This study is designed to help brand and marketing leaders identify winning lifecycle management (LCM) strategies they can use to extend the commercial life of bio-pharmaceutical products. The study examines ROI and future viability of 20 different LCM strategies. In addition, the research provides insights into which strategies will survive as they are faced with a changing pharmaceutical environment.

1. Lifecycle Management Excellence:
High-Performing Strategies
Used to Maximize Potential Of Mature Brands
Best Practices, LLC Strategic Benchmarking Research
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2. Table of Contents
Executive Summary, pp. 3-11
Research Overview, pp. 4
Benchmark Participants, pp. 5
Key Findings & Insights, pp. 6-11
Corporate LCM Goals & Policies, pp. 12-15
Use of Key LCM Strategies, pp. 16-19
Comparative Effectiveness of Key LCM Strategies, pp. 20-22
Relative Costs of Key LCM Strategies, pp. 23-25
Relative Time of Key LCM Strategies, pp. 26-28
ROI of Key LCM Strategies, pp. 29-31
Barriers of Key LCM Strategies, pp. 32-35
Key Strategy Profiles, pp. 36-39
Gains from Using LCM Strategies, pp. 40-46
Strategies Weakened By Regulation or Reform, pp. 47-48
Mature Brand Organizations, pp. 49-61
Success Factors & Lessons Learned, pp. 62-66
Case Example: Pfizer’s Lipitor, pp. 67-70
Appendix: Participant Demographic Data, pp. 71-75
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3. Research Project Objective & Methodology
Best Practices, LLC conducted this benchmarking study to examine the relative effectiveness of
20+ strategies for extending the commercial life of mature pharmaceutical products. The study also
compares the goals and responsibilities of Mature Brand (MB) organizations.
Business Issue:
With expiring patents & thin pipelines, pharmaceutical companies are increasingly focused
on lifecycle management (LCM) planning to make the most of each brand at every stage of
its life, including the somewhat neglected back end. In this context, executives seek to
understand what strategies and corporate structures are most effective for extending the
commercial life of its mature products.
Key Areas of Investigation: Field Research : Result:
1. Success rates & ROI of different Deployed online Provide
strategies that leading companies have survey to marketing &
used to maximize mature-brand value representative brand leaders
group of pharma with directional
2. Relative cost, time, complexity, & brand & data & proven
regulatory barriers encountered with
marketing practices they
using each strategy
leaders with can use to gain
3. An overview of the operation, expenses, experience in maximum value
responsibilities & business impact of LCM. from late-life
dedicated mature brand (MB) groups products
Sample Size: 25
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4. Universe of Learning: Benchmark Participants
Research participants included 25 executives and managers from 18 different pharmaceutical and
biotech companies. Respondents represented more than a dozen therapeutic areas. On average, this
seasoned group boasts U.S. leadership experience with eight mature products. Two-thirds of this group
currently work at the director level or above.
Benchmark Class:
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5. Key Findings: Selected Benchmark Metrics
The following key findings emerged from this study.
Litigation Has Highest ROI: Overall, litigation strategies achieved the highest ROI for
participants, with 40% realizing more than 100% ROI and another 20% realizing over 50%.
Fixed dose combination, one of the more expensive strategies, had the second highest ROI
rating. With respect to time and costs, branded/authorized generics was the most effective
strategy in garnering a high ROI.
Most Used LCM Strategies: Almost two-thirds of participants use strategic pricing or
publication strategies as a lifecycle management tactic.
Efficiency: Strategic pricing is rated by the benchmark class as the most cost- and
time-efficient strategy.
Time Used: On average, benchmark partners used each LCM strategy for 21 months in
support of mature brands, with a maximum time of 96 months for a strategy.
Financial Gain: Financial gain from using individual strategies among the benchmark class
ranged from $0 to $10 billion, with a median gain of $30 million. The average gain was $254
million.
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6. Benchmarked LCM Strategies for Use with Mature Brands
This study benchmarked the use of 19 development, new formulation, commercial, and legal
strategies used to extend the commercial life of mature, legacy pharmaceutical brands.
• Added safety features
Development & New • Extended release formulation
Formulation Strategies • Fixed dose combination
• New dosage form (e.g., patch)
• New dosing regimen
Aimed at
Aimed at • New Indication
enlarging
enlarging • Shelf-stable version
patient base
patient base
• Add-on services (e.g., reimbursement assistance)
• Brand loyalty programs
Commercial & Legal/ • Branded/authorized generics
Regulatory Strategies • Contracting with large-volume purchasers
• Extending into new, emerging markets (e.g., China)
Aimed at • Labeling changes
Aimed at • Litigation
maximizing
maximizing • OTC switching
commercial
commercial • Packaging innovations (e.g., co-packaging 2 drugs)
value &
value & • Publication strategy demonstrating clinical superiority
extending
extending • Repositioning product
protected life
protected life • Strategic pricing
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7. LCM Strategies Are Widely Used by Benchmark Participants
More than two-thirds of benchmark participants have experience with the top four LCM strategies
examined in this study. New dosage form is the most-used strategy overall (75%). More than half of
companies have experience with extending into emerging markets.
Q. Please indicate which of the following strategies you have used in the U.S. during your
career. (Check all that apply.)
LCM Strategy Usage
New dosage form (e.g., patch, liquid) 75%
Publication strategy demonstrating superior clinical
67%
attributes (safety, efficacy, convenience)
New dosing regimen 67%
New indication 67%
Strategic pricing (adjusting price to maintain sales or
63%
growth)
Branded/authorized generics 58%
Extending into new, emerging markets (e.g., China) 54%
Repositioning product 54%
Brand loyalty programs 54%
Add-on services (e.g., reimbursement
50%
assistance/patient support)
Contracting with large-volume purchasers 50%
% Responses
(n=24) * Other: Taste enhancements, Reduce complexity, Contract Sales Organizations
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8. All Strategies Used by at Least 25% of Participants; Other by 21%
* Benchmark partners listed eight additional strategies, indicated in the “Other” bars below.
Other Commercial strategies include: Building alternative promotional channels, CSOs, reducing
complexity, post-patent contracting, and taste enhancements. Other Development strategies include:
drug/device combination and packaging.
Q. Please indicate which of the following strategies you have used in the U.S. during your
career. (Check all that apply.)
LCM Strategy Usage, Continued
Packaging innovations (e.g., co-packaging
50%
complementary drugs)
Extended release formulation 50%
Labeling changes 46%
Added safety features (e.g., abuse resistant product) 38%
Fixed dose combination (e.g., combining two
38%
complimentary products)
Litigation strategies 29%
Benchmark
OTC switching 25% participants
* Other commercial strategies 21% used an
Shelf-stable version (e.g., no longer requires average of four
17%
Other
refrigeration) different LCM
8% strategies for
* Other development strategies
*
mature brands.
Other new formulations 4%
(n=24) % Responses
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9. Strategy Profiles: Overview of Mature Brand LCM Tactics
The next three slides summarize findings regarding the most commonly used strategies in this study.
NOTE: Green arrows indicate New Formulations strategies; Light blue = Commercial strategies; Dark
blue = Development strategies. Values in red type represent the % of respondents rating each strategy
“Highly Effective.” Only barriers with a response greater than 50% are shown.
Strategy: Overview: Considerations:
• 75% used • Average ROI: 58%
New Dosage Form • 88% users rated Effective (38%) • Barrier(s): Technical Feasibility (57%)
(e.g., patch, liquid) • Time: 76% Rated > 3 years • Weakened by Regulation: High
• Cost: 44% Rated > $10 million
• 67% used • Average ROI: 64%
Publication strategy
• 86% users rated Effective (7%) • Barrier(s): Length of Time (57%)
demonstrating superior
• Time: 80% Rated < 2 years • Weakened by Regulation: High
clinical attribute
• Cost: 54% Rated $1-5 Million
• 67% used • Average ROI: 51%
New Dosing Regimen • 71% users rated Effective (14%) • Barrier(s): Length of Time (61%),
• Time: 77% Rated > 3 years Regulatory Feasibility (57%)
• Cost: 42% Rated $1-5 Million • Weakened by Regulation: Medium
• 67% used • Average ROI: 69%
• 86% users rated Effective (40%) • Barrier(s): High Cost (83%), Length of
New Indication
• Time: 80% Rated > 3 years Time (74%), Reg. Feasibility (70%)
• Cost: 57% Rated > $10 million • Weakened by Regulation: Medium
• 63% used • Average ROI: 34%
• 72% users rated Effective (29%) • Barrier(s): None
Strategic Pricing
• Time: 93% Rated < 1 year • Weakened by Regulation: High
• Cost: 66% Rated < $1 million
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10. Regulation & Reform Are Weakening Current Strategies
More than a quarter of benchmark partners expect strategies used successfully in the past to be less
effective in the future, due to regulatory issues in the current healthcare environment. Publication
strategies and brand loyalty programs are viewed as the most vulnerable. Other strategies that will be
affected include new dosage form, branded/authorized generics, and strategic pricing.
Q. Given the current health care reform environment, politics, mature drug shortages and other regulatory issues, do
you expect any strategies that you have used successfully in the past to become ineffective or unusable within the next
12-24 months? (Check all that apply.)
Strategies Weakened by Regulation/Reform:
Publication strategy demonstrating superior clinical
28%
attributes (safety, efficacy, convenience) Other Strategies Selected
Other Strategies Selected
More Than Once:
More Than Once:
Brand loyalty programs 28% • Add-on services (e.g.,
• Add-on services (e.g.,
reimbursement assistance/
reimbursement assistance/
patient support)
patient support)
Strategic pricing (adjusting price to maintain sales
22%
or growth) • Extended release
• Extended release
formulation
formulation
Branded/authorized generics 22%
• New indication
• New indication
• New dosing regimen
• New dosing regimen
New dosage form (e.g., patch, liquid) 22%
• Repositioning product
• Repositioning product
Fixed dose combination (e.g., combining two • Packaging innovations (e.g.,
• Packaging innovations (e.g.,
17%
complimentary products) co-packaging
co-packaging
complementary drugs)
complementary drugs)
% Responses
(n=18)
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11. More Than Half Have a Dedicated Mature Brands Organization
Dedicated mature brand (MB) organizations are in place at 52% of the companies in this study.
For those with no dedicated MB group, brand teams are most often responsible for maximizing
the commercial success of mature products.
Q. Does your company have a group or function dedicated to managing and supporting mature/legacy products in the
U.S. market? (Choose one.) If no, who is responsible for maximizing mature products in the U.S.?
Dedicated Function Managing Responsible Party if No
Mature Brands in the U.S. Market: Dedicated MB:
Mature Products
Commercial Team
Brand 9%
Lead/Marketing
Director
9%
Yes No Global
52% 48% Marketing
9% Brand Teams
73%
(n=25) (n = 11)
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12. About Best Practices, LLC
Best Practices, LLC is a research and consulting firm that conducts work based on the simple yet
profound principle that organizations can chart a course to superior economic performance by studying
the best business practices, operating tactics, and winning strategies of world-class companies.
Best Practices, LLC
6350 Quadrangle Drive, Suite 200,
Chapel Hill, NC 27517
www.best-in-class.com
Telephone: 919-403-0251
best@best-in-class.com
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