C-BR- 1 Raptiva ™ (efalizumab) Benefit:Risk Assessment Charles Johnson, MB, ChB Senior Director Head of Specialty Biotherapeutics Genentech, Inc.

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Presentation transcript:

C-BR- 1 Raptiva ™ (efalizumab) Benefit:Risk Assessment Charles Johnson, MB, ChB Senior Director Head of Specialty Biotherapeutics Genentech, Inc.

C-BR- 2 A Significant Unmet Medical Need Exists Psoriasis is a chronic life-long disease with QOL impact similar to other major diseases (arthritis, diabetes, cancer, cardiovascular disease) Common physical symptoms of chronic psoriasis include skin pain, itching, and bleeding; these physical symptoms impair quality of life Topical medications are insufficient to treat moderate to severe disease Currently approved therapies for moderate to severe disease are effective, but have significant safety limitations and accessibility issues

C-BR- 3 Characteristics of Raptiva in Psoriasis Dosed once weekly as a single SC injection Has an early onset of action Effective at 12 weeks –27% of patients achieve PASI-75 (12 weeks) –59% of patients achieve PASI-50 (12 weeks) Extended treatment improves response at 24 weeks –44% of patients achieve PASI-75 (24 weeks) –66% of patients achieve PASI-50 (24 weeks) Response maintained with one year continuous therapy –45% of patients achieve PASI-75 Therefore best used as continuous therapy Safe and well tolerated

C-BR- 4 Raptiva Improves Plaque Psoriasis Day0 PASI50.4 Day91 PASI2.1 PGAExcellent Before TreatmentAfter Treatment

C-BR- 5 Quality of Life Improves Quickly * Hierarchical rank-sum test, Raptiva vs. placebo Study 2390 Study Week * * * Mean ± SE DLQI improvement * p < 0.001

C-BR- 6 Key Safety Outcomes Extensive safety database: 2762 treated patients Most common adverse events are mild flu-like symptoms following first 2 Raptiva injections Favorable overall adverse event profile, including infection and malignancy Psoriasis adverse events are infrequent and manageable Infrequent cases of reversible thrombocytopenia No evidence of renal or hepatic dysfunction

C-BR- 7 Raptiva is Safe and Effective Meaningful clinical benefit has been demonstrated in patients with moderate-to-severe plaque psoriasis Ongoing therapy with Raptiva provides extended benefit, with no increase in adverse events as exposure is prolonged Frequency of psoriasis adverse events is mitigated by: –Continued therapy in responders –Limiting dose to 1 mg/kg –Transition in non-responders (12 weeks)

C-BR- 8 Benefit:Risk Conclusions Based on the robust efficacy and reasonable safety, Raptiva should be available as a therapeutic option for patients with moderate to severe plaque psoriasis Post approval surveillance will further clarify the long term safety of Raptiva

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