CI-1 Update on the Safety of Erythropoietin Products in Patients With Cancer May 4, 2004 Robert DeLap, MD, PhD Vice President, Global Regulatory Affairs Johnson & Johnson Pharmaceutical Research & Development May 4, 2004 Robert DeLap, MD, PhD Vice President, Global Regulatory Affairs Johnson & Johnson Pharmaceutical Research & Development

CI-2 Background Chemotherapy-associated Anemia Chemotherapy frequently causes anemia –Debilitating symptoms, may require transfusion Erythropoietin products valuable alternative to transfusion –Patient benefits –Conservation of blood supply –Demonstrated safety profile in multiple indications Extensive clinical experience –Epoetin alfa—widely studied –Over 2 million patients with cancer treated with PROCRIT ® and EPREX ® Chemotherapy frequently causes anemia –Debilitating symptoms, may require transfusion Erythropoietin products valuable alternative to transfusion –Patient benefits –Conservation of blood supply –Demonstrated safety profile in multiple indications Extensive clinical experience –Epoetin alfa—widely studied –Over 2 million patients with cancer treated with PROCRIT ® and EPREX ®

CI-3 Erythropoietin Products for Chemotherapy-associated Anemia Molecule Sequence homology to human erythropoietin Year introduced for chemo anemia Available in US PROCRIT ® Epoetin alfa100%1993 ARANESP ® Darbepoetin alfa 97%2002 Available outside US EPREX ® Epoetin alfa100%1994 NeoRecormon ® Epoetin beta100%1995 ARANESP ® Darbepoetin alfa 97%2002

CI-4 Definitions Supportive anemia care: studies evaluating the established indication, treatment of anemia –Goal is to obtain sufficient rise in hemoglobin to reduce need for transfusion Beyond correction of anemia: investigational studies treating to higher hemoglobin levels –Includes most of the recent studies evaluating effects of erythropoietic agents on cancer treatment outcomes (response, progression, survival) Supportive anemia care: studies evaluating the established indication, treatment of anemia –Goal is to obtain sufficient rise in hemoglobin to reduce need for transfusion Beyond correction of anemia: investigational studies treating to higher hemoglobin levels –Includes most of the recent studies evaluating effects of erythropoietic agents on cancer treatment outcomes (response, progression, survival)

CI-5 Safety Data to Be Presented In supportive anemia care, data and extensive clinical experience support the favorable benefit/risk profile of epoetin alfa In some investigational studies of erythropoietin products used beyond correction of anemia, evidence of increased risk has been observed Additional data are being collected, and further research is under consideration In supportive anemia care, data and extensive clinical experience support the favorable benefit/risk profile of epoetin alfa In some investigational studies of erythropoietin products used beyond correction of anemia, evidence of increased risk has been observed Additional data are being collected, and further research is under consideration

CI-6 Today’s Agenda Evaluation of Studies Dr. Peter Bowers – Supportive Anemia Care – Beyond Correction of Anemia Future Clinical DataDr. Martine George ConclusionsDr. Martine George Evaluation of Studies Dr. Peter Bowers – Supportive Anemia Care – Beyond Correction of Anemia Future Clinical DataDr. Martine George ConclusionsDr. Martine George

CI-7 Advisors Jesse Berlin, ScDUniversity of Pennsylvania School of Medicine Philadelphia, PA Kimberly Blackwell, MDDuke University Medical Center Durham, NC Roger B. Cohen, MDFox Chase Cancer Center Philadelphia, PA George Demetri, MDDana-Farber Cancer Institute Boston, MA Mark Levine, MDMcMaster University Henderson General Hospital Hamilton, Ontario, Canada Brian Leyland-Jones, MDMcGill University Montreal, Quebec, Canada