Product Launch Failure & Success Report Summary

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Copyright © Best Practices®, LLC
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Success Factors and Failure Points in
Biopharmaceutical Product Launches: An
Updated Road Map for Strong Market Entry
Strategic Benchmarking Research, Analysis & Recommendations

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Table of ContentsTable 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 ContentsTable 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.
Insights,
Best Practices,
Pitfalls
Insights,
Best Practices,
Pitfalls 3. Invest in Launch &
Support
4. Engage
Thought Leaders
5. Educate Key
Stakeholders: (Physicians,
Patients, & Payers)
6. Demonstrate
Value Across
Multiple Fronts
2. Clearly Define Target
Patient Population
7. Utilize New
Technologies To Inform
1. Differentiate Your Product
8. Avoid Pitfalls &
Stumbling Blocks

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Differentiating Your Product - Secondary Benefits Can Be Win Themes:
Differentiated positioning begins on factors established in clinical trials – such as
efficacy, unmet needs, safety and target patient population. Secondary positioning
factors have less overall impact – but can be useful in a crowded market – and are
often more directly influenced through Marketing. Using secondary benefits can be an
effective strategy for positioning a product in a highly competitive market.
As one executive observed during interviews: “You like to go to market with an efficacy
message, that’s what you want.. If you can’t do efficacy, fall back to safety. If you can’t
do safety, you fall back to convenience. If you can’t do convenience, you fall back to
pricing.” Secondary or even tertiary positioning factors have been win themes. Quality
of life, ease of use, cost effectiveness, patient compliance, or even a celebrity
spokesperson are examples. Use of secondary factors varies considerably across TAs.
Differentiating Your Product - Secondary Benefits Can Be Win Themes:
Differentiated positioning begins on factors established in clinical trials – such as
efficacy, unmet needs, safety and target patient population. Secondary positioning
factors have less overall impact – but can be useful in a crowded market – and are
often more directly influenced through Marketing. Using secondary benefits can be an
effective strategy for positioning a product in a highly competitive market.
As one executive observed during interviews: “You like to go to market with an efficacy
message, that’s what you want.. If you can’t do efficacy, fall back to safety. If you can’t
do safety, you fall back to convenience. If you can’t do convenience, you fall back to
pricing.” Secondary or even tertiary positioning factors have been win themes. Quality
of life, ease of use, cost effectiveness, patient compliance, or even a celebrity
spokesperson are examples. Use of secondary factors varies considerably across TAs.
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.

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Universe of Learning: 38 Companies Engaged
Participating Companies
Research participants included 44 executives and managers from 38 leading
pharmaceutical, biotech and medical device companies.
Laboratorios Dermatologicos Darier
TGC MedTech

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Executive Interviews and Field Insights
Executive Interviews
Laboratorios Dermatologicos Darier
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 Field Insights

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Sample Participant Titles
Other:
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.
• Founder and President
• Principal
• Partner
• Coordinator, Marketing
• Product Physician
• Senior Consultant
Assistant/
Associate
Director, 5%
Other, 15%
Manager, 26%
Senior
Manager, 8%
Director, 26%
Senior Vice
President, 8%
Senior/
Executive
Director, 8%
Vice President,
5%
(n=39)
• Senior Vice President, Commercial
Strategy
• Senior Vice President, Marketing &
Sales
• Vice President, Marketing
• Director, Health Outcomes
• Director, Marketing
• Director, Medical
• Director, Strategic Planning
• Associate Director, Managed Care
Marketing
• Senior Manager, Global Marketing
• Manager, Business Intelligence
• Manager, Business Unit
• Manager, Category Marketing

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

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Efficacy, Unmet Need Offer Best Positioning Tools
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
Used
Highly
Ineffective
Somewhat
Ineffective
Somewhat
Effective
Highly
Effective
Total
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
/ Sub-population
5% 2% 5% 51% 37% 88%
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%
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.

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

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Ease-of-Use Seen as Secondary Benefits Differentiator
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.
Used
Highly
Ineffective
Somewhat
Ineffective
Somewhat
Effective
Highly
Effective
Total
Effective
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
or seizures)
20% 0% 2% 30% 48% 77%
43 Cost Effectiveness 14% 2% 12% 42% 30% 72%
43 Superior speed of action 21% 2% 7% 42% 28% 70%
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.

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New Product Needs 11-30% Higher Efficacy for Charge More
0%2%2%0%0%
5%
15%
32%34%
10%
1-10%
better
(i.e.more
11-20%
better
21-30%
better
31-40%
better
41-50%
better
51-60%
better
61-70%
better
71-80%
better
81-90%
better
91-100%
better
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
(n=41)
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.

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

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KOLs Should Span Across Various Levels of Influence
“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
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.
Source: http://pharmexec.findpharma.com/pharmexec/
article/articleDetail.jsp?id=197784

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Price, Reimbursement Discussions Effective for Payers
Q25. Payer Education: Rate the effectiveness of early payer education and engagement activities
that prove most critical to market entry and success.
Used
Highly
Ineffective
Somewhat
Ineffective
Somewhat
Effective
Highly
Effective
Total
Effective
30 Price Parameters: Get guidance on
acceptable parameters for label
7% 0% 7% 37% 50% 87%
30 Unmet Needs: Understand Managed
Markets' view of unmet medical needs
10% 0% 3% 50% 37% 87%
30 Reimbursement Prospects: Gain
insight on reimbursement prospects in
context of competitive landscape
17% 0% 0% 23% 60% 83%
30 Health Outcomes: Get reaction to
health outcomes/ economics data
17% 0% 3% 37% 43% 80%
29 Advisory Boards: Payer advisory
boards to hear payer perspectives
17% 0% 3% 17% 62% 79%
30 Improving Position: Understand how
to Improve formulary positioning
17% 0% 7% 43% 33% 77%
30 Efficacy & Safety: Learn minimum
requirements to enter market
13% 0% 13% 27% 47% 73%
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.

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Win Share: Focus Shifts to Specialists
n = TBC No Low High
35 Specialists 0% 20% 80%
33 KOLs 0% 24% 76%
31 Payers 10% 35% 55%
33 Primary Care
Physicians
15% 36% 48%
32 Patients / Patient
Advocacy Groups
13% 50% 38%
32 Policymakers /
Government
13% 53% 34%
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
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).

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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.
35%
45%
50%
60%
30%
30%Not applicable/ None
Communicate product benefits
Educate on symptom
identification
Provide disease state
information
Reach large patient
populations
Encourage patients to speak to
doctors
Total Benchmark Class
(n=20)

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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.
Total Benchmark
Class
(n=24)
Out of Step With
Thought Leader
Perspectives: New
product's clinical trials
lag thought leader
views or evolving
guidelines; product
claims are misaligned
with thought leader
perspectives.
Missed Critical
Specialists: New
product fails to
win critical
specialists or Key
Opinion Leaders -
who oppose new
product because
of unaddressed
concerns.
Failed Physician
Segmentation: New
product fails to
segment market in a
way that allows it to
address specific
physician segment
needs; market
execution fails to reach
critical segments.
New Science
Education Missteps:
New method-of-action
products change
treatment paradigms
but fail to inform
physicians on biology
/new science to
support paradigm shift.
Access Barriers:
New products
stumble or fail
because of limited
access to health
care providers,
managed care and
institutions.
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%
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.

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Best Practices, LLC is a research and consulting firm that conducts work based on the
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Product Launch Failure & Success Report Summary

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