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Ranexa ranolazine Extended Release Tablets

CI-2. RanexaTM (ranolazine) A Unique Anti-Anginal Pharmacodynamic Profile. Anti-anginal and anti-ischemic efficacy demonstratedNovel pharmacodynamic profile: anti-ischemic properties do not depend on changes inHeart rateBlood pressureComplementary therapy to existing agents that depend on hemody

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Ranexa ranolazine Extended Release Tablets

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    1. Ranexa™ (ranolazine) Extended Release Tablets Michael Sweeney, MD, FRCP VP, Medical Affairs CV Therapeutics, Inc.

    2. CI-2 RanexaTM (ranolazine) A Unique Anti-Anginal Pharmacodynamic Profile Anti-anginal and anti-ischemic efficacy demonstrated Novel pharmacodynamic profile: anti-ischemic properties do not depend on changes in Heart rate Blood pressure Complementary therapy to existing agents that depend on hemodynamic mechanisms

    3. CI-3 Ranexa™ (ranolazine) Proposed Indication and Dosing The sponsor seeks approval of Ranexa for the Treatment of chronic angina in patients with severe coronary artery disease Usual starting dose 500 mg bid, with upward titration to 750 mg and 1000 mg bid as needed

    4. CI-4 Benefit-Risk Benefit Anti-anginal and anti-ischemic efficacy Achieved with minimal hemodynamic effects Well tolerated Risk Adverse events Theoretical risk of TdP due to prolongation of QTc

    5. CI-5 Ranexa™ (ranolazine)— Effects on Ventricular Repolarization Extensively studied clinical and preclinical EP profile Small, dose-related mean increases in QTc 2 to 5 msec over proposed dose range Up to 20 msec under maximal inhibition of CYP3A4 Ranolazine and preclinical markers of torsadogenic risk No early afterdepolarizations (EADs) No increased dispersion of ventricular repolarization Reverses these effects when caused by other drugs No case of TdP in clinical development

    6. CI-6 Ranexa™ (ranolazine) for Chronic Angina—Sponsor Presentation

    7. CI-7 Advisors and Consultants (1)

    8. CI-8 Advisors and Consultants (2)

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