Success Factors and Failure Points in Cardiovascular Product Launches Report Summary

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Copyright © Best Practices, LLC
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Success Factors and Failure Points in
Cardiovascular Product Launches
Strategic Benchmarking Research, Analysis & Recommendations

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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.19-26
Main Deck
 Winning on Differentiated Product Positioning p.27-36
 Winning a Physician’s Initial Trial of a New Product p.37-39
 Articulating Benefits that Shape Positive Market Perception p.40-44
 New Product Pricing Strategy p.45-56
 Thought Leader Engagement p. 57-65
 Early Physician Education p.66-76
 Payer Education p. 77-81
 Patient Advocacy and Education p.82-86
 Preparing Market Constituents p.87-91
 Access Insights & Success Factors p.92-100
 Winning Hospital Formulary Access p.101-103
 Resource Allocation for Key Stakeholders in the Current & Future Marketplaces
p. 104-106
 Investment Requirements, Resource Allocation & Timing p.107-117

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Table of Contents
 Internal Launch Readiness p.118-131
 New Technologies for Informing Patients & Physicians p.132-137
 Pitfalls & Stumbling Blocks p.138-159
 Demonstrating Efficacy p.160-168
 Rating Different Safety Dimensions p.169-178
 Lessons Learned, Best Practices & Future Changes p.179-181
 About Best Practices, LLC p.182

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Business Issue & Corporate Challenge
Background:
 Many organizations in the biopharmaceutical sector have promising therapies in development
across multiple therapeutic areas, although high-growth areas such as diabetes, cardiology and
oncology have drawn considerable attention from the biopharma industry.
 However, recent industry product launches have produced noteworthy failures and successes.
Consequently, this field research was undertaken to illuminate both success and failure factors
informing recent market entry blockbusters and disappointments.
Use Insights To Inform &
Inspire Market-Entry
Success for New
Cardiovascular Products
Field Research & Insight Development:
 Engaged 44 external executives at 38 companies
to participate in an extensive online survey to
collect quantitative data around product launches.
 Collected data from executives who reflected on
some 30 products, including cardiovascular,
diabetes, and other therapeutic areas.
 Conducted deep-dive interviews with 6 external
companies
INFORM
Study Objective:
This project probed failure points and success factors in recent biopharmaceutical
product launches, including those in the cardiovascular therapeutic area. The insights
and lessons learned can inform market entry planning.

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 Best Engagement Strategies Vary By Therapeutic Area: Thought leader engagement
is a critical success factor across all therapeutic areas. However, key relationship tactics
score quite differently across Cardiology, Diabetes and the multi-therapeutic area class.
Consulting and Ad Boards score much higher in Diabetes than in Cardiology – and
both rate MSL (Medical Science Liaison) services as more valuable than in other
therapeutic areas. It’s imperative that product launch teams craft engagement strategies
reflecting therapeutic area needs and your company’s tenure in the therapeutic area.
 Medical Affairs Sub-Groups Are Key To Winning KOLS: Identifying the right key
opinion leaders to support a scientific platform is critical for successful launches. Just as
important is having the right number of KOLs involved. MSL and scientific publications
are also highly important engagement tools in Cardiology and other therapeutic areas. All
require the active support and coordinated engagement of Medical Affairs.
 Relationship Strategies Can Help Win Key Hospitals: Winning influential hospitals
requires strong relationship strategies to identify key decision makers and advocates. A
strategic approach calls for identifying decision makers, developing advocates and
executing a customized strategic plan for each hospital. This will require coordination
between marketing, key account managers and the field-based sales team.
4. Engage Thought Leaders For Success
Thought leader engagement remains key to a successful launch across all therapeutic
areas. However, relationship strategies need to be tailored to a therapeutic area to be
most effective. Medical Affairs plays a pivotal role in creating effective KOL strategies.

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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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Participant Titles
Cardiology Products
Benchmark Partners
Cardiology research participants included seven executives and managers at six different
companies, including four industry leaders.
• Product Physician
• Business Intelligence
Manager
• Marketing Manager
• Marketing Director
• Medical Director
• Partner
• Global Brand Leader - VP
TGC MedTech
Cardiology Segment: 7 Participants Engaged
Clivarine

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Unmeet Need, Efficacy Lead Cardiology 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 = Cardiology Not
Used
Highly
Ineffective
Somewhat
Ineffective
Somewhat
Effective
Highly
Effective
Total
Effective
7 Unmet medical need 0% 0% 0% 29% 71% 100%
7 Efficacy Profile 0% 0% 0% 29% 71% 100%
7 Safety Profile 0% 0% 0% 43% 57% 100%
7 Ease-of -use/ patient compliance 0% 0% 0% 57% 43% 100%
7 Differences from current therapies 0% 0% 0% 57% 43% 100%
7 Tolerability 0% 0% 14% 43% 43% 86%
7 Better Patient Compliance 0% 0% 14% 43% 43% 86%
7 Cost Effectiveness 0% 14% 0% 43% 43% 86%
6 Clearly Defined Patient Population
/ Sub-population
17% 0% 0% 67% 17% 83%
In the Cardiology segment, launch leaders felt there were many positioning tools available
that could be effective to differentiate from competitors. Whereas the Total Benchmark
Class did not give any of the positioning tools a total effectiveness rating of 100%, the
Cardiology segment gave five positioning strategies that designation (which combines
Somewhat Effective and Highly Effective).

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Value Approach to Pricing Strategy Favored by All
Q8. New Product Pricing Strategy: When developing your new product pricing strategy, what
approach do you favor?
Head to Head
Comparisons,
25%
Risk-based
Pricing, 2.5%
Value-based,
72.5%
Head to Head
Comparisons,
14.3%
Risk-based
Pricing, 14.3%
Value-based,
71.4%
(n=40)
Total Benchmark Class Cardiology
(n=7)
Launch leaders in the Total Benchmark Class & Cardiology segment clearly approach
pricing strategy with a focus on value. Interviewed executives noted that payers are
sophisticated enough to know the difference between price and value – value has to show
quality of life improvement for patients and reduced health care spending for payers (i.e.
fewer hospitalizations, strokes, heart attacks).

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Product Differences Can Leverage Superior Prices
Q9. Pricing & Differentiation: Please assess which product differentiation factors best permit
superior pricing against competitors.
n = Total Benchmark Class Not
Used
Not
Important
Less
Important
Somewhat
Important
Highly
Important
Total
Important
41 Superior Efficacy 5% 0% 0% 22% 73% 95%
41 Differences from current standard therapy 0% 0% 10% 27% 63% 90%
41 Superior Health outcomes 5% 0% 7% 22% 66% 88%
40 Addressing Unmet Medical Need 5% 0% 8% 13% 75% 88%
41 Targets New Patient Sub-population 5% 2% 7% 44% 41% 85%
41 Superior Safety 5% 0% 20% 39% 37% 76%
41 Reduced side effects / no side effects 5% 2% 37% 32% 24% 56%
41 Ease of use/ patient compliance 10% 10% 32% 37% 12% 49%
40 Superior Duration 20% 0% 33% 38% 10% 48%
40 Dosing Improvements 18% 5% 35% 33% 10% 43%
41 New Method of Action 10% 20% 41% 20% 10% 29%
While efficacy remain king in pricing, launch leaders clearly value the use of any
differences a new product has from existing therapies as a way to justify superior pricing
in the marketplace. Note the high importance that respondents placed on a product
meeting an unmet need, indicating the value of identifying any sub-populations that are
particularly impacted by a new product.

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Health Outcomes Vital for Pricing in Cardiology
Q9. Pricing & Differentiation: Please assess which product differentiation factors best permit
superior pricing against competitors.
n = Cardiology Not
Used
Not
Important
Less
Important
Somewhat
Important
Highly
Important
Total
Important
7 Superior Efficacy 0% 0% 0% 14% 86% 100%
7 Superior Health outcomes 0% 0% 14% 14% 71% 86%
7 Addressing Unmet Medical Need 0% 0% 14% 29% 57% 86%
7 Targets New Patient Sub-population 0% 0% 14% 43% 43% 86%
7 Superior Safety 0% 0% 14% 43% 43% 86%
7 Differences from current standard therapy 0% 0% 29% 29% 43% 71%
7 Reduced side effects / no side effects 0% 0% 29% 29% 43% 71%
7 Ease of use/ patient compliance 0% 14% 14% 57% 14% 71%
7 Superior Duration 0% 0% 29% 57% 14% 71%
7 Dosing Improvements 0% 14% 14% 57% 14% 71%
7 New Method of Action 0% 29% 29% 29% 14% 43%
Superior efficacy is the trump card for pricing in Cardiology; it received the highest ratings
as a differentiator that helps win superior pricing against competitors. Various other
factors also receive high impact scores to help with pricing differentiation. Health
outcomes, showing unmet need, new sub-populations, superior safety, positive
differences and reduced side effects – all receive high importance ratings for pricing.

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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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Protocol Design Top TL Strategy in Cardiology
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.
n = Cardiology Not
Used
Highly
Ineffective
Somewhat
Ineffective
Somewhat
Effective
Highly
Effective
Total
Effective
6 Protocol Design: Engage key thought
leaders to help design Phase III and
Phase IV clinical trial protocols
0% 0% 0% 17% 83% 100%
6 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% 33% 67% 100%
6 Medical Science Liaisons: Using MSLs to
educate thought leaders about benefits
of new drug compared with competitors.
0% 0% 0% 33% 67% 100%
6 Clinical trial involvement: Working with
thought leaders to gain their involvement
in investigators in clinical trials.
0% 0% 0% 67% 33% 100%
6 Scientific Publications: Engage in writing
scientific publications
0% 0% 17% 33% 50% 83%
Eighty-three percent of participants in Cardiology suggest engaging thought leaders in
protocol design for Phase III and IV clinical trials is “Highly Effective” for creating an
informed marketplace at launch. In addition to protocol design, harnessing information
from advisory boards, using MSLs to educate thought leaders, and involving thought
leaders in clinical trials also are effective engagement strategies in the Cardiology area.

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Medical Conferences and Sci Pubs Distribution
Sometimes Effective TL Strategies in Cardiology
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.
n = Cardiology Not
Used
Highly
Ineffective
Somewhat
Ineffective
Somewhat
Effective
Highly
Effective
Total
Effective
6 Medical Conferences: Attend medical
conferences to talk to thought leaders
0% 17% 0% 67% 17% 83%
6 Distribute scientific publications to
thought leaders
0% 0% 17% 83% 0% 83%
6 Professional Association: Engage
specialists and other key opinion leaders
through professional associations
17% 0% 17% 33% 33% 67%
6 Consulting: Hiring thought leaders to
provide insights into the best
educational approaches to convince
physicians to try a new therapy.
0% 0% 33% 50% 17% 67%
6 Thought Leader Views of Market: Share
and discuss market research findings
with thought leaders regarding the
market and clinical guidelines
0% 0% 33% 50% 17% 67%
Unlike the Total Benchmark Class, 83% of participants in the Cardiology segment find
that attending medical conferences and distributing scientific publications can be
effective ways to engage thought leaders at launch. Hiring thought leaders to provide
insights into the best physician education approaches and sharing research findings
with thought leaders are not as effective strategies in Cardiology when compared to TBC.

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Grow Market: TBC, Cardiology Value Patient Groups
n = TBC No Low High
33 Specialists 0% 30% 70%
34 KOLs 6% 29% 65%
34 Primary Care
Physicians
18% 18% 65%
35 Patients / Patient
Advocacy Groups
6% 31% 63%
30 Payers 7% 33% 60%
33 Policymakers /
Government
15% 42% 42%
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.
n = Cardiology No Low High
6 Specialists 0% 0% 100%
6 KOLs 0% 17% 83%
6 Primary Care
Physicians
0% 17% 83%
6 Patients / Patient
Advocacy Groups
0% 17% 83%
5 Payers 0% 20% 80%
6 Policymakers /
Government
0% 33% 67%
Grow Market
Going from 38% to 63% of TBC participants, patient and advocacy group education
becomes increasingly important when moving from winning share to growing the market.
For participants in Cardiology, continuing to educate and win support from policymakers/
government grows more important at this stage.

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Future Market: TBC, Cardiology See Few Changes in Allocations
Overall, market education resource allocations change very little when looking forward in
the next 36 months. Educating thought leaders and physicians still receives half of the
education resources for market entry. Cardiology area participants recommend spending
20% of market education resources on patient advocacy group education in the future.
Q21. Future Market Entry next 36 months: Looking forward in the next 36 months, what allocation
changes do you recommend to reach the same key stakeholder groups for successful market
entry in the same therapeutic area.
Other, 2%
Thought
Leader &
Physician
Education,
48%
Government /
Public Payers
Education,
15%
Private Payer
Education,
15%
Patient
Advocacy &
Education,
20%
Other, 3%
Patient
Advocacy &
Education, 15%
Private Payer
Education, 17%
Government /
Public Payers
Education, 18%
Thought Leader
& Physician
Education, 48%
(n=35)
Total Benchmark Class Cardiology
(n=6)
Increase of 5
percentage points
from current
allocation.

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Q42. Launch Risk & Market Change: Please estimate the risk level of each product shaping 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.
Cardiology
(n=6)
Safety & Side Effects
Pitfalls: Failure to address
safety signals, side effect
concerns, clinical trial size,
trial duration, and other FDA
or physician concerns.
Unclear Target Patient
Sub-Population: Unclear
target patient population
makes market entry difficult
against entrenched
competitors - confusing
physicians when to use new
drug.
Indication / Lifecycle
Planning Pitfalls: Lifecycle
planning missteps lead new
product to enter market with
wrong indication,
suboptimal dose or delivery
-- delaying market uptake
and tarnishing image.
Competitive
Positioning Errors:
Aggressive competitors
blunt new product's
market entry or damage
its perceived efficacy,
safety or differentiation -
and new product never
recovers.
Past 24 Months To Present
Red Alert- High Risk 100% 50% 83% 67%
Yellow Alert- Medium Risk 0% 50% 17% 33%
Green Alert- Low Risk 0% 0% 0% 0%
Next 24-36 Months- Anticipated Changes
Decreasing Risk or Priority 25% 0% 25% 0%
No Risk Change 50% 50% 25% 50%
Increasing Risk or Priority 25% 50% 50% 50%
Safety Top Concern in Cardiology Product Shaping
Failure to address safety signals, lifecycle planning, and competitive positioning errors
can be critical mistakes when trying to launch a successful Cardiology product. If there
are safety concerns from clinical trials, a creative competitive positioning strategy needs
to be developed before coming to market.

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High-Risk Products Require Targeted Sales
“The most skittish docs around - as related
to bleeding - are not the interventional
cardiologists. They don't care because they
could manage it. It is not primary care (docs)
because they never see it (bleeding). It's
‘clin cards.’ It's those docs that are
responsible for making that initial
prescription for platelet inhibitors outside of
a hospital setting. These cardiologists are
scared to death of bleeding complications.
They don't manage them every day in the
hospital. They don't want that on their
conscience or their record. And so, to the
extent that you've got a black box product
that forces you to start your conversation
with the risk of severe bleeding, it is going
to undermine any expectations you might
have had of driving new patient business
outside of the hospital setting.”
– Former Effient Launch Team Manager
• 850 reps were calling on
primary care physicians
and clinical cardiologists
• The absence of studies
and scientific papers to
help them see how to use
prasugrel was an early
problem that diminished its
launch potential.
Ironically, the high-potential of Effient, an anti-platelet therapy, worked against it at
launch. More than 85% of the sales force was calling immediately on physicians that
were not well targeted to be among the first users of Effient (prasugrel) – especially
outside of the hospital environment.

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