Adapting to New Market Realities: Achieving Launch Excellence in Oncology

IMS ONCOLOGY LAUNCH EXCELLENCETM STUDY

Biotechnology and pharmaceutical companies are paying a high price as the Oncology market is maturing and access is increasingly restricted. Ironically, the scientific advances that are transforming the treatment of cancers and the prognosis for patients are presenting new and complex commercial challenges for marketers.

Adapting to New Market Realities

IMS Oncology Launch Excellence Study
Maturity, as British playwright Tom Stoppard observed, is a high price to pay for growing up. In a twist on this, biotechnology companies and pharmaceutical manufacturers are paying a high price as the Oncology market is maturing and access is increasingly restricted. Ironically, the scientific advances that are transforming the treatment of cancers and the prognosis for patients are presenting new and complex commercial challenges for marketers. Commercial success with an Oncology launch is becoming more elusive. But it is well worth pursuing provided that you understand the new rules of the game and the most recent strategies that have proven to work. A PRESSING NEED FOR ANSWERS IMS expects that Oncology will remain the top therapy area by share value in the worlds leading eight geographic markets through 2020. Thus, quite predictably, the Oncology market is of intense interest to both large and small R&D companies, to those with existing Oncology franchises, as well as those not yet in the field. Indeed, the industrys collective pipeline is brimming with promise from significant innovation. Yet, all of this potential wont materialize as easily as it has in the past. In many tumor areas, the market has evolved from one of high unmet need to one in which payers can afford to be choosey and to impose access restrictions. It is already clear that the rate of growth for Oncology products, while still above the global industry average, is slowing. (See Fig. 1). In light of this moderating growth and with an eye to what the future holds, IMS undertook the FIGURE 1: GLOBAL ONCOLOGY SALES AND GROWTH
Global Oncology* Sales & Growth, 2000-2010
60 30

50

25

% GROWTH CONST U.S. $

40

20

SALES U.S. $BN

30

15

20

10

10

0 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
Global Oncology Global phama growth Global Oncology growth Japan Oncology growth Europe Oncology growth U.S. Oncology growth

Source: IMS Health MIDAS MAT September 2010 *Oncology defined as L1 and L2

IMS Oncology Launch Excellence Study to identify how the key levers for launch success might differ from general launch preparations in other therapeutic areas. We set out to understand what distinguishes successful Oncology launches in the pre-launch phases by 1.) interviewing experts from within leading Oncology manufacturers and from within IMS and 2.) studying 16 leading targeted therapy launches. IMSs prior three launch excellence studies intentionally excluded Oncology launches because the preparation for entering the Oncology market is much more complex and the market dynamics often radically different: Oncology is a class unto itself. With the following pages, we now give Oncology launches their due and identify the four drivers of launch excellence in Oncology.

IMS HEALTH IMS ONCOLOGY LAUNCH EXCELLENCE STUDY

DRIVER #1: PURSUE AN OPTIMAL INDICATION SEQUENCING STRATEGY Reaching blockbuster status ($1bn in annual sales) with an Oncology launch is becoming more elusive, so the first step to success is having the right indication sequencing strategy for optimal investment and maximum return. Since mode of actions can often be transferred between tumors, managing an Oncology agent is like a portfolio in itself. Managing multiple Oncology drugs can therefore become a daunting task. After Phase I, the available indication choices start becoming clearer as defined by the mode of action. Upon entering Phase II, companies then need to start forming their sequencing strategy which includes determining: How broad a therapeutic footprint they wish to pursue Whether to go for a speed-to-market or more comprehensive approach What sequence of indications will work best How the product can be differentiated and what clinical endpoints will be required The level of financial commitment needed in each scenario and whether the risk needs to be spread out

And, just as in other therapeutic areas, all of this must be evaluated within the context of the forecasted competitive intensity of the market and the size of the available population. Once a sequencing decision has been made companies can then determine what tumor indications are worthy of advancing into Phase III. While historically, large patient populations were the obvious first area for investment, today, one must also consider the payers' view of unmet need before selecting a path. Based on IMS research with payers, weve found that doing so changes the attractiveness of a number of tumor types, as illustrated in Figures 2 and 3. In both figures, tumor types are placed in quadrants according to the number of targeted therapies available (measured along the X axis). In Figure 2, the Y axis represents the number of available patients; in Figure 3, the payers perception of unmet need. Prostate cancer, for example, is in different quadrants in Figures 2 and 3 because while it has a large available patient population, payers perceive treatment needs to be well met.

FIGURES 2 & 3: TUMOR SEGMENTATION

FIG 2: Tumor Segmentation by Available Population FIG 3: Tumor Segmentation by Payer Need

HIGH

Limited alternatives and highly available population

HIGH

Numerous alternatives and highly available population

Limited alternatives and high unmet need

Bladder Cancer Ovarian Cancer Melanoma

NUMBER OF AVAILABLE PATIENTS*

Bladder Cancer Gastric Cancer

Colorectal Cancer NSCLC

PAYER PERCEPTION OF UNMET NEED

Prostate Cancer

Breast Cancer

Numerous alternatives however, unmet need remains for improved efficacy/safety

Colorectal Cancer

Limited alternatives, however, limitedly available population

Competitive landscape with limitedly available population

Limited alternatives, however, low unmet need Prostate Cancer Gastric Cancer Thyroid Cancer

Competitive landscape with limited unmet needs Renal Cell Carcinoma Breast Cancer Bone Metastases NSCLC

Melanoma Ovarian Cancer Thyroid Cancer Liver

Renal Cell Carcinoma

LOW

Pancreas

LOW

NUMBER OF TARGETED THERAPIES AVAILABLE

HIGH

LOW
LOW

NUMBER OF TARGETED THERAPIES AVAILABLE

HIGH

Source: *Based on Globocan prevalence

Source: Primary research with European payers

IMS HEALTH IMS ONCOLOGY LAUNCH EXCELLENCE STUDY

A CASE IN POINT: SUCCESS IN A NICHE MARKET THROUGH A TAILORED PHASE III PROGRAM
Pfizer successfully positioned Sutent in the renal cell carcinoma (RCC) market, in which there was high unmet need, by taking a non-traditional approach in its clinical trials. Pfizer sponsored Phase III trials that compared Sutent against an active comparator (rather than a placebo). The comparator was the current standard of care, interferon-a, against which Sutent showed an increased progression-free survival. In contrast, Bayer tested Nexavar against a placebo. Since Sutent had a strong value proposition, Pfizer employed a bold strategy, seeking, and gaining approval for first-line therapy from the outset. With follow-on studies, Pfizer demonstrated Sutents superior cost-effectiveness over three competitors, and rapidly became the clear market winner.

FIGURE 4: PATIENT EVOLUTION OF AVASTIN/SUTENT/NEXAVAR IN RCC

Patient Evolution of Avastin/Sutent/Nexavar in RCC (all stages)*

45,000 40,000 35,000

PROJECTED PATIENTS

30,000 25,000 20,000 15,000 10,000 5,000 0

Nexavar Launch

Sutent Launch

Q2 06

Q3 06

Q4 06

Q1 06

Q1 07

Q2 07

Q3 07

Q4 05

Q4 07

Q1 08

Q2 08

Q3 08

Q3 05

Q4 08

Q1 09

Q2 09

Q4 04

Q1 05

Q2 05

Avastin

Sutent

Nexavar

A. February 2007 FDA approves Sutent in first line based on Phase III trial results demonstrating increased progression-free survival (PFS)

B. June 2008 At American Society of Clinical Oncology (ASCO), Pfizer presents Phase III results, comparing Sutent with interferon alpha in untreated metastatic renal cell carcinoma (mRCC) patients, demonstrating overall survival (OS) of more than two years for the first time in mRCC

C. September 2008 Pfizer presents a cost-effectiveness trial comparing Sutent with Nexavar, Torisel and Avastin. Results show Sutent is more cost-effective in first line and provides better overall quality of life

Source: IMS Oncology AnalyzerTM (MAT QTRs) and IMS Knowledge link *Market includes U.S., EU5, Japan, Korea, China and Taiwan

IMS HEALTH IMS ONCOLOGY LAUNCH EXCELLENCE STUDY

Q3 09

Optimizing Clinical Trials The next hurdle will be to ensure that the right endpoints are built into the clinical trial plan. The clinical trial endpoints that will hold sway with payers depend upon payer perceptions of the unmet need and the number of targeted therapies available to treat a tumor type. One common thread is that payers want to see significant improvement in survival; however the definition of the word "significant" changes by tumor type. Today, payers regard response rate and time to progression as insufficient surrogate endpoints on which to base their reimbursement decisions. Overall Survival Measures of patients OS time gives payers the best grasp of a products value. Increasingly, payers require a demonstration of increased overall survival time, and it may be difficult to present a compelling health economic argument without it. So, what increase in survival time is sufficient? To achieve clear differentiation, particularly for tumor types where treatment alternatives exist, an increase of more than six months may be necessary; in areas of high unmet need, an increase of two-to-four months may be acceptable. Progression-Free Survival PFS statistics are usually considered surrogate endpoints for overall survival and are most acceptable for early-line therapies (payers expect companies to provide overall survival data at a later stage). Their acceptability, however, depends on the environment. In the EU and Japan, products supported only by PFS data may face access barriers, while in the U.S., they will likely be covered by payers.

DRIVER #2: MAKE THE RIGHT SEGMENTATION TRADE-OFFS Given how restrictive the market now is for some tumor types, one viable strategy that is gaining ground is to limit ones market to a sub-group of patients for whom the product produces a greater response rate and hopefully, also higher overall survival rate. Using biomarkers to segment the patient pool in this way, of course, means sacrificing a larger patient population for a stronger value proposition that translates into market access and, potentially, premium pricing. Bear in mind, though, that the alternative, aiming for a larger population, could fail to produce the necessary clinical endpoints and thus preclude you from gaining any market access. A strong value proposition, hence (easy) market access, will greatly enhance further indication approvals and possibly result in premium price reimbursement. The positive acceptance among the medical community will then rebalance the initial limitation of economic potential due to patient stratification. Therefore, in some tumor types, developing a biomarker early in the development cycle is a desirable priority, albeit a difficult one. One company representative likened developing a biomarker to developing another product, meaning that the process is that complex and also adds considerably to the overall cost of development. Advice from our interviewees on biomarkers includes: Examine the trends in physicians use of biomarkers in the selected market Think through how you can ensure correct use of the biomarker and make sure that it is practical and easy for physicians to adopt Consider the cost of the biomarker and who will pay for it Decide who will develop the biomarker (Can it be done in house, or should you partner with a diagnostics specialist?) Aim to have a biomarker as a competitive advantage against an existing gold standard treatment Consider foregoing a biomarker if the unmet need is high

IMS HEALTH IMS ONCOLOGY LAUNCH EXCELLENCE STUDY

A CASE IN POINT: THE VALUE OF A BIOMARKER IN THE COLORECTAL CANCER MARKET Amgen was the first company to show the use of Kirsten Rat Sarcoma (KRAS) mutation as a predictive biomarker for Epidermal Growth Factor Receptor (EGFR) metastatic colorectal cancer (CRC) and received approval in the EU for the use of Vectibix in patients with EGFR+ KRAS wild type CRC. The product was launched earlier in the U.S. without the benefit of a biomarker for EGFR+ patients, at a 20 percent discount over Erbitux, which was already on the market. ImClone/Merck Serono then followed with its own KRAS studies for Erbitux, confirming Amgens findings. In late 2008, both companies asked the U.S. Food and Drug Administration (FDA) to change their original labeling to limit the indication to KRAS wild type patients. Both products now are approved for the same type of patient population. Now, within this segment of patients, Erbitux has captured much more of the market than Avastin as second-line therapy, and both Erbitux and Vectibix outperform Avastin as third-line therapy (IMS Oncology Analyzer). FIGURE 5: EVOLVING ACCESS BARRIERS IN EU Evolving Access Barriers in EU

DRIVER #3: EMPLOY NOVEL APPROACHES TO GAIN PAYER ACCEPTANCE Even companies that have adopted successful lifecycle and segmentation strategies can meet with resistance from payers on their Oncology products. Universally, payers are struggling to find the balance between their desire to maintain access for patients and their need to control costs. On the one hand, they face political sensitivity and public pressure to make Oncology treatments available and they acquiesce. On the other hand, their budgets are constrained and must cover other therapy areas as well. The cost pressure is mounting for several reasons: the incidence of cancer is increasing, targeted therapies are expensive, and in some tumors, treatment is shifting from acute to more chronic care. Payers, therefore, employ a variety of tools some quite inventive to control pricing and market access and shift the risk to manufacturers. Payers in Europe have certainly become pioneers in this arena; today, the EU is one of the harshest payer environments for Oncology, both at a national and regional level. Figure 5 is a snapshot of management techniques used in the top-five European markets.

4
Regional restrictions Price

= In Place

= Future Impact

ONCOLOGY MANAGEMENT Health Technology Assessments Funding challenge Risk share agreements/ contracting Prescribing guidelines EVOLVING LANDSCAPE

ASMR ratings expected to become more challenging Extra-T2A budget cap and hospital payback scheme are increasing budget sensitivity at hospital level Stricter Authorisation Temporaire dUtilisation (ATU) (early marketing authorization) eligibility criteria Funding at regional level becoming a challenge Cost-effectiveness analyses, etc. Market access challenges now expected for all products

F
4 4 4

4 4 4 4 4 4 4 4
7

4 4

F
4

4 4 4

Regional differences in access are becoming the norm

Increasing requirement for proof-of-performance data and promotion of non-pharmaceutical treatments

IMS HEALTH IMS ONCOLOGY LAUNCH EXCELLENCE STUDY

Consequently, a product that is systematically reviewed across Europe can easily receive different outcomes from the clinical data analysis. Bayers Nexavar, for example, was recommended for coverage in France, Poland, Sweden, and the Netherlands (the latter with limitations), but denied in Denmark and the UK. What is more, the outcomes of the economic reviews by the assessors were more disparate still. Companies clearly need to prepare their dossiers to address the requirements and perspectives of individual countries. Each will have its own idea of what constitutes good value for the money. Trends in Risk Sharing For some companies, getting over the hurdles that payers construct has meant a further sacrifice through the use of risk-sharing agreements, whereby the manufacturer makes concessions if certain performance levels are not met or whereby the manufacturer limits the payers financial exposure. Risk-sharing agreements will continue to gain momentum, particularly in Europe, where the trend will be to follow the lead of Italy and the UK, the regions most restrictive markets. In Italy, risk-sharing agreements have been mandated since 2007, and in the UK, risksharing agreements have been employed in a number of launches. (See Fig. 6) FIGURE 6: DIFFERENCE IN YEARLY SALES
Difference in Yearly Sales in UK, 12 Months Post Risk-Sharing Agreement

At first glance, the dramatic lift in sales that products in the UK experienced (See Fig. 6) after entering into a risk-sharing agreement might suggest that the agreements were advantageous to the manufacturers in boosting sales. In reality, they simply made sales possible. In other words, the agreements gave products access that they would not otherwise have been granted. As one member of the industry commented, If we didnt enter into the risk-sharing scheme, we wouldnt really have a market here. We foresee that while risk-sharing will become more commonplace, the nature of the schemes will shift. Payers are eschewing schemes that require measuring patient response in favor of financial arrangements that amount to an upfront discount. These arrangements are much easier for all concerned to manage. There appears to be no avoiding it companies bringing new Oncology products to market need to be prepared to share some of the risk that payers bear, particularly in Europe. This rather harsh reality begs the question does sharing the risk, as payers are now demanding, render a launch in certain countries so unprofitable that they should be overlooked? Are some markets inconsequential enough, once the risk is shared, that they should be excluded from a global launch? Is this ethically and practically possible? The U.S. Payer Landscape In the U.S., the nature of the payer landscape, given that its being driven mostly by private insurers, means that companies are faced with different challenges than in Europe. Market access restrictions have traditionally been less stringent than in Europe and off-label use can often be reimbursed if there is a substantial body of evidence (compendia listed). However, commercial payer reviews have now become more cumbersome and private doctors offices are faced with highly bureaucratic processes, especially around submission of prior authorizations (PAs) for the use of oncologics in an on- or off-label setting. As a result, private office support in navigating this PA landscape has become an important part of a pharmaceutical companys approach to overcoming payer restrictions in the U.S..

45 40 35

76% 259% 164%

Yearly sales 12 months prior to scheme Yearly sales 12 months post-scheme Increase in yearly sales

YEARLY SALES (U.S. $BN)

30 25 20 15 10 5 0 SUTENT REVLIMID

59%

71%

VELCADE

TARCEVA

ERBITUX

Source: IMS Health MIDAS September 2010. Sales include all indications.

IMS HEALTH IMS ONCOLOGY LAUNCH EXCELLENCE STUDY

Out-of-pocket costs in the U.S. can also be a significant hurdle for about 20% of the patients, which can ultimately lead to a small percentage of overall patients (2-5%) changing either treatment setting or therapy. Product formulation is also a challenge as there are significant differences in reimbursement between orals and IVs, which can also limit product adoption. Once again, the support of pharmaceutical companies in running patient assistance programs, as well as early access programs, is a powerful tool in enabling patient access to treatment. Looking out into the future, the U.S. payer landscape is slowly following the footsteps of Europe and the arrival of U.S. healthcare reform will also contribute to that trend. Payer management is likely to become more restrictive for oncologics (increasing numbers of PAs) with an increased emphasis on comparative effectiveness and cost-shifting to patients. For pharmaceutical companies, this translates into more head-to-head trials and an increasing focus on biomarkers and demonstrating overall cost-effectiveness.

DRIVER #4: BUILD A STRONG ONCOLOGY FRANCHISE Another commonality among the successful launches we studied was the sponsor companies' investment in achieving a degree of prominence in the therapy area. They had or were focused on gaining a durable Oncology franchise. By this, we mean that they: Demonstrated a long-term commitment to Oncology Pursued ambitious goals Developed treatments across tumor types via multiple products/indications Established a reputation as a leading player in the field (which is perhaps more difficult in Oncology because oncologists themselves are so specialized that they may not see the breadth of what a company offers) This, in turn, gave them enviable access to key opinion leaders (KOLs), prescribers, and patients for clinical trials. Interestingly, few companies have gained such a presence; just three companies hold more than half of the value of the Oncology market. (See Fig. 7) Companies intending to enter the market face formidable competition from these market leaders and must aim to achieve their own critical mass in the market.

FIGURE 7: TOP GLOBAL ONCOLOGY FRANCHISES

Top Global Oncology Franchises Share of Sales* (Global sales = $47.2bn)
17% 2% 2% 2% 3% 4%

(Year of Launch) Avastin

35%

Mabthera
(1997)

Roche

(2004)

Herceptin
(1998)

Tarceva
(2004)

Novartis
8% 8%
Roche Lilly Takeda J&J

Glivec
(2001)

Tasigna Afinitor
(2007) (2009)

11% 8%
Novartis Sanofi MSD All others AstraZeneca Pfizer BMS

Arimidex AstraZeneca
(1995)

Zoladex
(1987)

Casodex
(1995)

Iressa
(2002)

Source: IMS MIDAS MAT September 2010 *Oncology defined as L1+L2 and limited to ethical, non-generic

IMS HEALTH IMS ONCOLOGY LAUNCH EXCELLENCE STUDY

However, with attention to the right factors (See Fig. 8), companies can break into the market and, over time, establish a leading franchise. Companies intending to strengthen their Oncology franchises must be mindful of these conditions: KOLs are themselves, customers. Given the small pool of oncologists, thought leaders in the field are more than usually influential, and engaging them in clinical trial design and expanded access programs is critical While payers are an important audience, their influence over prescribing decisions in Oncology has not overshadowed that of physicians, as it has in other therapeutic areas

Gaining access to physicians requires having the right talent and mix of medical and business skills on board. Increasingly, physicians prefer speaking with medical liaisons, given their deeper understanding of the science involved. As one person we interviewed explained, Its hard [for sales people] to get into the Oncology scene and understand the core dynamics Raising public awareness and inspiring brand advocacy is crucially important. Involvement of society beyond patient support groups and use of a battery of media outlets should become standard operating procedure. The future of Oncology lies at a conceptual, rather than at a drug level; concept not just pill

FIGURE 8: KEY SUCCESS FACTORS

Key Success Factors for an Oncology Franchise

VERBATIMS*

SUB-NATIONAL KOL MANAGEMENT

Small pool of oncologists and key thought leaders remain an influential, but increasingly selective, customer Engagement at local level via clinical trial design cooperation and expanded access programs are key success factors

For a small company like us, with little experience in Oncology, the focus was on creating goodwill with physicians

BALANCE TALENTS & ORGANIZATION

Importance of attracting the right Oncology-specific talent (e.g. medics for clinical development and medical liaisons) and balance with state-of-the-art management skills

Its hard to get into the Oncology scene and understand the core dynamics

ESTABLISH SOCIAL PUBLIC RELATIONS

Active involvement of patients and comprehensive use of media channels is crucial in order to help raise social awareness and push brand advocacy

More effort should have been spent on patient support groups and incorporation of their recommendations

NEW GO-TO-MARKET MODEL

Source: *IMS Oncology Launch Excellence interviews

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IMS HEALTH IMS ONCOLOGY LAUNCH EXCELLENCE STUDY

Case Study
A CASE IN POINT: NOVARTIS BUILDS A WORLD-RENOWNED FRANCHISE OVER A DECADE Novartis, now the second largest player in the global The company published Phase I results for Glivec Oncology market, was a newcomer to Oncology and generated an avalanche of public interest. With when it launched Glivec as first-line treatment for all of this media coverage, Glivec was a success chronic myeloid leukemia (CML) in 2000. Howd before it even launched they do it? Through a number of bold strategic moves In 2000, Novartis set up an expanded access and absolute commitment that made the most of program, enrolling 7,000 patients in 32 countries. Glivecs potential The product, on the FDA Fast Track list, was given The company, with the help of a noted oncologist/ accelerated approval and priority review researcher, established CML as the key indication for Novartis sought other indications for Glivec, Glivec, even though CML is a rare disease and had including the treatment of gastrointestinal tumors received limited medical attention (an example of The company then tailored its commercial model to the niche market/high unmet need discussed above) accommodate Tasigna, another treatment for CML. Novartis took the unusual step of altering the Initially, Novartis launched Tasigna as second-line formulation (from continuous infusion to oral) while treatment, so that it did not cannibalize Glivec sales. Glivec was in Phase I. This addressed patient But with Glivec's patent expiration looming, concerns and raised the value proposition of the Novartis began preparing Tasigna to become the drug new standard of care. The results of a head-to-head To aid clinical trial enrollment, Novartis convinced trial with Glivec proved Tasignas superiority, and Tasigna was approved as first-line treatment for key cancer centers in the U.S. to participate in the newly diagnosed patients. Novartis is now first CML Phase I clinical trials and used the undertaking multiple clinical trials to determine how Internet (a new social medium at the time) to best to switch patients from Glivec to Tasigna involve patient support groups

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Conclusion
Companies with a strategic focus on Oncology must accept the fact that the market has changed, with many tumors maturing and payers using new criteria to evaluate treatments. Success in Oncology requires new levels of both clinical leadership and commercial savvy. From our observation, discussions, and analysis, weve determined that the most successful Oncology launches all share the following characteristics: An investment strategy that maximizes returns using the best entry route and carefully considered indication sequencing A strategy for developing a patient profile that makes the right trade-offs between the benefits/drawbacks of targeting large patient populations versus sub-segments, which will drive the increasing need for biomarkers A realistic understanding of what payers in different countries are prepared to pay for and a flexible approach to meeting their criteria to maximize the possible access by country The positive halo that emanates from being part of an established and well-regarded Oncology franchise To enjoy the combined benefit of all four success factors, companies have to appreciate the unique timelines of preparation both pre- and post-launch and must begin working on the first three of these goals as early as Phase II. A successful Oncology launch requires companies to make more major investment decisions, earlier, and in a highly fluid and uncertain environment; a highly effective scenario evaluation and risk management strategy is absolutely essential. Companies also need to be more attuned to a countrys Oncology stakeholders than ever before, and to have a customer-facing organization with strong cross-functional integration to ensure a completely holistic approach to stakeholder management. Over time, mastering these areas will help develop a public image as a leader in Oncology but the journey is not over. Companies must remember that maintaining that reputation requires continual maintenance even post-launch.

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IMS HEALTH IMS ONCOLOGY LAUNCH EXCELLENCE STUDY

Appendix
THE STUDY APPROACH The IMS Oncology Launch Excellence Study combines both quantitative and qualitative findings. We analyzed the launch approaches and market results of 16 of the most influential launches for targeted therapies across 10 countries (U.S., Japan, Germany, France, China, Italy, Spain, UK, Korea,Taiwan), observing what has worked and what hasnt. The quantitative findings reflect sales results reported in IMS MIDASTM and from IMS Oncology Analyzer, which presents patient numbers and brand penetration by tumor type, disease stage, and line of therapy. The qualitative conclusions are drawn from interviews conducted with senior executives in R&D companies and within IMS. All have extensive experience in Oncology and were forthright in offering their views. The IMS Oncology Launch Excellence Study analyzed launch approaches and market results for the following products:

Avastin Erbitux Glivec Herceptin

Iressa Mabthera Nexavar Revlimid

Sprycel Sutent Tarceva Tasigna

Tykerb Vectibix Velcade Yondelis

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IMS Specialty Solutions

TM

Our Oncology offerings are part of IMS Specialty Solutions - a portfolio of next-generation market intelligence all focused exclusively on specialty markets.

With a full continuum of information assets, analytics and consulting services, IMS Specialty Solutions empowers clients to make more confident, evidence-based commercial decisions, faster and with greater efficiency.

IMS Capabilities in Launch Excellence

Our proven framework leveraged successfully with more than 50 launch teams ensures best-in-class diagnostics, planning and tracking for optimal launch performance. With an offering built on deep functional knowledge and expertise in more than 90 therapy areas, we combine the skills and experience of 1,700 IMS consultants across the launch spectrum, to drive best practice launch execution and internal change management for our clients.

About the Authors

DR. WOLFRAM LUX Principal, Management Consulting, IMS Health Wolfram is focusing on Launch Excellence projects on a global scale. Being a molecular biologist and chemist by training Wolfram started his career as a management consultant focusing on in-licensing and risk management. He then joined Scherings Oncology business before joining the IMS Management Consulting team in 2007 where he led the European Oncology Business Unit from 2009. NIKOLAOS KONTOS Consultant, Thought Leadership, IMS Health Nikolaos is a consultant on the Thought Leadership team, responsible for creating industry viewpoints on a wide range of issues and therapy areas. In his role, Nick has worked on a variety of initiatives primarily in specialist areas and with a particular focus on Oncology. Nick holds a Masters degree in Biochemical Engineering from University College London, in the UK.

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IMS HEALTH IMS ONCOLOGY LAUNCH EXCELLENCE STUDY

Companies with a strategic focus on Oncology must accept the fact that the market has changed, with many tumors maturing and payers using new criteria to evaluate treatments. Success in Oncology requires new levels of both clinical leadership and commercial savvy.

ABOUT IMS

IMS HEALTH CORPORATE HEADQUARTERS IMS Health 901 Main Avenue, Suite 612 Norwalk, CT 068511187 USA Tel: 203.845.5200 www.imshealth.com

IMS Health is the leading provider of information services for the healthcare industry around the world. The company draws on its global technology infrastructure and unique combination of in-depth, sophisticated analytics, on-shore and off-shore commercial services, and consulting platforms to help clients better understand the performance and value of medicines. With a presence in 100+ countries and more than 55 years of industry experience, IMS Health serves leading decision makers in healthcare, including pharmaceutical manufacturers and distributors, providers, payers, government agencies, policymakers, researchers and the financial community. Additional information is available at http://www.imshealth.com.

2011 IMS Health Incorporated or its affiliates. All Rights Reserved.

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