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American Diabetes Association 2008 Annual Meeting

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American Diabetes Association 2008 Annual Meeting American Diabetes Association 2008 Annual Meeting Investor Reception and Webcast Amylin Pharmaceuticals, Inc. June 8, 2008 Safe Harbor Statement This presentation contains forward-looking statements about Amylin. Our actual results could differ materially from those discussed due to a number of factors, including: risks that BYETTA and/or SYMLIN and the revenues we generate from these products, may be affected by competition, unexpected new data, technical issues, or manufacturing and supply issues; our financial results may fluctuate and may not meet market expectations; our clinical trials may not start when planned and/or confirm previous results; our pre-clinical studies may not be predictive; NDAs for our product candidates and sNDAs for our label expansion requests may not be submitted timely or receive regulatory approval; we may not be able to complete our manufacturing facility on a timely basis; and inherent scientific, regulatory and other risks in the drug development and commercialization process. Reimbursement, pricing decisions, the pace of market acceptance, and rate of patient adherence may also affect the potential of BYETTA and/or SYMLIN. These and additional risks and uncertainties are described more fully in the Company's recently filed Form 10-Q. Amylin disclaims any obligation to update these forward-looking statements. 2 Agenda • Introduction > Daniel Bradbury, President & CEO • Highlights from Clinical Trials > Steven Smith, MD, Professor; Assistant Executive Director of Clinical Research, Pennington Biomedical Research Center • Closing Remarks > Daniel Bradbury, President & CEO • Q&A 3 Driving Growth, Building Value NearNear TermTerm MidMid TermTerm LongLong TermTerm • BYETTA and SYMLIN • Exenatide once weekly: • Obesity program address unmet needs potential to transform harnesses natural in diabetes treatment – diabetes treatment hormone synergies glucose control and paradigm > Initiated Phase 2B dose- weight loss ranging clinical study of • Investing for diabetes pramlintide/metreleptin • Opportunities to market leadership combination after positive increase BYETTA proof-of-concept study prescription volume in the large primary • Peptide-focused care segment discovery platform > Field force expansion and optimization • SymlinPen launched 4 Amylin at ADA > Oral presentations, posters, and scientific sessions – BYETTA – SYMLIN – Exenatide once weekly – Obesity programs > Educational symposia grant support > Commercial exhibit – SYMLIN and BYETTA > Interactions with leading researchers and clinicians 5 Diabetes and Obesity Pandemic DiabetesDiabetes PrevalencePrevalence ObesityObesity PrevalencePrevalence No Data <5% 5%–6% No Data <10% 10%–14% 15%–19% 6%–7% 7%–8% >8% 20%–24% 25%–29% ≥30% Source: CDC BRFSS 2005 6 BMI 30 kg/m2 (~ 30 lbs. overweight for 5’ 4” person) Selected Outcome Studies in Type 2 Diabetes Targeting Glycemia, Blood Pressure and Lipids BloodBlood GlycemiaGlycemia LipidsLipids PressurePressure UKPDSUKPDS 9 9 ADVANCEADVANCE 9 9 ACCORDACCORD 9 99 VADTVADT 9 ACCORD Findings • “The findings of higher mortality in the intensive-therapy group led to a discontinuation of intensive therapy after a mean of 3.5 years of follow-up.” > New England Journal of Medicine, June 12 2008 StandardStandard IntensiveIntensive A1CA1C 7.5% 6.4% WeightWeight GainGain 0.9 lbs 7.7 lbs HypoglycemiaHypoglycemia 1.0% 3.1% InsulinInsulin UseUse 55.4% 77.3% 28%28% ofof patientspatients inin thethe intensiveintensive treatmenttreatment groupgroup gainedgained >20>20 lbslbs Improved Glucose Control Comes at a Cost: Weight Gain BloodBlood SugarSugar LevelsLevels (A1C)(A1C) WeightWeight (kg)(kg) 9 7 Conventional Therapy 6 Intensive Therapy 8 5 Intensive Therapy 4 7 3 Conventional Therapy 2 6 1 5 0 Pre- 0 1 2 3 4 5 6 7 8 9 101112131415 Pre- 0 1 2 3 4 5 6 7 8 9 101112131415 Rand- Rand- omization Years omization Years 9 Source: UKPDS study BYETTA and SYMLIN Redefine Diabetes Treatment Weight Loss GlucoseGlucose DPP4 DPP4 MetforminMetformin Lowering InhibitorInhibitor Lowering EffectEffect Sulfonylurea TZDTZD InsulinInsulin Weight Gain 10 Pramlintide, Exenatide and Amylin Obesity Development Program Clinical Update Steven Smith, MD Professor Assistant Executive Director of Clinical Research Pennington Biomedical Research Center Baton Rouge, Louisiana 11 PramlintidePramlintide ++ BasalBasal InsulinInsulin SafelySafely ImprovedImproved GlycemicGlycemic ControlControl WithWith WeightWeight LossLoss -0.0 Placebo (n = 106) 250 Pramlintide (n = 105) 225 -0.2 A1C 200 Δ -0.4 175 * * (mg/dL) 150 * -0.6 Mean (SE) Mean From Baseline (%) From Baseline 125 Baseline Week16 -0.8 Mean (SE) Blood Glucose 100 ** 1.5 Brk Lun Din Bed 1.0 0.5 > Incidence of hypoglycemia 0.0 Body Weight > Pramlintide + Basal insulin: 44% Δ -0.5 -2.3 ± 0.4 kg > Placebo + Basal insulin: 47% -1.0 * * > Severe hypoglycemia: 1 event in pramlintide From Baseline (kg) From Baseline -1.5 group (unrelated to treatment) * * Mean (SE) Mean -2.0 * 0 4 8 12 16 Time (Weeks) ITT LOCF N = 211, * p<0.0001, **p<0.05 Riddle, M. Diabetes Care 30:2794–2799, 2007 12 INSTEADINSTEAD StudyStudy RandomizedRandomized Trial:Trial: FixedFixed DoseDose PrPramlintideamlintide vsvs RapidRapid ActingActing InsulinInsulin Both Groups Basal Insulin ± OAD SYMLIN RA Insulin Baseline Screening Treatment Phase 1 Visit 1 Day 1 Week 4 Week 24 (Day -14) SYMLIN RA Primary Endpoint: Subjects achieving A1C ≤7% without weight gain or severe hypo Secondary Endpoints: A1c, weight, fasting glucose, insulin use 13 PramlintidePramlintide ADAADA PresentationsPresentations • Riddle, M et al. Pramlintide or mealtime insulin added to basal insulin treatment in patients with type 2 diabetes (Late Breaking Clinical Trial) • Riddle, M et al. Pramlintide Improved Glycemic Control and Reduced Weight in Patients with Type 2 Diabetes Treating to Target with Basal Insulin (524-Poster) • Chase, P et al. Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Pramlintide in Adolescent Subjects With Type 1 Diabetes (1802-Poster) 14 **DURATION-1DURATION-1 StudyStudy DesignDesign 30 weeks Exenatide 2 mg QW T2DM Exenatide A1C 7.1-11% 5 mcg BID Exenatide QW 2 mg QW D/E, MET, SU, TZD, or any 3 days Exenatide 10 mcg BID combo of 2 agents 4 weeks Endpoint Assessment Period Ongoing Assessment Period *DURATION: (Diabetes Therapy Utilization : Researching Changes in A1C, Weight and Other Factors Through Intervention with Exenatide ONce Weekly) 15 PatientPatient DemographicsDemographics andand BaselineBaseline CharacteristicsCharacteristics (ITT=295)(ITT=295) Ex(QW) Ex(BID) N = 148 N = 147 Gender: Male/Female (%) 55 / 45 51 / 49 Age (y) 55 ± 10 55 ± 10 Body Weight (kg) 101.7 ± 19 101.9 ± 21 BMI (kg/m2) 34.8 ± 5 35.0 ± 5 A1C (%) 8.3 ± 1.0 8.3 ± 1.0 Fasting Plasma Glucose (mg/dL) 173 ± 44 165 ± 41 Race – Caucasian/Black/Asian/Hispanic (%) 83/6/0/11 73/13/1/14 Duration of Diabetes (y) 7.0 ± 6 6.4 ± 5 Data are Mean ± SD 16 PatientPatient DispositionDisposition (ITT,(ITT, N=295)N=295) Ex(QW) Ex(BID) All Subjects N=148 N = 147 N = 295 All Withdrawals Prior to Week 30 20 (13.5%) 17 (11.6%) 37 (12.5%) Withdrawal of Consent 5 (3.4%) 2 (1.4%) 7 (2.4%) Adverse Event 9 (6.1%) 8 (5.4%) 17 (5.8%) Investigator Decision 1 (0.7%) 2 (1.4%) 3 (1.0%) Protocol Violation 0 1 (0.7%) 1 (0.3%) Lost to Follow-up 5 (3.4%) 4 (2.7%) 9 (3.1%) Administrative 0 0 0 Loss of Glucose Control 0 0 0 17 ProportionProportion ofof PatientsPatients AchievingAchieving A1CA1C TargetsTargets (Evaluable,(Evaluable, N=259)N=259) 80 * Exenatide QW, N=129 Exenatide BID, N=130 70 77% 60 61% 50 49% 40 42% 30 Proportion (%) 20 25% 18% 10 0 ≤7% ≤6.5% ≤6% *p=0.0039, QW vs BID 18 ChangeChange inin A1CA1C byby BaselineBaseline A1CA1C A1C <9% A1C ≥9% 10.0 10.0 9.5 9.5 9.0 9.0 8.5 8.5 8.0 8.0 -1.8% 7.5 7.5 HbA1c (%) 7.0 7.0 -1.1% -2.7% 6.5 -1.2% 6.5 6.0 6.0 0 6 10 14 18 22 26 30 0 6 10 14 18 22 26 30 Time (weeks) Time (weeks) Exenatide QW N=109, BL=7.8% Exenatide QW N=39, BL = 9.7% Exenatide BID N=107, BL=7.8% Exenatide BID N=40, BL = 9.7% 19 ChangeChange inin BodyBody WeightWeight atat 3030 WeeksWeeks 0 Exenatide QW, N=148, BL=102 kg Exenatide BID, N=147, BL=102 kg -1 -2 -3 Body Weight (kg) -3.6 kg Δ -3.7 kg -4 -5 0 3 6 10 14 18 22 26 30 Time (weeks) Data are LS mean (SE) 20 IndividualIndividual TreatmentTreatment ResponsesResponses forfor A1CA1C andand BodyBody WeightWeight 15 QW (23%) QW (1%) BID (16%) BID (5%) 10 5 0 -5 -10 -15 -20 Body Weight (kg) Δ -25 -30 QW (3%) -35 QW (73%) BID(74%) BID (5%) -40 -6 -5 -4 -3 -2 -1 0 1 2 3 Δ A1C (%) 21 EffectsEffects onon CardiovascularCardiovascular RiskRisk FactorsFactors Exenatide QW (N=148) Exenatide BID (N=147) Δ from Δ from Baseline Baseline Parameter baseline 95% CI baseline 95% CI (±SE) (±SE) (±SE) (±SE) Triglycerides (mg/dL) or (%) 166.0 (8.7) -15 (0.03) % -20,-9 157.8 (8.0) -11 (0.03)% -16,-4 Total cholesterol (mg/dL) 173.2 (3.4) -11.9 (2.3) -16.4,-7.4 182.2 (4.0) -3.8 (2.4) -8.4,+0.8 HDL-C (mg/dL) 43.9 (0.8) -0.9 (0.6) -2.0,+0.2 46.4 (0.9) -1.3 (0.6) -2.5,-0.2 LDL-C (mg/dL) 91.6 (2.9) -4.9 (2.0) -8.7,-1.1 100.3 (3.3) +1.2 (2.0) -2.7,+5.1 Systolic blood pressure 127.8 (13.0) -4.7 (1.1) -6.9,-2.6 129.5 (14.2) -3.4 (1.1) -5.5,-1.3 (mmHg) Diastolic blood pressure 77.7 (8.3) -1.7 (0.7) -3.1,-0.3 79.6 (7.7) -1.7 (0.7) -3.1,-0.3 (mmHg) LS mean % change ±SE is presented for triglycerides; LS mean change ±SE for all other data 22 LSLS MeanMean (SE)(SE) ChangeChange inin SBPSBP andand DBPDBP fromfrom BaselineBaseline atat WeekWeek 3030 byby BaselineBaseline OverallOverall BPBP StatusStatus (Normal/Abnormal)(Normal/Abnormal) ITTITT Population,Population,
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