1. Clinical Safety Data Review of Study NCIC CTG PA.3 Karsten Witt, MD Vice PresidentDrug Safety and Medical Writing OSI Pharmaceuticals, Inc.

2. Overall Tarceva Safety Experience • >18,000 patients† have been treated • No new safety signals • Approximately 6,300 subjects‡ participated in company-sponsored clinical trials: • 562 pancreatic cancer patients (PA.3) † From November 2004 to July 2005 ‡ As of February 2005

3. Tarceva/Placebo Exposure 100 mg Cohort • Patients received the intended dose intensity of Tarceva

4. Gemcitabine Exposure 100 mg Cohort • Tarceva did not compromise the dose intensity of concomitant gemcitabine

5. Discontinuation Due To Protocol Therapy-Associated Toxicity 100 mg Cohort Note: Patients may discontinue due to more than one event

6. Selected Adverse Events100 mg Cohort

7. Grade 3 or 4 Adverse EventsOccurring in ≥ 5% of Patients—100 mg Cohort

8. Serious Adverse EventsDefinition A serious adverse event is any event resulting in • Hospitalization or prolonged hospitalization† • Death • Life-threatening experience • Persistent or significant disability/incapacity • Congenital anomaly/birth defect • Important medical event † Excluding for palliative care and pain control, chemotherapy administration,routine procedures, investigations

9. Serious Adverse EventsOccurring in ≥ 2% of Patients—100 mg Cohort

10. ILD-Like Cases Reported as SAEs100 and 150 mg Cohorts

11. Deaths Attributed to Protocol Treatment • Five deaths were attributed to protocol treatment in the 100 mg cohort (all in Tarceva + gemcitabine arm)

12. Laboratory Abnormalities Maximum Grade per Patient on Study—100 mg Cohort

13. Safety Summary • Treatment with Tarceva 100 mg/day in combination with gemcitabine was tolerated by most patients • Rash and diarrhea were reported more often in the Tarceva arm • ILD-like serious adverse events were infrequent • Hematologic toxicity of gemcitabine was not increased by the addition of Tarceva