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Certican everolimus

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Certican everolimus

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    1. Certican® (everolimus) Cardiovascular and Renal Drugs Advisory Committee Meeting November 16, 2005

    2. Certican® (everolimus) Introduction and Regulatory Background Mathias Hukkelhoven, PhD Senior Vice President Global Head, Drug Regulatory Affairs Novartis Pharmaceuticals Corporation

    3. CI-3 Certican® Clinical Development Program Most comprehensive clinical development program in transplantation 25 trials (1 heart, 7 kidney, 17 clin-pharm) Approximately 3000 patients enrolled, 1800 patients treated 220 investigators worldwide Phase 3 heart study B253 634 patients Follow-up at 6, 12, 24, and 48 months

    4. CI-4 Certican® Long-term Studies in Heart and Kidney

    5. CI-5 Certican® Global Registration

    6. CI-6 Certican® NDA History

    7. CI-7 Overall Objectives Review the primary efficacy and safety data from the Certican® (everolimus) pivotal study in heart transplantation (B253) Provide dosing recommendations for everolimus in combination with Neoral® Present data that support a favorable benefit-risk profile for everolimus in heart transplantation

    8. CI-8 Certican® Proposed Indication Certican® (everolimus) is indicated for the prophylaxis of organ rejection in adult patients receiving a heart transplant It is recommended that Certican be used concurrently with Neoral® and corticosteroids

    9. CI-9 Certican® Proposed Dosage and Administration The pivotal heart study evaluated fixed doses of everolimus at 1.5 mg per day and 3.0 mg per day Initial dose regimen of 1.5 mg per day in 2 divided doses (BID) adjusted to target trough level of 3 to 8 ng/mL Certican should be used with reduced doses of cyclosporine after the first month

    10. CI-10 Today’s Agenda

    11. CI-11 Novartis Consultants

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