C-IN- 1 Raptiva ™ (efalizumab) Introduction Michelle Rohrer, PhD Director Regulatory Affairs Genentech, Inc.

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Presentation transcript:

C-IN- 1 Raptiva ™ (efalizumab) Introduction Michelle Rohrer, PhD Director Regulatory Affairs Genentech, Inc.

C-IN- 2 Agenda IntroductionMichelle Rohrer, PhD Moderate to Severe Psoriasis The Unmet Need Mark Lebwohl, MD Mount Sinai School of Medicine, NY Mechanism of Action and Dose Determination Charles Johnson, MB, ChB EfficacyLee Kaiser, PhD SafetyRichard Chin, MD Raptiva Benefit:Risk ProfileCharles Johnson, MB, ChB

C-IN- 3 Clinical Experts and Consultants Mark Lebwohl, MDChairman, Professor of Dermatology Mount Sinai School of Medicine New York, NY Alan Menter, MDChairman, Division of Dermatology Baylor University Medical Center Dallas, TX James Krueger, MD, PhDProfessor of Dermatology The Rockefeller University New York, NY Ted Warkentin, MDProfessor of Medicine and Pathology (Hematologist) McMaster University Hamilton, Ontario, Canada

C-IN- 4 Proposed Indication Raptiva ™ is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis.

C-IN- 5 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

C-IN- 6 Raptiva Psoriasis Studies Phase Study Number Study Design Number of Patients Enrolled III2390Placebo-controlled Double-blind Randomized556 III2600Placebo-controlled Double-blind Randomized686 III2058Placebo-controlled Double-blind Randomized498 III2059Placebo-controlled Double-blind Randomized597 III2062Open-label Retreatment536 III2243Open-label Long-Term339 III2391Open-label Follow-Up to IIHUPS252Placebo-controlled Double-blind Randomized145 IHU9602Open-label Single Dose31 IHUPS249Open-label Multiple Dose39 IHUPS254Open-label Single and Multiple Dose57 IHUPS256Open-label Randomized77 I2142Open-label PK70

C-IN- 7 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