1. CD-1 Update on the Safety of Erythropoietin Products in Patients With Cancer Martine George, MD Vice President, Therapeutic Area Head Hematology and Oncology Johnson & Johnson Pharmaceutical Research & Development Martine George, MD Vice President, Therapeutic Area Head Hematology and Oncology Johnson & Johnson Pharmaceutical Research & Development

2. CD-2 Today’s Agenda Evaluation of Studies Dr. Peter Bowers –Supportive Anemia Care –Beyond Correction of Anemia Future Clinical Data Dr. Martine George ConclusionsDr. Martine George Evaluation of Studies Dr. Peter Bowers –Supportive Anemia Care –Beyond Correction of Anemia Future Clinical Data Dr. Martine George ConclusionsDr. Martine George

3. CD-3 Proposed Trial in Breast Cancer Rationale Focus on breast cancer based on signal observed in INT-76, known presence of EPO-R, high incidence, and need for homogeneity (patient population and chemotherapy) Early trials in anemic patients have suggested a favorable cancer outcome with erythropoietin products The survival results in EPO-INT-76 do not preclude a potential benefit in anemic patients where adverse reactions might be reduced The trial should be powered to exclude a negative effect Focus on breast cancer based on signal observed in INT-76, known presence of EPO-R, high incidence, and need for homogeneity (patient population and chemotherapy) Early trials in anemic patients have suggested a favorable cancer outcome with erythropoietin products The survival results in EPO-INT-76 do not preclude a potential benefit in anemic patients where adverse reactions might be reduced The trial should be powered to exclude a negative effect

4. CD-4 Proposed Trial in Breast Cancer Objective Evaluate the effects of epoetin alfa on cancer outcomes in anemic patients with metastatic breast cancer receiving first-line chemotherapy

5. CD-5 Proposed Trial in Breast Cancer Design Double blind, randomized, placebo controlled Metastatic breast cancer –First-line chemotherapy (taxane and/or anthracycline) –Hb ≤ 11 g/dL at ≤ third cycle of chemotherapy EPREX ® weekly vs placebo until TTP, stop chemo, or death Target Hb 12 g/dL, hold drug if Hb > 13 g/dL Double blind, randomized, placebo controlled Metastatic breast cancer –First-line chemotherapy (taxane and/or anthracycline) –Hb ≤ 11 g/dL at ≤ third cycle of chemotherapy EPREX ® weekly vs placebo until TTP, stop chemo, or death Target Hb 12 g/dL, hold drug if Hb > 13 g/dL

6. CD-6 Proposed Trial in Breast Cancer Endpoints and Statistics Endpoints Primary:Progression-free survival Secondary:Overall survival Thrombotic events CR + PR TTP Statistics Non-inferiority/superiority study Study size: 2000 patients –80% power to exclude 15% reduction in PFS assuming no difference (non-inferiority) –80% power to show significant difference assuming 15% advantage in PFS (superiority) Endpoints Primary:Progression-free survival Secondary:Overall survival Thrombotic events CR + PR TTP Statistics Non-inferiority/superiority study Study size: 2000 patients –80% power to exclude 15% reduction in PFS assuming no difference (non-inferiority) –80% power to show significant difference assuming 15% advantage in PFS (superiority)

7. CD-7 Proposed Trial in Breast Cancer Challenges Placebo-controlled trial –Enrollment –“Crossover” for placebo patients Tissue acquisition for correlative studies of EPO receptors Chemotherapy regimen Analysis of TVEs Placebo-controlled trial –Enrollment –“Crossover” for placebo patients Tissue acquisition for correlative studies of EPO receptors Chemotherapy regimen Analysis of TVEs

8. CD-8 Ongoing Randomized Trials of Epoetin Alfa in Key Tumor Types Tumor type Study Final enrollmentDesign EPO therapy Cancer therapy Primary endpoint Data availability Head and neck EPO-GBR-7 301OLEPREX ® TIWRT2-yr local DFS2005 RTOG-99-03 † 117OLPROCRIT ® QWCT(+RT)1-yr local PFS2004 NSCLC GER-22 612OLEPREX QWCT+RT2-yr survival2007 EPO-CAN-20 † 66DBEPREX QW±CTQOL2004 Breast EPO-CAN-17 350OLEPREX QWCTQOL2005 (survival) Cervix AGO/NOGGO 264OLEPREX TIWCT+RT5-yr DFS2006 †Discontinued.

9. CD-9 Ongoing and Future Clinical Research Summary Significant data expected from recently completed and ongoing studies Large definitive prospective trial being planned ODAC input to finalize protocol Significant data expected from recently completed and ongoing studies Large definitive prospective trial being planned ODAC input to finalize protocol

10. CD-10 Today’s Agenda Evaluation of Studies Dr. Peter Bowers –Supportive Anemia Care –Beyond Correction of Anemia Future Clinical Data Dr. Martine George ConclusionsDr. Martine George Evaluation of Studies Dr. Peter Bowers –Supportive Anemia Care –Beyond Correction of Anemia Future Clinical Data Dr. Martine George ConclusionsDr. Martine George

11. CD-11 Overall Conclusions In supportive anemia care, data and extensive clinical experience support favorable benefit/risk profile Survival signal observed in MBC and head and neck cancer –Use beyond correction of anemia –No clear tumor proliferation signal –TVEs may account for some of the effect Some studies in supportive anemia care suggest potential benefit Future clinical evaluations should focus on tumor outcomes in supportive anemia care setting In supportive anemia care, data and extensive clinical experience support favorable benefit/risk profile Survival signal observed in MBC and head and neck cancer –Use beyond correction of anemia –No clear tumor proliferation signal –TVEs may account for some of the effect Some studies in supportive anemia care suggest potential benefit Future clinical evaluations should focus on tumor outcomes in supportive anemia care setting