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Oncologic Drugs Advisory Committee Bethesda, Maryland January 31, 2002

C. Oncologic Drugs Advisory Committee Bethesda, Maryland January 31, 2002. C. Introduction. Burkhard Daldrup, PhD Global Head, Drug Regulatory Affairs Oncology Business Unit Novartis Pharmaceuticals Corporation. ZOMETA belongs to a new class of highly potent bisphosphonates

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Oncologic Drugs Advisory Committee Bethesda, Maryland January 31, 2002

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  1. C Oncologic Drugs Advisory Committee Bethesda, Maryland January 31, 2002

  2. C Introduction Burkhard Daldrup, PhDGlobal Head, Drug Regulatory AffairsOncology Business Unit Novartis Pharmaceuticals Corporation

  3. 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 ZOMETA®Overview

  4. 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 ZOMETA® in Bone Metastases Proposed Indication

  5. ZOMETA® in Bone MetastasesPhase III Trials Three randomized, international, parallel, double-blind trials ZOMETA 4 mg and 8 mg PatientTrial 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

  6. 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 ZOMETA® in Bone MetastasesClinical Profile (1)

  7. 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 ZOMETA® in Bone MetastasesClinical Profile (2)

  8. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . Burkhard Daldrup, PhD Pathophysiology of Metastatic Bone Diseaseand 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 Agenda

  9. 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 Questions and Answers

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