/p\u003e \u003cp\u003eA.18 Expanding a Medical Aesthetics Franchise with an Ophthalmic Drug 332\u003c\/p\u003e \u003cp\u003eLatisse® 332\u003c\/p\u003e \u003cp\u003eLearnings 334\u003c\/p\u003e \u003cp\u003eA.19 Patent Expiry of the Biggest Drug Brand Ever 335\u003c\/p\u003e \u003cp\u003eLipitor® 335\u003c\/p\u003e \u003cp\u003eLearnings 336\u003c\/p\u003e \u003cp\u003eA.20 Early Out-Licensing by Biotech: Take the Money and Run 336\u003c\/p\u003e \u003cp\u003eMacugen® 336\u003c\/p\u003e \u003cp\u003eLearnings 338\u003c\/p\u003e \u003cp\u003eA.21 Codevelopment and Comarketing Deals End in a Megamerger 338\u003c\/p\u003e \u003cp\u003eMerck and Schering-Plough: Zetia®\/Vytorin® and Claritin\/Singulair® 338\u003c\/p\u003e \u003cp\u003eZetia\/Vytorin 339\u003c\/p\u003e \u003cp\u003eClaritin\/Singulair 342\u003c\/p\u003e \u003cp\u003eLearnings 343\u003c\/p\u003e \u003cp\u003eA.22 A Hugely Successful LLCM Switch Strategy: Business Needs and Reputational Issues Collide 344\u003c\/p\u003e \u003cp\u003ePrilosec® and Nexium 344\u003c\/p\u003e \u003cp\u003eThe Facts 344\u003c\/p\u003e \u003cp\u003eThe Public Reaction 345\u003c\/p\u003e \u003cp\u003eLearnings 347\u003c\/p\u003e \u003cp\u003eA.23 Combining Production Outsourcing with Settlement with a Generic Competitor 349\u003c\/p\u003e \u003cp\u003eNexium 349\u003c\/p\u003e \u003cp\u003eLearnings 351\u003c\/p\u003e \u003cp\u003eA.24 Reformulating for Success in Osteoporosis 351\u003c\/p\u003e \u003cp\u003eOsteoporosis Drugs: Fosamax, Actonel®, Boniva®, and Aclasta® 351\u003c\/p\u003e \u003cp\u003eLearnings 353\u003c\/p\u003e \u003cp\u003eA.25 Isomerism, Polymorphism, and Settlements 354\u003c\/p\u003e \u003cp\u003ePlavix® 354\u003c\/p\u003e \u003cp\u003eLearnings 355\u003c\/p\u003e \u003cp\u003eA.26 Payers versus Brand for Patient Selection 356\u003c\/p\u003e \u003cp\u003ePlavix and Brilinta 356\u003c\/p\u003e \u003cp\u003eLearnings 357\u003c\/p\u003e \u003cp\u003eA.27 Litigation Can Delay Generic Entry in the OTC Field Too 358\u003c\/p\u003e \u003cp\u003ePrilosec OTC 358\u003c\/p\u003e \u003cp\u003eLearnings 359\u003c\/p\u003e \u003cp\u003eA.28 Inconsistent Court Decisions Can Hurt Both Brandand Generic Companies 360\u003c\/p\u003e \u003cp\u003eProtonix® 360\u003c\/p\u003e \u003cp\u003eLearnings 361\u003c\/p\u003e \u003cp\u003eA.29 Holding on to an Antipsychotic Franchise 362\u003c\/p\u003e \u003cp\u003eRisperdal®\/Invega® 362\u003c\/p\u003e \u003cp\u003eLearnings 363\u003c\/p\u003e \u003cp\u003eA.30 LCM Creates an Almost Immortal Brand 364\u003c\/p\u003e \u003cp\u003eVoltaren® 364\u003c\/p\u003e \u003cp\u003eLearnings 365\u003c\/p\u003e \u003cp\u003eA.31 LCM of a Women’s Health Franchise 366\u003c\/p\u003e \u003cp\u003eThe Yasmin® Family 366\u003c\/p\u003e \u003cp\u003eLearnings 368\u003c\/p\u003e \u003cp\u003eA.32 Indication Expansion\/New Dosage Strength 369\u003c\/p\u003e \u003cp\u003eZometa\/Reclast® (Aclasta) 369\u003c\/p\u003e \u003cp\u003eLearnings 370\u003c\/p\u003e \u003cp\u003eIndex 371\u003c\/p\u003e  \u003cp\u003e“In conclusion, it should be stated that the authors reached their goals in providing a reference manual for potential measures that should be applied in case the life and profit of a brand are to be maximized.” (\u003ci\u003eGreen Processing and Synthesis\u003c\/i\u003e, 1 March 2014)\u003c\/p\u003e \u003cp\u003e \u003c\/p\u003e \u003cp\u003e \u003c\/p\u003e  \u003cp\u003e\u003cb\u003eTONY ELLERY\u003c\/b\u003e is a consultant with Ellery Pharma Consulting. Until September 2008, he was the Head of Pharmaceutical Lifecycle Management in Portfolio Management at Novartis AG. Prior to this, he occupied positions of increasing seniority in research, development, and marketing at different companies, including Roche, Ciba Vision, and Novartis. Dr. Ellery has served as a member of the Ciba-Geigy Research Advisory Board and the Novartis Pharma Development Management Board. He is a popular speaker on lifecycle, project, and portfolio management.  \u003c\/p\u003e\u003cp\u003e\u003cb\u003eNEAL HANSEN\u003c\/b\u003e is the Managing Director of Healthcare Consulting within the Informa Group, encompassing Datamonitor Healthcare Consulting and Phasic Strategy. Previously, he was the European Head of Consulting within Wood Mackenzie's Life Sciences Practice. He works with many key players in the pharmaceutical industry to support effective decision making for brand and portfolio strategy and has chaired and spoken at numerous conferences in the field of lifecycle management and the changing nature of the generic drug industry.\t \t \t \t \t  \u003c\/p\u003e\u003cp\u003e\u003cb\u003eA comprehensive guide to optimizing the lifecycle management of pharmaceutical brands\u003c\/b\u003e  \u003c\/p\u003e\u003cp\u003eThe mounting challenges posed by cost containment policies and the prevalence of generic alternatives make optimizing the lifecycle management (LCM) of brand drugs essential for pharmaceutical companies looking to maximize the value of their products. Demonstrating how different measures can be combined to create winning strategies, \u003ci\u003ePharmaceutical Lifecycle Management: Making the Most of Each and Every Brand\u003c\/i\u003e explores this increasingly important field to help readers understand what they can—and must—do to get the most out of their brands.  \u003c\/p\u003e\u003cp\u003eOffering a truly immersive introduction to LCM options for pharmaceuticals, the book incorporates numerous real-life case studies that demonstrate successful and failed lifecycle management initiatives, explaining the key takeaway of each example. Filled with practical information on the process of actually writing and presenting an LCM plan, as well as how to link corporate, portfolio, and individual brand strategies, the book also offers a look ahead to predict which LCM strategies will continue to be effective in the future.  \u003c\/p\u003e\u003cp\u003eWhile the development of new drugs designed to address unmet patient needs remains the single most important goal of any pharmaceutical company, effective LCM is invaluable for getting the greatest possible value from existing brands. \u003ci\u003ePharmaceutical Lifecycle Management\u003c\/i\u003e walks you through the process step by step, making it indispensable reading for pharmaceutical executives and managers, as well as anyone working in the fields of drug research, development, and regulation.\u003c\/p\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":47989772517605,"sku":"NP9780470487532","price":106.95,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9780470487532.jpg?v=1761785421","url":"https:\/\/k12savings.com\/products\/pharmaceutical-lifecycle-management-isbn-9780470487532","provider":"K12savings","version":"1.0","type":"link"}