Product Launch Failure & Success Report Summary

Success Factors and Failure Points in
Biopharmaceutical Product Launches: An
Updated Road Map for Strong Market Entry

%

Strategic Benchmarking Research, Analysis & Recommendations

BEST PRACTICES,
1 ®
Copyright © Best Practices®, LLC LLC

Table of Contents
Background
Summary of Business Issue, Key Insights, Findings and Lessons Learned p.4-18
Universe of Learning: Research Participants, Launch Experience, Cardiology,
Metabolics & Other Therapeutic Area Demographics p.19-25
Main Deck
Winning on Differentiated Product Positioning p.26-33
Winning a Physician’s Initial Trial of a New Product p.34-35
Articulating Benefits that Shape Positive Market Perception p.36-38
New Product Pricing Strategy p.39-49
Thought Leader Engagement p. 50-55
Early Physician Education p.56-64
Payer Education p. 65-67
Patient Advocacy and Education p.68-70
Preparing Market Constituents p.71-75
Access Insights & Success Factors p.76-83
Winning Hospital Formulary Access p.84-85
Resource Allocation for Key Stakeholders in the Current & Future Marketplaces
p. 86-88
Investment Requirements, Resource Allocation & Timing p.89-99

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Table of Contents

Internal Launch Readiness p.100-111
New Technologies for Informing Patients & Physicians p.112-115
Pitfalls & Stumbling Blocks p.116-130
Demonstrating Efficacy p.131-137
Rating Different Safety Dimensions p.138-144
Lessons Learned, Best Practices & Future Changes p.145-147
About Best Practices, LLC p.148

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Framework for Presenting Insights, Practices & Pitfalls
The performance benchmark and field research have harvested scores of insights and
observations. They have been organized into the following summary framework for
discussion and planning purposes.

8. Avoid Pitfalls &
1. Differentiate Your Product
Stumbling Blocks

7. Utilize New 2. Clearly Define Target
Technologies To Inform Insights, Patient Population

Best Practices,
6. Demonstrate Pitfalls 3. Invest in Launch &
Value Across
Support
Multiple Fronts

5. Educate Key 4. Engage
Stakeholders: (Physicians,
Patients, & Payers) Thought Leaders

BEST PRACTICES,
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1. Differentiate Your Product In A Crowded Market
Differentiation is a key factor in a new product’s launch success. While efficacy and
safety are considered the best ways to differentiate a new product, new therapies also
can use secondary benefits to gain traction at launch.

Differentiating Your Product - -Secondary Benefits Can Be Win Themes:
Differentiating Your Product Secondary Benefits Can Be Win Themes:
Differentiated positioning begins on factors established in clinical trials ––such as
Differentiated positioning begins on factors established in clinical trials such as
efficacy, unmet needs, safety and target patient population. Secondary positioning
efficacy, unmet needs, safety and target patient population. Secondary positioning
factors have less overall impact ––but can be useful in aacrowded market ––and are
factors have less overall impact but can be useful in crowded market and are
often more directly influenced through Marketing. Using secondary benefits can be an
often more directly influenced through Marketing. Using secondary benefits can be an
effective strategy for positioning aaproduct in aahighly competitive market.
effective strategy for positioning product in highly competitive market.

As one executive observed during interviews: “You like to go to market with an efficacy
As one executive observed during interviews: “You like to go to market with an efficacy
message, that’s what you want.. IfIfyou can’t do efficacy, fall back to safety. IfIfyou can’t
message, that’s what you want.. you can’t do efficacy, fall back to safety. you can’t
do safety, you fall back to convenience. IfIfyou can’t do convenience, you fall back to
do safety, you fall back to convenience. you can’t do convenience, you fall back to
pricing.” Secondary or even tertiary positioning factors have been win themes. Quality
pricing.” Secondary or even tertiary positioning factors have been win themes. Quality
of life, ease of use, cost effectiveness, patient compliance, or even aacelebrity
of life, ease of use, cost effectiveness, patient compliance, or even celebrity
spokesperson are examples. Use of secondary factors varies considerably across TAs.
spokesperson are examples. Use of secondary factors varies considerably across TAs.

BEST PRACTICES,
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Universe of Learning: 38 Companies Engaged
Research participants included 44 executives and managers from 38 leading
pharmaceutical, biotech and medical device companies.

Participating Companies

TGC MedTech

Laboratorios Dermatologicos Darier

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Executive Interviews and Field Insights
More than six hours of executive interviews, in addition to field commentaries and
insights from 17 executives, shed light on the market entry success and failure factors.
Perspectives range from frontline prescriber to veteran pharma executive with decades of
successful launch experiences.

Executive Interviews Executive Field Insights

Laboratorios Dermatologicos Darier

BEST PRACTICES,
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Vice President/Director Largest Respondent Group
Nearly 40 leaders in biotechnology and pharmaceutical product launches participated in
this research project. A majority of respondents were either at the vice president or
director levels.

Senior Vice
Sample Participant Titles
President, 8% • Senior Vice President, Commercial
Other, 15%
Vice President,
5%
Strategy
Senior/ • Senior Vice President, Marketing &
Executive Sales
Director, 8%
• Vice President, Marketing
• Director, Health Outcomes
Manager, 26% • Director, Marketing
• Director, Medical
Director, 26% • Director, Strategic Planning
• Associate Director, Managed Care
Senior Other: Marketing
Assistant/ • Founder and President • Senior Manager, Global Marketing
Manager, 8%
Associate
• Principal
Director, 5% • Manager, Business Intelligence
• Partner
• Coordinator, Marketing • Manager, Business Unit
(n=39) • Product Physician
• Manager, Category Marketing
• Senior Consultant
BEST PRACTICES,
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Participants Reflected on Wide Range of Therapies
Research participants reflected on almost 30 products, ranging from blockbusters like
Januvia and Rituxan to new products like Onglyza and Victoza. The broad spectrum of
products launch experiences informed the benchmark class’ understanding of critical
success factors, stumbling blocks and failure points.

Therapeutic Areas Products Represented by Participants
• Metabolics
Belatacept
• Cardiology
• Central Nervous System Clivarine Cladribine
(Movectro)
• Oncology
Enteral feeding products
• Neurology
• Pulmonary Endothelin Receptor Antagonist
• Immunology
• Gastro-enterology Levothyroxine
• Musculoskeletal MAb for Asthma/COPD
Naproxcinod
• Hormonal Systems New CTC
Advance catheter
• HIV Infections
• Medical Nutrition
• Urology (n=33) Taspoglutide

BEST PRACTICES,
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Efficacy, Unmet Need Offer Best Positioning Tools
For respondents as a whole, efficacy and unmet need remain the most attractive
positioning tools for differentiating. But participants indicated that an effective use of a
tight target patient population/sub-population presents an opportunity where efficacy and
unmet need may not be differentiating options for a new product’s launch.

Q5. Winning On Differentiated Product Positioning: Differentiated product positioning is critical to
market entry success. Rate the effectiveness of different positioning strategies and tactics for
winning in the marketplace.

n= Total Benchmark Class Not Highly Somewhat Somewhat Highly Total
Used Ineffective Ineffective Effective Effective Effective
43 Efficacy Profile 2% 0% 2% 35% 60% 95%
44 Unmet medical need 2% 2% 2% 14% 80% 93%
43 Clearly Defined Patient Population 5% 2% 5% 51% 37% 88%
/ Sub-population
44 Differences from current therapies 2% 5% 7% 32% 55% 86%
44 Safety Profile 5% 0% 14% 52% 30% 82%
44 Health Outcomes 7% 2% 16% 48% 27% 75%
44 Tolerability 2% 2% 23% 45% 27% 73%
44 Ease-of -use/ patient compliance 11% 9% 9% 48% 23% 70%
44 Dosing 11% 7% 14% 43% 25% 68%
44 Cost Effectiveness 14% 2% 18% 36% 30% 66%

BEST PRACTICES,
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Lack of Differentiation Creates Domino Effect
The fact that the BMS/AZ Diabetes product Onglyza had a safety and efficacy profile very
similar to market leader Januvia created problems across a number of critical fronts:
Payers, KOLs, Prescribers and Patients. The result - a disappointing launch.

Pitfalls Created by Onglyza’s “I think they didn’t have a great
Lack of Differentiation differentiation strategy. Their
efficacy was undifferentiated. If
Insurers reluctant to add to
formulary at same tier as like- you’re the same efficacy-wise, you
priced Januvia. have to have some other good
compelling reason, or interesting
No good reason for prescribers to
reason or a promotional reason to
shift from tried-and-true Januvia.
consider it. I never got the sense of
KOLs unlikely to advocate change what that really was.”
in prescribing habits. – Januvia Marketing Leader

“There isn’t anything good to say because there’s no mention of why is this
better or why this is different.” – Januvia Marketing Leader

BEST PRACTICES,
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Ease-of-Use Seen as Secondary Benefits Differentiator
Following efficacy and safety, launch leaders see ease-of-use and unmet need as the
product benefits that should be used to differentiate a new product at market entry. Note
that unmet medical need won the largest “Highly Effective” rating.

Q7. Articulating Benefits That Shape Positive Market Perception: Once you've established your
efficacy and safety profile, rate the effectiveness of various product benefits that can differentiate
one's market entry positioning to enable rapid launch uptake.

41 Ease-of-use 5% 2% 7% 44% 41% 85%
42 Unmet Medical Need 7% 2% 7% 12% 71% 83%
43 Reduced side effects 9% 2% 7% 60% 21% 81%
42 Health Outcomes 12% 0% 10% 48% 31% 79%
44 Health benefit (eg. Prevents stroke 20% 0% 2% 30% 48% 77%
or seizures)
43 Cost Effectiveness 14% 2% 12% 42% 30% 72%
43 Superior speed of action 21% 2% 7% 42% 28% 70%

BEST PRACTICES,
12 ®

New Product Needs 11-30% Higher Efficacy for Charge More
Two thirds of the overall Benchmark Class indicated a new product requires at least 11%
to 30% superior efficacy in order to win a higher price in a competitive market.

Q10. Efficacy & Pricing: Estimate what's the minimum level of superior efficacy required to charge
more than a branded competitor product in a crowded marketplace.

Total Benchmark Class
34% 32%

15%
10%
5% 2%
0% 0% 2% 0%
11-20%

21-30%

31-40%

41-50%

51-60%

61-70%

71-80%

81-90%

91-100%
(i.e. more

better

better

better

better

better

better

better

better

better
1-10%
better

(n=41)

BEST PRACTICES,
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Ad Boards & Trial Involvement Effective TL Strategies
To engage thought leaders, overall participants rate advisory boards and clinical trial
involvement as effective strategies for creating an informed, receptive marketplace at
launch. Asking key thought leaders to help design Phase III and IV clinical trial protocols
and to contribute to scientific publications are also effective engagement strategies.

Q22. Thought Leader Engagement: Rate the effectiveness of various thought leader engagement
strategies for creating an informed and receptive marketplace at launch for your new product.

34 Advisory boards: Using TLs from 0% 0% 0% 24% 76% 100%
therapeutic areas to understand what
aspects of the drug to focus on for
interactions with the physician
community
34 Clinical trial involvement: Working with 0% 0% 0% 44% 56% 100%
thought leaders to gain their involvement
in investigators in clinical trials.
34 Protocol Design: Engage key thought 0% 0% 3% 35% 62% 97%
leaders to help design Phase III and
Phase IV clinical trial protocols
34 Scientific Publications: Engage in writing 0% 0% 3% 44% 53% 97%
scientific publications
33 Medical Science Liaisons: Using MSLs to 3% 0% 6% 39% 52% 91%
educate thought leaders about benefits
of new drug compared with competitors.

BEST PRACTICES,
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KOLs Should Span Across Various Levels of Influence
The size of the KOL group needed to create market acceptance should be spread across
different levels of the KOL landscape – national, regional, academic and local. Look for
the influencers in your particular therapeutic area who may fall under the industry’s radar
or who may be shadow thought leaders in a related therapeutic area.

“Well, I’d say you have to have enough on sort
of every different level. You’ve got maybe the
top 50 or 100 national thought leaders and
those are obviously the same within a
therapeutic category. The second level is one
that is probably where there is a significant
amount of real influence like regional academic
medical centers. It’s in the regional KOLs
within certain hospital or academic systems
that may not have the publication power, but
get them involved and in on publications and
second author - stuff like that.”
– Marketing Manager, Top 10 Pharma
Source: http://pharmexec.findpharma.com/pharmexec/
article/articleDetail.jsp?id=197784
BEST PRACTICES,
15 ®

Price, Reimbursement Discussions Effective for Payers
Discussions around pricing, comparative effectiveness and reimbursement are effective
early payer education tactics, participants said. In interviews, executives said these
discussions need to be approached in a collaborative manner so that payers are learning
about your perspective while you are learning about their wants and needs as well.

Q25. Payer Education: Rate the effectiveness of early payer education and engagement activities
that prove most critical to market entry and success.

30 Price Parameters: Get guidance on 7% 0% 7% 37% 50% 87%
acceptable parameters for label
30 Unmet Needs: Understand Managed 10% 0% 3% 50% 37% 87%
Markets' view of unmet medical needs
30 Reimbursement Prospects: Gain 17% 0% 0% 23% 60% 83%
insight on reimbursement prospects in
context of competitive landscape
30 Health Outcomes: Get reaction to 17% 0% 3% 37% 43% 80%
health outcomes/ economics data
29 Advisory Boards: Payer advisory 17% 0% 3% 17% 62% 79%
boards to hear payer perspectives
30 Improving Position: Understand how 17% 0% 7% 43% 33% 77%
to Improve formulary positioning
30 Efficacy & Safety: Learn minimum 13% 0% 13% 27% 47% 73%
requirements to enter market

BEST PRACTICES,
16 ®

Win Share: Focus Shifts to Specialists
For winning share in the marketplace, 80% of participants place high importance on
educating and winning support from specialists. Also note at this stage education
increases for primary care physicians (from 6% at Enter Market to 48% at Win Share
stage).

Q19. Preparing Market Constituents: Rate the importance of educating and winning support from
each market constituency in order to (1) Enter market, (2) Win Share, and (3) Grow Market.

Win Share
n= TBC No Low High

35 Specialists 0% 20% 80%
33 KOLs 0% 24% 76%
31 Payers 10% 35% 55%
33 Primary Care 15% 36% 48%
Physicians
32 Patients / Patient 13% 50% 38%
Advocacy Groups
32 Policymakers / 13% 53% 34%
Government

BEST PRACTICES,
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DTC Campaigns Used to Push Patients to Doctors
A majority of participants see the value in DTC campaigns as a way to educate on the
disease and spur patients to engage with physicians about their ailments and speak to
their doctors about the new therapy they saw on TV. Will it work for them?

Q29. DTC Value Drivers: Note all factors that informed your rationale for employing DTC
campaigns after launch.

Total Benchmark Class

Encourage patients to speak to
60%
doctors

Reach large patient
50%
populations

Provide disease state
45%
information

Educate on symptom
35%
identification

Communicate product benefits 30%

Not applicable/ None 30%

(n=20)

BEST PRACTICES,
18 ®

Physician Pitfalls At Launch Across The Benchmark Class
Thought leaders and specialists are the highest risk physician stumbling blocks that can
trip up a new product upon market entry. Poor physician segmentation and weak access
also emerge as critical physician pitfalls. During the next 36 months, most of these risk
factors are expected to stay the same in terms of risk and priority at launch.
Q44. Launch Risk & Market Change: Please estimate the risk level of each physician pitfall that can
derail a new product coming into a crowded market. First assess each pitfall in terms of its current
importance / risk level observed during the past two years. Then estimate the risk-level / priority
change you anticipate for the next two to three years for this risk or failure point.
Out of Step With Missed Critical Failed Physician
New Science
Thought Leader Specialists: New Segmentation: New Access Barriers:
Education Missteps:
Perspectives: New product fails to product fails to New products
New method-of-action
Total Benchmark product's clinical trials win critical segment market in a
products change
stumble or fail
lag thought leader specialists or Key way that allows it to because of limited
Class views or evolving Opinion Leaders - address specific
treatment paradigms
access to health
but fail to inform
guidelines; product who oppose new physician segment care providers,
physicians on biology
claims are misaligned product because needs; market managed care and
/new science to
with thought leader of unaddressed execution fails to reach institutions.
support paradigm shift.
(n=24) perspectives. concerns. critical segments.

Past 24 Months To Present
Red Alert- High Risk 71% 70% 52% 39% 58%
Yellow Alert- Medium Risk 25% 30% 39% 52% 33%
Green Alert- Low Risk 4% 0% 9% 9% 8%
Next 24-36 Months- Anticipated Changes
Decreasing Risk or Priority 10% 14% 5% 0% 14%
No Risk Change 90% 86% 95% 100% 86%
Increasing Risk or Priority 0% 0% 0% 0% 0%

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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 PRACTICES,
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Product Launch Failure & Success Report Summary

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