AA-1-1 Mark B. Kreston President, Worldwide Consumer Medicines 7asdf

AA-1-2 The OTC Proposition Intended dose: Pravachol 10 mg once daily Use: Cholesterol lowering with diet and exercise –TC: mg/dl –LDL-C  130 mg/dl Defined population: –Men  35 years and women  45 years –Told by physician to lower cholesterol –Not on Rx therapy –No CHD or DM Likely to reach NCEP goal Maintain physician involvement

AA-1-3 Joint Meeting of Bristol-Myers Squibb and the Non Prescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committees July 14, 2000 Pravastatin 10 mg for OTC Status I.OTC Rationale J. Cohen, MD, FACC, FACP II.Pravachol SafetyR. Belder, MD III.OTC Clinical Program C. Friedman, MD, FACC IV.Education and Marketing ProgramsP. Kriger V.Summary C. Friedman, MD, FACC Agenda

AA-1-4 Consultants Michael Bottorff, PharmD University of Cincinnati Robert L. Brent, MD, PhD, DSc (Hon) Thomas Jefferson University and Alfred I. DuPont Hospital for Children W. Virgil Brown, MD Emory University School of Medicine Atlanta Department of Veterans Affairs Medical Center J. Jaime Caro, MDCM, FRCPC, FACP Caro Research Charles Hennekens, MD University of Miami School of Medicine Gary G. Koch, PhD University of North Carolina James H. Lewis, MD, FACP, FACG Georgetown University Medical Center Marc Pfeffer, MD, PhD Brigham & Women’s Hospital Cardiovascular Division Lorie Rice, MPH University of California at San Francisco Dimitrios Trichopoulos, MD Harvard School of Public Health C. Michael White, PharmD University of Connecticut