Pharmaceutical Lifecycle Management

Making the Most of Each and Every Brand
1. Auflage 2012
ISBN: 978-0-470-48753-2
Verlag: WILEY

Buch, Englisch, 412 Seiten, Format (B × H): 161 mm x 240 mm, Gewicht: 783 g

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.

Autoren/Hrsg.

Ellery, Tony

Hansen, Neal

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Pharmazie
• Naturwissenschaften Chemie Chemie Allgemein Pharmazeutische Chemie, Medizinische Chemie
• Wirtschaftswissenschaften Wirtschaftssektoren & Branchen Fertigungsindustrie Pharmaindustrie
• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Pharmazeutische Technologie

Inhaltsverzeichnis

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

1.9 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

3. The Life Cycle of a Pharmaceutical Brand 38

3.1 Lifecycle Curve of Pharmaceuticals 41

3.2 Factors Affecting Rate of Conversion to Generics 44

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

8.4 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

8.11 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 D rug Delivery 143

15.1 Reformulation and New Routes of Administration 143

15.2 Drug Delivery Devices 149

16. Fixed-Dose Combinations (FDCs) and C o-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 Development 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 Profitability of the Brand Franchise 171

20. Geographical Expansion and Optimization 172

20.1 Geographic Expansion 174

20.2 Harmonization and Rationalization 175

21. OTC S witching 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

25. Exit Strategies 204

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

27. Biosimilars and T heir 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

27.5 Substitution of Biosimilars 223

27.6 Innovator Responses to Biosimilar Threats 225

27.7 The Future for Biologics LCM 226

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

29.2 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

30.2 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

1 Case History: Market and Product-Shaping Dynamics in Action 294

2 Case History: Optimizing Clinical Profile versus Gold Standards 298

3 Case History: Partnering to Ensure Reimbursement and Collect Cost-Effectiveness Data 299

4 Case History: Active Metabolites and Late-Listed Patents 301

5 Case History: A Fixed-Dose Combination (FDC) that Could Not Fail, or Could It? 303

6 Case History: Indication Expansion 305

7 Case History: Killing a Franchise through Over-the-Counter (OTC) Switching 307

8 Case History: Moving FDCs to the Fore in Diabetes 308

9 Case History: FDCs and Multiple Dosage Strengths 310

10 Case History: Building Compliance Support Program 312

11 Case History: Targeting Responders with High-Price Cancer Agents 314

12 Case History: Failure of a "No-Brainer" LCM Strategy 315

13 Case History: At-Risk Launches and Prodrug Patents 320

14 Case History: New Dosages, FDC, and Patent Litigation 322

15 Case History: High Regulatory Hurdles for Lifestyle Drugs 325

16 Case History: Big Money from Orphan Indications 327

17 Case History: Not Giving Up on a Controversial Brand 330

18 Case History: Expanding a Medical Aesthetics Franchise with an Ophthalmic Drug 332

19 Case History: Patent Expiry of the Biggest Drug Brand Ever 335

20 Case History: Early Out-Licensing by Biotech: Take the Money and Run 336

21 Case History: Codevelopment and Comarketing Deals End in a Megamerger 338

22 Case History: A Hugely Successful LLCM Switch Strategy: Business Needs and Reputational Issues Collide 344

23 Case History: Combining Production Outsourcing with Settlement with a Generic Competitor 349

24 Case History: Reformulating for Success in Osteoporosis 351

25 Case History: Isomerism, Polymorphism, and Settlements 354

26 Case History: Payers versus Brand for Patient Selection 356

27 Case History: Litigation Can Delay Generic Entry in the OTC Field Too 358

28 Case History: Inconsistent Court Decisions Can Hurt Both Brand and Generic Companies 360

29 Case History: Holding on to an Antipsychotic Franchise 362

30 Case History: LCM Creates an Almost Immortal Brand 364

31 Case History: LCM of a Women's Health Franchise 366

32 Case History: Indication Expansion/New Dosage Strength 369

INDEX 371

Über Autor(innen)

Hansen, Neal
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.

Ellery, Tony
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.

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.