Pharmaceutical Lifecycle Management Making the Most of Each and Every Brand

by Ellery, Tony; Hansen, Neal

• ISBN13: 9780470487532
• ISBN10: 0470487534
• Edition: 1st
• Format: Hardcover
• Copyright: 2012-06-05
• Publisher: Wiley

Summary

This book systematically explains how LCM strategies can help the pharmaceutical industry maximize drug development programs and brand management. The author shares his 30-years of experience in the industry, citing 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.

Author Biography

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.

Table of Contents

Acknowledgments	p. xvii
Introduction	p. xix
Lifecycle Ma nagement Business Environment	p. 1
Challenges F acing the Branded D rug Industry	p. 3
Depleted NME Pipelines/Lower R&D Efficiency	p. 4
Higher Development Costs	p. 8
Safety Concerns	p. 9
Tougher Environment for Pricing, Reimbursement, and Listing	p. 12
Increased Competition	p. 16
Earlier Genericization	p. 17
Faster Sales Erosion Following Patent Expiry	p. 18
Poor Image of Branded Drug Industry	p. 20
Diversification	p. 26
The L ife C ycle of Industries, T echnologies, and Brands	p. 30
Diffusion of Innovations	p. 30
The Lifecycle Curve	p. 32
Lifecycle Phases	p. 34
The L ife C ycle of a Pharmaceutical Brand	p. 38
Lifecycle Curve of Pharmaceuticals	p. 41
Factors Affecting Rate of Conversion to Generics	p. 44
The Life Cycle of a Pharmaceutical Brand	p. 46
Lifecycle Ma nagement R egulatory and L egal E nvironment	p. 55
The G eneric Approval Process	p. 57
United States	p. 57
Europe	p. 59
Japan	p. 61
Hatch-Waxman L egislation and Its E ffects on LCM	p. 62
Hatch-Waxman Act of 1984	p. 62
Medicare Modernization Act of 2003	p. 64
FDA Amendments Act of 2007	p. 65
Q1 Program Supplemental Funding Act of 2008	p. 66
Discussion of Hatch-Waxman Legislation	p. 66
U.S. Health-Care R eform 2010	p. 69
European S ector Inquiry	p. 72
Patents a nd E xclusivities	p. 77
Patents and O ther Intellectual Property R ights	p. 79
Nonpatent Intellectual Property Rights	p. 79
What Are Patents?	p. 81
What Is Patentable?	p. 83
How Long Does a Patent Last?	p. 87
Patent Term Restoration in the United States	p. 87
Supplementary Protection Certificates in Europe	p. 88
Patent Term Extension in Japan	p. 89
How Are Patents Obtained?	p. 89
Patent Enforcement	p. 91
Types of Patents	p. 92
KSR versus Teleflex-Raising the Nonobviousness Bar	p. 94
Patent Strategy	p. 96
Nonpatent E xclusivities	p. 99
NCE Exclusivity (United States)	p. 99
New Clinical Study Exclusivity (United States)	p. 100
Data and Marketing Exclusivity (Europe)	p. 100
Data Exclusivity (Japan)	p. 101
Orphan Drug Exclusivity	p. 101
Pediatric Exclusivity	p. 103
180-Day Generic Product Exclusivity	p. 105
Patent S ettlements	p. 107
Developmental LCM	p. 113
Strategic Principles of D evelopmental LCM	p. 115
Developmental LCM Goal 1: Provide a Meaningful Improvement in Clinical Profile	p. 116
Developmental LCM Goal 2: Increase the Potential Real-World Patient Potential for the Brand	p. 118
Developmental LCM Goal 3: The Ability to Generate an ROI	p. 120
Developmental LCM Goal 4: The Ability to Enhance Market Exclusivity of the Brand Franchise	p. 121
Indication E xpansion and S equencing	p. 123
Categories of Indication Expansion	p. 123
Patient S ubpopulations and Personalized M edicine	p. 131
What Does a Good Patient Selection Strategy Look Like?	p. 135
Patient Selection without Predictive Criteria: Post Hoc Approaches	p. 138
What about the Patients Who Are Not Selected?	p. 139
New D osage S trengths, N ew D osage R egimens	p. 140
New Dosage Strengths	p. 140
New Dosage Regimens	p. 141
Reformulation, N ew R outes of Administration, and D rug D elivery	p. 143
Reformulation and New Routes of Administration	p. 143
Drug Delivery Devices	p. 149
Fixed-Dose C ombinations (FDCs) and C o-Packaging	p. 152
Second-Generation Products and M odified C hemistry	p. 159
Isomerism	p. 160
Polymorphism	p. 161
Salts, Ethers, and Esters	p. 162
Prodrugs and Metabolites	p. 163
Other D evelopment LCM S trategies	p. 165
Manufacturing Strategies	p. 165
White Papers and Citizen Petitions	p. 166
Commercial LCM	p. 167
Strategic Principles of C ommercial LCM	p. 169
Commercial LCM Goal 1: The Ability to Drive Widespread and Preferential Patient Access to the Brand	p. 170
Commercial LCM Goal 2: The Ability to Defend Market Access and Formulary Position	p. 170
Commercial LCM Goal 3: The Ability to Optimize Profitability of the Brand Franchise	p. 171
Geographical E xpansion and O ptimization	p. 172
Geographic Expansion	p. 174
Harmonization and Rationalization	p. 175
OTC S witching	p. 178
What to Switch: Choosing the Best Approach	p. 179
Where to Switch: Dealing with Intermarket Variability	p. 181
When to Switch: Balancing the Product Life Cycle?	p. 183
How to Make the Switch Successful: What Corporate Support Is Required?	p. 184
Brand L oyalty and S ervice Programs	p. 186
Strategic Pricing S trategies	p. 190
Pricing Strategy and Tactics in the Launch and Growth Phases	p. 190
Pricing Strategy and Tactics Following Patent Expiry	p. 193
Generic S trategies and T actics	p. 198
Exit S trategies	p. 204
Biologics a nd Biosimilars	p. 207
Biologics and LCM	p. 209
Emergence of Biotech	p. 209
Some Definitions	p. 210
Biologics	p. 210
Uptake and Value of Biologics	p. 211
LCM of Biologics	p. 213
Biosimilars and T heir Impact on Biologic LCM	p. 217
Changing Terminology: Biogenerics, Biosimilars, and FOBs	p. 217
Why Are Biosimilars a Big Deal?	p. 219
How Are Biosimilars Different?	p. 220
Biosimilar Approval Pathways	p. 220
Substitution of Biosimilars	p. 223
Innovator Responses to Biosimilar Threats	p. 225
The Future for Biologics LCM	p. 226
The Emergence of the "Innovasimilar" Biopharma Company	p. 229
Final Words	p. 231
The Integrated Brand LCM S trategy and Its Implementation	p. 233
Strategic G oals of LCM Brand Plans	p. 235
Position to Market	p. 235
Comparative Clinical Profile versus Gold Standard	p. 237
Level of Market Unmet Need	p. 237
Ten K eys to S uccessful LCM	p. 238
Excellent Functional Expertise	p. 238
Visible Management Support	p. 244
Unambiguous Ownership	p. 245
An Early Start	p. 246
A Robust "Broad to Bespoke" Process	p. 248
Focus on "High LCM Value Brands"	p. 249
Adequate Resources	p. 250
Measurements and Rewards	p. 250
Training and Support	p. 252
Realism	p. 252
Organizational S tructures and S ystems for E nsuring Successful LCM	p. 254
Organization of Project and Brand Management	p. 254
Project and Brand LCM Structures	p. 259
LCM Center of Excellence	p. 263
Composition of the LCM CoE	p. 266
The LCM Process: D escription, T iming, and Participants	p. 268
Purpose of the LCM Process	p. 268
Timing of theLCM Process	p. 269
Description of the LCM Process	p. 271
Integrating LCM with Portfolio Management	p. 277
Principles of Portfolio M anagement	p. 279
LCM Projects in the D evelopment Portfolio	p. 284
Managing E stablished Brand Portfolios	p. 286
What Do You Do with a Priority Established Brand?	p. 288
What about the Nonpriority Brands?	p. 289
Building the Ideal Established Brands Portfolio	p. 290
Conclusions	p. 291
Appendix: Ca se Histories	p. 294
Case History: Market and Product-Shaping Dynamics in Action	p. 294
Case History: Optimizing Clinical Profile versus Gold Standards	p. 298
Case History: Partnering to Ensure Reimbursement and Collect Cost-Effectiveness Data	p. 299
Case History: Active Metabolites and Late-Listed Patents	p. 301
Case History: A Fixed-Dose Combination (FDC) that Could Not Fail, or Could It?	p. 303
Case History: Indication Expansion	p. 305
Case History: Killing a Franchise through Over-the-Counter (OTC) Switching	p. 307
Case History: Moving FDCs to the Fore in Diabetes	p. 308
Case History: FDCs and Multiple Dosage Strengths	p. 310
Case History: Building Compliance Support Program	p. 312
Case History: Targeting Responders with High-Price Cancer Agents	p. 314
Case History: Failure of a "No-Brainer" LCM Strategy	p. 315
Case History: At-Risk Launches and Prodrug Patents	p. 320
Case History: New Dosages, FDC, and Patent Litigation	p. 322
Case History: High Regulatory Hurdles for Lifestyle Drugs	p. 325
Case History: Big Money from Orphan Indications	p. 327
Case History: Not Giving Up on a Controversial Brand	p. 330
Case History: Expanding a Medical Aesthetics Franchise with an Ophthalmic Drug	p. 332
Case History: Patent Expiry of the Biggest Drug Brand Ever	p. 335
Case History: Early Out-Licensing by Biotech: Take the Money and Run	p. 336
Case History: Codevelopment and Comarketing Deals End in a Megamerger	p. 338
Case History: A Hugely Successful LLCM Switch Strategy: Business Needs and Reputational Issues Collide	p. 344
Case History: Combining Production Outsourcing with Settlement with a Generic Competitor	p. 349
Case History: Reformulating for Success in Osteoporosis	p. 351
Case History: Isomerism, Polymorphism, and Settlements	p. 354
Case History: Payers versus Brand for Patient Selection	p. 356
Case History: Litigation Can Delay Generic Entry in the OTC Field Too	p. 358
Case History: Inconsistent Court Decisions Can Hurt Both Brand and Generic Companies	p. 360
Case History: Holding on to an Antipsychotic Franchise	p. 362
Case History: LCM Creates an Almost Immortal Brand	p. 364
Case History: LCM of a Women's Health Franchise	p. 366
Case History: Indication Expansion/New Dosage Strength	p. 369
Index	p. 371
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