This document discusses success factors and failure points for biopharmaceutical product launches based on research with 38 companies. Key findings include: 1. Differentiation through efficacy, safety profile, and clearly defined patient population are most effective for positioning. Secondary benefits like ease-of-use can also differentiate in crowded markets. 2. Thought leader engagement, such as through advisory boards and clinical trial involvement, is important for educating physicians. 3. Educating payers on pricing, comparative effectiveness and reimbursement is also critical for market entry success.

1. % Success Factors and Failure Points in Biopharmaceutical Product Launches: An Updated Road Map for Strong Market Entry Strategic Benchmarking Research, Analysis & Recommendations

4. 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 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

6. 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. 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

14. 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. 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. 91% 52% 39% 6% 0% 3% Medical Science Liaisons: Using MSLs to educate thought leaders about benefits of new drug compared with competitors. 33 97% 53% 44% 3% 0% 0% Scientific Publications: Engage in writing scientific publications 34 97% 62% 35% 3% 0% 0% Protocol Design: Engage key thought leaders to help design Phase III and Phase IV clinical trial protocols 34 100% 56% 44% 0% 0% 0% Clinical trial involvement: Working with thought leaders to gain their involvement in investigators in clinical trials. 34 100% 76% 24% 0% 0% 0% Advisory boards: Using TLs from therapeutic areas to understand what aspects of the drug to focus on for interactions with the physician community 34 Total Effective Highly Effective Somewhat Effective Somewhat Ineffective Highly Ineffective Not Used Total Benchmark Class n =

15. 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. 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. 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. 73% 47% 27% 13% 0% 13% Efficacy & Safety: Learn minimum requirements to enter market 30 77% 33% 43% 7% 0% 17% Improving Position: Understand how to Improve formulary positioning 30 79% 62% 17% 3% 0% 17% Advisory Boards: Payer advisory boards to hear payer perspectives 29 80% 43% 37% 3% 0% 17% Health Outcomes: Get reaction to health outcomes/ economics data 30 83% 60% 23% 0% 0% 17% Reimbursement Prospects: Gain insight on reimbursement prospects in context of competitive landscape 30 87% 37% 50% 3% 0% 10% Unmet Needs: Understand Managed Markets' view of unmet medical needs 30 87% 50% 37% 7% 0% 7% Price Parameters: Get guidance on acceptable parameters for label 30 Total Effective Highly Effective Somewhat Effective Somewhat Ineffective Highly Ineffective Not Used Total Benchmark Class n =

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

19. Physician Pitfalls At Launch Across The Benchmark Class 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. 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. 0% 0% 0% 0% 0% Increasing Risk or Priority 86% 100% 95% 86% 90% No Risk Change 14% 0% 5% 14% 10% Decreasing Risk or Priority Next 24-36 Months- Anticipated Changes 8% 9% 9% 0% 4% Green Alert- Low Risk 33% 52% 39% 30% 25% Yellow Alert- Medium Risk 58% 39% 52% 70% 71% Red Alert- High Risk Past 24 Months To Present Access Barriers: New products stumble or fail because of limited access to health care providers, managed care and institutions. 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. 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. Missed Critical Specialists: New product fails to win critical specialists or Key Opinion Leaders - who oppose new product because of unaddressed concerns. 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. Total Benchmark Class (n=24)

20. About Best Practices, LLC Best Practices, LLC 6350 Quadrangle Drive, Suite 200, Chapel Hill, NC 27517 www.best-in-class.com Telephone: 919-403-0251 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.