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Pipeline Insight: Antiarrhythmics

RSD1235 in a class of its own

Publication Date   May 2006
Publisher   Datamonitor
Product Type   Strategic Report
Pages   160
ISBN Number   not applicable
Product Code   DAT495
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Price £6,495.00

approximately: $13,031 | €8,153

Summary


Introduction

Datamonitor believes that RSD1235 (iv) has the potential to have a significant impact on the treatment of atrial fibrillation. In addition, P&G's Stedicor and Sanofi-Aventis' Multaq also offer advances on current treatments, with improvements in efficacy and safety therein.

Highlights

  • 2005 saw sales in the antiarrhythmics drug market decline. With key problems of current antiarrhythmic drug therapy surrounding their pro-arrhythmic and toxic side effects, it may be sufficient for developmental compounds to demonstrate equivalent efficacy but superior safety profiles to gain market share from the current genericized treatments.
  • By 2015 the global antiarrhythmic market will be worth $3.5 billion, with sales of pipeline products accounting for over two thirds of the market by this time. RSD1235 (iv) is predicted to command 27% of the whole market by 2015 on the back of good trial data and the involvement of Astellas in the promotion of the product in the US.
  • P&G Pharma's Stedicor (azimilide) looks set to become the most successful orally active antiarrhythmic due to a combination of robust late-stage clinical trial data for Stedicor, particularly from the SHIELD (Shock Inhibition Evaluation with Azimilide) study, and lingering concerns over the relative safety of Sanofi-Aventis' Multaq (dronedarone).

Scope

  • Evaluation of patient potential for developmental antiarrhythmics over the period 2006-2015h3>
  • Scrutiny of key impacts on the R&D approach and cost, evaluation of optimal clinical trial end points and identification of suitable comparators
  • Evaluation of key players in the arrhthymics market and opposing company approaches to development and commercialization
  • Analysis of key antiarrhymic drugs in development and their ability to satisfy major unmet needs and compete with existing agents

Reasons to Purchase

  • Explore physician attitudes to the newer antiarrhythmic drugs, and the threats faced by existing and developmental products
  • Predict future market leaders using our independent sales forecasts for products in late stage development in both existing and novel classes
  • Identify early stage antiarrhythmic compounds with high potential being developed by companies seeking a marketing partner

Content


  • Chapter 1 Executive Summary
    • Scope of the analysis
    • Historical perspective of the antiarrhythmics market
    • Size of the antiarrhythmics market in 2005
    • Datamonitor insight into the antiarrhythmic market
    • At the end of 2005, sales within the antiarrhythmics drug market were in decline. With the main problems of current antiarrhythmic drug therapy surrounding their pro-arrhythmic and toxic side effects, it may be sufficient for developmental compounds to demonstrate equivalent efficacy but superior safety profiles to gain market share from the current genericized treatments.
    • By 2015 the global antiarrhythmic market will be worth $3.5 billion, with sales of pipeline products accounting for over two thirds of the market by this time. Cardiome's RSD1235 (intravenous formulation) is predicted to command 27% of the whole market by 2015 on the back of good safety and efficacy data, combined with the involvement of Japanese pharmaceutical giant, Astellas, in the sales and marketing of the product in the US.
    • Of the orally active antiarrhythmics currently vying for amiodarone's crown, P&G Pharmaceuticals' Stedicor (azimilide) looks set to win the battle with Sanofi-Aventis' next generation antiarrhythmic Multaq (dronedarone), due to a combination of robust late-stage clinical trial data for Stedicor, particularly from the SHIELD (Shock Inhibition Evaluation with Azimilide) study, and lingering concerns over the relative safety of Multaq.
    • Summary
    • Key metrics
  • Chapter 2 Patient Potential
    • Normal heart electrical activity
    • What do we mean by the term arrhythmia?
    • Bradycardia
    • Tachycardia
    • Supraventricular tachycardias (SVTs)
    • Ventricular tachycardias
    • Other arrhythmias originating in the atria
    • Premature supraventricular contraction or premature atrial contraction (PAC)
    • Other arrhythmias originating in the ventricle
    • Premature ventricular contraction (PVC)
    • Pathophysiology of cardiac arrhythmia
    • Normal cardiac electrical activity vs irregularity
    • Non-nodal/fast response action potentials
    • Nodal/pacemaker action potentials
    • Epidemiology of atrial fibrillation
    • Future trends in the incidence and prevalence of AF
    • Methodology
    • Unmet needs in arrhythmia
    • Decreased mortality
    • Improved safety
    • Improved quality of life (QoL)
    • Improved treatment options for patients with underlying co-morbid conditions
    • Other unmet needs
    • The ideal anti-AF drug!
  • Chapter 3 Pipeline Overview
    • Pipeline overview
    • Breakdown by development stage
    • Breakdown by company
    • Breakdown by mechanism
  • Chapter 4 R&d Approach
    • Principles of antiarrhythmic pharmacotherapy
    • Classification of current antiarrhythmics
    • Class I antiarrhythmics
    • Class II antiarrhythmics
    • Class III antiarrhythmics
    • Class IV antiarrhythmics
    • Classification of pipeline products
    • Novel targets for the treatment of cardiac arrhythmias
    • Potassium channel blockers
    • Sodium channel blockers
    • Adenosine A1 receptor agonists
    • Clinical trial design in arrhythmia
    • Comparator therapy
    • There is no single gold standard therapy
    • Chronic trials
    • In-hospital trials
    • Clinical trial endpoints in arrhythmia
    • Mortality rates
    • Efficacy
    • Chronic trials
    • In-hospital trials
    • Safety data
    • Cost efficacy
    • Patient numbers
    • Chronic trials
    • In-hospital trials
    • Trial length
    • Starting points
    • Patient selection
    • Hybrid therapy trials
  • Chapter 5 Class Iii Oral Antiarrhythmics Late-Stage Drug Analysis & Forecasts
    • Definition of current comparator therapies
    • Cordarone (amiodarone)
    • Indications
    • Side effects
    • Amiodarone's efficacy
    • Conclusion
    • Multaq (dronedarone; SR-33589)
    • Drug overview
    • Clinical trial data
    • Datamonitor comments
    • Patient potential
    • Marketing factors
    • SWOT analysis of dronedarone
    • Performance against benchmark criteria
    • Forecasts to 2015
    • Stedicor (azimilide)
    • Drug overview
    • Clinical trial data
    • ASAP
    • ALIVE
    • SHIELD
    • Ongoing Trials
    • A-STAR (Azimilide supraventricular Tachyarrhythmia reduction)
    • A-COMET I and II (The azimilide cardioversion maintenance trials)
    • Patient potential
    • Azimilide in the ICD population
    • Azimilide in the AF population
    • Marketing factors
    • SWOT analysis
    • Performance against benchmark criteria
    • Forecast to 2015
  • Chapter 6 Class Iii Intravenous Antiarryhthmic Late-Stage Drug Analysis & Forecasts
    • Definition of current comparator therapies
    • Corvert (ibutilide)
    • Conclusion
    • RSD1235 (intravenous formulation)
    • Drug overview
    • Development history
    • Clinical trial data
    • Phase I
    • Phase II
    • Phase III
    • Ongoing trials
    • Patient potential
    • Marketing Factors
    • Performance against benchmark criteria
    • SWOT analysis
    • Forecast to 2015
    • Pulzium (tedisamil)
    • Drug overview
    • Clinical trial data
    • Phase I
    • Phase II
    • Phase III
    • Patient potential
    • Marketing Factors
    • Performance against benchmark criteria
    • SWOT analysis: Tedisamil compared to Flecainide
    • Forecast to 2015
  • Chapter 7 Adenosine Receptor Agonist Late-Stage Drug Analysis & Forecasts
    • Definition of current comparator therapies
    • Adenosine
    • Tecadenoson (CVT-510)
    • Drug overview
    • Clinical trial data
    • Phase III
    • Patient potential
    • Marketing factors
    • Performance against benchmark criteria
    • SWOT analysis
    • Forecast to 2015
  • Chapter 8 Other Pipeline Antiarrhythmics
    • Phase II compounds
    • AVE-0118
    • Drug overview
    • Preclinical data
    • Phase II trials
    • AZD-7009
    • Drug overview
    • Phase I trials
    • Nibentan
    • Drug overview
    • Preclinical data
    • RSD1235 Oral
    • Drug overview
    • Phase I trials
    • Phase II trials
    • Selodenoson IV
    • Drug overview
    • Phase II trials
    • Preclinical data
    • Phase I trials
    • SSR-149744
    • Preclinical studies
    • Clinical trials
    • Phase I compounds
    • AVE-1231
    • PJ-875
    • Selodenoson (oral controlled release)
  • Chapter 9 Comparative Analysis Of Antiarrhythmic Pipeline
    • Comparative forecasts
    • Comparative analysis
  • Appendix A
    • Methodology
    • Datamonitor forecast methodology.
    • Epidemiology forecasts
    • Product forecasts
    • Datamonitor drug assessment summary
    • Contributing experts
    • References
    • Report methodology
  • Appendix B
    • About Datamonitor
    • About Datamonitor Healthcare
    • Datamonitor Healthcare's therapy area capabilities
    • About the cardiovascular analysis team
    • Key therapy team members
    • Dr Allison Fleetwood, Director, Cardiovascular, Diabetes and Women's Health
    • Dr Duncan Emerton, Senior Analyst, Cardiovascular (report contact)
    • Disclaimer