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Raptiva™ (efalizumab)Introduction

Michelle Rohrer, PhD

DirectorRegulatory Affairs

Genentech, Inc.

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Agenda

Introduction Michelle Rohrer, PhD

Moderate to Severe PsoriasisThe Unmet Need

Mark Lebwohl, MD

Mount Sinai School of Medicine, NY

Mechanism of Actionand Dose Determination

Charles Johnson, MB, ChB

Efficacy Lee Kaiser, PhD

Safety Richard Chin, MD

Raptiva Benefit:Risk Profile Charles Johnson, MB, ChB

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Clinical Experts and Consultants

Mark Lebwohl, MD Chairman, Professor of DermatologyMount Sinai School of MedicineNew York, NY

Alan Menter, MD Chairman, Division of DermatologyBaylor University Medical CenterDallas, TX

James Krueger, MD, PhD Professor of DermatologyThe Rockefeller University New York, NY

Ted Warkentin, MD Professor of Medicine and Pathology (Hematologist)McMaster University Hamilton, Ontario, Canada

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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

Phase StudyNumber Study Design

Number ofPatients Enrolled

III 2390 Placebo-controlled Double-blind Randomized 556

III 2600 Placebo-controlled Double-blind Randomized 686

III 2058 Placebo-controlled Double-blind Randomized 498

III 2059 Placebo-controlled Double-blind Randomized 597

III 2062 Open-label Retreatment 536

III 2243 Open-label Long-Term 339

III 2391 Open-label Follow-Up to 2390 516

II HUPS252 Placebo-controlled Double-blind Randomized 145

I HU9602 Open-label Single Dose 31

I HUPS249 Open-label Multiple Dose 39

I HUPS254 Open-label Single and Multiple Dose 57

I HUPS256 Open-label Randomized 77

I 2142 Open-label PK 70

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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 <12 years– Deferral for adolescents (12-18 years)

• Genentech is committed to a phase IV surveillance study to further characterize Raptiva’s long-term safety profile