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  • 1. Oncologic Drugs Advisory Committee Bethesda, Maryland January 31, 2002 C
  • 2. Introduction Burkhard Daldrup, PhD Global Head, Drug Regulatory Affairs Oncology Business Unit Novartis Pharmaceuticals Corporation C
  • 3. ZOMETA ® Overview
    • ZOMETA belongs to a new class of highly potent bisphosphonates
    • Treatment of hypercalcemia of malignancy
      • Approved by FDA in August 2001
      • Approved in over 60 countries
    • Treatment of bone metastases
      • Filed July 2001 in EU and August 2001 in US and other major countries
      • Dose: Zoledronic acid 4 mg infused over 15 min q 3 to 4 wk
    • Non-oncologic uses under evaluation
      • Paget’s disease, osteoporosis, rheumatoid arthritis
  • 4. ZOMETA ® in Bone Metastases Proposed Indication
    • ZOMETA (zoledronic acid) is indicated for the treatment of osteolytic, osteoblastic, and mixed bone metastases of solid tumors and osteolytic lesions of multiple myeloma, in conjunction with standard antineoplastic therapy
  • 5. ZOMETA ® in Bone Metastases Phase III Trials ZOMETA 4 mg and 8 mg Patient Trial N versus population Duration 010 1,648 Pamidronate Multiple myeloma 13 mo Breast cancer 039 643 Placebo Prostate cancer 15 mo 011 773 Placebo Other solid tumors 9 mo Three randomized, international, parallel, double-blind trials
  • 6. ZOMETA ® in Bone Metastases Clinical Profile (1)
    • ZOMETA is bone specific, not tumor specific; effective in a broad variety of tumor types studied
      • Breast cancer and multiple myeloma
      • Prostate and other solid tumors
        • Other bisphosphonates have not demonstrated efficacy in these tumor types
  • 7. ZOMETA ® in Bone Metastases Clinical Profile (2)
    • First bisphosphonate shown to be effective across a wide variety of solid tumor types in treatment of bone metastases
    • Safety is comparable with that of i.v. pamidronate
      • Overall safety profile is supported by data from over 3,000 patients treated with ZOMETA
  • 8. Agenda
    • Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . Burkhard Daldrup, PhD
    • Pathophysiology of Metastatic Bone Disease and the Role of Bisphosphonates . . . . . . . . . . Prof. Robert Coleman, MD, FRCP
    • ZOMETA ® in Breast Cancer and Multiple Myeloma . . . . . . . . . . . . . . . . . . . . . James Berenson, MD, Paul Gallo, PhD
    • ZOMETA ® in Prostate Cancer and Solid Tumors Other Than Prostate Cancer
    • and Breast Cancer . . . . . . . . . . . . . . . . . . . . . . . . . Matthew Smith, MD Prof. Robert Coleman,
    • MD, FRCP
    • Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . David Parkinson, MD
  • 9. Questions and Answers
    • Novartis Oncology
    • Clinical Research and Development . . John Seaman, PharmD
    • Consultants
    • Statistics . . . . . . . . . . . . . . . . . . . . . . . . . . Richard J. Cook, PhD
    • Thomas R. Fleming, PhD
    • Clinical Experts
    • Lung and Other Cancers . . . . . . . Pierre P. Major, MD, FRCPC
    • Radiologic Analysis . . . . . . . . . Joseph F. Simeone, MD, FACR
    • Renal Advisory Board . . . . . . . . . . Raimund R. Hirschberg, MD