BEST PRACTICES,
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Copyright © Best Practices®, LLC
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Success Factors and Failure Points in
Biopharmaceutical Product...
BEST PRACTICES,
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LLC
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Copyright © Best Practices®, LLC
Table of ContentsTable of Contents
Background
Summary of Business...
BEST PRACTICES,
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Copyright © Best Practices®, LLC
Table of ContentsTable of Contents
Internal Launch Readiness p.10...
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Copyright © Best Practices®, LLC
Framework for Presenting Insights, Practices & Pitfalls
The perfo...
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Copyright © Best Practices®, LLC
Differentiating Your Product - Secondary Benefits Can Be Win Them...
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Copyright © Best Practices®, LLC
Universe of Learning: 38 Companies Engaged
Participating Companie...
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Copyright © Best Practices®, LLC
Executive Interviews and Field Insights
Executive Interviews
Labo...
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Copyright © Best Practices®, LLC
Sample Participant Titles
Other:
Vice President/Director Largest ...
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Copyright © Best Practices®, LLC
• Metabolics
• Cardiology
• Central Nervous System
• Oncology
• N...
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Copyright © Best Practices®, LLC
Efficacy, Unmet Need Offer Best Positioning Tools
Q5. Winning On...
BEST PRACTICES,
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Copyright © Best Practices®, LLC
The fact that the BMS/AZ Diabetes product Onglyza had a safety a...
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Copyright © Best Practices®, LLC
Ease-of-Use Seen as Secondary Benefits Differentiator
Q7. Articu...
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Copyright © Best Practices®, LLC
New Product Needs 11-30% Higher Efficacy for Charge More
0%2%2%0...
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Copyright © Best Practices®, LLC
Ad Boards & Trial Involvement Effective TL Strategies
Q22. Thoug...
BEST PRACTICES,
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Copyright © Best Practices®, LLC
KOLs Should Span Across Various Levels of Influence
“Well, I’d s...
BEST PRACTICES,
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Copyright © Best Practices®, LLC
Price, Reimbursement Discussions Effective for Payers
Q25. Payer...
BEST PRACTICES,
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Copyright © Best Practices®, LLC
Win Share: Focus Shifts to Specialists
n = TBC No Low High
35 Sp...
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Copyright © Best Practices®, LLC
DTC Campaigns Used to Push Patients to Doctors
A majority of par...
BEST PRACTICES,
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Copyright © Best Practices®, LLC
Q44. Launch Risk & Market Change: Please estimate the risk level...
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Copyright © Best Practices®, LLC
Best Practices, LLC
6350 Quadrangle Drive, Suite 200,
Chapel Hil...
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Product Launch Failure & Success Report Summary

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In the biopharmaceutical sector, new therapies are continually being developed and launched across various therapeutic areas. While there are many issues affecting a product launch, product characteristics such as differentiation, pricing and product benefits play an important role.
Best Practices ®, LLC undertook this study to highlight the differentiation, pricing and product benefit approaches that launch leaders think are most effective. The study also reviews issues surrounding a product's safety and efficacy profile to determine how much more effective or safe a new product needs to be to have a successful market entry in a competitive market. This study can be used by launch leaders to plan market entry strategies for their pipeline products.

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Product Launch Failure & Success Report Summary

  1. 1. BEST PRACTICES, ® LLC 1 Copyright © Best Practices®, LLC % Success Factors and Failure Points in Biopharmaceutical Product Launches: An Updated Road Map for Strong Market Entry Strategic Benchmarking Research, Analysis & Recommendations
  2. 2. BEST PRACTICES, ® LLC 2 Copyright © Best Practices®, LLC 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
  3. 3. BEST PRACTICES, ® LLC 3 Copyright © Best Practices®, LLC 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
  4. 4. BEST PRACTICES, ® LLC 4 Copyright © Best Practices®, LLC 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
  5. 5. BEST PRACTICES, ® LLC 5 Copyright © Best Practices®, LLC 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.
  6. 6. BEST PRACTICES, ® LLC 6 Copyright © Best Practices®, LLC 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
  7. 7. BEST PRACTICES, ® LLC 7 Copyright © Best Practices®, LLC 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
  8. 8. BEST PRACTICES, ® LLC 8 Copyright © Best Practices®, LLC 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
  9. 9. BEST PRACTICES, ® LLC 9 Copyright © Best Practices®, LLC • 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
  10. 10. BEST PRACTICES, ® LLC 10 Copyright © Best Practices®, LLC 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.
  11. 11. BEST PRACTICES, ® LLC 11 Copyright © Best Practices®, LLC 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.
  12. 12. BEST PRACTICES, ® LLC 12 Copyright © Best Practices®, LLC 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. n = Total Benchmark Class Not 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.
  13. 13. BEST PRACTICES, ® LLC 13 Copyright © Best Practices®, LLC 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.
  14. 14. BEST PRACTICES, ® LLC 14 Copyright © Best Practices®, LLC 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. n = Total Benchmark Class Not 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.
  15. 15. BEST PRACTICES, ® LLC 15 Copyright © Best Practices®, LLC 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
  16. 16. BEST PRACTICES, ® LLC 16 Copyright © Best Practices®, LLC 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. n = Total Benchmark Class Not 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.
  17. 17. BEST PRACTICES, ® LLC 17 Copyright © Best Practices®, LLC 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).
  18. 18. BEST PRACTICES, ® LLC 18 Copyright © Best Practices®, LLC 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)
  19. 19. BEST PRACTICES, ® LLC 19 Copyright © Best Practices®, LLC 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.
  20. 20. BEST PRACTICES, ® LLC 20 Copyright © Best Practices®, LLC Best Practices, LLC 6350 Quadrangle Drive, Suite 200, Chapel Hill, NC 27517 www.best-in-class.com Telephone: 919-403-0251 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.

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