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Pharmaceutical Lifecycle Management
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Acknowledgments xvii Introduction xix Part A Lifecycle Management Business Environment 1 1. Challenges Facing the Branded Drug Industry 3 1.1 Depleted NME Pipelines/Lower R&D Efficiency 4 1.2 Higher Development Costs 8 1.3 Safety Concerns 9 1.4 Tougher Environment for Pricing, Reimbursement, and Listing 12 1.5 Increased Competition 16 1.6 Earlier Genericization 17 1.7 Faster Sales Erosion Following Patent Expiry 18 1.8 Poor Image of Branded Drug Industry 20 1.8.1 Prosperity of the Branded Drug Industry 21 1.8.2 Lack of Innovation 22 1.8.3 Marketing Spend and Tactics 22 1.8.4 Safety Issues 23 1.8.5 Keeping Generics Off the Market 24 1.9 Diversification 26 2. The Life Cycle of Industries, Technologies, and Brands 30 2.1 Diffusion of Innovations 30 2.2 The Lifecycle Curve 32 2.3 Lifecycle Phases 34 2.3.1 Development Phase 34 2.3.2 Introduction Phase 35 2.3.3 Growth Phase 35 2.3.4 Maturity Phase 36 2.3.5 Decline Phase 36 3. The Life Cycle of a Pharmaceutical Brand 38 3.1 Lifecycle Curve of Pharmaceuticals 41 3.1.1 Slow Rate of Growth during the Growth Phase 42 3.1.2 Lack of a True Maturity Phase 43 3.1.3 Precipitous Decline Phase 43 3.2 Factors Affecting Rate of Conversion to Generics 44 3.2.1 Government Policy 44 3.2.2 Disease 44 3.2.3 Size of Brand 45 3.2.4 Hospital versus Nonhospital Drug Usage 45 3.2.5 Active Substance and Other Barriers to Entry 46 3.3 The Life Cycle of a Pharmaceutical Brand 46 Part B Lifecycle Management Regulatory and Legal Environment 55 4. The Generic Approval Process 57 4.1 United States 57 4.2 Europe 59 4.3 Japan 61 5. Hatch-Waxman Legislation and Its Effects on LCM 62 5.1 Hatch-Waxman Act of 1984 62 5.2 Medicare Modernization Act of 2003 64 5.3 FDA Amendments Act of 2007 65 5.4 Q1 Program Supplemental Funding Act of 2008 66 5.5 Discussion of Hatch-Waxman Legislation 66 6. U.S. Health-Care Reform 2010 69 7. European Sector Inquiry 72 Part C Patents and Exclusivities 77 8. Patents and Other Intellectual Property Rights 79 8.1 Nonpatent Intellectual Property Rights 79 8.2 What Are Patents? 81 8.3 What Is Patentable? 83 8.3.1 Patentable Subject Matter 83 8.3.2 Novelty 84 8.3.3 Inventive Step 85 8.3.4 Utility 86 8.3.5 Disclosure 86 8.4 How Long Does a Patent Last? 87 8.5 Patent Term Restoration in the United States 87 8.6 Supplementary Protection Certificates in Europe 88 8.7 Patent Term Extension in Japan 89 8.8 How Are Patents Obtained? 89 8.9 Patent Enforcement 91 8.10 Types of Patents 92 8.10.1 Composition of Matter Patent 93 8.10.2 Medical Use Patent 93 8.10.3 Formulation Patent 94 8.11 KSR versus Teleflex-Raising the Nonobviousness Bar 94 8.12 Patent Strategy 96 9. Nonpatent Exclusivities 99 9.1 NCE Exclusivity (United States) 99 9.2 New Clinical Study Exclusivity (United States) 100 9.3 Data and Marketing Exclusivity (Europe) 100 9.4 Data Exclusivity (Japan) 101 9.5 Orphan Drug Exclusivity 101 9.6 Pediatric Exclusivity 103 9.7 180-Day Generic Product Exclusivity 105 10. Patent Settlements 107 Part D Developmental LCM 113 11. Strategic Principles of Developmental LCM 115 11.1 Developmental LCM Goal 1: Provide a Meaningful Improvement in Clinical Profile 116 11.2 Developmental LCM Goal 2: Increase the Potential Real-World Patient Potential for the Brand 118 11.3 Developmental LCM Goal 3: The Ability to Generate an ROI 120 11.4 Developmental LCM Goal 4: The Ability to Enhance Market Exclusivity of the Brand Franchise 121 12. Indication Expansion and Sequencing 123 12.1 Categories of Indication Expansion 123 13. Patient Subpopulations and Personalized Medicine 131 13.1 What Does a Good Patient Selection Strategy Look Like? 135 13.2 Patient Selection without Predictive Criteria: Post Hoc Approaches 138 13.3 What about the Patients Who Are Not Selected? 139 14. New Dosage Strengths, New Dosage Regimens 140 14.1 New Dosage Strengths 140 14.2 New Dosage Regimens 141 15. Reformulation, New Routes of Administration, and Drug Delivery 143 15.1 Reformulation and New Routes of Administration 143 15.1.1 Switch and Grow Strategy 143 15.1.2 Expand and Grow Strategy 145 15.1.3 Generic Defense 145 15.2 Drug Delivery Devices 149 16. Fixed-Dose Combinations (FDCs) and Co-Packaging 152 17. Second-Generation Products and Modified Chemistry 159 17.1 Isomerism 160 17.2 Polymorphism 161 17.3 Salts, Ethers, and Esters 162 17.4 Prodrugs and Metabolites 163 18. Other Developmental LCM Strategies 165 18.1 Manufacturing Strategies 165 18.2 White Papers and Citizen Petitions 166 Part E Commercial LCM 167 19. Strategic Principles of Commercial LCM 169 19.1 Commercial LCM Goal 1: The Ability to Drive Widespread and Preferential Patient Access to the Brand 170 19.2 Commercial LCM Goal 2: The Ability to Defend Market Access and Formulary Position 170 19.3 Commercial LCM Goal 3: The Ability to Optimize Profi tability of the Brand Franchise 171 20. Geographical Expansion and Optimization 172 20.1 Geographic Expansion 174 20.2 Harmonization and Rationalization 175 21. OTC Switching 178 21.1 What to Switch: Choosing the Best Approach 179 21.2 Where to Switch: Dealing with Intermarket Variability 181 21.3 When to Switch: Balancing the Product Life Cycle? 183 21.4 How to Make the Switch Successful: What Corporate Support Is Required? 184 22. Brand Loyalty and Service Programs 186 23. Strategic Pricing Strategies 190 23.1 Pricing Strategy and Tactics in the Launch and Growth Phases 190 23.2 Pricing Strategy and Tactics Following Patent Expiry 193 24. Generic Strategies and Tactics 198 Building a Generic Portfolio: Old versus New Thinking 202 25. Exit Strategies 204 Executing the Exit Strategy 206 Part F Biologics and Biosimilars 207 26. Biologics and LCM 209 26.1 Emergence of Biotech 209 26.2 Some Definitions 210 26.2.1 Biologics 210 26.3 Uptake and Value of Biologics 211 26.4 LCM of Biologics 213 26.4.1 Next-Generation Biologics 213 26.4.2 Reformulation 214 26.4.3 Indication Expansion 215 26.4.4 Self-Injection Devices 215 27. Biosimilars and Their Impact on Biologic LCM 217 27.1 Changing Terminology: Biogenerics, Biosimilars, and FOBs 217 27.2 Why Are Biosimilars a Big Deal? 219 27.3 How Are Biosimilars Different? 220 27.4 Biosimilar Approval Pathways 220 27.4.1 Biosimilars in Europe 220 27.4.2 Biosimilars in the United States 221 27.4.3 Biosimilars around the World 222 27.5 Substitution of Biosimilars 223 27.5.1 Automatic Substitution 223 27.5.2 Therapeutic Substitution 224 27.6 Innovator Responses to Biosimilar Threats 225 27.7 The Future for Biologics LCM 226 27.7.1 Legal Strategies in the United States 227 27.7.2 Indication Expansion in Europe 228 27.7.3 Brand Loyalty Programs and Services 229 27.8 The Emergence of the "Innovasimilar" Biopharma Company 229 27.9 Final Words 231 Part G The Integrated Brand LCM Strategy And its Implementation 233 28. Strategic Goals of LCM Brand Plans 235 28.1 Position to Market 235 28.2 Comparative Clinical Profile versus Gold Standard 237 28.3 Level of Market Unmet Need 237 29. Ten Keys to Successful LCM 238 29.1 Excellent Functional Expertise 238 29.1.1 Patent Attorneys 239 29.1.2 Regulatory Affairs 240 29.1.3 Clinical Development 240 29.1.4 Formulation Scientists 241 29.1.5 Marketing and Sales 242 29.1.6 Manufacturing 243 29.2 Visible Management Support 244 29.3 Unambiguous Ownership 245 29.4 An Early Start 246 29.5 A Robust "Broad to Bespoke" Process 248 29.6 Focus on "High LCM Value Brands" 249 29.7 Adequate Resources 250 29.8 Measurements and Rewards 250 29.9 Training and Support 252 29.10 Realism 252 30. Organizational Structures and Systems for Ensuring Successful LCM 254 30.1 Organization of Project and Brand Management 254 30.1.1 Functional Structure 255 30.1.2 Project Structure 255 30.1.3 Matrix Structure 257 30.2 Project and Brand LCM Structures 259 30.3 LCM Center of Excellence 263 30.4 Composition of the LCM CoE 266 31. The LCM Process: Description, Timing, and Participants 268 31.1 Purpose of the LCM Process 268 31.2 Timing of the LCM Process 269 31.3 Description of the LCM Process 271 Part H Integrating LCM with Portfolio Management 277 32. Principles of Portfolio Management 279 33. LCM Projects in the Development Portfolio 284 34. Managing Established Brand Portfolios 286 34.1 What Do You Do with a Priority Established Brand? 288 34.2 What about the Nonpriority Brands? 289 34.3 Building the Ideal Established Brands Portfolio 290 Conclusions 291 Appendix: Case histories 294 A.1 Market and Product-Shaping Dynamics in Action 294 Alzheimer's Disease Therapies: Aricept (R), Exelon (R), and Reminyl (R)/Razadyne (R) 294 Learnings 297 A.2 Optimizing Clinical Profi le versus Gold Standards 298 Angiotensin II Receptor Blockers (ARBs): Cozaar (R), Micardis (R), and Benicar (R) 298 Learnings 299 A.3 Partnering to Ensure Reimbursement and Collection of Cost-Effectiveness Data 299 Aricept 299 Learnings 301 A.4 Active Metabolites and Late-Listed Patents 301 Buspar (R) 301 Learnings 303 A.5 A Fixed-Dose Combination (FDC) That Could Not Fail, or Could It? 303 Caduet (R) 303 Learnings 304 A.6 Indication Expansion 305 Certican (R)/Zortress (R) and Afi nitor (R) 305 Learnings 306 A.7 Killing a Franchise through Over-the-Counter (OTC) Switching 307 Claritin (R) 307 Learnings 308 A.8 Moving FDCs to the Fore in Diabetes 308 Diabetes Therapies: Glucophage (R), Avandia (R), Actos (R), and Januvia (R) 308 Learnings 310 A.9 FDCs and Multiple Dosage Strengths 310 Diovan (R) and Tekturna (R)/Rasilez (R) 310 Learnings 312 A.10 Building a Compliance Support Program 312 Enbrel (R) 312 Learnings 314 A.11 Targeting Responders with High-Price Cancer Agents 314 Erbitux (R) 314 Learnings 315 A.12 Failure of a "No-Brainer" LCM Strategy 315 Exubera (R) 315 Learnings 319 A.13 At-Risk Launches and Prodrug Patents 320 Famvir (R) 320 Learnings 321 A.14 New Dosages, FDC, and Patent Litigation 322 Fosamax (R) 322 Learnings 324 A.15 High Regulatory Hurdles for Lifestyle Drugs 325 Girosa (R) 325 Learnings 327 A.16 Big Money from Orphan Indications 327 Gleevec (R) 327 Learnings 329 A.17 Not Giving Up on a Controversial Brand 330 Iressa (R) 330 Learnings 332 A.18 Expanding a Medical Aesthetics Franchise with an Ophthalmic Drug 332 Latisse (R) 332 Learnings 334 A.19 Patent Expiry of the Biggest Drug Brand Ever 335 Lipitor (R) 335 Learnings 336 A.20 Early Out-Licensing by Biotech: Take the Money and Run 336 Macugen (R) 336 Learnings 338 A.21 Codevelopment and Comarketing Deals End in a Megamerger 338 Merck and Schering-Plough: Zetia (R)/Vytorin (R) and Claritin/Singulair (R) 338 Zetia/Vytorin 339 Claritin/Singulair 342 Learnings 343 A.22 A Hugely Successful LLCM Switch Strategy: Business Needs and Reputational Issues Collide 344 Prilosec (R) and Nexium 344 The Facts 344 The Public Reaction 345 Learnings 347 A.23 Combining Production Outsourcing with Settlement with a Generic Competitor 349 Nexium 349 Learnings 351 A.24 Reformulating for Success in Osteoporosis 351 Osteoporosis Drugs: Fosamax, Actonel (R), Boniva (R), and Aclasta (R) 351 Learnings 353 A.25 Isomerism, Polymorphism, and Settlements 354 Plavix (R) 354 Learnings 355 A.26 Payers versus Brand for Patient Selection 356 Plavix and Brilinta 356 Learnings 357 A.27 Litigation Can Delay Generic Entry in the OTC Field Too 358 Prilosec OTC 358 Learnings 359 A.28 Inconsistent Court Decisions Can Hurt Both Brandand Generic Companies 360 Protonix (R) 360 Learnings 361 A.29 Holding on to an Antipsychotic Franchise 362 Risperdal (R)/Invega (R) 362 Learnings 363 A.30 LCM Creates an Almost Immortal Brand 364 Voltaren (R) 364 Learnings 365 A.31 LCM of a Women's Health Franchise 366 The Yasmin (R) Family 366 Learnings 368 A.32 Indication Expansion/New Dosage Strength 369 Zometa/Reclast (R) (Aclasta) 369 Learnings 370 Index 371

About the Author

TONY ELLERY 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. NEAL HANSEN 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.

Reviews

In conclusion, it should be stated that the authorsreached their goals in providing a reference manual for potentialmeasures that should be applied in case the life and profit of abrand are to be maximized. (Green Processing andSynthesis, 1 March 2014)

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