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BACK-UP SLIDES

BACK-UP SLIDES. Presented during Cardiovascular and Renal Drugs Advisory Committee Q&A Sessions December 11, 2007. KYNAPID ™ (vernakalant hydrochloride injection) Cardiovascular and Renal Drugs Advisory Committee. Astellas Pharma US, Inc. December 11, 2007.

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BACK-UP SLIDES

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  1. BACK-UP SLIDES Presented during Cardiovascular and Renal Drugs Advisory CommitteeQ&A Sessions December 11, 2007

  2. KYNAPID™(vernakalant hydrochloride injection)Cardiovascular and Renal DrugsAdvisory Committee Astellas Pharma US, Inc. December 11, 2007

  3. Subjects without AF Symptomsby Conversion StatusPooled Primary Studies (3 Hours – 7 Days) EF 097

  4. Treatment of Non-converters within First 24 hPooled Primary Studies (>3h - ≤7d) The majority of patients that remained in AF after study treatment were treated with either ECV or other antiarrhythmic agents within the first 24 hours. EF 096

  5. Figure 9 (page 55) Logistic Regression Analysis of Treatment-Induced Conversion from Atrial Fibrillation to Sinus Rhythm versus the Duration of Atrial Fibrillation Full Analysis Set: all randomized patients who received any amount of study drug (ACT I) Analysis based on treatment induced conversion as determined by the CEC from Holter monitor or 12-lead ECG data if Holter results were missing or not interpretable. (1) A logistic regression model with AF duration (hours) as explanatory variable. (2) Treatment-induced conversion from AF to sinus rhythm as determined by the CEC from results of the Holter monitor or 12-lead ECG data if Holter results were missing or not interpretable. (3) P-value from Wald chi-square test (4) The extent to which the odds of conversion decrease per day. BB 028

  6. Probability ofDetecting Infrequent Events AE 175

  7. Life-Table Estimate of the Maintenance of Sinus Rhythm for Subjects Who Converted to Sinus Rhythm within 90 Minutes(ACT II – AF Patients) Subject base: full analysis set subjects who converted within 90 minutes SR: survival rate; SE: standard error EF 022

  8. Maintenance of SR post Cardiac Surgery with Ibutilide VanderLugt JT, Mattioni T, Denker S, Torchiana D, Ahern T, Wakefield LK, Perry KT, Kowey PR. Efficacy and safety of ibutilide fumarate for the conversion of atrial arrhythmias after cardiac surgery. Circulation 1999; 100: 369-375 EF 035

  9. ACT II – Serious Adverse Events(0-24 Hours) Source: ACT II study report Table 14.3.4.2.1 AE 011

  10. Prevalence and Timing of Bradycardia/Sinus Bradycardia AEs Occurring in First 24 HoursAll Patients Infusion Infusion AE 015

  11. Baseline Characteristics by Ejection FractionAll Phase 3 with EF collected AE 036 SCS Amendment Table 4.7

  12. Treatment-Induced Conversion of AF to Sinus Rhythm within 90 Minutes(Short-Duration AF)ACT I EF 098

  13. Treatment-Induced Conversion of AF to Sinus Rhythm within 90 Minutes(Short-Duration AF)ACT III EF 099

  14. Cumulative Benefit (>3h-≤7d)Pooled Primary Population EF 100

  15. Safety EventsAll Patients EF 101

  16. Safety EventsAll Patients EF 102

  17. Randomized but Did Not Receive Study DrugPooled Primary (ACT I and III) Studies • 31 patients randomized but not dosed • 4.4% Placebo Group (11/247) • Conversion to SR = 2.8% (7/247) • Did not meet I/E Criteria = 1.6% (4/247) • 5.6% Vernakalant Group (20/359) • Conversion to SR = 3.3% (12/359) • Did not meet I/E criteria = 1.7% (6/359) • Drug not available = 0.3% (1/359) • Not specified = 0.3% (1/359) AE 173

  18. Peri-infusional Hypotension AEsAll Patients Infusion Infusion AE 016

  19. Bradycardia and ConversionBetween 0-2 Hours Post-DoseAll Phase 3 Studies AE 153 3/11/2014 11:16 AM

  20. Bradycardia and Electrical CardioversionBetween 2-24 Hours Post-DoseAll Phase 3 Studies AE 154 3/11/2014 11:16 AM

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