Stakeholder Insight: Rheumatoid Arthritis Biologics battle up the treatment algorithm

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1 A Datamonitor report Stakeholder Insight: Rheumatoid Arthritis Biologics battle up the treatment algorithm Published: Sep-06 Product Code: Providing you with: Disease overview including epidemiology, physician estimated diagnosis rates and split, including mild to severe and early active disease Breakdown of treatment trends in the following markets: US, Japan, France, Germany, Italy, Spain and the UK Use this report to... Gain access to estimated treatment class patient numbers allowing the forecast of product use across the seven major markets PCPs and rheumatologists surveyed to capture the treatment of the ranging severities with traditional NSAIDs, COX-2s, traditional and biologic DMARDs Brand assessment on key attributes of the following products: Enbrel, Remicade, Humira, Orencia, Rituxan/MabThera, Kineret and methotrexate

2 Stakeholder Insight: Rheumatoid Arthritis Biologics battle up the treatment algorithm Introduction Rheumatoid arthritis is a debilitating and life-long disease that is estimated to affect approximately five million people in the seven major markets. The launch of anti-tnf products over six years ago and more recent novel target biologic therapies have added significantly to the treatment options, but have resulted in a crowded market for moderate to severe patients. Data from clinical trials suggests the early use of DMARDs results in a better clinical response, creating a new patient segment target for these therapies. However, the particularly conservative rheumatology community and key cost issues mean that these treatments are just beginning to move up the treatment algorithm. Key findings and highlights Inclusion of relevant early active RA patients in clinical studies will assist timely approval in this indication, increasing the patient base for any RA product. Definition of 'early' RA requires a balance between the physician ideal of less than 12 months, giving the best patient response, and capturing a substantial proportion of the market. Physicians estimate nine months from disease onset to diagnosis. 25 per cent of RA patients are estimated to be severe, and take an average of four months before the first DMARD is prescribed, being methotrexate in 60 per centof physicians. It can be months before a severe patient is likely to use a biologic. Anti-TNF therapy is expected to continue to dominate first-line biologic use. Humira is perceived to be the most effective in terms of disease modification, indicating a very positive future status for this brand, but Remicade and Kineret could lose the brand battle if perception on certain attributes doesn't improve. Reasons to buy Use estimated treatment class patient numbers to forecast product use across the seven major markets Exploit physician perceptions of key product brands on clinical and market attributes, to differentiate products in the crowded rheumatoid arthritis market Understand differential treatment in niche populations such as severe and early active rheumatoid arthritis For more information... Contact Ben Greener, CLIENT SERV MNGR tel: fax: hcmarketing@datamonitor.com

3 Sample pages from the report Country Treatment Trees US Figure 2: US RA patient population, split by physician-estimated diagnoses, disease, drug-treated RA Population 3,010,000 Diagnosed 58.3% 1,754,000 Mild Moderate Severe Early Active 37.4% 39.9% 22.8% 42.7% 656, , , ,000 Drug Nondrudrudrudrug Both Drug Non- Both Drug Non- Both Drug Non- Both 51.7% 17.5% 30.8% 31.3% 3.1% 65.7% 26.5% 0.3% 73.3% 44.4% 17.1% 38.5% Total drug treated Total drug treated Total drug treated Total drug treated 82.5%, 541, %, 678, %, 399, %, 621,000 Class Class Class Class Analgesic Analgesic = 37.4% Analgesic = 21.0% Analgesic = 16.8% = 29.0% NSAID = 47.8% NSAID = 59.3% NSAID = 62.8% NSAID = 48.8% Cox-2 = 14.6% Cox-2 Cox-2 = 17.9% Cox-2 = 24.9% Weighting = 12.9% DMARD = 32.9% DMARD = 20.8% DMARD = 41.3% DMARD = 60.3% Biologic = 9.0% Biologic = 0.0% Biologic = 7.4% Biologic = 18.2% Steroid = 20.4% Steroid = 13.2% Steroid = 39.9% Steroid = 51.9% Opioids = 1.2% Opioid = 2.9% Opioid = 4.9% Opioid = 18.3% Disease Stakeholder Insight Source: Rheumatoid Arthritis, Q1.1, Q1.3, Q2.1, Q2.4, Q2.7, Q2,8, Q2.9 D A T A M O N I T O R modification Brand Assessment Side-effect Stakeholder Insight: Rheumatoid Arthritis Datamonitor (Published 09/2006) Page 18 Speed of This report is a licensed action product and is not to be photocopied) that pain relief is significantly more important for traditional products than for biologics. Figure 43: Average influence on prescribing decision: weightings assigned by surveyed physicians to key attributes for biologic and traditional DMARDs Biologics Traditional DMARDs Pain relief Formulary/ reimbursement Ability to combine Drug delivery Diagnosis and Treatment Options Dosing frequency Comorbidities Attribute CHAPTER 5 DIAGNOSIS AND TREATMENT OPTIONS Source: Stakeholder Insight Rheumatoid Arthritis, Q3.1 D A T A M O N I T O R Compliance The purpose of this chapter is to give an overview of treatment pathways for RA by An opinion leader s comment correlated with the results: identifying how patients are diagnosed, the treatment modality options, referral patterns and physician involvement by specialty. Disease modification efficacy, I think is most important and then side effects. To be perfectly honest it would be hard to actually rank the others after those two. Those two are by far the most important; Presentation all the and diagnosis lower than in previous others are vastly inferior in regards to importance as compared Datamonitor to those surveys two. Physicians were asked to estimate the percentage of RA patients diagnosed in their country. EU As KOL Table 8 shows, interviewed physicians believe that just under two-thirds of patients suffering from RA have been diagnosed. Some country variance does exist in assigning importance to these 10 attributes. For example, in Japan pain relief is estimated by the physicians interviewed Table to 8: be morediagnosed RA patients, physician-estimated, by country important than disease modification and side effects for traditional DMARD therapies, but less important for biologic treatments. In Italy disease modification is the dominant prescribing influence for traditional therapies, with 36% of the allocated points. The Total US Japan France Germany Italy Spain UK EU countries in general show a unified trend towards the influence Mean of attributes % of diagnosed in biologic prescribing, which is similar to the US, leaving Japan as an outlier. RA patients Stakeholder Insight: Rheumatoid Arthritis Source: Stakeholder Insight Rheumatoid Arthritis, Q1.1 D A T A M O N I T O R Datamonitor (Published 09/2006) Page 89 This report is a licensed product and is not to be photocopied) When asked exactly the same question in 2003 during a previous Datamonitor survey, physicians estimated the average percentage of diagnosed RA sufferers at 72% (Datamonitor, Stakeholder Insight: Rheumatoid Arthritis, Dec 2003, DMHC1908). However, the general trend across countries was similar to the data collected here, in 2006, with German physicians consistently estimating the lowest diagnosis rate. The differences between the estimates may be due simply to the different sample, but many changes have taken place in the RA market during this time, including high-profile product launches, which should have increased awareness of the disease. Indeed, opinion leaders interviewed by Datamonitor agreed that the 2006 diagnosis figure may be a bit low: I would have put it a little bit higher, maybe about 66% or two thirds but I think we re still in the ballpark. US KOL Stakeholder Insight: Rheumatoid Arthritis Datamonitor (Published 09/2006) Page 52 This report is a licensed product and is not to be photocopied)...the anti-tnf agents are generally first choice biologic agents, Orencia is generally a third or fourth agent and rituximab might even be a fifth agent... Key US Opinion Leader, Stakeholder Insight: Rheumatoid Arthritis Biologics battle up the treatment algorithm

4 Stakeholder Insight: Rheumatoid Arthritis Biologics battle up the treatment algorithm Table of contents EXECUTIVE SUMMARY Scope of the analysis Datamonitor insight into the rheumatoid arthritis market INTRODUCTION AND SCOPE What is rheumatoid arthritis (RA)? How is it treated? Coverage of the Stakeholder Insight Survey - Country level "treatment trees" - Supporting data sets COUNTRY TREATMENT TREES US Japan France Germany Italy Spain UK EPIDEMIOLOGY AND PATIENT SEGMENTATION Definition of the disease Epidemiology of rheumatoid arthritis Key patient segmentations - Disease shows an even split among mild and moderate disease, with fewer severe patients - Early active RA should be defined as less than one-year duration for maximum patient benefit Co-morbidities, complications and risk factors - Hypertension, elevated cholesterol and, to a lesser extent, heart attacks are common in RA patients - Osteoporosis is also common, but likely to be due to long-term steroid use - Depression is two to three times greater in RA patients than in the general population - Other co-morbidities include additional autoimmune diseases and stomach ulcers DIAGNOSIS AND TREATMENT OPTIONS Presentation and diagnosis lower than in previous Datamonitor surveys Treatment types - Pharmacological and non-pharmacological therapy is often used in combination for moderate and severe patients - Use of combination drug therapy also increases with - NSAIDs, analgesics and traditional DMARDs are the most commonly prescribed drug classes Treatment options Treatment guidelines Referral patterns - Direct consultation, or referral, for rheumatologists? - The next referral move PRESCRIBING TRENDS NSAID prescribing trends - The most commonly-used NSAID molecule is diclofenac - Use of NSAIDs and COX-2s since the withdrawal of Vioxx - High, and possibly inappropriate, co-prescription of a gastro-protective agent with NSAIDs - Use of NSAIDs before and in combination with DMARDs Traditional DMARD prescribing trends - Methotrexate most commonly used as first-line therapy - Infection and inadequate response are the main reasons for switching BRAND ASSESSMENT Factors influencing physician decision making - Disease modification and side-effects are the most important factors to prescribing physicians Biologic DMARD brand assessment - Biologic DMARD overview shows Enbrel leads in terms of total brand sales for all indications - Interpreting a brand map IMPROVING TREATMENT OUTCOMES Treatment outcomes - Physician patient conversation is the most commonly used outcome measure in the clinic - Expected outcome measures before and after anti- TNF treatment don't always correlate with published data - Compliance rates improve with disease Unmet needs For more information... Contact Ben Greener, CLIENT SERV MNGR tel: fax: hcmarketing@datamonitor.com

5 - Efficacy and side-effects are key, but other challenges should also be addressed by the pharmaceutical industry APPENDIX A Bibliography - Other sources and websites APPENDIX B Physician research methodology - Physician sample breakdown - US - Japan - France - Germany - Italy - Spain - UK Contributing experts APPENDIX C TABLES Table 1: RA patient population, 2006 Table 2: Point prevalence of RA, by age and sex, per 100 patients in Norfolk UK study, 2002 Table 3: Estimated RA population based on population aged >60: CAGR for each country, Table 4: RA disease as a percentage of total diagnosed RA population, by country Table 5: Physician-estimated proportion of patients defined has having early active RA, by country Table 6: Proportion of patients defined has having early active RA, by physician specialty Table 7: Percentage of RA patients with each comorbidity, by country Table 8: Diagnosed RA patients, physician-estimated, by country Table 9: Number of months from symptom onset to presentation to physician Table 10: Percent of patients receiving pharmacological versus non-pharmacological treatment, by country Table 11: Pharmacological versus non-pharmacological treatment, by physician specialty and percentage of diagnosed patients Table 12: Percentage of patients on each number of drugs, by and by country Table 13: Percentage of patients receiving each drug class, by Table 14: Number of physicians using each set of guidelines, by physician specialty Table 15: Percentage of mild, moderate and severe RA patients referred on to another physician, by specialty Table 16: Percentage of physicians referring to each specialty, by country Table 17: Percentage of patients receiving each NSAID molecule, by Table 18: Action taken on traditional NSAID prescribing, percentage of physicians, by country, Table 19: Action taken on COX-2 prescribing, percentage of physicians, by country Table 20: Average length of time RA patients are given only an analgesic/ anti-inflammatory before being prescribed a DMARD, in months, by and country Table 21: Percentage of RA patients taking analgesic or anti-inflammatory treatment in addition to a DMARD, by and country Table 22: Percentage of patients on traditional DMARDs receiving key molecules, by country and Table 23: Number and percentage of physicians able to rate each brand Table 24: Comparative erosion and joint space narrowing (JSN) scores after 12 months, found in prescribing information, by brand Table 25: Efficacy comparison among key brands Table 26: Key biologic brand characteristics Table 27: Methotrexate's attribute scores, by country Table 28: Enbrel's attribute scores, by country Table 29: Remicade's attribute scores, by country Table 30: Humira attribute scores, by country Table 31: Kineret attribute scores, by country Table 32: Orencia's attribute scores, by country Table 33: Rituxan/MabThera's attribute scores, by country Table 34: Healthy ESR values Table 35: Commonly used outcome measures, by country Table 36: Average expected outcome measures before and after anti-tnf therapy Table 37: Published anti-tnf impacts on key outcome measures Table 38: Average VAS before and after anti-tnf therapy Table 39: Rheumatologist estimates of 28 tender and swollen joint counts before and after anti-tnf therapy Table 40: Compliance estimates by disease...the development of new treatments needs to incorporate the 'real world' RA patient who is likely to be hypertensive (33%) and may also suffer from stomach ulcers (12%) and depression (24%)... Datamonitor Analyst, Stakeholder Insight: Rheumatoid Arthritis Biologics battle up the treatment algorithm

6 Stakeholder Insight: Rheumatoid Arthritis Biologics battle up the treatment algorithm Table 41: Importance of challenges facing the RA market, by country Table 42: US physician sample breakdown, 2006 Table 43: Japan physician sample breakdown, 2006 Table 44: France physician sample breakdown, 2006 Table 45: Germany physician sample breakdown, 2006 Table 46: Italy physician sample breakdown, 2006 Table 47: Spain physician sample breakdown, 2006 Table 48: UK physician sample breakdown, 2006 FIGURES Figure 1: Overview of the coverage of Stakeholder Insight: Rheumatoid Arthritis survey, 2006 Figure 2: US RA patient population, split by physicianestimated diagnoses, disease, drugtreated Figure 3: Key NSAID, traditional DMARD and biologic DMARD molecules used in the US, by disease Figure 4: US treatment algorithm from onset of Figure 5: Japan RA patient population, split by estimated diagnoses, disease, drug-treated Figure 6: Key NSAID, traditional DMARD and biologic DMARD molecules used in Japan, by disease Figure 7: Japanese treatment algorithm from onset of Figure 8: France RA patient population, split by physician-estimated diagnoses, disease, drug-treated population and drug-class usage Figure 9: Key NSAID, traditional DMARD and biologic DMARD molecules used in France, by disease Figure 10: France treatment algorithm from onset of Figure 11: Germany RA patient population, split by physician-estimated diagnoses, disease, drug-treated population and drug-class usage Figure 12: Key NSAID, traditional DMARD and biologic DMARD molecules used in Germany, by disease Figure 13: Germany treatment algorithm from onset of Figure 14: Italy RA patient population, split by physicianestimated diagnoses, disease, drugtreated Figure 15: Key NSAID, traditional DMARD and biologic DMARD molecules used in Italy, by disease Figure 16: Italy treatment algorithm from onset of Figure 17: Spain RA patient population, split by physicianestimated diagnoses, disease, drugtreated Figure 18: Key NSAID, traditional DMARD and biologic DMARD molecules used in Spain, by disease Figure 19: Spain treatment algorithm from onset of Figure 20: UK RA patient population, split by physicianestimated diagnoses, disease, drugtreated Figure 21: Key NSAID, traditional DMARD and biologic DMARD molecules used in UK, by disease Figure 22: UK treatment algorithm from onset of Figure 23: Percentage of physicians with RA patients who have at least one co-morbidity Figure 24: Prevalence of hypertension in US RA patients, 2004 Figure 25: Treatment algorithm for RA Figure 26: Percentage of physicians using each set of guidelines, by country Figure 27: Number of physicians using different guidelines, by specialty Figure 28: Percentage of patients consulting a rheumatologist directly or via referral, by country For more information... Contact Ben Greener, CLIENT SERV MNGR tel: fax: hcmarketing@datamonitor.com

7 Figure 29: Percentage of mild, moderate and severe RA patients referred on to another physician, by specialty Figure 30: Percentage of physicians that refer to each specialist type, split by PCPs and rheumatologists Figure 31: US NSAID/COX-2 quarterly prescriptions (Rx), Figure 32: Percentage of drug-treated RA patients receiving celecoxib and etoricoxib, by country Figure 33: Trend in prescribing of NSAIDs and COX-2s after the withdrawal of Vioxx Figure 34: Results of Jack Cush's US physician survey, November 2005 Figure 35: Decision tree for physicians treating arthritis patients developing GI complications with NSAIDs Figure 36: Percentage of NSAID-treated patients also receiving a gastro-protective agent, by country and by physician specialty Figure 37: Co-prescription of a PPI with an NSAID, comparing RA to all indications, % RX-Days, 2005 Figure 38: Percentage of RA patients using NSAIDs (including COX-2s), by physician specialty and by disease Figure 39: Most commonly used traditional DMARD molecules, by disease Figure 40: Number of months a patient will be continued on DMARD therapy before moving to the next line of therapy, by country and by physician specialty Figure 41: Percentage of physicians using DMARD molecules at each line of therapy Figure 42: Percentage of patients on biologics switching or terminating therapy, and key reasons Figure 43: Average influence on prescribing decision: weightings assigned by surveyed physicians to key attributes for biologic and traditional DMARDs Figure 44: Biologic and traditional DMARD attribute weightings assigned by physicians, by country Figure 45: Comparative erosion and JSN scores, by brand Figure 46: Physicians' scores of disease-modification efficacy, by brand Figure 47: Importance of side effects to prescribing of biologic and traditional DMARDs, by country and by physician specialty Figure 48: Physicians' scores of side effects, by brand Figure 49: Comparative ACR 20, 50 and 70 scores for biologic therapies based on their prescribing information Figure 50: Physicians' scores for therapeutic efficacy attributes, by brand Figure 51: Importance of reimbursement/formulary status to prescribing of biologic and traditional DMARDs, by country and by physician specialty Figure 52: Importance of dosing frequency and delivery method to prescribing of biologic and traditional DMARDs, by country and by physician specialty Figure 53: Total biologics brand sales, seven major markets, $m Figure 54: Comparison of total scores for all brands rated, by country and specialist Figure 55: Total score for each brand across the seven major markets Figure 56: Overview brand map of attributes versus brand perception Figure 57: Physician perception of the anti-tnf inhibitors Figure 58: Enbrel map, country preference to prescribing attributes Figure 59: Remicade map, country preference to prescribing attributes Figure 60: Humira attribute scores Figure 61: Kineret attribute scores Figure 62: Orencia attribute scores Figure 63: Rituxan/MabThera attribute scores Figure 64: Patient assessment form, American College of Rheumatology Figure 65: Physician's global assessment Figure 66: Commonly used outcome measures, by specialist Figure 67: Comparison between survey results for expected improvement in disease activity measures after anti-tnf and prescribing information data Figure 68: Average VAS before and after anti-tnf therapy Figure 69: Swollen and tender joint count assessment Figure 70: Compliance estimates by disease Figure 71: Reasons why patients do not fill prescriptions or comply with drug regimes, 2002 Figure 72: Importance of challenges facing the RA market Figure 73: IFPMA clinical trials portal For more information... Contact Ben Greener, CLIENT SERV MNGR tel: fax: hcmarketing@datamonitor.com

8 Stakeholder Insight: Rheumatoid Arthritis Biologics battle up the treatment algorithm Datamonitor: Your total information solution Datamonitor is a premium business information company helping 5,000 of the world's leading companies across the Automotive, Consumer Markets, Energy, Financial Services, Healthcare and Technology sectors. Our products and services are specifically designed to support our clients key business processes from corporate strategy to competitive intelligence. We provide an independent and trustworthy source of data, analysis and forecasts to improve these processes and ultimately, to help grow your business. Corporate Strategy & Business Planning Quality Data Make more effective strategic and business decisions Product Development & Commercialization Targeting & Influencing the Market Expert Analysis Accelerate delivery of commercial success Assess and influence your commercial and market environment HELPING TO GROW YOUR BUSINESS Market & Competitive Intelligence Future Forecasts Maintain or obtain critical competitive advantage Nothing speaks louder than our clients 3M Abbott Accenture Alcon Labs Allergan Almirall-Prodesfarma Altana Pharma AG Amersham Amgen Amrad Angelini Acraf Astellas AstraZeneca AT Kearney Baxter Bayer Healthcare AG Beaufour Ipsen Biochemie Biogen Idec Boehringer Ingelheim Boots Bristol-Myers Squibb Cantab Caremark International Chiesi Chiron Chugai CMC Co Daiichi Deutsche Morgan Grenfell Elan Eli Lilly Esteve Flamel Fournier Gehe Genzyme Gilead Gist Brocades GlaxoSmithKline IBM Immuno AG Johnson & Johnson Jouveinal LEK Lipha Lundbeck Merck KGaA Merck & Co Millennium Pharmaceuticals Nabi Biopharmaceuticals Novartis Novo Nordisk Pfizer Pharmachemie Pierre Fabre Pliva Procter & Gamble Ranbaxy Recordati Sankyo sanofi-aventis Schering AG Schering-Plough Schwarz Pharma AG Serono Shire Pharmaceuticals Solvay Pharmaceuticals Takeda TAP Pharmaceutical Teva UCB Uriach Vernalis Viatris Wyeth...89% of our clients use Datamonitor research to develop competitive intelligence... Source: Datamonitor Customer Research

9 Also available in this portfolio Stakeholder Opinions: Osteoarthritis Preconceptions damage awareness and treatments Key issues in osteoarthritis therapy, including unmet needs, current treatment controversies, advancements in patient involvement and clinical trial end-points, and novel therapies in the developmental pipeline. Published: Mar-06 Product code: DMHC2162 Commercial Insight: Disease Modification in Rheumatoid Arthritis The biologics boom Detailed analysis of the Disease Modifying Anti-Rheumatic Drugs (DMARDs) on the market, including an assessment of country specific events and company strategies. Includes an indication specific ten-year forecast for key products. Published: Dec05 Product code: DMHC2146 Juvenile Arthritis A Niche In The Market This brief provides clarification and definitions for the key juvenile arthritis indications. The key drug classes used to treat juvenile arthritis are described and the recently published trial data and treatment guidelines are summarized. Published: Dec-05 Product code: BFHC0717 Pipeline Insight: Disease Modification In Rheumatoid Arthritis Pipeline uptake inhibited by Anti-TNFs Detailed analysis of Disease Modifying Anti-Rheumatic Drugs (DMARDs) in the pipeline, including an assessment of the latest trial data and clinical strategies. Includes an indication specific ten-year forecast for future key products. Published: Oct-05 Product code: DMHC2141 Event Analysis and Response Service: Cox-2s - Cox-2 Crisis Dents Big Pharma Confidence This report is a collation of short statements that were published across a six-month time period in response to changing events in the Cox-2 market. It concisely analyzes the events leading up to and following the Vioxx withdrawal. Published: Jun-05 Product code: DMHC2105 For more information about our products visit Subscribe to Healthcare Monitor A monthly update of the latest Healthcare products, events, news and special offers from Datamonitor delivered to you by . To subscribe your contact details to hcmonitor@datamonitor.com with subscribe in the subject line.

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