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Pulmonary Arterial Hypertension (PAH) Survey By MedPanel, Inc. August 18, 2006

Pulmonary Arterial Hypertension (PAH) Survey By MedPanel, Inc. August 18, 2006. Contents Project Objective 2 Methodology & Sample 3 Executive Summary 4 - 6 Detailed Findings 7 - 20. Study Objectives. Primary Objective:.

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Pulmonary Arterial Hypertension (PAH) Survey By MedPanel, Inc. August 18, 2006

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  1. Pulmonary Arterial Hypertension (PAH) SurveyBy MedPanel, Inc.August 18, 2006

  2. Contents • Project Objective 2 • Methodology & Sample 3 • Executive Summary 4 - 6 • Detailed Findings 7 - 20

  3. Study Objectives Primary Objective: • To understand current perceptions and usage as well as the future potential of Tracleer (bosentan) in the treatment of PAH Specific Objectives: • To assess current physician opinion and prescribing practices of Tracleer (bosentan) for PAH • To evaluate current patient perceptions of Tracleer (bosentan) • To estimate future use of Tracleer (bosentan) given availability of emerging agents for PAH

  4. Methodology and Sample • Survey Specifics: • A 20-minute self-administered survey was fielded online via MedPanel’s website from August 14, 2006 – August 16, 2006. • Sample: • The sample consists of 41 Pulmonologists from across the US • Respondents were required to meet the following criteria: • Be board-certified in their specialty (Pulmonology) • Be in practice between 3 and 30 years (Mean: 13.6 years) • Spend at least 75% of their professional time in clinical practice (Mean: 95%) • Manage at least 10 PAH patients per month (Mean: 19 / Range: 10-50) • Currently prescribe Tracleer

  5. Executive Summary

  6. Executive Summary Section 1: Current Treatment • Tracleer monotherapy (41%) and Revatio monotherapy (26%) are the two most commonly prescribed treatments for PAH. • Of the PAH patients who are treated with Revatio, almost half receive the agent as a monotherapy. • Twenty-four percent of patients treated with Tracleer choose to end treatment. • Elevated liver enzymes and disease worsening are the most common reasons to end Tracleer treatment. • Pulmonologists report adding Revatio to greater than fifty percent (56%) of PAH patient who progress on Tracleer • Flolan is also used as a potential alternative treatment Section 2: Potential Future Treatment • Upon FDA approval, Thelin is likely to be prescribed to over forty percent (41%) of newly diagnosed PAH patients. • If Thelin and ambrisentan were both FDA approved, pulmonologists report that the agents would be prescribed to thirty (31%) and twenty percent of newly diagnosed patients, respectively. • Tracleer’s efficacy profile is rated similar to that of ambrisentan. However, when compared to Tracleer in terms of side effects, ambrisentan receives a higher rating.

  7. Executive Summary Section 2: Potential Future Treatment (continued) • Pulmonologists show a willingness to switch patients with elevated enzymes to the new agents; they report a slightly higher likelihood to switch to ambrisentan compared to Thelin, For patients who deteriorate on Tracleer, pulmonologists are also likely to switch to new agents; they do not indicate a preference for either agent. • The lower incidence of liver toxicity and overall safety profile are the most common reasons for pulmonologists to switch from Tracleer to Thelin. • The major reasons to switch to ambrisentan include: 1) Lower incidence of liver toxicity 2) Attempt to use an alternative treatment. • Surveyed physicians indicate a likelihood of Tracleer data being extrapolated to Thelin or ambrisentan.

  8. Detailed Findings

  9. Section 1: Current Treatment

  10. Section 1: Current Treatment Tracleer monotherapy is used to treat more than forty percent of PAH patients; Revatio monotherapy is prescribed to approximately one-fourth of PAH patients. Current Treatments (n=41) 1.What proportion of your PAH patients do you currently treat with the following therapies? Please make sure your responses sum to 100%.

  11. Section 1: Current Treatment According to over half of the surveyed pulmonologists, forty-four percent of patients treated with Revatio receive Revatio as a monotherapy Patients Receiving Revatio Monotherapy (n=27) 2.Of the patients you treat with Revatio, what proportion receives this drug as monotherapy?

  12. Section 1: Current Treatment Twenty-four percent of patients who take Tracleer choose to end treatment; elevated liver enzymes and disease worsening are the most common reasons patients to end treatment. Reasons to End Treatment (n=36) 3.Of your patients treated with Tracleer (bosentan), approximately what percentage chose to end treatment? 4.Of your patients who chose to end treatment with Tracleer (bosentan), what proportion ended treatment for each of the following reasons?

  13. Section 1: Current Treatment Pulmonologists indicate that they add Revatio for over half of PAH patients who progress on Tracleer. Flolan monotherapy or combination therapy with Tracleer may also be used as a treatment alternative. Current Treatment Strategy PAH patients (n=41) 5.What is your current treatment strategy for patients whose disease progresses while on Tracleer (bosentan)? Please make sure your responses sum to 100%.

  14. Section 2: Potential Future Treatment

  15. Section 2: Potential Future Treatment Surveyed pulmonologists indicate that assuming FDA approval, over forty percent of newly diagnosed patients would receive Thelin. Impact of Thelin on Prescribing of Tracleer(n=41) 6.Based on the safety and efficacy data you have seen for Thelin (sitaxsentan) and assuming the agent was FDA approved, how would the availability of Thelin (sitaxsentan) impact your prescribing of newly diagnosed patients? What proportion would receive each agent?

  16. Section 2: Potential Future Treatment Surveyed pulmonologists indicate that assuming FDA approval, thirty percent of newly diagnosed patients would receive Thelin and twenty percent would receive ambrisentan. Impact of Thelin and Ambrisentan on Prescribing of Tracleer(n=41) 7.Based on the safety and efficacy data you have seen for both Thelin (sitaxsentan) and ambrisentan, and assuming both agents were FDA approved, how would the availability of the new agents impact your treatment of newly diagnosed patients? What proportion would receive each agent?

  17. Section 2: Potential Future Treatment Targeted pulmonologists indicate an overall similar efficacy of ambrisentan in comparison to Tracleer. However, in terms of side effects, Ambrisentan receives a higher rating. Comparison of Ambrisentan to Tracleer (n=41) 8.Based on the data below, how do you perceive the efficacy and side effect profile of ambrisentan compared to Tracleer (bosentan)? Please rate ambrisentan compared to Tracleer (bosentan) on efficacy and side effects a scale from 1 to 5, 1 being “Much worse”, 5 being “Much better.”

  18. Section 2: Potential Future Treatment Survey Details Pulmonologists indicate a willingness to switch patients with elevated enzymes from Tracleer to the new agents; they seem more willing to switch to ambrisentan than to Thelin. For patients who deteriorate on Tracleer, pulmonologists appear to have a similar preference for both agents. Likelihood of Patients Being Switched from Tracleer to Thelin or Ambrisentan (n=41) Ambrisentan Thelin (sitaxsentan) Patients who deteriorate while on Tracleer Patients with elevated liver enzymes Patients with elevated liver enzymes Patients who deteriorate while on Tracleer 9.In the future, when patients develop elevated liver enzymes and/or deteriorate while on Tracleer (bosentan) do you believe that these patients could be switched onto Thelin (sitaxsentan) or ambrisentan?

  19. Section 2: Potential Future Treatment According to surveyed pulmonologists, the lower incidence of liver toxicity and overall safety profile are the most common reasons to switch to Thelin (sitaxsentan). Reasons for Switching from Tracleer to Thelin (n=31) 10.You indicated that you would switch patients to Thelin (sitaxsentan) if they developed elevated liver enzymes or deteriorated while on Tracleer (bosentan). Please comment on your reasons for doing so.

  20. Section 2: Future Potential Treatment Similar to Thelin, lower incidence of liver toxicity, general safety as well as use of an alternative treatment are the most common reasons pulmonologists would to switch to Ambrisentan Reasons for Switching from Tracleer to Ambrisentan (n=34) 11.You indicated that you would switch patients to ambrisentan if they developed elevated liver enzymes or deteriorated while on Tracleer (bosentan). Please comment on your reasons for doing so.

  21. Section 2: Potential Future Treatment Overall, pulmonologists indicate a likelihood that Tracleer data will be extrapolated to Thelin or ambrisentan. Extrapolation of Tracleer Data to Thelin or ambrisentan (n=40) 12.Tracleer has demonstrated clinical efficacy in scleroderma, HIV and Eisenmenger’s patients, and in the future may have data on sickle cell disease and chronic thrombo-embolic pulmonary hypertension. To what extent do you believe Tracleer’s data can be extrapolated to Thelin (sitaxsentan) or ambrisentan? Please rate on a scale from 1 to 5, 1 being “Not likely to be extrapolated”, 5 being “Very likely to be extrapolated.”

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