Summary of Efficacy

5/4/00


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Table of Contents

Summary of Efficacy

Efficacy

Efficacy

Efficacy

Advantages of Home-Use Questionnaire vs. Retrospective Questionnaire (e.g., IIEF)

PPT Slide

Patient Population

Patient Population (cont.)

Definition of “No Major Organic Component”

Patient Demographics

Representative ED Patient Population

Major Subgroups

Baseline ED Severity Based on IIEF*

ED Population

Comparison of Uprima® NPT Values with Values for Normals

Comparison of Uprima® NPT Values with Values for Normals

Representative ED Patient Population Conclusion

Efficacy Endpoints

Efficacy Endpoints for Phase III Studies

Efficacy Endpoints for Phase III Studies

Uprima®-Efficacy Endpoints

Efficacy

Crossover Study Schematic

Crossover Studies

Patient Response (per attempt) “Erection Firm Enough for Intercourse”

Patient Response (per attempt) “Did Attempt Result in Intercourse”

Intercourse Rates Comparison of Uprima® to Viagra®

Partner Responses

Partner Involvement in Uprima® Studies

Partner Response (per attempt) “Erection Firm Enough for Intercourse”

Partner Response (per attempt) “Did Attempt Result in Intercourse”

Primary Endpoint Subgroup Analyses

Patient Response (per attempt) “Erection Firm Enough for Intercourse”

Patient Response (per attempt) “Erection Firm Enough for Intercourse”

ED Severity

Assessment of Effect of ED Severity on Efficacy

Definition of ED Severity Based on IIEF

Patient Response (per attempt) “Erection Firm Enough for Intercourse”

Patient Response (per attempt) “Erection Firm Enough for Intercourse”

Patient Response (per attempt) “Erection Firm Enough for Intercourse”

ED Severity Conclusion

Other Endpoints

Other Endpoints

Median Time to Erection (Using Only Attempts When an Erection Was Achieved)

Patient Assessment Percentage of Patients Deemed a Treatment Success

Percent of Patients with Mean Intercourse Attempt Satisfaction ɯ and an Improvement Over Baseline

Percent of Partners with Mean Intercourse Attempt Satisfaction ɯ and an Improvement Over Baseline

Percent of Patients with 4 Point Improvement in the Erectile Function Domain Index of the IIEF

Phase III Crossover Studies Conclusion

Phase III Crossover Studies Conclusion (cont.)

Efficacy

PPT Slide

Diabetes Study Baseline ED Severity

Patient Response (per attempt) “Did You Achieve an Erection Firm Enough for Intercourse”

Patient Response (per attempt) “Erection Firm Enough for Intercourse”

Diabetes Efficacy Conclusion

Uprima® Efficacy

Parallel Study Schematic Design

Patient Response (per attempt) “Erections Firm Enough for Intercourse”

Partner Response (per attempt) “Erections Firm Enough for Intercourse”

Patient Response (per attempt) “Did Attempt Result in Intercourse”

Efficacy

Discontinuations in Long-Term Studies

Long-Term Studies

Percentage of Erections Firm Enough for Intercourse

Long-Term Studies

Percentage of Erections Firm Enough for Intercourse

Percentage of Erections Firm Enough for Intercourse

Efficacy in Long-Term Studies Conclusion

Overall Efficacy Conclusions

Overall Efficacy Conclusions

Overall Efficacy Conclusions (cont.)

Author: Andrea_Poffenberger