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James W. Freston M.D., Ph.D. Professor of Medicine and Clinical Pharmacology University of Connecticut Health Center

Uprima ® Presentation TAP Holdings Inc. James W. Freston M.D., Ph.D. Professor of Medicine and Clinical Pharmacology University of Connecticut Health Center. Safety. Safety Assessment. Safety-Assessment. Exposure Overview of adverse events Syncope

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James W. Freston M.D., Ph.D. Professor of Medicine and Clinical Pharmacology University of Connecticut Health Center

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  1. Uprima® PresentationTAP Holdings Inc. James W. Freston M.D., Ph.D.Professor of Medicine and Clinical PharmacologyUniversity of Connecticut Health Center

  2. Safety

  3. Safety Assessment Safety-Assessment • Exposure • Overview of adverse events • Syncope • Evaluation of cardiovascular effects in prospective studies in special populations • Diabetics • Patients taking anti-hypertensives and nitrates • Subjects given Uprima® with alcohol • Nausea • Other safety considerations

  4. Overall Uprima® Experience (Phase I, II, III) Safety-Exposure • Patients/subjects treated: • 3,035 (2, 4, 5, and 6 mg) • 1,988 (2 and 4 mg) • Number of treatment administrations • 75,449 (2, 4, 5, and 6 mg) • 35,531 (2 and 4 mg) • Patients treated for at least 6 months – 461* • Patients treated for more than one year – 127* * At the time of the NDA.

  5. Age Distribution Safety-Patient Population Phase II/III Studies % Age Group

  6. ED Population Safety-Patient Population Uprima® Studies Viagra® Studies1 Duration of ED (mean) 4.8 years 5 years Medical Condition (%) Hypertension 31% 25% Coronary Artery Disease (CAD) 16% 14% Dyslipidemia 16% 14% Diabetes 16% 18% 1 Approval Package for Viagra® (Sildenafil Citrate). FDA.GOV/CDER/CONSUMERINFO/VIAGRA/VIAGRA/HTM. Joint Clinical Review p. 14. April 1999.

  7. Concurrent Medications Safety-Patient Population Phase II/III Studies N=2,379n (%) Total Patients Taking Concurrent Medication 2,155 90.6 Antihypertensive agents 715 30.1 Cardiac drugs 503 21.1 Psychotherapeutic agents 438 18.4 Antihyperlipidemic agents 416 17.5 Anxiolytics, sedatives, and hypnotics 356 15.0 Antidiabetic Agents 330 13.9 Diuretics 227 9.5

  8. Related Treatment-Emergent Adverse Events >5% Safety-Adverse Events Phase II/III Studies Includes Higher Than Recommended Doses Recommended Doses 2, 4, 5, 6 mg N=2379 n (%) 2, 4 mg N=1925n (%) Adverse Event 298 (15.5) 180 (9.4) 111 (5.8) 155 (8.1) 117 (6.1) 53 (2.8) 102 (5.3) 57 (3.0) 51 (2.6) 756 (31.8) 423 (17.8) 334 (14.0) 320 (13.5) 262 (11.0) 195 (8.2) 189 (7.9) 149 (6.3) 140 (5.9) Nausea Dizziness Sweating Somnolence Yawning Vomiting Headaches Asthenia Vasodilatation

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