Raptiva efalizumab Introduction

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Raptiva (efalizumab)Introduction

• Michelle Rohrer, PhD
• DirectorRegulatory Affairs
• Genentech, Inc.

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Agenda
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Clinical Experts and Consultants
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Proposed Indication

• Raptiva is indicated for the treatment of adult
  patients (18 years or older) with moderate to
  severe plaque psoriasis.

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Raptiva Product Description

• Recombinant humanized monoclonal antibody which
  blocks CD11a
• Supplied as lyophilized sterile powder
• Single-use 2-cc vial
• Reconstituted with SWFI to 100 mg/mL
  concentration
• Recommended dose
• 1 mg/kg subcutaneous injection given once per week

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Raptiva Psoriasis Studies
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Raptiva Overview

• Effective in clinical trials
• Improves plaque psoriasis
• Well tolerated
• Safe for continuous use
• Pediatrics
• Waiver for infants and children lt12 years
• Deferral for adolescents (12-18 years)
• Genentech is committed to a phase IV surveillance
  study to further characterize Raptivas long-term
  safety profile