A Guidebook to Pharma Brand Optimization

Lifecycle Management Strategy

QUICK SUMMARY A Guidebook to Pharma Brand Optimization (PH108) examines the

Report Features 1 organizational structures, budgets, staffing, strategies, processes,
Table of Contents 2 timeframes, and tactics that top performing companies employ to support
Sample Content 3 their lifecycle management efforts for their brands.
Metrics Introduction 7
If you are looking for strategies and benchmarks to win additional
Charts & Graphics Index 10 resource support for your lifecycle management initiatives, to prolong
About CEI 14 a brand’s time on the market, or to elevate the strategic importance of
lifecycle management in your company, this report is for you.

REPORT DATE AND Back your position with the power of industry intelligence. Our report
FORMAT gives you support for your ideas and prepares you for meetings,
2008 presentations and strategy discussions with key executives. Real-world
Adobe PDF E-Copy examples show how great companies, such as AstraZeneca, Bristol-
Myers Squibb, Genentech, Novartis and Sanofi-Aventis, integrate and
organize their lifecycle management tasks to deliver the most strategic
TOTAL NUMBERS OF
impact.
PROFILED COMPANIES
15 Pharmaceutical and Our reports are ready to use from the moment you get them. Skim
Biotech Companies the chapter introductions and high-level process charts to get a quick
understanding of the report’s key concepts. Then read the detailed best
REPORT LENGTH practices and case studies that interest you the most -- and find the detail
268 pages and data you need for your own team. Throughout the report, you will
learn from extensive practices, charts and real-world case studies.
METRICS AND CHARTS
CONTACT INFORMATION
500+ Metrics Adam Bianchi
185 Data Charts and Tables 919-433-0202
adam_bianchi@cuttingedgeinfo.com

www.cuttingedgeinfo.com
 A GUIDEBOOK TO PHARMA BRAND OPTIMIZATION  

TABLE OF CONTENTS
15 Executive Summary
20 Profiled Companies
21 Study Methodology
23 Lifecycle Management: Five Principles for Success

31 LCM Structure, Processes and Challenges

33 Establishing Best Practices in LCM Structure and Funding

46 LCM Processes and Challenges

63 Pre-Launch Time Period

69 Divestitures
75 New Formulations/Delivery Systems
82 Strategic Alliances/Licensing
89 Publications Strategy
96 Contracting with Large Volume Purchasers

103 Peak Time Period

110 Strategic Pricing

117 New Dosing Frequency
124 New Dosing Strength
132 New Indication
139 CRM/Disease Management
147 Market Repositioning
155 Repurposing

163 Mature Time Period

170 Pediatric Indications

178 New Combinations
187 Next Generation Product
194 Patent Litigation
202 Branded Generics
210 Rx-to-OTC
217 Removal from Market

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TABLE OF CONTENTS
225 Individual Brand LCM Profiles

227 Brand 1
233 Brand 2
239 Brand 3
245 Brand 4
251 Brand 5
257 Brand 6
263 Brand 7

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SAMPLE CONTENT
The following samples from A Guidebook to Pharma Brand
Optimization offer brief insight into the report and its findings. If you
are interested in learning how the report addresses other specific needs
or would like to read more from the report, please call Adam Bianchi at
919-433-0202.

The following is an excerpt from Chapter 1, “LCM Structure, Processes

and Challenges,” Section 1, “Establishing Best Practices in LCM
Structure and Funding.”

Understanding Various Lifecycle Management Team Structures

Lifecycle management plays a critical part in a product’s life. To be

in the best position to have a positive and most influential input into
a brand, lifecycle managers should be involved throughout a brand’s
life. However, the structure of lifecycle management support at
pharmaceutical companies tends to differ greatly depending on the
internal infrastructure of the organization. In fact, there is a 50-50

Figure 1.3: Dedicated Lifecycle Management Team Reports to

Which Department

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split in the participating companies’ LCM structures. Fifty percent

have an established, dedicated lifecycle management team, whereas
the remaining participants do not have a formal team, as Figure 1.2
illustrates.

The presence of a dedicated lifecycle management team underscores

the importance that lifecycle management plays in a brand’s and in a
company’s overall strategy. Through the establishment of a lifecycle
management team, companies ensure that lifecycle management
activities will not be swept to the side in the flurry of other brand
activities during the various stages of a brand’s life. This ability to focus
is a notable advantage of having a dedicated LCM team because often
brand teams and others responsible for LCM are often overwhelmed
with other activities and LCM foresight can be overshadowed by the
immediate needs of a brand.

Of the 50% of companies that do have a dedicated lifecycle

management team, 49% of the dedicated LCM teams report into
marketing, as seen in Figure 1.3. As lifecycle management focuses on
maximizing the value of a brand, this structure makes sense. However,
the remaining dedicated LCM teams report into business development,
38%, and into R&D/clinical, 13%. As one LCM executive explained,
business development often serves as a catch-all department for many
companies and, therefore, it is not uncommon to locate LCM teams
under this umbrella. However, there are also more strategic reasons
behind having LCM teams report up through business development. For
one, this reporting structure allows LCM teams to have easy access....

More details about pharmaceutical lifecycle management structures

can be found in the full report.

The following is excerpted from Chapter 2, “Pre-Launch Time Period,”

Section 2, “New Formulations/Delivery Systems.”

Strategy Overview

The best time to consider new formulations strategies is early in drug

development. The ability to deliver medicine through multiple forms
can make or break the decision to go forward with the drug’s later
development phases. Portfolio managers will need to understand how
multiple formulations fit into the brand strategy, when they will launch,
and whether the technology used in a future launch of a delivery system
will warrant a new or extended patent.

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Clinical development teams typically determine their primary

formulations by Phase II. Once Phase II testing begins, pharmaceutical
companies begin to develop their target product profiles, which outline
the drug’s development, commercialization and lifecycle management
strategy for most of its remaining patent life. Of course, companies
will not know enough about a drug in Phase II to determine its
complete path, but they will know enough to understand which lifecycle
management strategies may be options to consider.

Commercial and clinical teams must communicate and work together

to determine which formulation is the best for the brand’s launch. If the
drug is indicated for a disease best treated in the hospital setting, then
an injectable may be the best formulation. However, a pill form may be
the best option if the drug is dispensed through a commercial pharmacy.
The formulation will, of course, depend on the drug’s therapeutic area
and patients’ needs. More often than not, however, pharmaceutical
companies launch brands in the formulations that are easiest to
manufacture. By pursuing an easy-to-manufacture formulation at
launch, companies can establish a patient population, knowing that
additional formulations are soon to follow.

Each new formulation that a brand team decides to launch adds

a barrier to entry for competitor companies, especially generics.
Companies can take advantage of delivery systems that offer faster
absorption, or those that open up new patient populations – such as in
countries where some formulations may be easier or safer to administer
than others......

More details about individual pharmaceutical lifecycle management

tactics can be found in the full report.

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Figure 2.10: New Formulations/Delivery Systems Dashboard

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PROFILED COMPANIES
Information for this study was developed through both primary and
secondary sources. To gather data, analysts administered surveys
and conducted interviews with lifecycle management, marketing and
business development managers, directors and vice presidents at
several top pharmaceutical companies. Cutting Edge Information’s
analysts also interviewed third-party vendors to gather some portions of
the information for this study. Participating companies include:

PROFILED COMPANIES

AstraZeneca Janssen-Cilag

Biogen Idec Prescription for Strategy LLC

Bristol-Myers Squibb Novartis

Farma S.A. Replidyne, Inc

Genentech Sanofi-Aventis

Genzyme Valeant Pharmaceuticals

Grey Healthcare Group Expert Patent Lawyer

Implicit Bioscience

THERAPEUTIC AREAS PROFILED IN CHAPTER 5

Autoimmune Urology

Diabetes Type 2 Women’s Health

Gastroenterology

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CHARTS AND GRAPHICS

Executive Summary
17 Figure Ex.1: Study Context: Therapeutic Areas Explored in Chapter 5
25 Figure Ex.2: Dedicated Lifecycle Management Team

LCM Structure, Processes and Challenges

33 Figure 1.1: Companies’ LCM Structures

Establishing Best Practices in LCM Structure and Funding

35 Figure 1.2: Dedicated Lifecycle Management Team
35 Figure 1.3: Dedicated Lifecycle Management Team Reports to Which Department
36 Figure 1.4: Departments Responsible for LCM when No Dedicated Team Exists
37 Figure 1.5: Company F’s LCM Structure
40 Figure 1.6: Responsible for Spearheading LCM
41 Figure 1.7: Other Functions Involved in LCM During Various Time Periods
44 Figure 1.8: LCM Budgets Tied to Individual Brands
44 Figure 1.9: Funding of LCM Budgets
45 Figure 1.10: Lifecycle Management Ratings

LCM Processes and Challenges

47 Figure 1.11: Important Factors to Have a Successful LCM Effort
48 Figure 1.12: Areas with Greatest Room for Improvement
52 Figure 1.13: Importance of Criteria in Assessing LCM Tactics
60 Figure 1.14: LCM Success Measurements

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CHARTS AND GRAPHICS

Pre-Launch Time Period

64 Figure 2.1: Pre-Launch LCM Tactical Timeline

66 Figure 2.2: Pre-Launch LCM Strategy Investment Levels
67 Figure 2.3: Average Time to Implement Pre-Launch LCM Strategies
68 Figure 2.4: Pre-Launch LCM Strategy Time to Implement vs. Return on Investment
68 Figure 2.5: Pre-Launch LCM Strategy Return on Investment

Divestitures
69 Figure 2.6: Divestitures Dashboard
72 Figure 2.7: Planning for Divestitures Begins
73 Figure 2.8: Implementation for Divestitures Begins
74 Figure 2.9: Effectiveness of LCM Tactic: Divestitures

New Formulations/Delivery Systems

75 Figure 2.10: New Formulations/Delivery Systems Dashboard
78 Figure 2.11: Planning for New Formulations/Delivery Systems Begins
79 Figure 2.12: Implementation for New Formulations/Delivery Systems Begins
81 Figure 2.13: Effectiveness of LCM Tactic: New Formulations/Delivery Systems

Strategic Alliances/Licensing
82 Figure 2.14: Strategic Alliances/Licensing Dashboard
86 Figure 2.15: Planning for Strategic Alliances/Licensing Begins
87 Figure 2.16: Implementation for Strategic Alliances/Licensing Begins
88 Figure 2.17: Effectiveness of LCM Tactic: Strategic Alliances/Licensing

Publications Strategy
89 Figure 2.18: Publications Strategy Dashboard
92 Figure 2.19: Planning for Publications Strategy Begins
93 Figure 2.20: Implementation for Publications Strategy Begins
95 Figure 2.21: Effectiveness of LCM Tactic: Publications Strategy

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CHARTS AND GRAPHICS

Contracting with Large Volume Purchasers
96 Figure 2.22: Contracting with Large Volume Purchasers Dashboard 96
98 Figure 2.23: Planning for Contracting with Large Volume Purchasers Begins 98
99 Figure 2.24: Implementation for Contracting with Large Volume Purchasers Begins 99
101 Figure 2.25: Effectiveness of LCM Tactic: Contracting with Large Volume Purchasers 101

Peak Time Period

104 Figure 3.1: Peak (Launch until two years prior to US patent expiration) LCM 104
Tactical Timeline
104 Figure 3.2: Peak LCM Strategy Investment Levels 106
107 Figure 3.3: Average Time to Implement Peak LCM Strategies 107
108 Figure 3.4: Peak LCM Strategy Time to Implement vs. Return on Investment 108
109 Figure 3.5: Peak LCM Strategy Return on Investment 109

Strategic Pricing
110 Figure 3.6: Strategic Pricing Dashboard 110
113 Figure 3.7: Planning for Strategic Pricing Begins 113
114 Figure 3.8: Implementation for Strategic Pricing Begins 114
115 Figure 3.9: Effectiveness of LCM Tactic: Strategic Pricing 115

New Dosing Frequency

117 Figure 3.10: New Dosing Frequency Dashboard 117
119 Figure 3.11: Planning for New Dosing Frequency Begins 119
120 Figure 3.12: Implementation for New Dosing Frequency Begins 120
121 Figure 3.13: Effectiveness of LCM Tactic: New Dosing Frequency 121

New Dosing Strength

124 Figure 3.14: New Dosing Strength Dashboard 124
127 Figure 3.15: Planning for New Dosing Strength Begins 127
128 Figure 3.16: Implementation for New Dosing Strength Begins 128
129 Figure 3.17: Effectiveness of LCM Tactic: New Dosing Strength 129

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CHARTS AND GRAPHICS

New Indication
132 Figure 3.18: New Indication Dashboard
135 Figure 3.19: Planning for New Indications Begins
136 Figure 3.20: Implementation for New Indications Begins
137 Figure 3.21: Effectiveness of LCM Tactic: New Indications

CRM/Disease Management
139 Figure 3.22: CRM/Disease Management Dashboard
143 Figure 3.23: Planning for CRM/Disease Management Begins
144 Figure 3.24: Implementation for CRM/Disease Management Begins
145 Figure 3.25: Effectiveness of LCM Tactic: CRM/Disease Management

Market Repositioning
147 Figure 3.26: Market Repositioning Dashboard
151 Figure 3.27: Planning for Market Repositioning Begins
152 Figure 3.28: Implementation for Market Repositioning Begins
153 Figure 3.29: Effectiveness of LCM Tactic: Market Repositioning

Repurposing
155 Figure 3.30: Repurposing Dashboard
158 Figure 3.31: Planning for Repurposing Begins
159 Figure 3.32: Implementation for Repurposing Begins
160 Figure 3.33: Effectiveness of LCM Tactic: Repurposing

Mature Time Period

164 Figure 4.1: Mature (Two years prior to US patent expiration and beyond) LCM
Tactical Timeline
166 Figure 4.2: Mature LCM Strategy Investment Levels
167 Figure 4.3: Average Time to Implement Mature LCM Strategies
168 Figure 4.4: Mature LCM Strategy Time to Implement vs. Return on Investment
169 Figure 4.5: Mature LCM Strategy Return on Investment

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CHARTS AND GRAPHICS

Pediatric Indications
170 Figure 4.6: Pediatric Indications Dashboard
173 Figure 4.7: Planning for Pediatric Indications Begins
174 Figure 4.8: Implementation for Pediatric Indications Begins
175 Figure 4.9: Effectiveness of LCM Tactic: Pediatric Indications

New Combinations
178 Figure 4.10: New Combinations Dashboard
181 Figure 4.11: Planning for New Combinations Begins
182 Figure 4.12: Implementation for New Combinations Begins
183 Figure 4.13: Effectiveness of LCM Tactic: New Combinations

Next Generation Product

187 Figure 4.14: Next Generation Product Dashboard
190 Figure 4.15: Planning for Next Generation Product Begins
191 Figure 4.16: Implementation for Next Generation Product Begins
192 Figure 4.17: Effectiveness of LCM Tactic: Next Generation Product

Patent Litigation
194 Figure 4.18: Patent Litigation Dashboard
196 Figure 4.19: Altace Timeline: Litigation, Settlement, Patent Invalidation, Launch
199 Figure 4.20: Planning for Patent Litigation Begins
200 Figure 4.21: Implementation for Patent Litigation Begins
200 Figure 4.22: Effectiveness of LCM Tactic: Patent Litigation

Branded Generics
202 Figure 4.23: Branded Generics Dashboard
205 Figure 4.24: Planning for Branded Generics Begins
206 Figure 4.25: Implementation for Branded Generics Begins
207 Figure 4.26: Effectiveness of LCM Tactic: Branded Generics
209 Figure 4.27: Zoloft Timeline: Litigation, Settlement, Generic Launch

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CHARTS AND GRAPHICS

Rx-to-OTC
210 Figure 4.28: Rx-to-OTC Dashboard
211 Table 4.1: FDA Rx-to-OTC Switch List
213 Figure 4.29: Planning for Rx-to-OTC Begins
214 Figure 4.30: Implementation for Rx-to-OTC Begins
216 Figure 4.31: Effectiveness of LCM Tactic: Rx-to-OTC

Removal from Market

217 Figure 4.32: Removal from Market Dashboard
219 Figure 4.33: Planning for Removal from Market Begins
220 Figure 4.34: Implementation for Removal from Market Begins
221 Figure 4.35: Effectiveness of LCM Tactic: Removal from Market

Individual Brand LCM Profiles

Brand 1
227 Brand 1: Figure 1: Brand 1 Overview
228 Brand 1: Figure 2: Brand 1 Competitive Outlook
228 Brand 1: Figure 3: Greatest Threats to Brand 1
229 Brand 1: Figure 4: Brand 1’s Tactical Approach
229 Brand 1: Figure 5: Brand 1’s LCM Tactic Timelines
230 Brand 1: Figure 6: Brand 1: Annual LCM Strategy Investments
230 Brand 1: Figure 7: Brand 1: LCM Strategy Annual Investments by Time Period
231 Brand 1: Figure 8: Brand 1’s LCM Headcount Support
231 Brand 1: Figure 9: Percentage of Brand 1’s Marketing Budget Allocated to LCM
232 Brand 1: Figure 10: Brand 1: LCM Strategy Investments, Returns and Returns on
Investment Percentages
232 Brand 1: Figure 11: Brand 1: LCM Strategies’ Average Returns Per Dollar Invested

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CHARTS AND GRAPHICS

Brand 2
233 Brand 2: Figure 1: Brand 2 Overview
234 Brand 2: Figure 2: Brand 2 Competitive Outlook
234 Brand 2: Figure 3: Greatest Threats to Brand 2
235 Brand 2: Figure 4: Brand 2’s Tactical Approach
235 Brand 2: Figure 5: Brand 2’s LCM Tactic Timelines
236 Brand 2: Figure 6: Brand 2: Annual LCM Strategy Investments
236 Brand 2: Figure 7: Brand 2: LCM Strategy Annual Investments by Time Period
237 Brand 2: Figure 8: Brand 2’s LCM Headcount Support
237 Brand 2: Figure 9: Percentage of Brand 2’s Marketing Budget Allocated to LCM
238 Brand 2: Figure 10: Brand 2: LCM Strategy Investments, Returns and Returns on
Investment Percentages
238 Brand 2: Figure 11: Brand 2: LCM Strategies’ Average Returns Per Dollar Invested

Brand 3
239 Brand 3: Figure 1: Brand 3 Overview
240 Brand 3: Figure 2: Brand 3 Competitive Outlook
240 Brand 3: Figure 3: Greatest Threats to Brand 3
241 Brand 3: Figure 4: Brand 3’s Tactical Approach
241 Brand 3: Figure 5: Brand 3’s LCM Tactic Timelines
242 Brand 3: Figure 6: Brand 3: Annual LCM Strategy Investments
242 Brand 3: Figure 7: Brand 3: LCM Strategy Annual Investments by Time Period
243 Brand 3: Figure 8: Brand 3’s LCM Headcount Support
243 Brand 3: Figure 9: LCM Strategy Investments, Returns and Return on Investment
Percentages
244 Brand 3: Figure 10: Brand 3: LCM Strategies’ Average Returns Per Dollar Invested

Brand 4
245 Brand 4: Figure 1: Brand 4 Overview
246 Brand 4: Figure 2: Brand 4 Competitive Outlook
246 Brand 4: Figure 3: Greatest Threats to Brand 4
247 Brand 4: Figure 4: Brand 4’s Tactical Approach
247 Brand 4: Figure 5: Brand 4’s LCM Tactic Timelines
248 Brand 4: Figure 6: Brand 4: Annual LCM Strategy Investments

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CHARTS AND GRAPHICS

248 Brand 4: Figure 7: Brand 4: LCM Strategy Annual Investments by Time Period
249 Brand 4: Figure 8: Brand 4’s LCM Headcount Support
249 Brand 4: Figure 9: Percentage of Brand 4’s Marketing Budget Allocated to
LCM
250 Brand 4: Figure 10: Brand 4: LCM Strategy Investments, Returns and Returns on
Investment Percentages
250 Brand 4 Figure 11: Brand 4: LCM Strategies’ Average Returns Per Dollar
Invested

Brand 5
251 Brand 5: Figure 1: Brand 5 Overview 251
252 Brand 5: Figure 2: Brand 5 Competitive Outlook
253 Brand 5: Figure 3: Greatest Threats to Brand 5
253 Brand 5: Figure 4: Brand 5’s Tactical Approach
253 Brand 5: Figure 5: Brand 5’s LCM Tactic Timelines
254 Brand 5: Figure 6: Brand 5: Annual LCM Strategy Investments
254 Brand 5: Figure 7: Brand 5: LCM Strategy Annual Investments by Time Period
255 Brand 5: Figure 8: Brand 5’s LCM Headcount Support
255 Brand 5: Figure 9: Percentage of Brand 5’s Marketing Budget Allocated to LCM
256 Brand 5: Figure 10: Brand 5: LCM Strategy Investments, Returns and Returns on
Investment Percentages
256 Brand 5: Figure 11: Brand 5: LCM Strategies’ Average Returns Per Dollar Invested

Brand 6
257 Brand 6: Figure 1: Brand 6 Overview
258 Brand 6: Figure 2: Brand 6 Competitive Outlook
258 Brand 6: Figure 3: Greatest Threats to Brand 6
259 Brand 6: Figure 4: Brand 6’s Tactical Approach
259 Brand 6: Figure 5: Brand 6’s LCM Tactic Timelines
260 Brand 6: Figure 6: Brand 6: Annual LCM Strategy Investments
260 Brand 6: Figure 7: Brand 6: LCM Strategy Annual Investments by Time Period
261 Brand 6: Figure 8: Brand 6’s LCM Headcount Support
261 Brand 6: Figure 9: Percentage of Brand 6’s Marketing Budget Allocated to LCM
262 Brand 6: Figure 10: Brand 6: LCM Strategy Investments, Returns and Returns on
Investment Percentages
262 Brand 6: Figure 11: Brand 6: LCM Strategies’ Average Returns Per Dollar Invested

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CHARTS AND GRAPHICS

Brand 7
263 Brand 7: Figure 1: Brand 7 Overview
264 Brand 7: Figure 2: Brand 7 Competitive Outlook
264 Brand 7: Figure 3: Greatest Threats to Brand 7
265 Brand 7: Figure 4: Brand 7’s Tactical Approach
265 Brand 7: Figure 5: Brand 7’s LCM Tactic Timelines
266 Brand 7: Figure 6: Brand 7: Annual LCM Strategy Investments
266 Brand 7: Figure 7: Brand 7: LCM Strategy Annual Investments by Time Period
267 Brand 7: Figure 8: Brand 7’s LCM Headcount Support
267 Brand 7: Figure 9: Percentage of Brand 7’s Marketing Budget Allocated to LCM
268 Brand 7: Figure 10: Brand 7: LCM Strategy Investments, Returns and Returns on
Investment Percentages
268 Brand 7: Figure 11: Brand 7: LCM Strategies’ Average Returns Per Dollar Invested

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REPORT LINKS
More Cutting Edge Information Reports:

Combating Generics: Counter-Generics Strategy, Tactics and Execution

http://www.cuttingedgeinfo.com/counter-generics/

Pharmaceutical Product Relaunch: Preserving Market Share through Line

Extension and New Market Entry Strategies

http://www.cuttingedgeinfo.com/product-relaunch/

Pharmaceutical Portfolio Management Strategy

http://www.cuttingedgeinfo.com/portfolio-management/

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